conducting a research project on

Illustration by James Round

How to plan a research project

Whether for a paper or a thesis, define your question, review the work of others – and leave yourself open to discovery.

by Brooke Harrington   + BIO

is professor of sociology at Dartmouth College in New Hampshire. Her research has won international awards both for scholarly quality and impact on public life. She has published dozens of articles and three books, most recently the bestseller Capital without Borders (2016), now translated into five languages.

Edited by Sam Haselby

Need to know

‘When curiosity turns to serious matters, it’s called research.’ – From Aphorisms (1880-1905) by Marie von Ebner-Eschenbach

Planning research projects is a time-honoured intellectual exercise: one that requires both creativity and sharp analytical skills. The purpose of this Guide is to make the process systematic and easy to understand. While there is a great deal of freedom and discovery involved – from the topics you choose, to the data and methods you apply – there are also some norms and constraints that obtain, no matter what your academic level or field of study. For those in high school through to doctoral students, and from art history to archaeology, research planning involves broadly similar steps, including: formulating a question, developing an argument or predictions based on previous research, then selecting the information needed to answer your question.

Some of this might sound self-evident but, as you’ll find, research requires a different way of approaching and using information than most of us are accustomed to in everyday life. That is why I include orienting yourself to knowledge-creation as an initial step in the process. This is a crucial and underappreciated phase in education, akin to making the transition from salaried employment to entrepreneurship: suddenly, you’re on your own, and that requires a new way of thinking about your work.

What follows is a distillation of what I’ve learned about this process over 27 years as a professional social scientist. It reflects the skills that my own professors imparted in the sociology doctoral programme at Harvard, as well as what I learned later on as a research supervisor for Ivy League PhD and MA students, and then as the author of award-winning scholarly books and articles. It can be adapted to the demands of both short projects (such as course term papers) and long ones, such as a thesis.

At its simplest, research planning involves the four distinct steps outlined below: orienting yourself to knowledge-creation; defining your research question; reviewing previous research on your question; and then choosing relevant data to formulate your own answers. Because the focus of this Guide is on planning a research project, as opposed to conducting a research project, this section won’t delve into the details of data-collection or analysis; those steps happen after you plan the project. In addition, the topic is vast: year-long doctoral courses are devoted to data and analysis. Instead, the fourth part of this section will outline some basic strategies you could use in planning a data-selection and analysis process appropriate to your research question.

Step 1: Orient yourself

Planning and conducting research requires you to make a transition, from thinking like a consumer of information to thinking like a producer of information. That sounds simple, but it’s actually a complex task. As a practical matter, this means putting aside the mindset of a student, which treats knowledge as something created by other people. As students, we are often passive receivers of knowledge: asked to do a specified set of readings, then graded on how well we reproduce what we’ve read.

Researchers, however, must take on an active role as knowledge producers . Doing research requires more of you than reading and absorbing what other people have written: you have to engage in a dialogue with it. That includes arguing with previous knowledge and perhaps trying to show that ideas we have accepted as given are actually wrong or incomplete. For example, rather than simply taking in the claims of an author you read, you’ll need to draw out the implications of those claims: if what the author is saying is true, what else does that suggest must be true? What predictions could you make based on the author’s claims?

In other words, rather than treating a reading as a source of truth – even if it comes from a revered source, such as Plato or Marie Curie – this orientation step asks you to treat the claims you read as provisional and subject to interrogation. That is one of the great pieces of wisdom that science and philosophy can teach us: that the biggest advances in human understanding have been made not by being correct about trivial things, but by being wrong in an interesting way . For example, Albert Einstein was wrong about quantum mechanics, but his arguments about it with his fellow physicist Niels Bohr have led to some of the biggest breakthroughs in science, even a century later.

Step 2: Define your research question

Students often give this step cursory attention, but experienced researchers know that formulating a good question is sometimes the most difficult part of the research planning process. That is because the precise language of the question frames the rest of the project. It’s therefore important to pose the question carefully, in a way that’s both possible to answer and likely to yield interesting results. Of course, you must choose a question that interests you, but that’s only the beginning of what’s likely to be an iterative process: most researchers come back to this step repeatedly, modifying their questions in light of previous research, resource limitations and other considerations.

Researchers face limits in terms of time and money. They, like everyone else, have to pose research questions that they can plausibly answer given the constraints they face. For example, it would be inadvisable to frame a project around the question ‘What are the roots of the Arab-Israeli conflict?’ if you have only a week to develop an answer and no background on that topic. That’s not to limit your imagination: you can come up with any question you’d like. But it typically does require some creativity to frame a question that you can answer well – that is, by investigating thoroughly and providing new insights – within the limits you face.

In addition to being interesting to you, and feasible within your resource constraints, the third and most important characteristic of a ‘good’ research topic is whether it allows you to create new knowledge. It might turn out that your question has already been asked and answered to your satisfaction: if so, you’ll find out in the next step of this process. On the other hand, you might come up with a research question that hasn’t been addressed previously. Before you get too excited about breaking uncharted ground, consider this: a lot of potentially researchable questions haven’t been studied for good reason ; they might have answers that are trivial or of very limited interest. This could include questions such as ‘Why does the area of a circle equal π r²?’ or ‘Did winter conditions affect Napoleon’s plans to invade Russia?’ Of course, you might be able to make the argument that a seemingly trivial question is actually vitally important, but you must be prepared to back that up with convincing evidence. The exercise in the ‘Learn More’ section below will help you think through some of these issues.

Finally, scholarly research questions must in some way lead to new and distinctive insights. For example, lots of people have studied gender roles in sports teams; what can you ask that hasn’t been asked before? Reinventing the wheel is the number-one no-no in this endeavour. That’s why the next step is so important: reviewing previous research on your topic. Depending on what you find in that step, you might need to revise your research question; iterating between your question and the existing literature is a normal process. But don’t worry: it doesn’t go on forever. In fact, the iterations taper off – and your research question stabilises – as you develop a firm grasp of the current state of knowledge on your topic.

Step 3: Review previous research

In academic research, from articles to books, it’s common to find a section called a ‘literature review’. The purpose of that section is to describe the state of the art in knowledge on the research question that a project has posed. It demonstrates that researchers have thoroughly and systematically reviewed the relevant findings of previous studies on their topic, and that they have something novel to contribute.

Your own research project should include something like this, even if it’s a high-school term paper. In the research planning process, you’ll want to list at least half a dozen bullet points stating the major findings on your topic by other people. In relation to those findings, you should be able to specify where your project could provide new and necessary insights. There are two basic rhetorical positions one can take in framing the novelty-plus-importance argument required of academic research:

• Position 1 requires you to build on or extend a set of existing ideas; that means saying something like: ‘Person A has argued that X is true about gender; this implies Y, which has not yet been tested. My project will test Y, and if I find evidence to support it, that will change the way we understand gender.’
• Position 2 is to argue that there is a gap in existing knowledge, either because previous research has reached conflicting conclusions or has failed to consider something important. For example, one could say that research on middle schoolers and gender has been limited by being conducted primarily in coeducational environments, and that findings might differ dramatically if research were conducted in more schools where the student body was all-male or all-female.

Your overall goal in this step of the process is to show that your research will be part of a larger conversation: that is, how your project flows from what’s already known, and how it advances, extends or challenges that existing body of knowledge. That will be the contribution of your project, and it constitutes the motivation for your research.

Two things are worth mentioning about your search for sources of relevant previous research. First, you needn’t look only at studies on your precise topic. For example, if you want to study gender-identity formation in schools, you shouldn’t restrict yourself to studies of schools; the empirical setting (schools) is secondary to the larger social process that interests you (how people form gender identity). That process occurs in many different settings, so cast a wide net. Second, be sure to use legitimate sources – meaning publications that have been through some sort of vetting process, whether that involves peer review (as with academic journal articles you might find via Google Scholar) or editorial review (as you’d find in well-known mass media publications, such as The Economist or The Washington Post ). What you’ll want to avoid is using unvetted sources such as personal blogs or Wikipedia. Why? Because anybody can write anything in those forums, and there is no way to know – unless you’re already an expert – if the claims you find there are accurate. Often, they’re not.

Step 4: Choose your data and methods

Whatever your research question is, eventually you’ll need to consider which data source and analytical strategy are most likely to provide the answers you’re seeking. One starting point is to consider whether your question would be best addressed by qualitative data (such as interviews, observations or historical records), quantitative data (such as surveys or census records) or some combination of both. Your ideas about data sources will, in turn, suggest options for analytical methods.

You might need to collect your own data, or you might find everything you need readily available in an existing dataset someone else has created. A great place to start is with a research librarian: university libraries always have them and, at public universities, those librarians can work with the public, including people who aren’t affiliated with the university. If you don’t happen to have a public university and its library close at hand, an ordinary public library can still be a good place to start: the librarians are often well versed in accessing data sources that might be relevant to your study, such as the census, or historical archives, or the Survey of Consumer Finances.

Because your task at this point is to plan research, rather than conduct it, the purpose of this step is not to commit you irrevocably to a course of action. Instead, your goal here is to think through a feasible approach to answering your research question. You’ll need to find out, for example, whether the data you want exist; if not, do you have a realistic chance of gathering the data yourself, or would it be better to modify your research question? In terms of analysis, would your strategy require you to apply statistical methods? If so, do you have those skills? If not, do you have time to learn them, or money to hire a research assistant to run the analysis for you?

Please be aware that qualitative methods in particular are not the casual undertaking they might appear to be. Many people make the mistake of thinking that only quantitative data and methods are scientific and systematic, while qualitative methods are just a fancy way of saying: ‘I talked to some people, read some old newspapers, and drew my own conclusions.’ Nothing could be further from the truth. In the final section of this guide, you’ll find some links to resources that will provide more insight on standards and procedures governing qualitative research, but suffice it to say: there are rules about what constitutes legitimate evidence and valid analytical procedure for qualitative data, just as there are for quantitative data.

Circle back and consider revising your initial plans

As you work through these four steps in planning your project, it’s perfectly normal to circle back and revise. Research planning is rarely a linear process. It’s also common for new and unexpected avenues to suggest themselves. As the sociologist Thorstein Veblen wrote in 1908 : ‘The outcome of any serious research can only be to make two questions grow where only one grew before.’ That’s as true of research planning as it is of a completed project. Try to enjoy the horizons that open up for you in this process, rather than becoming overwhelmed; the four steps, along with the two exercises that follow, will help you focus your plan and make it manageable.

Key points – How to plan a research project

• Planning a research project is essential no matter your academic level or field of study. There is no one ‘best’ way to design research, but there are certain guidelines that can be helpfully applied across disciplines.
• Orient yourself to knowledge-creation. Make the shift from being a consumer of information to being a producer of information.
• Define your research question. Your question frames the rest of your project, sets the scope, and determines the kinds of answers you can find.
• Review previous research on your question. Survey the existing body of relevant knowledge to ensure that your research will be part of a larger conversation.
• Choose your data and methods. For instance, will you be collecting qualitative data, via interviews, or numerical data, via surveys?
• Circle back and consider revising your initial plans. Expect your research question in particular to undergo multiple rounds of refinement as you learn more about your topic.

Good research questions tend to beget more questions. This can be frustrating for those who want to get down to business right away. Try to make room for the unexpected: this is usually how knowledge advances. Many of the most significant discoveries in human history have been made by people who were looking for something else entirely. There are ways to structure your research planning process without over-constraining yourself; the two exercises below are a start, and you can find further methods in the Links and Books section.

The following exercise provides a structured process for advancing your research project planning. After completing it, you’ll be able to do the following:

• describe clearly and concisely the question you’ve chosen to study
• summarise the state of the art in knowledge about the question, and where your project could contribute new insight
• identify the best strategy for gathering and analysing relevant data

In other words, the following provides a systematic means to establish the building blocks of your research project.

Exercise 1: Definition of research question and sources

This exercise prompts you to select and clarify your general interest area, develop a research question, and investigate sources of information. The annotated bibliography will also help you refine your research question so that you can begin the second assignment, a description of the phenomenon you wish to study.

Jot down a few bullet points in response to these two questions, with the understanding that you’ll probably go back and modify your answers as you begin reading other studies relevant to your topic:

• What will be the general topic of your paper?
• What will be the specific topic of your paper?

b) Research question(s)

Use the following guidelines to frame a research question – or questions – that will drive your analysis. As with Part 1 above, you’ll probably find it necessary to change or refine your research question(s) as you complete future assignments.

• Your question should be phrased so that it can’t be answered with a simple ‘yes’ or ‘no’.
• Your question should have more than one plausible answer.
• Your question should draw relationships between two or more concepts; framing the question in terms of How? or What? often works better than asking Why ?

c) Annotated bibliography

Most or all of your background information should come from two sources: scholarly books and journals, or reputable mass media sources. You might be able to access journal articles electronically through your library, using search engines such as JSTOR and Google Scholar. This can save you a great deal of time compared with going to the library in person to search periodicals. General news sources, such as those accessible through LexisNexis, are acceptable, but should be cited sparingly, since they don’t carry the same level of credibility as scholarly sources. As discussed above, unvetted sources such as blogs and Wikipedia should be avoided, because the quality of the information they provide is unreliable and often misleading.

To create an annotated bibliography, provide the following information for at least 10 sources relevant to your specific topic, using the format suggested below.

Name of author(s):

Publication date:

Title of book, chapter, or article:

If a chapter or article, title of journal or book where they appear:

Brief description of this work, including main findings and methods ( c 75 words):

Summary of how this work contributes to your project ( c 75 words):

Brief description of the implications of this work ( c 25 words):

Identify any gap or controversy in knowledge this work points up, and how your project could address those problems ( c 50 words):

Exercise 2: Towards an analysis

Develop a short statement ( c 250 words) about the kind of data that would be useful to address your research question, and how you’d analyse it. Some questions to consider in writing this statement include:

• What are the central concepts or variables in your project? Offer a brief definition of each.
• Do any data sources exist on those concepts or variables, or would you need to collect data?
• Of the analytical strategies you could apply to that data, which would be the most appropriate to answer your question? Which would be the most feasible for you? Consider at least two methods, noting their advantages or disadvantages for your project.

Links & books

One of the best texts ever written about planning and executing research comes from a source that might be unexpected: a 60-year-old work on urban planning by a self-trained scholar. The classic book The Death and Life of Great American Cities (1961) by Jane Jacobs (available complete and free of charge via this link ) is worth reading in its entirety just for the pleasure of it. But the final 20 pages – a concluding chapter titled ‘The Kind of Problem a City Is’ – are really about the process of thinking through and investigating a problem. Highly recommended as a window into the craft of research.

Jacobs’s text references an essay on advancing human knowledge by the mathematician Warren Weaver. At the time, Weaver was director of the Rockefeller Foundation, in charge of funding basic research in the natural and medical sciences. Although the essay is titled ‘A Quarter Century in the Natural Sciences’ (1960) and appears at first blush to be merely a summation of one man’s career, it turns out to be something much bigger and more interesting: a meditation on the history of human beings seeking answers to big questions about the world. Weaver goes back to the 17th century to trace the origins of systematic research thinking, with enthusiasm and vivid anecdotes that make the process come alive. The essay is worth reading in its entirety, and is available free of charge via this link .

For those seeking a more in-depth, professional-level discussion of the logic of research design, the political scientist Harvey Starr provides insight in a compact format in the article ‘Cumulation from Proper Specification: Theory, Logic, Research Design, and “Nice” Laws’ (2005). Starr reviews the ‘research triad’, consisting of the interlinked considerations of formulating a question, selecting relevant theories and applying appropriate methods. The full text of the article, published in the scholarly journal Conflict Management and Peace Science , is available, free of charge, via this link .

Finally, the book Getting What You Came For (1992) by Robert Peters is not only an outstanding guide for anyone contemplating graduate school – from the application process onward – but it also includes several excellent chapters on planning and executing research, applicable across a wide variety of subject areas. It was an invaluable resource for me 25 years ago, and it remains in print with good reason; I recommend it to all my students, particularly Chapter 16 (‘The Thesis Topic: Finding It’), Chapter 17 (‘The Thesis Proposal’) and Chapter 18 (‘The Thesis: Writing It’).

How to use ‘possibility thinking’

Have you hit an impasse in your personal or professional life? Answer these questions to open your mind to what’s possible

by Constance de Saint Laurent & Vlad Glăveanu

The nature of reality

How to think about time

This philosopher’s introduction to the nature of time could radically alter how you see your past and imagine your future

by Graeme A Forbes

Cognitive and behavioural therapies

How to stop living on auto-pilot

Are you going through the motions? Use these therapy techniques to set meaningful goals and build a ‘life worth living’

by Kiki Fehling

• Skip to main content
• Skip to primary sidebar
• Skip to footer
• QuestionPro

• Solutions Industries Gaming Automotive Sports and events Education Government Travel & Hospitality Financial Services Healthcare Cannabis Technology Use Case NPS+ Communities Audience Contactless surveys Mobile LivePolls Member Experience GDPR Positive People Science 360 Feedback Surveys
• Resources Blog eBooks Survey Templates Case Studies Training Help center

Home Market Research Research Tools and Apps

Research Process Steps: What they are + How To Follow

There are various approaches to conducting basic and applied research. This article explains the research process steps you should know. Whether you are doing basic research or applied research, there are many ways of doing it. In some ways, each research study is unique since it is conducted at a different time and place.

Conducting research might be difficult, but there are clear processes to follow. The research process starts with a broad idea for a topic. This article will assist you through the research process steps, helping you focus and develop your topic.

Research Process Steps

The research process consists of a series of systematic procedures that a researcher must go through in order to generate knowledge that will be considered valuable by the project and focus on the relevant topic.

To conduct effective research, you must understand the research process steps and follow them. Here are a few steps in the research process to make it easier for you:

Step 1: Identify the Problem

Finding an issue or formulating a research question is the first step. A well-defined research problem will guide the researcher through all stages of the research process, from setting objectives to choosing a technique. There are a number of approaches to get insight into a topic and gain a better understanding of it. Such as:

• A preliminary survey
• Case studies
• Interviews with a small group of people
• Observational survey

Step 2: Evaluate the Literature

A thorough examination of the relevant studies is essential to the research process . It enables the researcher to identify the precise aspects of the problem. Once a problem has been found, the investigator or researcher needs to find out more about it.

This stage gives problem-zone background. It teaches the investigator about previous research, how they were conducted, and its conclusions. The researcher can build consistency between his work and others through a literature review. Such a review exposes the researcher to a more significant body of knowledge and helps him follow the research process efficiently.

Step 3: Create Hypotheses

Formulating an original hypothesis is the next logical step after narrowing down the research topic and defining it. A belief solves logical relationships between variables. In order to establish a hypothesis, a researcher must have a certain amount of expertise in the field. 

It is important for researchers to keep in mind while formulating a hypothesis that it must be based on the research topic. Researchers are able to concentrate their efforts and stay committed to their objectives when they develop theories to guide their work.

Step 4: The Research Design

Research design is the plan for achieving objectives and answering research questions. It outlines how to get the relevant information. Its goal is to design research to test hypotheses, address the research questions, and provide decision-making insights.

The research design aims to minimize the time, money, and effort required to acquire meaningful evidence. This plan fits into four categories:

• Exploration and Surveys
• Data Analysis
• Observation

Step 5: Describe Population

Research projects usually look at a specific group of people, facilities, or how technology is used in the business. In research, the term population refers to this study group. The research topic and purpose help determine the study group.

Suppose a researcher wishes to investigate a certain group of people in the community. In that case, the research could target a specific age group, males or females, a geographic location, or an ethnic group. A final step in a study’s design is to specify its sample or population so that the results may be generalized.

Step 6: Data Collection

Data collection is important in obtaining the knowledge or information required to answer the research issue. Every research collected data, either from the literature or the people being studied. Data must be collected from the two categories of researchers. These sources may provide primary data.

• Questionnaire

Secondary data categories are:

• Literature survey
• Official, unofficial reports
• An approach based on library resources

Step 7: Data Analysis

During research design, the researcher plans data analysis. After collecting data, the researcher analyzes it. The data is examined based on the approach in this step. The research findings are reviewed and reported.

Data analysis involves a number of closely related stages, such as setting up categories, applying these categories to raw data through coding and tabulation, and then drawing statistical conclusions. The researcher can examine the acquired data using a variety of statistical methods.

Step 8: The Report-writing

After completing these steps, the researcher must prepare a report detailing his findings. The report must be carefully composed with the following in mind:

• The Layout: On the first page, the title, date, acknowledgments, and preface should be on the report. A table of contents should be followed by a list of tables, graphs, and charts if any.
• Introduction: It should state the research’s purpose and methods. This section should include the study’s scope and limits.
• Summary of Findings: A non-technical summary of findings and recommendations will follow the introduction. The findings should be summarized if they’re lengthy.
• Principal Report: The main body of the report should make sense and be broken up into sections that are easy to understand.
• Conclusion: The researcher should restate his findings at the end of the main text. It’s the final result.

LEARN ABOUT: 12 Best Tools for Researchers

The research process involves several steps that make it easy to complete the research successfully. The steps in the research process described above depend on each other, and the order must be kept. So, if we want to do a research project, we should follow the research process steps.

QuestionPro’s enterprise-grade research platform can collect survey and qualitative observation data. The tool’s nature allows for data processing and essential decisions. The platform lets you store and process data. Start immediately!

LEARN MORE         FREE TRIAL

MORE LIKE THIS

Employee Lifecycle Management Software: Top of 2024

Apr 15, 2024

Top 15 Sentiment Analysis Software That Should Be on Your List

Top 13 A/B Testing Software for Optimizing Your Website

Apr 12, 2024

21 Best Contact Center Experience Software in 2024

Other categories.

• Academic Research
• Artificial Intelligence
• Assessments
• Brand Awareness
• Case Studies
• Communities
• Consumer Insights
• Customer effort score
• Customer Engagement
• Customer Experience
• Customer Loyalty
• Customer Research
• Customer Satisfaction
• Employee Benefits
• Employee Engagement
• Employee Retention
• Friday Five
• General Data Protection Regulation
• Insights Hub
• Life@QuestionPro
• Market Research
• Mobile diaries
• Mobile Surveys
• New Features
• Online Communities
• Question Types
• QuestionPro Products
• Release Notes
• Research Tools and Apps
• Revenue at Risk
• Survey Templates
• Training Tips
• Uncategorized
• Video Learning Series
• What’s Coming Up
• Workforce Intelligence

WashU Libraries

Conducting research, the research process.

• Step 1: Exploring an idea
• Step 2: Finding background info.
• Step 3: Gathering more info.
• Get it This link opens in a new window
• Step 5: Evaluating your sources
• Step 6: Citing your sources
• FAQs This link opens in a new window
• Library Vocabulary
• Research in the Humanities
• Research in the Social Sciences
• Research in the Sciences

Step 1: Exploring Your Research Idea and Constructing Your Search

If you know you are interested in doing research in a broad subject area, try to think of ways you can make your subject more specific. One way is by stating your topic as a question. For example, if you are interested in writing about sleep disorders you might ask yourself the following question: Can sleep disorders affect academic success in college students? If you don't have enough information to express your topic idea as a specific question, do some background reading first.

Step 2:  Finding Background Information

Consult general reference sources, e.g., an encyclopedia, before jumping into more specialized and specific searches. Encyclopedias provide information on key concepts, context, and vocabulary for many different fields. Subject-specific encyclopedias will provide additional information that may lead to ideas for additional search terms.

Step 3:  Gathering More Information

Use the search terms/keywords you brainstormed in Step 1: Exploring your Research Idea to search the Classic Catalog . Note where the item is located in the library and the circulation status. When you find a good book, scan the bibliography for additional sources. Look for book-length bibliographies, literature reviews, and annual reviews in your research area; this type of resource lists hundreds of books and articles in one subject area. To find these resources, use your keywords/search terms followed by the word "AND bibliographies" in the Classic Catalog .

Step 4:  Locating Current Research

Journal articles are a great resource for learning about cutting-edge research in your area. Indexes and databases allow you to search across many journal publishers at once to find citations, abstracts, and full-text to articles.

Step 5:  Evaluating Your Sources

As you search and find citations and/or abstracts for specific books, articles, or websites, consider the following established criteria for evaluating the quality of books, journal articles, and websites.

Step 6:  Cite What You Find in Discipline-Appropriate Format

When conducting research, it’s necessary to document sources you use; commonly, this is called citing your sources. Citing your sources is an important part of research and scholarship; it is important to give credit to the ideas of others. In addition, readers of your work may want to find and read some of the sources you used. Different academic disciplines follow different citation styles. Two of the more common citation styles are APA or MLA. Failing to cite properly is plagiarism. For further details on other aspects of plagiarism, consult WU’s Academic Integrity Policy .

• Research Tips
• Responsible and Efficient Literature Searching
• Next: Step 1: Exploring an idea >>
• Last Updated: Apr 11, 2024 3:23 PM
• URL: https://libguides.wustl.edu/research

Key Steps in the Research Process - A Comprehensive Guide

Embarking on a research journey can be both thrilling and challenging. Whether you're a student, journalist, or simply inquisitive about a subject, grasping the research process steps is vital for conducting thorough and efficient research. In this all-encompassing guide, we'll navigate you through the pivotal stages of what is the research process, from pinpointing your topic to showcasing your discoveries.

We'll delve into how to formulate a robust research question, undertake preliminary research, and devise a structured research plan. You'll acquire strategies for gathering and scrutinizing data, along with advice for effectively disseminating your findings. By adhering to these steps in the research process, you'll be fully prepared to confront any research endeavor that presents itself.

Step 1: Identify and Develop Your Topic

Identifying and cultivating a research topic is the foundational first step in the research process. Kick off by brainstorming potential subjects that captivate your interest, as this will fuel your enthusiasm throughout the endeavor. 

Employ the following tactics to spark ideas and understand what is the first step in the research process:

• Review course materials, lecture notes, and assigned readings for inspiration
• Engage in discussions with peers, professors, or experts in the field
• Investigate current events, news pieces, or social media trends pertinent to your field of study to uncover valuable market research insights.
• Reflect on personal experiences or observations that have sparked your curiosity

Once you've compiled a roster of possible topics, engage in preliminary research to evaluate the viability and breadth of each concept. This initial probe may encompass various research steps and procedures to ensure a comprehensive understanding of the topics at hand.

• Scanning Wikipedia articles or other general reference sources for an overview
• Searching for scholarly articles, books, or media related to your topic
• Identifying key concepts, theories, or debates within the field
• Considering the availability of primary sources or data for analysis

While amassing background knowledge, begin to concentrate your focus and hone your topic. Target a subject that is specific enough to be feasible within your project's limits, yet expansive enough to permit substantial analysis. Mull over the following inquiries to steer your topic refinement and address the research problem effectively:

• What aspect of the topic am I most interested in exploring?
• What questions or problems related to this topic remain unanswered or unresolved?
• How can I contribute new insights or perspectives to the existing body of knowledge?
• What resources and methods will I need to investigate this topic effectively?

Step 2: Conduct Preliminary Research

Having pinpointed a promising research topic, it's time to plunge into preliminary research. This essential phase enables you to deepen your grasp of the subject and evaluate the practicality of your project. Here are some pivotal tactics for executing effective preliminary research using various library resources:

• Literature Review

To effectively embark on your scholarly journey, it's essential to consult a broad spectrum of sources, thereby enriching your understanding with the breadth of academic research available on your topic. This exploration may encompass a variety of materials.

• Online catalogs of libraries (local, regional, national, and special)
• Meta-catalogs and subject-specific online article databases
• Digital institutional repositories and open access resources
• Works cited in scholarly books and articles
• Print bibliographies and internet sources
• Websites of major nonprofit organizations, research institutes, museums, universities, and government agencies
• Trade and scholarly publishers
• Discussions with fellow scholars and peers
• Identify Key Debates

Engaging with the wealth of recently published materials and seminal works in your field is a pivotal part of the research process definition. Focus on discerning the core ideas, debates, and arguments that define your topic, which will in turn sharpen your research focus and guide you toward formulating pertinent research questions.

• Narrow Your Focus

Hone your topic by leveraging your initial findings to tackle a specific issue or facet within the larger subject, a fundamental step in the research process steps. Consider various factors that could influence the direction and scope of your inquiry.

• Subtopics and specific issues
• Key debates and controversies
• Timeframes and geographical locations
• Organizations or groups of people involved

A thorough evaluation of existing literature and a comprehensive assessment of the information at hand will pinpoint the exact dimensions of the issue you aim to explore. This methodology ensures alignment with prior research, optimizes resources, and can bolster your case when seeking research funding by demonstrating a well-founded approach.

Step 3: Establish Your Research Question

Having completed your preliminary research and topic refinement, the next vital phase involves formulating a precise and focused research question. This question, a cornerstone among research process steps, will steer your investigation, keeping it aligned with relevant data and insights. When devising your research question, take into account these critical factors:

Initiate your inquiry by defining the requirements and goals of your study, a key step in the research process steps. Whether you're testing a hypothesis, analyzing data, or constructing and supporting an argument, grasping the intent of your research is crucial for framing your question effectively.

Ensure that your research question is feasible, given your constraints in time and word count, an important consideration in the research process steps. Steer clear of questions that are either too expansive or too constricted, as they may impede your capacity to conduct a comprehensive analysis.

Your research question should transcend a mere 'yes' or 'no' response, prompting a thorough engagement with the research process steps. It should foster a comprehensive exploration of the topic, facilitating the analysis of issues or problems beyond just a basic description.

• Researchability

Ensure that your research question opens the door to quality research materials, including academic books and refereed journal articles. It's essential to weigh the accessibility of primary data and secondary data that will bolster your investigative efforts.

When establishing your research question, take the following steps:

• Identify the specific aspect of your general topic that you want to explore
• Hypothesize the path your answer might take, developing a hypothesis after formulating the question
• Steer clear of certain types of questions in your research process steps, such as those that are deceptively simple, fictional, stacked, semantic, impossible-to-answer, opinion or ethical, and anachronistic, to maintain the integrity of your inquiry.
• Conduct a self-test on your research question to confirm it adheres to the research process steps, ensuring it is flexible, testable, clear, precise, and underscores a distinct reason for its importance.

By meticulously formulating your research question, you're establishing a solid groundwork for the subsequent research process steps, guaranteeing that your efforts are directed, efficient, and yield productive outcomes.

Step 4: Develop a Research Plan

Having formulated a precise research question, the ensuing phase involves developing a detailed research plan. This plan, integral to the research process steps, acts as a navigational guide for your project, keeping you organized, concentrated, and on a clear path to accomplishing your research objectives. When devising your research plan, consider these pivotal components:

• Project Goals and Objectives

Articulate the specific aims and objectives of your research project with clarity. These should be in harmony with your research question and provide a structured framework for your investigation, ultimately aligning with your overarching business goals.

• Research Methods

Select the most appropriate research tools and statistical methods to address your question effectively. This may include a variety of qualitative and quantitative approaches to ensure comprehensive analysis.

• Quantitative methods (e.g., surveys, experiments)
• Qualitative methods (e.g., interviews, focus groups)
• Mixed methods (combining quantitative and qualitative approaches)
• Access to databases, archives, or special collections
• Specialized equipment or software
• Funding for travel, materials, or participant compensation
• Assistance from research assistants, librarians, or subject matter experts
• Participant Recruitment

If your research involves human subjects, develop a strategic plan for recruiting participants. Consider factors such as the inclusion of diverse ethnic groups and the use of user interviews to gather rich, qualitative data.

• Target population and sample size
• Inclusion and exclusion criteria
• Recruitment strategies (e.g., flyers, social media, snowball sampling)
• Informed consent procedures
• Instruments or tools for gathering data (e.g., questionnaires, interview guides)
• Data storage and management protocols
• Statistical or qualitative analysis techniques
• Software or tools for data analysis (e.g., SPSS, NVivo)

Create a realistic project strategy for your research project, breaking it down into manageable stages or milestones. Consider factors such as resource availability and potential bottlenecks.

• Literature review and background research
• IRB approval (if applicable)
• Participant recruitment and data collection
• Data analysis and interpretation
• Writing and revising your findings
• Dissemination of results (e.g., presentations, publications)

By developing a comprehensive research plan, incorporating key research process steps, you'll be better equipped to anticipate challenges, allocate resources effectively, and ensure the integrity and rigor of your research process. Remember to remain flexible and adaptable to navigate unexpected obstacles or opportunities that may arise.

Step 5: Conduct the Research

With your research plan in place, it's time to dive into the data collection phase. As you conduct your research, adhere to the established research process steps to ensure the integrity and quality of your findings.

Conduct your research in accordance with federal regulations, state laws, institutional SOPs, and policies. Familiarize yourself with the IRB-approved protocol and follow it diligently, as part of the essential research process steps.

• Roles and Responsibilities

Understand and adhere to the roles and responsibilities of the principal investigator and other research team members. Maintain open communication lines with all stakeholders, including the sponsor and IRB, to foster cross-functional collaboration.

• Data Management

Develop and maintain an effective system for data collection and storage, utilizing advanced research tools. Ensure that each member of the research team has seamless access to the most up-to-date documents, including the informed consent document, protocol, and case report forms.

• Quality Assurance

Implement comprehensive quality assurance measures to verify that the study adheres strictly to the IRB-approved protocol, institutional policy, and all required regulations. Confirm that all study activities are executed as planned and that any deviations are addressed with precision and appropriateness.

• Participant Eligibility

As part of the essential research process steps, verify that potential study subjects meet all eligibility criteria and none of the ineligibility criteria before advancing with the research.

To maintain the highest standards of academic integrity and ethical conduct:

• Conduct research with unwavering honesty in all facets, including experimental design, data generation, and analysis, as well as the publication of results, as these are critical research process steps.
• Maintain a climate conducive to conducting research in strict accordance with good research practices, ensuring each step of the research process is meticulously observed.
• Provide appropriate supervision and training for researchers.
• Encourage open discussion of ideas and the widest dissemination of results possible.
• Keep clear and accurate records of research methods and results.
• Exercise a duty of care to all those involved in the research.

When collecting and assimilating data:

• Use professional online data analysis tools to streamline the process.
• Use metadata for context
• Assign codes or labels to facilitate grouping or comparison
• Convert data into different formats or scales for compatibility
• Organize documents in both the study participant and investigator's study regulatory files, creating a central repository for easy access and reference, as this organization is a pivotal step in the research process.

By adhering to these guidelines and upholding a commitment to ethical and rigorous research practices, you'll be well-equipped to conduct your research effectively and contribute meaningful insights to your field of study, thereby enhancing the integrity of the research process steps.

Step 6: Analyze and Interpret Data

Embarking on the research process steps, once you have gathered your research data, the subsequent critical phase is to delve into analysis and interpretation. This stage demands a meticulous examination of the data, spotting trends, and forging insightful conclusions that directly respond to your research question. Reflect on these tactics for a robust approach to data analysis and interpretation:

• Organize and Clean Your Data

A pivotal aspect of the research process steps is to start by structuring your data in an orderly and coherent fashion. This organizational task may encompass:

• Creating a spreadsheet or database to store your data
• Assigning codes or labels to facilitate grouping or comparison
• Cleaning the data by removing any errors, inconsistencies, or missing values
• Converting data into different formats or scales for compatibility
• Calculating measures of central tendency (mean, median, mode)
• Determining measures of variability (range, standard deviation)
• Creating frequency tables or histograms to visualize the distribution of your data
• Identifying any outliers or unusual patterns in your data
• Perform Inferential Analysis

Integral to the research process steps, you might engage in inferential analysis to evaluate hypotheses or extrapolate findings to a broader demographic, contingent on your research design and query. This analytical step may include:

• Selecting appropriate statistical tests (e.g., t-tests, ANOVA, regression analysis)
• As part of the research process steps, establishing a significance threshold (e.g., p < 0.05) is essential to gauge the likelihood of your results being a random occurrence rather than a significant finding.
• Interpreting the results of your statistical tests in the context of your research question
• Considering the practical significance of your findings, in addition to statistical significance

When interpreting your data, it's essential to:

• Look for relationships, patterns, and trends in your data
• Consider alternative explanations for your findings
• Acknowledge any limitations or potential biases in your research design or data collection
• Leverage data visualization techniques such as graphs, charts, and infographics to articulate your research findings with clarity and impact, thereby enhancing the communicative value of your data.
• Seek feedback from peers, mentors, or subject matter experts to validate your interpretations

It's important to recognize that data interpretation is a cyclical process that hinges on critical thinking, inventiveness, and the readiness to refine your conclusions with emerging insights. By tackling data analysis and interpretation with diligence and openness, you're setting the stage to derive meaningful and justifiable inferences from your research, in line with the research process steps.

Step 7: Present the Findings

After meticulous analysis and interpretation of your research findings, as dictated by the research process steps, the moment arrives to disseminate your insights. Effectively presenting your research is key to captivating your audience and conveying the importance of your findings. Employ these strategies to create an engaging and persuasive presentation:

• Organize Your Findings : 

Use the PEEL method to structure your presentation:

• Point: Clearly state your main argument or finding
• Evidence: Present the data and analysis that support your point
• Explanation: Provide context and interpret the significance of your evidence
• Link: Connect your findings to the broader research question or field
• Tailor Your Message

Understanding your audience is crucial to effective communication. When presenting your research, it's important to tailor your message to their background, interests, and level of expertise, effectively employing user personas to guide your approach.

• Use clear, concise language and explain technical terms
• Highlight what makes your research unique and impactful
• Craft a compelling narrative with a clear structure and hook
• Share the big picture, emphasizing the significance of your findings
• Engage Your Audience : Make your presentation enjoyable and memorable by incorporating creative elements:
• Use visual aids, such as tables, charts, and graphs, to communicate your findings effectively
• To vividly convey your research journey, consider employing storytelling techniques, such as UX comics or storyboards, which can make complex information more accessible and engaging.
• Injecting humor and personality into your presentation can be a powerful tool for communication. Utilize funny messages or GIFs to lighten the mood, breaking up tension and refocusing attention, thereby enhancing the effectiveness of humor in communication.

By adhering to these strategies, you'll be well-prepared to present your research findings in a manner that's both clear and captivating. Ensure you follow research process steps such as citing your sources accurately and discussing the broader implications of your work, providing actionable recommendations, and delineating the subsequent phases for integrating your findings into broader practice or policy frameworks.

The research process is an intricate journey that demands meticulous planning, steadfast execution, and incisive analysis. By adhering to the fundamental research process steps outlined in this guide, from pinpointing your topic to showcasing your findings, you're setting yourself up for conducting research that's both effective and influential. Keep in mind that the research journey is iterative, often necessitating revisits to certain stages as fresh insights surface or unforeseen challenges emerge.

As you commence your research journey, seize the chance to contribute novel insights to your field and forge a positive global impact. By tackling your research with curiosity, integrity, and a dedication to excellence, you're paving the way towards attaining your research aspirations and making a substantial difference with your work, all while following the critical research process steps.

Sign up for more like this.

• Privacy Policy

Buy Me a Coffee

Home » Research Project – Definition, Writing Guide and Ideas

Research Project – Definition, Writing Guide and Ideas

Table of Contents

Research Project

Definition :

Research Project is a planned and systematic investigation into a specific area of interest or problem, with the goal of generating new knowledge, insights, or solutions. It typically involves identifying a research question or hypothesis, designing a study to test it, collecting and analyzing data, and drawing conclusions based on the findings.

Types of Research Project

Types of Research Projects are as follows:

Basic Research

This type of research focuses on advancing knowledge and understanding of a subject area or phenomenon, without any specific application or practical use in mind. The primary goal is to expand scientific or theoretical knowledge in a particular field.

Applied Research

Applied research is aimed at solving practical problems or addressing specific issues. This type of research seeks to develop solutions or improve existing products, services or processes.

Action Research

Action research is conducted by practitioners and aimed at solving specific problems or improving practices in a particular context. It involves collaboration between researchers and practitioners, and often involves iterative cycles of data collection and analysis, with the goal of improving practices.

Quantitative Research

This type of research uses numerical data to investigate relationships between variables or to test hypotheses. It typically involves large-scale data collection through surveys, experiments, or secondary data analysis.

Qualitative Research

Qualitative research focuses on understanding and interpreting phenomena from the perspective of the people involved. It involves collecting and analyzing data in the form of text, images, or other non-numerical forms.

Mixed Methods Research

Mixed methods research combines elements of both quantitative and qualitative research, using multiple data sources and methods to gain a more comprehensive understanding of a phenomenon.

Longitudinal Research

This type of research involves studying a group of individuals or phenomena over an extended period of time, often years or decades. It is useful for understanding changes and developments over time.

Case Study Research

Case study research involves in-depth investigation of a particular case or phenomenon, often within a specific context. It is useful for understanding complex phenomena in their real-life settings.

Participatory Research

Participatory research involves active involvement of the people or communities being studied in the research process. It emphasizes collaboration, empowerment, and the co-production of knowledge.

Research Project Methodology

Research Project Methodology refers to the process of conducting research in an organized and systematic manner to answer a specific research question or to test a hypothesis. A well-designed research project methodology ensures that the research is rigorous, valid, and reliable, and that the findings are meaningful and can be used to inform decision-making.

There are several steps involved in research project methodology, which are described below:

Define the Research Question

The first step in any research project is to clearly define the research question or problem. This involves identifying the purpose of the research, the scope of the research, and the key variables that will be studied.

Develop a Research Plan

Once the research question has been defined, the next step is to develop a research plan. This plan outlines the methodology that will be used to collect and analyze data, including the research design, sampling strategy, data collection methods, and data analysis techniques.

Collect Data

The data collection phase involves gathering information through various methods, such as surveys, interviews, observations, experiments, or secondary data analysis. The data collected should be relevant to the research question and should be of sufficient quantity and quality to enable meaningful analysis.

Analyze Data

Once the data has been collected, it is analyzed using appropriate statistical techniques or other methods. The analysis should be guided by the research question and should aim to identify patterns, trends, relationships, or other insights that can inform the research findings.

Interpret and Report Findings

The final step in the research project methodology is to interpret the findings and report them in a clear and concise manner. This involves summarizing the results, discussing their implications, and drawing conclusions that can be used to inform decision-making.

Research Project Writing Guide

Here are some guidelines to help you in writing a successful research project:

• Choose a topic: Choose a topic that you are interested in and that is relevant to your field of study. It is important to choose a topic that is specific and focused enough to allow for in-depth research and analysis.
• Conduct a literature review : Conduct a thorough review of the existing research on your topic. This will help you to identify gaps in the literature and to develop a research question or hypothesis.
• Develop a research question or hypothesis : Based on your literature review, develop a clear research question or hypothesis that you will investigate in your study.
• Design your study: Choose an appropriate research design and methodology to answer your research question or test your hypothesis. This may include choosing a sample, selecting measures or instruments, and determining data collection methods.
• Collect data: Collect data using your chosen methods and instruments. Be sure to follow ethical guidelines and obtain informed consent from participants if necessary.
• Analyze data: Analyze your data using appropriate statistical or qualitative methods. Be sure to clearly report your findings and provide interpretations based on your research question or hypothesis.
• Discuss your findings : Discuss your findings in the context of the existing literature and your research question or hypothesis. Identify any limitations or implications of your study and suggest directions for future research.
• Write your project: Write your research project in a clear and organized manner, following the appropriate format and style guidelines for your field of study. Be sure to include an introduction, literature review, methodology, results, discussion, and conclusion.
• Revise and edit: Revise and edit your project for clarity, coherence, and accuracy. Be sure to proofread for spelling, grammar, and formatting errors.
• Cite your sources: Cite your sources accurately and appropriately using the appropriate citation style for your field of study.

Examples of Research Projects

Some Examples of Research Projects are as follows:

• Investigating the effects of a new medication on patients with a particular disease or condition.
• Exploring the impact of exercise on mental health and well-being.
• Studying the effectiveness of a new teaching method in improving student learning outcomes.
• Examining the impact of social media on political participation and engagement.
• Investigating the efficacy of a new therapy for a specific mental health disorder.
• Exploring the use of renewable energy sources in reducing carbon emissions and mitigating climate change.
• Studying the effects of a new agricultural technique on crop yields and environmental sustainability.
• Investigating the effectiveness of a new technology in improving business productivity and efficiency.
• Examining the impact of a new public policy on social inequality and access to resources.
• Exploring the factors that influence consumer behavior in a specific market.

Characteristics of Research Project

Here are some of the characteristics that are often associated with research projects:

• Clear objective: A research project is designed to answer a specific question or solve a particular problem. The objective of the research should be clearly defined from the outset.
• Systematic approach: A research project is typically carried out using a structured and systematic approach that involves careful planning, data collection, analysis, and interpretation.
• Rigorous methodology: A research project should employ a rigorous methodology that is appropriate for the research question being investigated. This may involve the use of statistical analysis, surveys, experiments, or other methods.
• Data collection : A research project involves collecting data from a variety of sources, including primary sources (such as surveys or experiments) and secondary sources (such as published literature or databases).
• Analysis and interpretation : Once the data has been collected, it needs to be analyzed and interpreted. This involves using statistical techniques or other methods to identify patterns or relationships in the data.
• Conclusion and implications : A research project should lead to a clear conclusion that answers the research question. It should also identify the implications of the findings for future research or practice.
• Communication: The results of the research project should be communicated clearly and effectively, using appropriate language and visual aids, to a range of audiences, including peers, stakeholders, and the wider public.

Importance of Research Project

Research projects are an essential part of the process of generating new knowledge and advancing our understanding of various fields of study. Here are some of the key reasons why research projects are important:

• Advancing knowledge : Research projects are designed to generate new knowledge and insights into particular topics or questions. This knowledge can be used to inform policies, practices, and decision-making processes across a range of fields.
• Solving problems: Research projects can help to identify solutions to real-world problems by providing a better understanding of the causes and effects of particular issues.
• Developing new technologies: Research projects can lead to the development of new technologies or products that can improve people’s lives or address societal challenges.
• Improving health outcomes: Research projects can contribute to improving health outcomes by identifying new treatments, diagnostic tools, or preventive strategies.
• Enhancing education: Research projects can enhance education by providing new insights into teaching and learning methods, curriculum development, and student learning outcomes.
• Informing public policy : Research projects can inform public policy by providing evidence-based recommendations and guidance on issues related to health, education, environment, social justice, and other areas.
• Enhancing professional development : Research projects can enhance the professional development of researchers by providing opportunities to develop new skills, collaborate with colleagues, and share knowledge with others.

Research Project Ideas

Following are some Research Project Ideas:

Field: Psychology

• Investigating the impact of social support on coping strategies among individuals with chronic illnesses.
• Exploring the relationship between childhood trauma and adult attachment styles.
• Examining the effects of exercise on cognitive function and brain health in older adults.
• Investigating the impact of sleep deprivation on decision making and risk-taking behavior.
• Exploring the relationship between personality traits and leadership styles in the workplace.
• Examining the effectiveness of cognitive-behavioral therapy (CBT) for treating anxiety disorders.
• Investigating the relationship between social comparison and body dissatisfaction in young women.
• Exploring the impact of parenting styles on children’s emotional regulation and behavior.
• Investigating the effectiveness of mindfulness-based interventions for treating depression.
• Examining the relationship between childhood adversity and later-life health outcomes.

Field: Economics

• Analyzing the impact of trade agreements on economic growth in developing countries.
• Examining the effects of tax policy on income distribution and poverty reduction.
• Investigating the relationship between foreign aid and economic development in low-income countries.
• Exploring the impact of globalization on labor markets and job displacement.
• Analyzing the impact of minimum wage laws on employment and income levels.
• Investigating the effectiveness of monetary policy in managing inflation and unemployment.
• Examining the relationship between economic freedom and entrepreneurship.
• Analyzing the impact of income inequality on social mobility and economic opportunity.
• Investigating the role of education in economic development.
• Examining the effectiveness of different healthcare financing systems in promoting health equity.

Field: Sociology

• Investigating the impact of social media on political polarization and civic engagement.
• Examining the effects of neighborhood characteristics on health outcomes.
• Analyzing the impact of immigration policies on social integration and cultural diversity.
• Investigating the relationship between social support and mental health outcomes in older adults.
• Exploring the impact of income inequality on social cohesion and trust.
• Analyzing the effects of gender and race discrimination on career advancement and pay equity.
• Investigating the relationship between social networks and health behaviors.
• Examining the effectiveness of community-based interventions for reducing crime and violence.
• Analyzing the impact of social class on cultural consumption and taste.
• Investigating the relationship between religious affiliation and social attitudes.

Field: Computer Science

• Developing an algorithm for detecting fake news on social media.
• Investigating the effectiveness of different machine learning algorithms for image recognition.
• Developing a natural language processing tool for sentiment analysis of customer reviews.
• Analyzing the security implications of blockchain technology for online transactions.
• Investigating the effectiveness of different recommendation algorithms for personalized advertising.
• Developing an artificial intelligence chatbot for mental health counseling.
• Investigating the effectiveness of different algorithms for optimizing online advertising campaigns.
• Developing a machine learning model for predicting consumer behavior in online marketplaces.
• Analyzing the privacy implications of different data sharing policies for online platforms.
• Investigating the effectiveness of different algorithms for predicting stock market trends.

Field: Education

• Investigating the impact of teacher-student relationships on academic achievement.
• Analyzing the effectiveness of different pedagogical approaches for promoting student engagement and motivation.
• Examining the effects of school choice policies on academic achievement and social mobility.
• Investigating the impact of technology on learning outcomes and academic achievement.
• Analyzing the effects of school funding disparities on educational equity and achievement gaps.
• Investigating the relationship between school climate and student mental health outcomes.
• Examining the effectiveness of different teaching strategies for promoting critical thinking and problem-solving skills.
• Investigating the impact of social-emotional learning programs on student behavior and academic achievement.
• Analyzing the effects of standardized testing on student motivation and academic achievement.

Field: Environmental Science

• Investigating the impact of climate change on species distribution and biodiversity.
• Analyzing the effectiveness of different renewable energy technologies in reducing carbon emissions.
• Examining the impact of air pollution on human health outcomes.
• Investigating the relationship between urbanization and deforestation in developing countries.
• Analyzing the effects of ocean acidification on marine ecosystems and biodiversity.
• Investigating the impact of land use change on soil fertility and ecosystem services.
• Analyzing the effectiveness of different conservation policies and programs for protecting endangered species and habitats.
• Investigating the relationship between climate change and water resources in arid regions.
• Examining the impact of plastic pollution on marine ecosystems and biodiversity.
• Investigating the effects of different agricultural practices on soil health and nutrient cycling.

Field: Linguistics

• Analyzing the impact of language diversity on social integration and cultural identity.
• Investigating the relationship between language and cognition in bilingual individuals.
• Examining the effects of language contact and language change on linguistic diversity.
• Investigating the role of language in shaping cultural norms and values.
• Analyzing the effectiveness of different language teaching methodologies for second language acquisition.
• Investigating the relationship between language proficiency and academic achievement.
• Examining the impact of language policy on language use and language attitudes.
• Investigating the role of language in shaping gender and social identities.
• Analyzing the effects of dialect contact on language variation and change.
• Investigating the relationship between language and emotion expression.

Field: Political Science

• Analyzing the impact of electoral systems on women’s political representation.
• Investigating the relationship between political ideology and attitudes towards immigration.
• Examining the effects of political polarization on democratic institutions and political stability.
• Investigating the impact of social media on political participation and civic engagement.
• Analyzing the effects of authoritarianism on human rights and civil liberties.
• Investigating the relationship between public opinion and foreign policy decisions.
• Examining the impact of international organizations on global governance and cooperation.
• Investigating the effectiveness of different conflict resolution strategies in resolving ethnic and religious conflicts.
• Analyzing the effects of corruption on economic development and political stability.
• Investigating the role of international law in regulating global governance and human rights.

Field: Medicine

• Investigating the impact of lifestyle factors on chronic disease risk and prevention.
• Examining the effectiveness of different treatment approaches for mental health disorders.
• Investigating the relationship between genetics and disease susceptibility.
• Analyzing the effects of social determinants of health on health outcomes and health disparities.
• Investigating the impact of different healthcare delivery models on patient outcomes and cost effectiveness.
• Examining the effectiveness of different prevention and treatment strategies for infectious diseases.
• Investigating the relationship between healthcare provider communication skills and patient satisfaction and outcomes.
• Analyzing the effects of medical error and patient safety on healthcare quality and outcomes.
• Investigating the impact of different pharmaceutical pricing policies on access to essential medicines.
• Examining the effectiveness of different rehabilitation approaches for improving function and quality of life in individuals with disabilities.

Field: Anthropology

• Analyzing the impact of colonialism on indigenous cultures and identities.
• Investigating the relationship between cultural practices and health outcomes in different populations.
• Examining the effects of globalization on cultural diversity and cultural exchange.
• Investigating the role of language in cultural transmission and preservation.
• Analyzing the effects of cultural contact on cultural change and adaptation.
• Investigating the impact of different migration policies on immigrant integration and acculturation.
• Examining the role of gender and sexuality in cultural norms and values.
• Investigating the impact of cultural heritage preservation on tourism and economic development.
• Analyzing the effects of cultural revitalization movements on indigenous communities.

About the author

Muhammad Hassan

Researcher, Academic Writer, Web developer

You may also like

Data Collection – Methods Types and Examples

Delimitations in Research – Types, Examples and...

Research Process – Steps, Examples and Tips

Research Design – Types, Methods and Examples

Institutional Review Board – Application Sample...

Evaluating Research – Process, Examples and...

• High School
• College Search
• College Admissions
• Financial Aid
• College Life

Your Guide to Conducting Independent Research Projects

For me, asking questions is the best way to stay curious and inspire others.

I am currently earning my undergraduate degree in Dance and minor in Modern Languages – French at Point Park University . I am a part of their honors program in which I have been given various opportunities to do research that has been published and presented at national conferences.

I want to note that you do not have to do research through an organization. The project I’m currently working on is for a conference and will not receive any academic credit for it.

You probably have already done a research project and did not even realize it. I was first introduced to how to do research in high school, so after finding what worked best for me, I wanted to share my process to make the project less daunting and more fun. 

Step 1: Define the project 

What is your subject?

Normally the subject is related to your major, but if you are interested in a subject, your project can be based on something you have no previous knowledge about.

When applying to conferences, my research typically fit under a certain category and theme. When choosing a subject, look at the requirements closely to determine if the subject will work. 

What is its purpose? 

Answer the question: Why do I want to do this research project?  Is it to forward your academic goals, spread awareness, inform or persuade a group of people, or to learn more about a subject you are passionate about?

Having a purpose behind your work can fuel your passion and help with motivation. Whatever your research entails will make an impact, so recognizing this could also help you feel more fulfilled after it is finished. 

If you have to do it as a requirement, try to reframe your mindset to a more positive one where you can find something positive to gain from your research. This could be a new skill acquired or improved upon.

What format will it be in?  

Some examples of different formats could be an essay, poster, speech, or an artistic piece.

Depending on the format, there could be different requirements for the information or an element incorporated that is not included in the other formats. 

If you have a choice of format, be sure to assess your strengths and weaknesses. I pride myself on being a good public speaker and performer, so I prefer giving a speech rather than writing an essay. 

However, if you want to improve a certain skill, you could choose a format that challenges a skill you want to work on.

What question is being answered? 

I have been taught that good research answers a complex but specific question. Therefore, create a question that requires critical thinking and is focused enough to be answered by a comprehensive thesis statement.

Step 2: Gather information

This may be self-explanatory, but it’s time to research! H ave a variety of primary, secondary, and tertiary sources.

• Examples: Journals/Diaries, Speeches, Photographs, Raw Data 
• Examples: Journal Articles, Biographies, Textbooks / Encyclopedias / Dictionaries 
• Examples: Manuals, Textbooks / Encyclopedias / Dictionaries, Bibliographies

Good places to find sources are your local library, school databases, or Google Scholar .  Since not everything on the internet is true, vetting your source is crucial.  Some things to keep in mind before using a source are the author, time period, peer-review status, publisher, and intended audience.  

Step 3: Compile findings and provide a takeaway

Using the data you have collected to support your thesis, answer your initial question. This article explains how different kinds of theses are used in different research contexts. 

The thesis is generally at the end of the first introductory paragraph. Coming up with a thesis is easier said than done, but finally reaching an answer should be gratifying.

Make sure all the points in your paper answer the initial question and support the amazing thesis you just created.  You may need to write a proposal or abstract for your research. 

Try to focus on the main ideas in your work and provide a bit of context that would make the reader or listener more interested to learn additional information.

Be sure to proofread your work, double check it meets all the requirements, and verify your citations are in the correct citation style.

A service I find useful to check my grammar is Grammarly . You can also get your friends to look over it and get their thoughts. 

Step 4: *Optional* Peer / Advisor Review

On my research projects, I have had the privilege of having an advisor to give me advice who is an expert in the field of research I am interested in. This advisor offered great advice when I got stuck or needed a push in the right direction.

Some tips on finding an advisor are to:

• See if their past research aligns with what you are interested in
• Investigate how other’s experiences were if they have been an advisor in the past
• Reach out through email or attend their office hours to see if they would be interested in helping you
• Keep your options open because you never know who you could have the potential to connect to

Starting an independent research project can be scary. Whether your research is formal or informal, I encourage you to keep learning and asking questions.

In the words of author, anthropologist, and filmmaker Zora Neale Hurston, “Research is formalized curiosity. It is poking and prying with a purpose.”

Good luck! You got this. We would love to hear your experiences and how you found where you belong , so direct message us on Instagram for a chance to be featured.

Author: Rosalie Anthony

Rosalie is currently attending Point Park University earning her Dance- B.F.A degree with a minor in French. Previously, she attended and graduated from the Alabama School of Fine Arts in dance. She is passionate about learning, teaching and mentoring. In her spare time, she enjoys working out, chatting with friends, and discovering new places to go in Pittsburgh.

More Articles By Niche

When it comes to extracurricular activities, there’s no set rule concerning how many you should be involved in or how involved you must be.

It may seem like a daunting task, but securing an internship as a high school student is a realistic and possible thing.

Here you’ll find information about how best to be prepared to meet with your college/career counselor so that they can help you achieve your goals. They were really helpful when I was going through the college application process.

Our websites may use cookies to personalize and enhance your experience. By continuing without changing your cookie settings, you agree to this collection. For more information, please see our University Websites Privacy Notice .

Office of Undergraduate Research

Tips for starting an independent research project.

By Grace Vaidian, Peer Research Ambassador 

Here at UConn, a prevalent avenue for delving into research is to reach out to professors and join their existing projects. While the structure and guidance that this approach offers can be undeniably valuable (it’s how I obtained the research opportunities I’m currently working on!), there are students who feel like they have a brilliant research idea of their own but lack the know-how to bring these projects to life. I’m here to offer some tips on how to initiate and successfully navigate an independent research project.

Where to Begin: Identifying the Knowledge Gap

The first step in embarking on your independent research journey is to pinpoint a gap in knowledge. This is essentially an underexplored area that could greatly benefit from further research and discoveries. For some, this gap might be immediately apparent, but for others, including myself, it might require a bit more digging. One effective way to identify this gap is through a thorough literature review on a topic of interest. Most academic publications include insights into the unanswered questions and areas that warrant further investigation in the discussion or conclusion sections. This is a great starting point for coming up with your own research question. Additionally, this literature review process can give you ideas for a methodology to follow.

Finding a Mentor: A Valuable Guide on Your Journey

I know, the focus of this blog is how to do independent research, so why am I now suggesting finding a mentor? It’s important to recognize that even if you possess extensive knowledge on a particular topic, you’re still a student with much to learn. Having an expert to provide feedback and guidance on your project idea is invaluable and often mandatory to move a project forward. Once you’ve formulated a research question, you should collaborate with faculty or professionals willing to support your future steps. A case in point is a self-initiated project I worked on involving fentanyl overdose deaths. I realized that having open access to autopsy and toxicology reports would be impossible for a 16-year-old. However, by proposing my project idea to a local forensic pathologist and securing her mentorship, I was welcomed into the Medical Examiner’s Office and was able to review the necessary reports. A mentor can play a pivotal role in helping you secure the essential resources for your project.

Crafting Your Project: Defining Goals and Objectives

With your research question in place, it’s time to define your project’s goals. Do you want to be published? Create a product? Enter a competition? With your goals in mind, you can outline your objectives, methods, and create a timeline. At UConn, there are some great programs that support independent research, such as the Holster Scholar Program and the UConn IDEA Grant . As you explore these possibilities, remember to be realistic about the time and resources your project will require.

Taking the Leap: Go for It!

Independent research projects offer a unique opportunity to delve into your passions, build critical thinking skills, and contribute to new discoveries. The journey may be challenging, but the knowledge and skills you acquire are invaluable. Throughout the process, remember to enjoy the journey. I wish you the best of luck on your independent research adventure!

Grace is a senior double majoring in Molecular & Cell Biology and Drugs, Disease, and Illness (Individualized Major).  Click here  to learn more about Grace. 

13.5 Research Process: Making Notes, Synthesizing Information, and Keeping a Research Log

Learning outcomes.

By the end of this section, you will be able to:

• Employ the methods and technologies commonly used for research and communication within various fields.
• Practice and apply strategies such as interpretation, synthesis, response, and critique to compose texts that integrate the writer’s ideas with those from appropriate sources.
• Analyze and make informed decisions about intellectual property based on the concepts that motivate them.
• Apply citation conventions systematically.

As you conduct research, you will work with a range of “texts” in various forms, including sources and documents from online databases as well as images, audio, and video files from the Internet. You may also work with archival materials and with transcribed and analyzed primary data. Additionally, you will be taking notes and recording quotations from secondary sources as you find materials that shape your understanding of your topic and, at the same time, provide you with facts and perspectives. You also may download articles as PDFs that you then annotate. Like many other students, you may find it challenging to keep so much material organized, accessible, and easy to work with while you write a major research paper. As it does for many of those students, a research log for your ideas and sources will help you keep track of the scope, purpose, and possibilities of any research project.

A research log is essentially a journal in which you collect information, ask questions, and monitor the results. Even if you are completing the annotated bibliography for Writing Process: Informing and Analyzing , keeping a research log is an effective organizational tool. Like Lily Tran’s research log entry, most entries have three parts: a part for notes on secondary sources, a part for connections to the thesis or main points, and a part for your own notes or questions. Record source notes by date, and allow room to add cross-references to other entries.

Summary of Assignment: Research Log

Your assignment is to create a research log similar to the student model. You will use it for the argumentative research project assigned in Writing Process: Integrating Research to record all secondary source information: your notes, complete publication data, relation to thesis, and other information as indicated in the right-hand column of the sample entry.

Another Lens. A somewhat different approach to maintaining a research log is to customize it to your needs or preferences. You can apply shading or color coding to headers, rows, and/or columns in the three-column format (for colors and shading). Or you can add columns to accommodate more information, analysis, synthesis, or commentary, formatting them as you wish. Consider adding a column for questions only or one for connections to other sources. Finally, consider a different visual format , such as one without columns. Another possibility is to record some of your comments and questions so that you have an aural rather than a written record of these.

Writing Center

At this point, or at any other point during the research and writing process, you may find that your school’s writing center can provide extensive assistance. If you are unfamiliar with the writing center, now is a good time to pay your first visit. Writing centers provide free peer tutoring for all types and phases of writing. Discussing your research with a trained writing center tutor can help you clarify, analyze, and connect ideas as well as provide feedback on works in progress.

Quick Launch: Beginning Questions

You may begin your research log with some open pages in which you freewrite, exploring answers to the following questions. Although you generally would do this at the beginning, it is a process to which you likely will return as you find more information about your topic and as your focus changes, as it may during the course of your research.

• What information have I found so far?
• What do I still need to find?
• Where am I most likely to find it?

These are beginning questions. Like Lily Tran, however, you will come across general questions or issues that a quick note or freewrite may help you resolve. The key to this section is to revisit it regularly. Written answers to these and other self-generated questions in your log clarify your tasks as you go along, helping you articulate ideas and examine supporting evidence critically. As you move further into the process, consider answering the following questions in your freewrite:

• What evidence looks as though it best supports my thesis?
• What evidence challenges my working thesis?
• How is my thesis changing from where it started?

Creating the Research Log

As you gather source material for your argumentative research paper, keep in mind that the research is intended to support original thinking. That is, you are not writing an informational report in which you simply supply facts to readers. Instead, you are writing to support a thesis that shows original thinking, and you are collecting and incorporating research into your paper to support that thinking. Therefore, a research log, whether digital or handwritten, is a great way to keep track of your thinking as well as your notes and bibliographic information.

In the model below, Lily Tran records the correct MLA bibliographic citation for the source. Then, she records a note and includes the in-text citation here to avoid having to retrieve this information later. Perhaps most important, Tran records why she noted this information—how it supports her thesis: The human race must turn to sustainable food systems that provide healthy diets with minimal environmental impact, starting now . Finally, she makes a note to herself about an additional visual to include in the final paper to reinforce the point regarding the current pressure on food systems. And she connects the information to other information she finds, thus cross-referencing and establishing a possible synthesis. Use a format similar to that in Table 13.4 to begin your own research log.

Types of Research Notes

Taking good notes will make the research process easier by enabling you to locate and remember sources and use them effectively. While some research projects requiring only a few sources may seem easily tracked, research projects requiring more than a few sources are more effectively managed when you take good bibliographic and informational notes. As you gather evidence for your argumentative research paper, follow the descriptions and the electronic model to record your notes. You can combine these with your research log, or you can use the research log for secondary sources and your own note-taking system for primary sources if a division of this kind is helpful. Either way, be sure to include all necessary information.

Bibliographic Notes

These identify the source you are using. When you locate a useful source, record the information necessary to find that source again. It is important to do this as you find each source, even before taking notes from it. If you create bibliographic notes as you go along, then you can easily arrange them in alphabetical order later to prepare the reference list required at the end of formal academic papers. If your instructor requires you to use MLA formatting for your essay, be sure to record the following information:

• Title of source
• Title of container (larger work in which source is included)
• Other contributors
• Publication date

When using MLA style with online sources, also record the following information:

• Date of original publication
• Date of access
• DOI (A DOI, or digital object identifier, is a series of digits and letters that leads to the location of an online source. Articles in journals are often assigned DOIs to ensure that the source can be located, even if the URL changes. If your source is listed with a DOI, use that instead of a URL.)

It is important to understand which documentation style your instructor will require you to use. Check the Handbook for MLA Documentation and Format and APA Documentation and Format styles . In addition, you can check the style guide information provided by the Purdue Online Writing Lab .

Informational Notes

These notes record the relevant information found in your sources. When writing your essay, you will work from these notes, so be sure they contain all the information you need from every source you intend to use. Also try to focus your notes on your research question so that their relevance is clear when you read them later. To avoid confusion, work with separate entries for each piece of information recorded. At the top of each entry, identify the source through brief bibliographic identification (author and title), and note the page numbers on which the information appears. Also helpful is to add personal notes, including ideas for possible use of the information or cross-references to other information. As noted in Writing Process: Integrating Research , you will be using a variety of formats when borrowing from sources. Below is a quick review of these formats in terms of note-taking processes. By clarifying whether you are quoting directly, paraphrasing, or summarizing during these stages, you can record information accurately and thus take steps to avoid plagiarism.

Direct Quotations, Paraphrases, and Summaries

A direct quotation is an exact duplication of the author’s words as they appear in the original source. In your notes, put quotation marks around direct quotations so that you remember these words are the author’s, not yours. One advantage of copying exact quotations is that it allows you to decide later whether to include a quotation, paraphrase, or summary. ln general, though, use direct quotations only when the author’s words are particularly lively or persuasive.

A paraphrase is a restatement of the author’s words in your own words. Paraphrase to simplify or clarify the original author’s point. In your notes, use paraphrases when you need to record details but not exact words.

A summary is a brief condensation or distillation of the main point and most important details of the original source. Write a summary in your own words, with facts and ideas accurately represented. A summary is useful when specific details in the source are unimportant or irrelevant to your research question. You may find you can summarize several paragraphs or even an entire article or chapter in just a few sentences without losing useful information. It is a good idea to note when your entry contains a summary to remind you later that it omits detailed information. See Writing Process Integrating Research for more detailed information and examples of quotations, paraphrases, and summaries and when to use them.

Other Systems for Organizing Research Logs and Digital Note-Taking

Students often become frustrated and at times overwhelmed by the quantity of materials to be managed in the research process. If this is your first time working with both primary and secondary sources, finding ways to keep all of the information in one place and well organized is essential.

Because gathering primary evidence may be a relatively new practice, this section is designed to help you navigate the process. As mentioned earlier, information gathered in fieldwork is not cataloged, organized, indexed, or shelved for your convenience. Obtaining it requires diligence, energy, and planning. Online resources can assist you with keeping a research log. Your college library may have subscriptions to tools such as Todoist or EndNote. Consult with a librarian to find out whether you have access to any of these. If not, use something like the template shown in Figure 13.8 , or another like it, as a template for creating your own research notes and organizational tool. You will need to have a record of all field research data as well as the research log for all secondary sources.

As an Amazon Associate we earn from qualifying purchases.

This book may not be used in the training of large language models or otherwise be ingested into large language models or generative AI offerings without OpenStax's permission.

Want to cite, share, or modify this book? This book uses the Creative Commons Attribution License and you must attribute OpenStax.

Access for free at https://openstax.org/books/writing-guide/pages/1-unit-introduction

• Authors: Michelle Bachelor Robinson, Maria Jerskey, featuring Toby Fulwiler
• Publisher/website: OpenStax
• Book title: Writing Guide with Handbook
• Publication date: Dec 21, 2021
• Location: Houston, Texas
• Book URL: https://openstax.org/books/writing-guide/pages/1-unit-introduction
• Section URL: https://openstax.org/books/writing-guide/pages/13-5-research-process-making-notes-synthesizing-information-and-keeping-a-research-log

© Dec 19, 2023 OpenStax. Textbook content produced by OpenStax is licensed under a Creative Commons Attribution License . The OpenStax name, OpenStax logo, OpenStax book covers, OpenStax CNX name, and OpenStax CNX logo are not subject to the Creative Commons license and may not be reproduced without the prior and express written consent of Rice University.

How to Plan and Conduct a Research Project: 12 Simple Steps

Let’s have a brief and clear discussion on what we should do for achieving success in our research project.

Well! For planning and conduction we have to go through following steps.

1. Topic selection

Many of us have a clear research topic of mind but some are also there who come up with various ideas. When we are in pressure, we often get panicked and anxious, therefore we should select topic well before time by following ways.

2. Discussing with others: We should discuss with others (e.g., friends, lab mates, seniors, teachers and colleagues) about what they are mostly considering, what is sparking interest in us and whatever question arises we should freely discuss with others as their suggestions and comments will help us in refining our focus.

3. Having a look on other writings or previous people research topics:  Books and journals are major sources of ideas. We can spend some time in library and get some idea on title of other research paper of recent years, or we can go through previous people research projects. Similar studies have also been published in journals. Those articles we have to collect and plan how to make a difference.

Now-a-days many things are available online from internet. Websites like  Google ,  PubMed ,  Scopus ,  Science Direct  and others are some of the best learning sources and provides latest information of research. We can search many related topics and finalize a plan.

4. Considering our own interest:  Final and the vital point is considering our own interest like is giving us more interest. We can focus on that to find out whether that is covered in the syllabus. We should remain extra critical while choosing a topic so that we can find out which thing needs some extra studies. While choosing a topic certain points we should keep in mind like a research study can duplicate of already existing study in a completely different manner, extension of existing study, exploring the unexplored part, reviewing the knowledge in s particular field, application of theoretical idea to a real world problem.

5. Developing a research question

Once topic selection is done and it is accepted by department, we should start focusing on refining the topic and finding something like

• Issue for investigating
• What we want to prove, disapprove or discover
• Research limitations

6. Effectual planning of the research

Well!  Research proposal  is the detailed explanation of the whole project that we are going to conduct. It is like a formal need. It should include your thinking about the research problem, all discussions with your guide and all initial findings on the topic.

This step will include strategies to manage the time and how effectively we carry out all tasks. A plan should be made in such a way that it should allocate required time for each and every task. For this we have to see how much total time we have and accordingly we will divide time for each task. It is vital to remain as much realistic as we can about the timing each task will take. The more focused we will remain at the planning stage the more hours we can save while carrying out task. Better to note down about all the resources we need in each stage like how much time we should spend in  library , working hours, equipment lists, space required etc.

It is one of the common problems while conducting research and we should remain well prepared for it. For  several reasons people procrastinate  like for improper management of time, dauted by scale of the work, motivation loss, perfectionism, negative thoughts and many more. When we recognize these problems early, it will help us in minimizing it to larger extent. To avoid we should be realistic about when we should start, devote more time for planning and revising the research plan, allocation of proper time, highly focused etc.

Early identification of the signs of procrastination will give you the best chance of minimizing any negative effects. Once you suspect that you are procrastinating, it can be helpful to review what you are expecting of yourself, and check that those expectations are realistic. This is where planning is vital. After a research plan is made it is a better idea to show it to some other people of our team or our teachers/guides, who can help us in finding out some missing tasks, or some mistakes.

Conducting Research

After the planning stage is over now comes the time to conduct the research. Here also we should remain highly organized and methodical to achieve success. Let’s have a discussion on each step.

6 thoughts on “How to Plan and Conduct a Research Project: 12 Simple Steps”

We are a group of volunteers and starting a new scheme in our community. Your website offered us with valuable info to work on. You have done an impressive job and our whole community will be thankful to you.|

Very impressive

I find the explanation given very informative.

informative

excellent work

your planning is very helpful for me. please this written planning doc file send me.

Leave a Comment Cancel reply

Save my name, email, and website in this browser for the next time I comment.

Have a language expert improve your writing

Run a free plagiarism check in 10 minutes, generate accurate citations for free.

• Knowledge Base

Methodology

Research Methods | Definitions, Types, Examples

Research methods are specific procedures for collecting and analyzing data. Developing your research methods is an integral part of your research design . When planning your methods, there are two key decisions you will make.

First, decide how you will collect data . Your methods depend on what type of data you need to answer your research question :

• Qualitative vs. quantitative : Will your data take the form of words or numbers?
• Primary vs. secondary : Will you collect original data yourself, or will you use data that has already been collected by someone else?
• Descriptive vs. experimental : Will you take measurements of something as it is, or will you perform an experiment?

Second, decide how you will analyze the data .

• For quantitative data, you can use statistical analysis methods to test relationships between variables.
• For qualitative data, you can use methods such as thematic analysis to interpret patterns and meanings in the data.

Table of contents

Methods for collecting data, examples of data collection methods, methods for analyzing data, examples of data analysis methods, other interesting articles, frequently asked questions about research methods.

Data is the information that you collect for the purposes of answering your research question . The type of data you need depends on the aims of your research.

Qualitative vs. quantitative data

Your choice of qualitative or quantitative data collection depends on the type of knowledge you want to develop.

For questions about ideas, experiences and meanings, or to study something that can’t be described numerically, collect qualitative data .

If you want to develop a more mechanistic understanding of a topic, or your research involves hypothesis testing , collect quantitative data .

You can also take a mixed methods approach , where you use both qualitative and quantitative research methods.

Primary vs. secondary research

Primary research is any original data that you collect yourself for the purposes of answering your research question (e.g. through surveys , observations and experiments ). Secondary research is data that has already been collected by other researchers (e.g. in a government census or previous scientific studies).

If you are exploring a novel research question, you’ll probably need to collect primary data . But if you want to synthesize existing knowledge, analyze historical trends, or identify patterns on a large scale, secondary data might be a better choice.

Descriptive vs. experimental data

In descriptive research , you collect data about your study subject without intervening. The validity of your research will depend on your sampling method .

In experimental research , you systematically intervene in a process and measure the outcome. The validity of your research will depend on your experimental design .

To conduct an experiment, you need to be able to vary your independent variable , precisely measure your dependent variable, and control for confounding variables . If it’s practically and ethically possible, this method is the best choice for answering questions about cause and effect.

Here's why students love Scribbr's proofreading services

Discover proofreading & editing

Your data analysis methods will depend on the type of data you collect and how you prepare it for analysis.

Data can often be analyzed both quantitatively and qualitatively. For example, survey responses could be analyzed qualitatively by studying the meanings of responses or quantitatively by studying the frequencies of responses.

Qualitative analysis methods

Qualitative analysis is used to understand words, ideas, and experiences. You can use it to interpret data that was collected:

• From open-ended surveys and interviews , literature reviews , case studies , ethnographies , and other sources that use text rather than numbers.
• Using non-probability sampling methods .

Qualitative analysis tends to be quite flexible and relies on the researcher’s judgement, so you have to reflect carefully on your choices and assumptions and be careful to avoid research bias .

Quantitative analysis methods

Quantitative analysis uses numbers and statistics to understand frequencies, averages and correlations (in descriptive studies) or cause-and-effect relationships (in experiments).

You can use quantitative analysis to interpret data that was collected either:

• During an experiment .
• Using probability sampling methods .

Because the data is collected and analyzed in a statistically valid way, the results of quantitative analysis can be easily standardized and shared among researchers.

Prevent plagiarism. Run a free check.

If you want to know more about statistics , methodology , or research bias , make sure to check out some of our other articles with explanations and examples.

• Chi square test of independence
• Statistical power
• Descriptive statistics
• Degrees of freedom
• Pearson correlation
• Null hypothesis
• Double-blind study
• Case-control study
• Research ethics
• Data collection
• Hypothesis testing
• Structured interviews

Research bias

• Hawthorne effect
• Unconscious bias
• Recall bias
• Halo effect
• Self-serving bias
• Information bias

Quantitative research deals with numbers and statistics, while qualitative research deals with words and meanings.

Quantitative methods allow you to systematically measure variables and test hypotheses . Qualitative methods allow you to explore concepts and experiences in more detail.

In mixed methods research , you use both qualitative and quantitative data collection and analysis methods to answer your research question .

A sample is a subset of individuals from a larger population . Sampling means selecting the group that you will actually collect data from in your research. For example, if you are researching the opinions of students in your university, you could survey a sample of 100 students.

In statistics, sampling allows you to test a hypothesis about the characteristics of a population.

The research methods you use depend on the type of data you need to answer your research question .

• If you want to measure something or test a hypothesis , use quantitative methods . If you want to explore ideas, thoughts and meanings, use qualitative methods .
• If you want to analyze a large amount of readily-available data, use secondary data. If you want data specific to your purposes with control over how it is generated, collect primary data.
• If you want to establish cause-and-effect relationships between variables , use experimental methods. If you want to understand the characteristics of a research subject, use descriptive methods.

Methodology refers to the overarching strategy and rationale of your research project . It involves studying the methods used in your field and the theories or principles behind them, in order to develop an approach that matches your objectives.

Methods are the specific tools and procedures you use to collect and analyze data (for example, experiments, surveys , and statistical tests ).

In shorter scientific papers, where the aim is to report the findings of a specific study, you might simply describe what you did in a methods section .

In a longer or more complex research project, such as a thesis or dissertation , you will probably include a methodology section , where you explain your approach to answering the research questions and cite relevant sources to support your choice of methods.

Is this article helpful?

Other students also liked, writing strong research questions | criteria & examples.

• What Is a Research Design | Types, Guide & Examples
• Data Collection | Definition, Methods & Examples

More interesting articles

• Between-Subjects Design | Examples, Pros, & Cons
• Cluster Sampling | A Simple Step-by-Step Guide with Examples
• Confounding Variables | Definition, Examples & Controls
• Construct Validity | Definition, Types, & Examples
• Content Analysis | Guide, Methods & Examples
• Control Groups and Treatment Groups | Uses & Examples
• Control Variables | What Are They & Why Do They Matter?
• Correlation vs. Causation | Difference, Designs & Examples
• Correlational Research | When & How to Use
• Critical Discourse Analysis | Definition, Guide & Examples
• Cross-Sectional Study | Definition, Uses & Examples
• Descriptive Research | Definition, Types, Methods & Examples
• Ethical Considerations in Research | Types & Examples
• Explanatory and Response Variables | Definitions & Examples
• Explanatory Research | Definition, Guide, & Examples
• Exploratory Research | Definition, Guide, & Examples
• External Validity | Definition, Types, Threats & Examples
• Extraneous Variables | Examples, Types & Controls
• Guide to Experimental Design | Overview, Steps, & Examples
• How Do You Incorporate an Interview into a Dissertation? | Tips
• How to Do Thematic Analysis | Step-by-Step Guide & Examples
• How to Write a Literature Review | Guide, Examples, & Templates
• How to Write a Strong Hypothesis | Steps & Examples
• Inclusion and Exclusion Criteria | Examples & Definition
• Independent vs. Dependent Variables | Definition & Examples
• Inductive Reasoning | Types, Examples, Explanation
• Inductive vs. Deductive Research Approach | Steps & Examples
• Internal Validity in Research | Definition, Threats, & Examples
• Internal vs. External Validity | Understanding Differences & Threats
• Longitudinal Study | Definition, Approaches & Examples
• Mediator vs. Moderator Variables | Differences & Examples
• Mixed Methods Research | Definition, Guide & Examples
• Multistage Sampling | Introductory Guide & Examples
• Naturalistic Observation | Definition, Guide & Examples
• Operationalization | A Guide with Examples, Pros & Cons
• Population vs. Sample | Definitions, Differences & Examples
• Primary Research | Definition, Types, & Examples
• Qualitative vs. Quantitative Research | Differences, Examples & Methods
• Quasi-Experimental Design | Definition, Types & Examples
• Questionnaire Design | Methods, Question Types & Examples
• Random Assignment in Experiments | Introduction & Examples
• Random vs. Systematic Error | Definition & Examples
• Reliability vs. Validity in Research | Difference, Types and Examples
• Reproducibility vs Replicability | Difference & Examples
• Reproducibility vs. Replicability | Difference & Examples
• Sampling Methods | Types, Techniques & Examples
• Semi-Structured Interview | Definition, Guide & Examples
• Simple Random Sampling | Definition, Steps & Examples
• Single, Double, & Triple Blind Study | Definition & Examples
• Stratified Sampling | Definition, Guide & Examples
• Structured Interview | Definition, Guide & Examples
• Survey Research | Definition, Examples & Methods
• Systematic Review | Definition, Example, & Guide
• Systematic Sampling | A Step-by-Step Guide with Examples
• Textual Analysis | Guide, 3 Approaches & Examples
• The 4 Types of Reliability in Research | Definitions & Examples
• The 4 Types of Validity in Research | Definitions & Examples
• Transcribing an Interview | 5 Steps & Transcription Software
• Triangulation in Research | Guide, Types, Examples
• Types of Interviews in Research | Guide & Examples
• Types of Research Designs Compared | Guide & Examples
• Types of Variables in Research & Statistics | Examples
• Unstructured Interview | Definition, Guide & Examples
• What Is a Case Study? | Definition, Examples & Methods
• What Is a Case-Control Study? | Definition & Examples
• What Is a Cohort Study? | Definition & Examples
• What Is a Conceptual Framework? | Tips & Examples
• What Is a Controlled Experiment? | Definitions & Examples
• What Is a Double-Barreled Question?
• What Is a Focus Group? | Step-by-Step Guide & Examples
• What Is a Likert Scale? | Guide & Examples
• What Is a Prospective Cohort Study? | Definition & Examples
• What Is a Retrospective Cohort Study? | Definition & Examples
• What Is Action Research? | Definition & Examples
• What Is an Observational Study? | Guide & Examples
• What Is Concurrent Validity? | Definition & Examples
• What Is Content Validity? | Definition & Examples
• What Is Convenience Sampling? | Definition & Examples
• What Is Convergent Validity? | Definition & Examples
• What Is Criterion Validity? | Definition & Examples
• What Is Data Cleansing? | Definition, Guide & Examples
• What Is Deductive Reasoning? | Explanation & Examples
• What Is Discriminant Validity? | Definition & Example
• What Is Ecological Validity? | Definition & Examples
• What Is Ethnography? | Definition, Guide & Examples
• What Is Face Validity? | Guide, Definition & Examples
• What Is Non-Probability Sampling? | Types & Examples
• What Is Participant Observation? | Definition & Examples
• What Is Peer Review? | Types & Examples
• What Is Predictive Validity? | Examples & Definition
• What Is Probability Sampling? | Types & Examples
• What Is Purposive Sampling? | Definition & Examples
• What Is Qualitative Observation? | Definition & Examples
• What Is Qualitative Research? | Methods & Examples
• What Is Quantitative Observation? | Definition & Examples
• What Is Quantitative Research? | Definition, Uses & Methods

Unlimited Academic AI-Proofreading

✔ Document error-free in 5minutes ✔ Unlimited document corrections ✔ Specialized in correcting academic texts

• Undergraduate courses
• Postgraduate courses
• Foundation courses
• Apprenticeships
• Part-time and short courses
• Apply undergraduate
• Apply postgraduate

Search for a course

Search by course name, subject, and more

• Undergraduate
• Postgraduate
• (suspended) - Available in Clearing Not available in Clearing location-sign UCAS

Fees and funding

• Tuition fees
• Scholarships
• Funding your studies
• Student finance
• Cost of living support

Why study at Kent

Student life.

• Careers and employability
• Student support and wellbeing
• Our locations
• Placements and internships
• Year abroad
• Student stories
• Schools and colleges
• International
• International students
• Your country
• Applicant FAQs
• International scholarships
• University of Kent International College
• Campus Tours
• Applicant Events
• Postgraduate events
• Maps and directions
• Research strengths
• Research centres
• Research impact

Research institutes

• Durrell Institute of Conservation and Ecology
• Institute of Cyber Security for Society
• Institute of Cultural and Creative Industries
• Institute of Health, Social Care and Wellbeing

Research students

• Graduate and Researcher College
• Research degrees
• Find a supervisor
• How to apply

Popular searches

• Visits and Open Days
• Jobs and vacancies
• Accommodation
• Student guide
• Library and IT
• Partner with us
• Student Guide
• Student Help
• Health & wellbeing
• Student voice
• Living at Kent
• Careers & volunteering
• Diversity at Kent
• Finance & funding
• Life after graduation

Research projects & dissertations

Managing a research project.

The following guide has been created for you by the  Student Learning Advisory Service . For more detailed guidance and to speak to one of our advisers, please book an  appointment  or join one of our  workshops . Alternatively, have a look at our  SkillBuilder  skills videos.   

The stages of a research project

The basic stages involved in undertaking a university research project are as follows:

1. Choose your research area

Usually, it is best choose an area that you have already studied or are studying within your academic field. Not only will this help you identify potential research, but you can be confident in finding a suitable supervisor and reliable sources within the university. Choosing an area that you also find particularly interesting will help sustain your engagement. 

2. Conduct preliminary research (scope out the topic)

Survey current research surrounding your chosen subject area. Reflect on it carefully, and take advice from academic staff to establish what has already been written on your chosen subject area. This will enable you to identify what you can do that has not been done before.

3. Decide your research topic

Clearly define and delineate your research topic. The more clearly you do so the more confidence and clarity you will have in what you are trying to achieve, and the easier it will be for you to monitor your progress. If you’re uncertain what you’re trying to achieve, how will you know whether you’re on course or not?

At this stage you might also formulate a provisional research question – that is, the question your research will answer:

Research topic: Investigate ‘A’ and ‘B’ to see if/how they interrelate.

Research Question: ‘To what extent is A caused by B?’

4. Decide your methodology

As you are deciding your topic, you should be investigating and considering your research methodology – how you will conduct your research. Is it going to be experimental, observational, theoretical, textual, qualitative, quantitative? Will it involve human subjects? Are there ethical considerations – specific protocols, procedures or approaches to follow? Think about the research method you have chosen; what advantages does it give? What insights might it yield? What difficulties might it pose? How has it been used before in your field of study?

5. Submit/present your research proposal for approval

Most schools have a formal deadline for receiving research proposals/dissertation plans, and a formal approval process. In some cases this is an assessment stage – so make sure you know exactly what you need to submit, and when, in order to progress with your project. Your school will have given you guidance about what your proposal should include. Generally, the common elements are:

• Your main research question/problem/title
• Questions or concerns that will help you solve your main research problem
• A brief literature review or list of key texts/sources
• An overview of your methodology
• A timeline showing your main research project tasks

6. Finalise your topic and methodology

You may need to revise your research plan in the light of feedback you receive during the approval process. Many students are overambitious in their aims; academic staff have a much clearer idea of what is achievable and necessary in terms of a successful research project, so be guided by their advice. You may also need to modify your methodology in the light of your initial research, or a pilot study. It may be necessary, for example, to alter a questionnaire that isn’t generating the data you were expecting.

7. Conduct your research (fieldwork)

This might take place in a laboratory, in a library or archive, at a computer, on the streets or in a field. Whatever the location, this is the practical activity of collecting raw information or data. Be aware that what you think you are going to find out, and what you actually do find out, can often be very different, so be prepared to alter your research aims/question accordingly.

8. Analysis/data processing

Whatever your research topic, you will need to analyse and process the information you have collected in order to make sense of it. This might involve statistical analysis, generating graphs, charts or tables, organising information into categories, or critical appraisal of texts or events. As well as finding out something, you need to understand what it means within your academic field.

9. Writing up

This is the process of producing the written document – your dissertation or thesis – upon which your research project will be assessed. Allow enough time to improve and revise your work through a series of drafts, and to edit and proof-read the final document – including ensuring that any graphs/images referred to in the text are properly numbered and labelled, and that your referencing is error-free – before formatting and binding the finished document. Do not underestimate how long the writing up process will take.

10. Submission

All academic research projects are time constrained, so you will have a specific deadline for submitting your work. With longer research projects, you will also have intermediate deadlines (e.g. progress/upgrade boards). Consequently, you will need to time-manage each stage of your work to ensure that you complete the overall project on time.

Project managing your research

Any complex project involving multiple activities and deadlines requires some form of management. Using simple project management techniques will allow you to keep control of your research project – to schedule your work more effectively, to identify how much time you have to spend on each stage, to create intermediate milestones that will tell you if you’re on schedule or not (and allow you to respond accordingly) and give you a clear overview of your progress.

One simple but highly effective technique is to produce a Gantt chart. This provides you with a clear visual plan of your research project, based on scheduling the different stages involved against a time base. The example below (Figure 1) is based on the ten basic research project stages, scheduled against two (hypothetical) formal deadlines – submission of the proposal in week 10 and submission of the finished dissertation in week 24:  

Figure 1: Simple research project Gantt chart    

This example is typical of an undergraduate or taught Masters’ dissertation. Longer research projects (PhD, Masters by research, etc.) will generally have more activities spread over a longer timeframe (See below, Figure 2, for an example of a project plan for a humanities PhD).  

Figure 2: Humanities PhD example Gantt chart

In project management, the scheduling of individual activities is always worked backwards from the deadline. Thus, the amount of time that you have to complete each task is a function of the overall project schedule. As shown above, some tasks have to be carried out consecutively (i.e., you can’t start the next task until you’ve completed the previous one), but other tasks can be carried out at the same time, or started before the previous task has been completed, (e.g. you might be able to start analysing your data whilst you’re still collecting it). What you also need to bear in mind with undergraduate dissertations is that your research project constitutes only one part (25%) of your academic activities, and that you’ll be working on other assignments, reading, exam revision, etc, at the same time. As such, it is important that you make full use of the available time period and balance your priorities accordingly.

Tip: With longer-term projects such as these, it can be difficult to stay focused and motivated. Try to dedicate some time to your project every day/week (depending on your other academic commitments) and break your tasks down into smaller chunks so that they are more manageable. The Pomodoro technique can also be helpful for generating small bursts of concentration. If you are struggling, maybe read an article on your topic to remind yourself of your interest in the area, or talk to fellow students or your supervisor(s).    

Conducting Research Projects

These resources are intended to help residents and students understand the basic steps and principles of conducting practice-based research projects. Pharmacists who want to conduct practice-based projects can also benefit from the information presented. These presentations start with generating the project topic and proceed through planning, design, funding and sharing project results. Knowing how to manage complex projects from start to finish is critical whether you pursue a clinical, managerial, or academic career track. By sharing the results of your project with the health care community, you can contribute important information that helps advance pharmacy practice.

Keep two important considerations in mind as you move along the continuum of developing, implementing, and evaluating a project. You must:

• Understand the limitations of your project and recognize how it does or does not compare with the "ideal" research project.
• Actively develop your project management skills to ensure that the project is as sound and effective as possible. 

Selecting Your Project

Perhaps the hardest step in your project is figuring out where to start. Once you've determined your focus and worked up a timeline, however, you have a road map to help you move forward productively. This presentation gives you concrete suggestions for identifying valuable project ideas. 

Selecting Your Project Recording

Selecting Your Project Slides

Designing and Planning Your Project

This presentation explains the three categories most residency projects fall into, discusses important aspects of research studies and walks you through the process of creating a project plan. 

Designing and Planning Your Project Recording

Designing and Planning Your Project Slides

Procuring Funding for Your Project

Determining your project's needs and identifying resources to meet those needs are critical for success. This presentation will discuss ways to obtain monetary resources for your project or research. It reviews common and no-so-common sources of grant funding as well as tips for soliciting funds. 

Procuring Funding for Your Project Recording

Procuring Funding for Your Project Slides  

Avoiding Pitfalls in Implementing Your Project

One of the most gratifying things you can do is to completing a project that leads to improved patient care or documents the professional role of the pharmacist. With careful preparation, contingency plans, and a good attitude, problems can often be avoided or overcome. This presentation discusses how to avoid pitfalls and minimize problems as you implement your project, allowing you to complete it on time and create a product you are proud of. 

Avoiding Pitfalls in Implementing Your Project Recording

Avoiding Pitfalls in Implementing Your Project Slides  

Evaluating Your Project's Impact: Important Considerations

You selected the right project. You struggled with the design, data collection, and analysis. You are poised to write your abstract and present the project to colleagues at an upcoming professional meeting. Isn't that enough? Actually, no. Focusing on project evaluation before you write your abstract and project report is time well spent. This presentation will focus on reviewing your project's impact, communicating the "so what?" of your project effectively and exploring next steps. 

Evaluating Your Project's Impact: Important Considerations Recording

Evaluating Your Project's Impact: Important Considerations Slides

Presenting and Publishing Your Project

Making presentations about your project and seeking to publish your findings help you practice essential skills. These activities also get the word out to colleagues about new information, procedures, and evidence, and they give you the opportunity to network with other professionals and receive feedback. 

Presenting and Publishing Your Project Recording 

Presenting and Publishing Your Project Slides

Acknowledgement

APhA would like to thank Cortney M. Mospan, PharmD, BCACP, BCGP, Assistant Professor of Pharmacy, Wingate University School of Pharmacy, for the development and presentation of these valuable tools. 

An official website of the United States government

The .gov means it’s official. Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

The site is secure. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

• Publications
• Account settings

Preview improvements coming to the PMC website in October 2024. Learn More or Try it out now .

• Advanced Search
• Journal List
• J Pharmacol Pharmacother
• v.4(2); Apr-Jun 2013

The critical steps for successful research: The research proposal and scientific writing: (A report on the pre-conference workshop held in conjunction with the 64 th annual conference of the Indian Pharmaceutical Congress-2012)

Pitchai balakumar.

Pharmacology Unit, Faculty of Pharmacy, AIMST University, Semeling, 08100 Bedong. Kedah Darul Aman, Malaysia

Mohammed Naseeruddin Inamdar

1 Department of Pharmacology, Al-Ameen College of Pharmacy, Bengaluru, Karnataka, India

Gowraganahalli Jagadeesh

2 Division of Cardiovascular and Renal Products, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, USA

An interactive workshop on ‘The Critical Steps for Successful Research: The Research Proposal and Scientific Writing’ was conducted in conjunction with the 64 th Annual Conference of the Indian Pharmaceutical Congress-2012 at Chennai, India. In essence, research is performed to enlighten our understanding of a contemporary issue relevant to the needs of society. To accomplish this, a researcher begins search for a novel topic based on purpose, creativity, critical thinking, and logic. This leads to the fundamental pieces of the research endeavor: Question, objective, hypothesis, experimental tools to test the hypothesis, methodology, and data analysis. When correctly performed, research should produce new knowledge. The four cornerstones of good research are the well-formulated protocol or proposal that is well executed, analyzed, discussed and concluded. This recent workshop educated researchers in the critical steps involved in the development of a scientific idea to its successful execution and eventual publication.

INTRODUCTION

Creativity and critical thinking are of particular importance in scientific research. Basically, research is original investigation undertaken to gain knowledge and understand concepts in major subject areas of specialization, and includes the generation of ideas and information leading to new or substantially improved scientific insights with relevance to the needs of society. Hence, the primary objective of research is to produce new knowledge. Research is both theoretical and empirical. It is theoretical because the starting point of scientific research is the conceptualization of a research topic and development of a research question and hypothesis. Research is empirical (practical) because all of the planned studies involve a series of observations, measurements, and analyses of data that are all based on proper experimental design.[ 1 – 9 ]

The subject of this report is to inform readers of the proceedings from a recent workshop organized by the 64 th Annual conference of the ‘ Indian Pharmaceutical Congress ’ at SRM University, Chennai, India, from 05 to 06 December 2012. The objectives of the workshop titled ‘The Critical Steps for Successful Research: The Research Proposal and Scientific Writing,’ were to assist participants in developing a strong fundamental understanding of how best to develop a research or study protocol, and communicate those research findings in a conference setting or scientific journal. Completing any research project requires meticulous planning, experimental design and execution, and compilation and publication of findings in the form of a research paper. All of these are often unfamiliar to naïve researchers; thus, the purpose of this workshop was to teach participants to master the critical steps involved in the development of an idea to its execution and eventual publication of the results (See the last section for a list of learning objectives).

THE STRUCTURE OF THE WORKSHOP

The two-day workshop was formatted to include key lectures and interactive breakout sessions that focused on protocol development in six subject areas of the pharmaceutical sciences. This was followed by sessions on scientific writing. DAY 1 taught the basic concepts of scientific research, including: (1) how to formulate a topic for research and to describe the what, why , and how of the protocol, (2) biomedical literature search and review, (3) study designs, statistical concepts, and result analyses, and (4) publication ethics. DAY 2 educated the attendees on the basic elements and logistics of writing a scientific paper and thesis, and preparation of poster as well as oral presentations.

The final phase of the workshop was the ‘Panel Discussion,’ including ‘Feedback/Comments’ by participants. There were thirteen distinguished speakers from India and abroad. Approximately 120 post-graduate and pre-doctoral students, young faculty members, and scientists representing industries attended the workshop from different parts of the country. All participants received a printed copy of the workshop manual and supporting materials on statistical analyses of data.

THE BASIC CONCEPTS OF RESEARCH: THE KEY TO GETTING STARTED IN RESEARCH

A research project generally comprises four key components: (1) writing a protocol, (2) performing experiments, (3) tabulating and analyzing data, and (4) writing a thesis or manuscript for publication.

Fundamentals in the research process

A protocol, whether experimental or clinical, serves as a navigator that evolves from a basic outline of the study plan to become a qualified research or grant proposal. It provides the structural support for the research. Dr. G. Jagadeesh (US FDA), the first speaker of the session, spoke on ‘ Fundamentals in research process and cornerstones of a research project .’ He discussed at length the developmental and structural processes in preparing a research protocol. A systematic and step-by-step approach is necessary in planning a study. Without a well-designed protocol, there would be a little chance for successful completion of a research project or an experiment.

Research topic

The first and the foremost difficult task in research is to identify a topic for investigation. The research topic is the keystone of the entire scientific enterprise. It begins the project, drives the entire study, and is crucial for moving the project forward. It dictates the remaining elements of the study [ Table 1 ] and thus, it should not be too narrow or too broad or unfocused. Because of these potential pitfalls, it is essential that a good or novel scientific idea be based on a sound concept. Creativity, critical thinking, and logic are required to generate new concepts and ideas in solving a research problem. Creativity involves critical thinking and is associated with generating many ideas. Critical thinking is analytical, judgmental, and involves evaluating choices before making a decision.[ 4 ] Thus, critical thinking is convergent type thinking that narrows and refines those divergent ideas and finally settles to one idea for an in-depth study. The idea on which a research project is built should be novel, appropriate to achieve within the existing conditions, and useful to the society at large. Therefore, creativity and critical thinking assist biomedical scientists in research that results in funding support, novel discovery, and publication.[ 1 , 4 ]

Elements of a study protocol

Research question

The next most crucial aspect of a study protocol is identifying a research question. It should be a thought-provoking question. The question sets the framework. It emerges from the title, findings/results, and problems observed in previous studies. Thus, mastering the literature, attendance at conferences, and discussion in journal clubs/seminars are sources for developing research questions. Consider the following example in developing related research questions from the research topic.

Hepatoprotective activity of Terminalia arjuna and Apium graveolens on paracetamol-induced liver damage in albino rats.

How is paracetamol metabolized in the body? Does it involve P450 enzymes? How does paracetamol cause liver injury? What are the mechanisms by which drugs can alleviate liver damage? What biochemical parameters are indicative of liver injury? What major endogenous inflammatory molecules are involved in paracetamol-induced liver damage?

A research question is broken down into more precise objectives. The objectives lead to more precise methods and definition of key terms. The objectives should be SMART-Specific, Measurable, Achievable, Realistic, Time-framed,[ 10 ] and should cover the entire breadth of the project. The objectives are sometimes organized into hierarchies: Primary, secondary, and exploratory; or simply general and specific. Study the following example:

To evaluate the safety and tolerability of single oral doses of compound X in normal volunteers.

To assess the pharmacokinetic profile of compound X following single oral doses.

To evaluate the incidence of peripheral edema reported as an adverse event.

The objectives and research questions are then formulated into a workable or testable hypothesis. The latter forces us to think carefully about what comparisons will be needed to answer the research question, and establishes the format for applying statistical tests to interpret the results. The hypothesis should link a process to an existing or postulated biologic pathway. A hypothesis is written in a form that can yield measurable results. Studies that utilize statistics to compare groups of data should have a hypothesis. Consider the following example:

• The hepatoprotective activity of Terminalia arjuna is superior to that of Apium graveolens against paracetamol-induced liver damage in albino rats.

All biological research, including discovery science, is hypothesis-driven. However, not all studies need be conducted with a hypothesis. For example, descriptive studies (e.g., describing characteristics of a plant, or a chemical compound) do not need a hypothesis.[ 1 ]

Relevance of the study

Another important section to be included in the protocol is ‘significance of the study.’ Its purpose is to justify the need for the research that is being proposed (e.g., development of a vaccine for a disease). In summary, the proposed study should demonstrate that it represents an advancement in understanding and that the eventual results will be meaningful, contribute to the field, and possibly even impact society.

Biomedical literature

A literature search may be defined as the process of examining published sources of information on a research or review topic, thesis, grant application, chemical, drug, disease, or clinical trial, etc. The quantity of information available in print or electronically (e.g., the internet) is immense and growing with time. A researcher should be familiar with the right kinds of databases and search engines to extract the needed information.[ 3 , 6 ]

Dr. P. Balakumar (Institute of Pharmacy, Rajendra Institute of Technology and Sciences, Sirsa, Haryana; currently, Faculty of Pharmacy, AIMST University, Malaysia) spoke on ‘ Biomedical literature: Searching, reviewing and referencing .’ He schematically explained the basis of scientific literature, designing a literature review, and searching literature. After an introduction to the genesis and diverse sources of scientific literature searches, the use of PubMed, one of the premier databases used for biomedical literature searches world-wide, was illustrated with examples and screenshots. Several companion databases and search engines are also used for finding information related to health sciences, and they include Embase, Web of Science, SciFinder, The Cochrane Library, International Pharmaceutical Abstracts, Scopus, and Google Scholar.[ 3 ] Literature searches using alternative interfaces for PubMed such as GoPubMed, Quertle, PubFocus, Pubget, and BibliMed were discussed. The participants were additionally informed of databases on chemistry, drugs and drug targets, clinical trials, toxicology, and laboratory animals (reviewed in ref[ 3 ]).

Referencing and bibliography are essential in scientific writing and publication.[ 7 ] Referencing systems are broadly classified into two major types, such as Parenthetical and Notation systems. Parenthetical referencing is also known as Harvard style of referencing, while Vancouver referencing style and ‘Footnote’ or ‘Endnote’ are placed under Notation referencing systems. The participants were educated on each referencing system with examples.

Bibliography management

Dr. Raj Rajasekaran (University of California at San Diego, CA, USA) enlightened the audience on ‘ bibliography management ’ using reference management software programs such as Reference Manager ® , Endnote ® , and Zotero ® for creating and formatting bibliographies while writing a manuscript for publication. The discussion focused on the use of bibliography management software in avoiding common mistakes such as incomplete references. Important steps in bibliography management, such as creating reference libraries/databases, searching for references using PubMed/Google scholar, selecting and transferring selected references into a library, inserting citations into a research article and formatting bibliographies, were presented. A demonstration of Zotero®, a freely available reference management program, included the salient features of the software, adding references from PubMed using PubMed ID, inserting citations and formatting using different styles.

Writing experimental protocols

The workshop systematically instructed the participants in writing ‘ experimental protocols ’ in six disciplines of Pharmaceutical Sciences.: (1) Pharmaceutical Chemistry (presented by Dr. P. V. Bharatam, NIPER, Mohali, Punjab); (2) Pharmacology (presented by Dr. G. Jagadeesh and Dr. P. Balakumar); (3) Pharmaceutics (presented by Dr. Jayant Khandare, Piramal Life Sciences, Mumbai); (4) Pharmacy Practice (presented by Dr. Shobha Hiremath, Al-Ameen College of Pharmacy, Bengaluru); (5) Pharmacognosy and Phytochemistry (presented by Dr. Salma Khanam, Al-Ameen College of Pharmacy, Bengaluru); and (6) Pharmaceutical Analysis (presented by Dr. Saranjit Singh, NIPER, Mohali, Punjab). The purpose of the research plan is to describe the what (Specific Aims/Objectives), why (Background and Significance), and how (Design and Methods) of the proposal.

The research plan should answer the following questions: (a) what do you intend to do; (b) what has already been done in general, and what have other researchers done in the field; (c) why is this worth doing; (d) how is it innovative; (e) what will this new work add to existing knowledge; and (f) how will the research be accomplished?

In general, the format used by the faculty in all subjects is shown in Table 2 .

Elements of a research protocol

Biostatistics

Biostatistics is a key component of biomedical research. Highly reputed journals like The Lancet, BMJ, Journal of the American Medical Association, and many other biomedical journals include biostatisticians on their editorial board or reviewers list. This indicates that a great importance is given for learning and correctly employing appropriate statistical methods in biomedical research. The post-lunch session on day 1 of the workshop was largely committed to discussion on ‘ Basic biostatistics .’ Dr. R. Raveendran (JIPMER, Puducherry) and Dr. Avijit Hazra (PGIMER, Kolkata) reviewed, in parallel sessions, descriptive statistics, probability concepts, sample size calculation, choosing a statistical test, confidence intervals, hypothesis testing and ‘ P ’ values, parametric and non-parametric statistical tests, including analysis of variance (ANOVA), t tests, Chi-square test, type I and type II errors, correlation and regression, and summary statistics. This was followed by a practice and demonstration session. Statistics CD, compiled by Dr. Raveendran, was distributed to the participants before the session began and was demonstrated live. Both speakers worked on a variety of problems that involved both clinical and experimental data. They discussed through examples the experimental designs encountered in a variety of studies and statistical analyses performed for different types of data. For the benefit of readers, we have summarized statistical tests applied frequently for different experimental designs and post-hoc tests [ Figure 1 ].

Conceptual framework for statistical analyses of data. Of the two kinds of variables, qualitative (categorical) and quantitative (numerical), qualitative variables (nominal or ordinal) are not normally distributed. Numerical data that come from normal distributions are analyzed using parametric tests, if not; the data are analyzed using non-parametric tests. The most popularly used Student's t -test compares the means of two populations, data for this test could be paired or unpaired. One-way analysis of variance (ANOVA) is used to compare the means of three or more independent populations that are normally distributed. Applying t test repeatedly in pair (multiple comparison), to compare the means of more than two populations, will increase the probability of type I error (false positive). In this case, for proper interpretation, we need to adjust the P values. Repeated measures ANOVA is used to compare the population means if more than two observations coming from same subject over time. The null hypothesis is rejected with a ‘ P ’ value of less than 0.05, and the difference in population means is considered to be statistically significant. Subsequently, appropriate post-hoc tests are used for pairwise comparisons of population means. Two-way or three-way ANOVA are considered if two (diet, dose) or three (diet, dose, strain) independent factors, respectively, are analyzed in an experiment (not described in the Figure). Categorical nominal unmatched variables (counts or frequencies) are analyzed by Chi-square test (not shown in the Figure)

Research and publication ethics

The legitimate pursuit of scientific creativity is unfortunately being marred by a simultaneous increase in scientific misconduct. A disproportionate share of allegations involves scientists of many countries, and even from respected laboratories. Misconduct destroys faith in science and scientists and creates a hierarchy of fraudsters. Investigating misconduct also steals valuable time and resources. In spite of these facts, most researchers are not aware of publication ethics.

Day 1 of the workshop ended with a presentation on ‘ research and publication ethics ’ by Dr. M. K. Unnikrishnan (College of Pharmaceutical Sciences, Manipal University, Manipal). He spoke on the essentials of publication ethics that included plagiarism (attempting to take credit of the work of others), self-plagiarism (multiple publications by an author on the same content of work with slightly different wordings), falsification (manipulation of research data and processes and omitting critical data or results), gift authorship (guest authorship), ghostwriting (someone other than the named author (s) makes a major contribution), salami publishing (publishing many papers, with minor differences, from the same study), and sabotage (distracting the research works of others to halt their research completion). Additionally, Dr. Unnikrishnan pointed out the ‘ Ingelfinger rule ’ of stipulating that a scientist must not submit the same original research in two different journals. He also advised the audience that authorship is not just credit for the work but also responsibility for scientific contents of a paper. Although some Indian Universities are instituting preventive measures (e.g., use of plagiarism detecting software, Shodhganga digital archiving of doctoral theses), Dr. Unnikrishnan argued for a great need to sensitize young researchers on the nature and implications of scientific misconduct. Finally, he discussed methods on how editors and peer reviewers should ethically conduct themselves while managing a manuscript for publication.

SCIENTIFIC COMMUNICATION: THE KEY TO SUCCESSFUL SELLING OF FINDINGS

Research outcomes are measured through quality publications. Scientists must not only ‘do’ science but must ‘write’ science. The story of the project must be told in a clear, simple language weaving in previous work done in the field, answering the research question, and addressing the hypothesis set forth at the beginning of the study. Scientific publication is an organic process of planning, researching, drafting, revising, and updating the current knowledge for future perspectives. Writing a research paper is no easier than the research itself. The lectures of Day 2 of the workshop dealt with the basic elements and logistics of writing a scientific paper.

An overview of paper structure and thesis writing

Dr. Amitabh Prakash (Adis, Auckland, New Zealand) spoke on ‘ Learning how to write a good scientific paper .’ His presentation described the essential components of an original research paper and thesis (e.g., introduction, methods, results, and discussion [IMRaD]) and provided guidance on the correct order, in which data should appear within these sections. The characteristics of a good abstract and title and the creation of appropriate key words were discussed. Dr. Prakash suggested that the ‘title of a paper’ might perhaps have a chance to make a good impression, and the title might be either indicative (title that gives the purpose of the study) or declarative (title that gives the study conclusion). He also suggested that an abstract is a succinct summary of a research paper, and it should be specific, clear, and concise, and should have IMRaD structure in brief, followed by key words. Selection of appropriate papers to be cited in the reference list was also discussed. Various unethical authorships were enumerated, and ‘The International Committee of Medical Journal Editors (ICMJE) criteria for authorship’ was explained ( http://www.icmje.org/ethical_1author.html ; also see Table 1 in reference #9). The session highlighted the need for transparency in medical publication and provided a clear description of items that needed to be included in the ‘Disclosures’ section (e.g., sources of funding for the study and potential conflicts of interest of all authors, etc.) and ‘Acknowledgements’ section (e.g., writing assistance and input from all individuals who did not meet the authorship criteria). The final part of the presentation was devoted to thesis writing, and Dr. Prakash provided the audience with a list of common mistakes that are frequently encountered when writing a manuscript.

The backbone of a study is description of results through Text, Tables, and Figures. Dr. S. B. Deshpande (Institute of Medical Sciences, Banaras Hindu University, Varanasi, India) spoke on ‘ Effective Presentation of Results .’ The Results section deals with the observations made by the authors and thus, is not hypothetical. This section is subdivided into three segments, that is, descriptive form of the Text, providing numerical data in Tables, and visualizing the observations in Graphs or Figures. All these are arranged in a sequential order to address the question hypothesized in the Introduction. The description in Text provides clear content of the findings highlighting the observations. It should not be the repetition of facts in tables or graphs. Tables are used to summarize or emphasize descriptive content in the text or to present the numerical data that are unrelated. Illustrations should be used when the evidence bearing on the conclusions of a paper cannot be adequately presented in a written description or in a Table. Tables or Figures should relate to each other logically in sequence and should be clear by themselves. Furthermore, the discussion is based entirely on these observations. Additionally, how the results are applied to further research in the field to advance our understanding of research questions was discussed.

Dr. Peush Sahni (All-India Institute of Medical Sciences, New Delhi) spoke on effectively ‘ structuring the Discussion ’ for a research paper. The Discussion section deals with a systematic interpretation of study results within the available knowledge. He said the section should begin with the most important point relating to the subject studied, focusing on key issues, providing link sentences between paragraphs, and ensuring the flow of text. Points were made to avoid history, not repeat all the results, and provide limitations of the study. The strengths and novel findings of the study should be provided in the discussion, and it should open avenues for future research and new questions. The Discussion section should end with a conclusion stating the summary of key findings. Dr. Sahni gave an example from a published paper for writing a Discussion. In another presentation titled ‘ Writing an effective title and the abstract ,’ Dr. Sahni described the important components of a good title, such as, it should be simple, concise, informative, interesting and eye-catching, accurate and specific about the paper's content, and should state the subject in full indicating study design and animal species. Dr. Sahni explained structured (IMRaD) and unstructured abstracts and discussed a few selected examples with the audience.

Language and style in publication

The next lecture of Dr. Amitabh Prakash on ‘ Language and style in scientific writing: Importance of terseness, shortness and clarity in writing ’ focused on the actual sentence construction, language, grammar and punctuation in scientific manuscripts. His presentation emphasized the importance of brevity and clarity in the writing of manuscripts describing biomedical research. Starting with a guide to the appropriate construction of sentences and paragraphs, attendees were given a brief overview of the correct use of punctuation with interactive examples. Dr. Prakash discussed common errors in grammar and proactively sought audience participation in correcting some examples. Additional discussion was centered on discouraging the use of redundant and expendable words, jargon, and the use of adjectives with incomparable words. The session ended with a discussion of words and phrases that are commonly misused (e.g., data vs . datum, affect vs . effect, among vs . between, dose vs . dosage, and efficacy/efficacious vs . effective/effectiveness) in biomedical research manuscripts.

Working with journals

The appropriateness in selecting the journal for submission and acceptance of the manuscript should be determined by the experience of an author. The corresponding author must have a rationale in choosing the appropriate journal, and this depends upon the scope of the study and the quality of work performed. Dr. Amitabh Prakash spoke on ‘ Working with journals: Selecting a journal, cover letter, peer review process and impact factor ’ by instructing the audience in assessing the true value of a journal, understanding principles involved in the peer review processes, providing tips on making an initial approach to the editorial office, and drafting an appropriate cover letter to accompany the submission. His presentation defined the metrics that are most commonly used to measure journal quality (e.g., impact factor™, Eigenfactor™ score, Article Influence™ score, SCOPUS 2-year citation data, SCImago Journal Rank, h-Index, etc.) and guided attendees on the relative advantages and disadvantages of using each metric. Factors to consider when assessing journal quality were discussed, and the audience was educated on the ‘green’ and ‘gold’ open access publication models. Various peer review models (e.g., double-blind, single-blind, non-blind) were described together with the role of the journal editor in assessing manuscripts and selecting suitable reviewers. A typical checklist sent to referees was shared with the attendees, and clear guidance was provided on the best way to address referee feedback. The session concluded with a discussion of the potential drawbacks of the current peer review system.

Poster and oral presentations at conferences

Posters have become an increasingly popular mode of presentation at conferences, as it can accommodate more papers per meeting, has no time constraint, provides a better presenter-audience interaction, and allows one to select and attend papers of interest. In Figure 2 , we provide instructions, design, and layout in preparing a scientific poster. In the final presentation, Dr. Sahni provided the audience with step-by-step instructions on how to write and format posters for layout, content, font size, color, and graphics. Attendees were given specific guidance on the format of text on slides, the use of color, font type and size, and the use of illustrations and multimedia effects. Moreover, the importance of practical tips while delivering oral or poster presentation was provided to the audience, such as speak slowly and clearly, be informative, maintain eye contact, and listen to the questions from judges/audience carefully before coming up with an answer.

Guidelines and design to scientific poster presentation. The objective of scientific posters is to present laboratory work in scientific meetings. A poster is an excellent means of communicating scientific work, because it is a graphic representation of data. Posters should have focus points, and the intended message should be clearly conveyed through simple sections: Text, Tables, and Graphs. Posters should be clear, succinct, striking, and eye-catching. Colors should be used only where necessary. Use one font (Arial or Times New Roman) throughout. Fancy fonts should be avoided. All headings should have font size of 44, and be in bold capital letters. Size of Title may be a bit larger; subheading: Font size of 36, bold and caps. References and Acknowledgments, if any, should have font size of 24. Text should have font size between 24 and 30, in order to be legible from a distance of 3 to 6 feet. Do not use lengthy notes

PANEL DISCUSSION: FEEDBACK AND COMMENTS BY PARTICIPANTS

After all the presentations were made, Dr. Jagadeesh began a panel discussion that included all speakers. The discussion was aimed at what we do currently and could do in the future with respect to ‘developing a research question and then writing an effective thesis proposal/protocol followed by publication.’ Dr. Jagadeesh asked the following questions to the panelists, while receiving questions/suggestions from the participants and panelists.

• Does a Post-Graduate or Ph.D. student receive adequate training, either through an institutional course, a workshop of the present nature, or from the guide?
• Are these Post-Graduates self-taught (like most of us who learnt the hard way)?
• How are these guides trained? How do we train them to become more efficient mentors?
• Does a Post-Graduate or Ph.D. student struggle to find a method (s) to carry out studies? To what extent do seniors/guides help a post graduate overcome technical difficulties? How difficult is it for a student to find chemicals, reagents, instruments, and technical help in conducting studies?
• Analyses of data and interpretation: Most students struggle without adequate guidance.
• Thesis and publications frequently feature inadequate/incorrect statistical analyses and representation of data in tables/graphs. The student, their guide, and the reviewers all share equal responsibility.
• Who initiates and drafts the research paper? The Post-Graduate or their guide?
• What kind of assistance does a Post-Graduate get from the guide in finalizing a paper for publication?
• Does the guide insist that each Post-Graduate thesis yield at least one paper, and each Ph.D. thesis more than two papers, plus a review article?

The panelists and audience expressed a variety of views, but were unable to arrive at a decisive conclusion.

WHAT HAVE THE PARTICIPANTS LEARNED?

At the end of this fast-moving two-day workshop, the participants had opportunities in learning the following topics:

• Sequential steps in developing a study protocol, from choosing a research topic to developing research questions and a hypothesis.
• Study protocols on different topics in their subject of specialization
• Searching and reviewing the literature
• Appropriate statistical analyses in biomedical research
• Scientific ethics in publication
• Writing and understanding the components of a research paper (IMRaD)
• Recognizing the value of good title, running title, abstract, key words, etc
• Importance of Tables and Figures in the Results section, and their importance in describing findings
• Evidence-based Discussion in a research paper
• Language and style in writing a paper and expert tips on getting it published
• Presentation of research findings at a conference (oral and poster).

Overall, the workshop was deemed very helpful to participants. The participants rated the quality of workshop from “ satisfied ” to “ very satisfied .” A significant number of participants were of the opinion that the time allotted for each presentation was short and thus, be extended from the present two days to four days with adequate time to ask questions. In addition, a ‘hands-on’ session should be introduced for writing a proposal and manuscript. A large number of attendees expressed their desire to attend a similar workshop, if conducted, in the near future.

ACKNOWLEDGMENT

We gratefully express our gratitude to the Organizing Committee, especially Professors K. Chinnasamy, B. G. Shivananda, N. Udupa, Jerad Suresh, Padma Parekh, A. P. Basavarajappa, Mr. S. V. Veerramani, Mr. J. Jayaseelan, and all volunteers of the SRM University. We thank Dr. Thomas Papoian (US FDA) for helpful comments on the manuscript.

The opinions expressed herein are those of Gowraganahalli Jagadeesh and do not necessarily reflect those of the US Food and Drug Administration

Source of Support: Nil

Conflict of Interest: None declared.

Thank you for visiting nature.com. You are using a browser version with limited support for CSS. To obtain the best experience, we recommend you use a more up to date browser (or turn off compatibility mode in Internet Explorer). In the meantime, to ensure continued support, we are displaying the site without styles and JavaScript.

• View all journals
• My Account Login
• Explore content
• About the journal
• Publish with us
• Sign up for alerts
• Open access
• Published: 13 April 2024

Towards a common European ethical and legal framework for conducting clinical research: the GATEKEEPER experience

• Alessia Maccaro   ORCID: orcid.org/0000-0001-9338-9884 1 ,
• Vasiliki Tsiompanidou 2 ,
• Davide Piaggio 1 ,
• Alba M. Gallego Montejo   ORCID: orcid.org/0000-0003-2858-0919 3 ,
• Gloria Cea Sánchez   ORCID: orcid.org/0000-0002-6947-4672 3 ,
• Jordi de Batlle   ORCID: orcid.org/0000-0003-3500-6608 4 ,
• Adrian Quesada Rodriguez 2 ,
• Giuseppe Fico   ORCID: orcid.org/0000-0003-1551-4613 3 , 5 &
• Leandro Pecchia 6 , 7  

npj Digital Medicine volume  7 , Article number:  95 ( 2024 ) Cite this article

57 Accesses

1 Altmetric

Metrics details

• Health policy
• Outcomes research

This paper examines the ethical and legal challenges encountered during the GATEKEEPER Project and how these challenges informed the development of a comprehensive framework for future Large-Scale Pilot (LSP) projects. GATEKEEPER is a LSP Project with 48 partners conducting 30 implementation studies across Europe with 50,000 target participants grouped into 9 Reference Use Cases. The project underscored the complexity of obtaining ethical approval across various jurisdictions with divergent regulations and procedures. Through a detailed analysis of the issues faced and the strategies employed to navigate these challenges, this study proposes an ethical and legal framework. This framework, derived from a comparative analysis of ethical application forms and regulations, aims to streamline the ethical approval process for future LSP research projects. By addressing the hurdles encountered in GATEKEEPER, the proposed framework offers a roadmap for more efficient and effective project management, ensuring smoother implementation of similar projects in the future.

Similar content being viewed by others

Integrating stakeholder feedback in translational genomics research: an ethnographic analysis of a study protocol’s evolution

Stephanie A. Kraft, Carmit McMullen, … Sandra Soo-Jin Lee

The effects of government policies targeting ethics and governance processes on clinical trial activity and expenditure: a systematic review

Sam Crosby, Esther Rajadurai, … Bruce Neal

Genomic medicine implementation protocols in the PhenX Toolkit: tools for standardized data collection

Wendy K. Chung, Kyle Brothers, … Erin M. Ramos

Introduction

Digital health is revolutionizing the approach to healthcare, particularly in the context of healthy aging 1 . Through innovative technologies such as wearable devices, mobile apps, and telemedicine platforms, digital health empowers individuals to monitor and manage their health proactively 2 . This means easier access to medical consultations, real-time health monitoring, and personalised fitness programs, enabling elderly people to maintain their well-being and independence 3 . Furthermore, digital health tools facilitate the seamless sharing of health data between patients and healthcare providers, fostering more personalised and efficient healthcare solutions tailored to the specific needs of aging populations 4 . As a result, healthy aging is no longer just about adding years to life but ensuring those added years are lived in good health and vitality, thanks to the transformative potential of digital health technologies. However, the efficacy, cost-effectiveness, and scalability of eHealth interventions must be tested before large-scale adoption. In this framework, large-scale pilots (LSPs) are key as a last step in the implementation strategy towards real-world adoption of such technologies.

In this remit, the European Horizon 2020 project GATEKEEPER (GK) ( https://www.gatekeeper-project.eu/ ) aims to connect healthcare providers, businesses, entrepreneurs, older citizens, and the communities in which they live, to create an open and trust-based arena to combine user ideas, technologies, needs, and processes, to ensure a healthier independent life for aging populations 5 . As a result, GATEKEEPER has created an open-source, European, standard-based, interoperable, and secure framework available to all developers, for the creation of combined digital solutions for personalised early detection and interventions that cover the entire care cycle for elderly citizens. The system envisaged by GATEKEEPER is broader in scope than other eHealth solutions: instead of focusing on one disease or condition, it tries to meet the heterogeneous health needs of the elderly. In this context, and with the aim of validating the project’s technical developments in real scenarios, GATEKEEPER is an LSP project organised into 8 Pilot sites in Europe (Aragon, Basque Country, Cyprus, Greece, Poland, Puglia, Saxony, and the UK [Milton Keynes and Bangor]). Up to 30 implementation trials tackling 9 reference use cases (RUCs) are being conducted (see Table 1 ). However, the added value of GATEKEEPER lies not only in its many implementation trials but in their pooling via a federated approach, aiming at demonstrating the effectiveness and the cost-effectiveness of Key Enabling Technologies (KETs) such as AI, big data, and Internet of Things (IoT) for the prevention of adverse events and the management of health in later life. In order to get the gears going, looking into obtaining several ethical approvals was essential (see Table 1 ).

In fact, a project such as GATEKEEPER, which includes the use of KETs for people and, in particular, on patients suffering from pathologies of different complexity and the use of their data, requires attention to a multitude of ethical questions. The ever-increasing use of Internet of Things (IoT) and Artificial Intelligence (AI) in healthcare itself is deeply intertwined with numerous ethical challenges concerning the interrelations between “things”/machines and humans. Specifically, the use of ICT (including IoT) in applications for personal assistance presents several challenges 6 . These include the complexity and pervasiveness of the technology that users find difficult to understand, significant privacy and confidentiality concerns, difficulties in ensuring the security of personal data, the absence of a trusted framework for data protection, and a lack of transparency in data collection and processing 7 .

As can be seen from above, and as confirmed by a literature review on the subject 8 , a frequent theme in the debate on ethics, AI, and IoT, relates to privacy, and, more prominently, to the issues regarding personal data sharing and protection 9 . It has been argued that one key feature of the use of digital devices is the passive and continuous collection of information 10 , which makes it difficult for the users to feel in complete control of the sharing and use of their data 11 .

Ethical aspects of interrelations between humans and technology are even more relevant when it comes to the application of AI and IoT in the field of health and the medical sector. Health-related data necessarily touch upon the user’s identity and the most intimate sphere of their private life. Due to the sensitivity of the data 12 and the potential consequences for the users, human control over algorithms and decision-making systems is paramount for these applications. This is further highlighted in the European Health Data Space Regulation 13 , the ambitious initiative held by the European Union aimed at improving the healthcare sector by facilitating the secure and efficient exchange of health data across member states.

Currently, although a unified legal ethical framework of reference for AI applications is still missing, there are many different regulatory efforts to address these ethical aspects, such as The Ethics Guidelines for Trustworthy Artificial Intelligence, published by the High-level Expert Group on AI, in April 2019 14 . Another important document in this field is the EU AI Act, which is expected to reach its final adoption by the end of 2024.

To safely navigate this “uncharted” territory, since its beginning, the GATEKEEPER project has established some overarching ethical principles. The list of guiding principles was informed by the principalist approach to medical ethics 15 and the Organization for Economic Cooperation and Development (OECD)’s Privacy Framework 16 . These principles are listed below, with a comment on their relation to the four principles embedded in the Ethics Guidelines for Trustworthy AI, namely (1) Respect for human autonomy, (2) Prevention of harm, (3) Fairness, and (4) Explicability:

Collect the minimum required data and ensure that data processing protocols are transparent and accountable (principles 2 and 4);

Support the ethical capabilities of human beings such as agency, awareness and reflexivity (requiring transparency on how data are collected and distributed) (principles 1 and 4);

Create and maintain trust and confidentiality between users and providers (all 4 principles);

Embed inclusiveness in design (principle 3);

Facilitate public health actions and user engagement related to IoT for health (principles 1, 3 and 4).

Nevertheless, in an LSP Project, apart from the overarching ethical principles guidelines (see also Supplementary Note 1 ), each pilot should refer to their respective ethical committee and follow their own ethical procedure. As such, the Ethical approval procedure is an integral part of the research process as it aims to protect both researchers and participants. Participants should be provided with enough details to make informed, autonomous decisions 17 . Therefore, while respecting shared principles, within GATEKEEPER each pilot has followed the procedures requested by their local Ethical Committees for submitting their ethical approvals, preparing the required documentation following the official forms and the languages locally requested.

During the preparation of the pilot application, a multiformity of ethical application procedures and documents to be submitted to different Local Ethical Review Boards (LERBs) different for each pilot and sometimes for each RUC emerged, resulting in a jeopardised situation, which revealed a complexity of the procedural mechanism that it seemed appropriate to rethink starting from a unified perspective 18 . In fact, it was noted that even if the framework of existing principles is very well-structured and satisfying, there is a lack of tools that can concretely, and in a harmonized way, guide the application of such principles in the management of a LSP research project.

For all the reasons anticipated, this manuscript provides an overview of the ethical management strategy implemented in the GATEKEEPER project and the proposed idea of building a common European ethical legal framework that could serve as a model for supporting and guiding the management of LSP research projects in the future.

The Unified Ethics Application Form

Due to its nature, GATEKEEPER, one of the biggest and most highly financed EU research projects, could not refer to other similar experiences for ethical legal management and the development of an architecture of strategies in a manner that would lead to consistent results and, therefore, had to design its own framework.

In order to better comprehend the results and ensure alignment with the methodology structure described below, the results were divided into two main phases, as follows:

The Phase 1 involved:

A mapping was performed of all the legal and regulatory referrals for the GATEKEEPER Project (see Supplementary Table 2 ), along with a list of the ethical principles that would be applicable to the project’s activities which were disseminated to the project’s partners (Supplementary Table 1 ) with the aim of building the ethical-legal GATEKEEPER framework.

In order to facilitate the performance of ethical risk assessments on pilot sites, a checklist was created to better guide the partners in the procedure to be followed and the points to be taken into consideration when performing their own ethical impact assessments (Supplementary Table 4 ).

Based on the literature review conducted, the lack of specific scientific literature on the topic of the ethical management of LSP research projects became apparent, which, in turn, led to the project’s attempts and mitigation actions described in this section, which were progressively adjusted to ensure compliance with ethical requirements.

- E) - F) The absence of adequate guidelines on the management and governance of LSP led to the pilots being requested to fill in the Questionnaire on the ethical procedure and to collect the Ethical Applications and the English Summaries. Those documents highlighted two crucial elements within the management of LSP research projects: (1) the incredibly complex situation among different pilot sites which not only have different ethical forms and procedures to be followed, but even different LERBs (i.e., of the Hospital, of the University, Regional ones, National ones etc.) which jeopardises the adequate performance of their activities, and (2) the plurality of languages of the documents collected, which implies that the management team must be comprised of members with multilingual competences in order to revise in-depth the documentation.

As demonstrated above, the ethical procedures in the various sites differed significantly depending, among others, on the type of institution performing it and the location. Given this lack of homogeneity even though the information requested and provided was similar, there were two main consequences on a project coordination level, notably that (a) the project’s coordination team could not provide unified pilot-wide support in preparing the required information and documentation, and proceeding without delays, and (b) further monitoring and validation of the ethics procedures at a project level were hindered.

As a result, the methodological analysis led to the identification of the need for a unique application form for research ethics that can serve as a model for the universalisation of ethical procedures in research projects, particularly relevant for LSP ones (Phase 2). The main objective behind the unique application form for research ethics is to overcome the challenges posed by the co-existence of multiple languages and formats required to complete the Ethical Approval forms and procedures. As such, the form has been designed to be used by pilots in the course of individual organisation procedures towards the Ethical Approvals, and replace existing local solutions, that are specific to one organisation exclusively. Such a step, albeit ambitious, would require a single adjustment of the organisation’s framework that would facilitate all relevant future actions and its participation in research projects where ethical elements would need to be both duly considered and reported in a verifiable manner.

This form establishes an ethical legal framework in which all the pilot sites can be represented, without compromising the need for ad hoc adjustments in accordance with national legislation and other regulatory requirements. The above-described comparative analysis served as the baseline in order to identify the elements that needed to be included in the Unified Ethics Application Form.

The form is complemented by supporting documentation that may be requested, which can always be expanded according to the needs of each organisation. Overall, the form is divided into four main sections, as follows:

The first section lays down the foundation of general information with regard to the research project requesting Ethical Approval;

The second section provides a detailed description of the research, including information on its duration, participation criteria, and funding;

The third section focuses on the main ethical and legal considerations to be taken into consideration, as well as on the research project’s management from an ethical and legal perspective;

The final section includes additional provisions that may be applicable according to national dispositions and ad hoc requirements of each research organisation.

Each element included in the Unified Ethics Approval Form is accompanied by further guidance on which information should be particularly considered and how to fill in the requested information. This additional guidance is meant to provide further clarity surrounded the information required, facilitate researchers filling in the form and ensuring no information is omitted.

The form’s overview can be found below (Fig. 1 ), while the complete form is submitted as Supplementary Table 5 .

Overview of the proposed model for an Ethical Approval Form.

Taking the above into consideration, the form furthermore serves as a tool for the streamlining, simplification, and acceleration of ethical procedures in research projects, both at the beginning of the projects and during potential revisions. At the same time, it constitutes a reference framework for the ethical principles and legal requirements to be respected in EU research projects related to the use of technologies for human health, in alignment with the principles enshrined in European and International regulations, declarations, and guidelines.

The GATEKEEPER project provided the possibility to reflect on the ethical and legal aspects of an LSP research project on two distinct levels of analysis: the first concerning the ethical procedures for a research project, and, the second examining, at a macro level, how to manage LSP projects.

As anticipated, one of the main considerations that emerged during the management of the ethical aspects present in GATEKEEPER was the fact that, despite the existence of a number of evident gaps that could negatively impact the success of the project, there were no formal guidelines or references to support their management. As such, the main gaps underlined were:

The lack of universal tools to manage an LSP project from an ethical and legal perspective. On the contrary, the existence of a number of guidelines and different procedures per country or per pilot implies the need for every research project to have Legal and Ethical Managers to identify, map, and interpret them for each research project. Even in the latter scenario, it is necessary to have clear and unambiguous guidelines when performing their duties, without having to repeatedly establish them on the basis of general Declarations of Principles or non-binding documents originating from a number of different bodies.

The extreme differences in the ethical application procedures per each pilot and even RUCs, and of the type of LERBs the pilots should address. This is problematic because it multiplies the documents, while also requiring the repetition of information, thus increasing the amount of work due from the researcher and slowing down the process of obtainment of the approvals. This is considered a crucial problem by the research community, which tried to argue in favour of a common perspective 18 . Yet, the establishment of a uniform ethical and legal approach that can serve as a model for the Ethical Approval procedures was never explicitly addressed.

The fact that per each pilot site or RUC, the ethical approval in the local language was sufficient and its translation was not required in any official document, not even when it was made known that it would be shared with the LSP project management or the European Commission. This consideration does not have a blind critique nor suspicion that the pilot sites involved could have hidden behind the language’s unambiguousness to conceal a lack of adherence to ethical principles or lack of compliance with ethics and law. On the contrary, it is well known that all the pilots’ sites for their ethical application follow the instructions of LERBs, which in order to be recognised as such, must follow international commonly agreed ethical and legal requirements. The committees’ official status guarantees the trustworthiness of their work. Nevertheless, it is true that LSP Projects may also include non-European countries or countries not adhering to values and principles shared in the EU territory. For this reason, adapting the Ethical Approval Forms and relevant documentation in an international language, such as English is a priority. This does not have to be necessarily on a pilot level, but it is paramount to forward to the management of these projects and the Commission, not only the summary, as was the case in the GATEKEEPER project, but of all the documents’ content 19 .

The response time of the Ethics Committees or respective Bodies is not predictable and varies according to the workload of their members, as well as the number of meetings planned. Any delays in response times, which can exceed a year, can be exacerbated by the committee’s request for amendments or clarifications 20 . This has a significant impact on research projects, especially if they are multicentric or large-scale because a delay in the pilot phase ensues that could hinder the research project’s success 21 . This falls outside the scope of responsibility of the consortium of researchers, often required to deal more with soliciting the LERBs rather than carrying out their tasks. Therefore, the proposal for a single framework for all pilots of European research projects could represent a streamlining of the procedure and a speeding up of practices which will positively impact the future of the research 22 .

The COVID-19 pandemic outbreak, as anticipated, further slowed down the work of the LERBs, which prioritised the evaluation of the research projects related to the pandemic, postponing all the other ethical applications. This halt continued for almost two years (2020–2021) and negatively affected the deployment and development of the GATEKEEPER project. However, this not only confirms that the multiformity of LERBs complicates and slows down an already complex process but also highlights that a uniform approach would have expedited the evaluation contemporarily the projects related to COVID-19 and the others without a long delay, in case this hiatus is to occur again in the future. It is anticipated that the COVID-19 pandemic was only one of the first global health emergencies and, for this reason, scientists, policymakers, and regulators are working to be “prepared” for future pandemics 23 . This stresses the importance of not repeating the errors of the past and finding new strategies to accelerate the evaluation of research projects in times of emergency. The idea of a unique legal and ethical framework could be considered part of this process of preparing for the future of research projects, in particular related to health.

Moreover, there were striking differences noted regarding the pilots’ Ethical Approval Forms themselves. For reference, based on the comparative analysis performed, it became evident that the approaches widely differ based on jurisdiction and the field of activities of each pilot. In particular, the following was noted:

Where the pilot was performed in the context of a University Hospital, the requirements tended to be stricter and more extensive compared to pilots performed outside the context of university hospitals and clinics. This is understandable considering not only the frequency in which university hospitals and clinics are subject to such procedures but also the overall sensitive nature of their activities. Considering that their performance of research activities almost always involves patients, vulnerable populations, health data, clinical and medical studies, or a combination of those, it is logical that a higher level of protection and attention to detail is imperative.

Pilots performed outside of the EU, albeit still in the EEA, were inclined to impose stricter requirements and request additional information/documentation, frequently simulating the information requested and the structure of the Horizon 2020 and Horizon Europe programmes. The proposed Ethical Application Form has taken into consideration those requirements, even though they do not reflect the situation in the entirety of the pilots, so as to ensure that all pilot sites are adequately represented. As such, the proposed Ethical Application Form leaves room for the application and compliance with national dispositions that may be applicable.

The description and analysis of measures and safeguards adopted throughout the research with regard to privacy and personal data protection have been a central focal point in the procedures of all pilots. Given the transition to a data-centred economy and the ever-increasing processing of personal data, ensuring data subjects’ privacy is becoming more and more essential to democratic societies. This focus on privacy and personal data protection reflects precisely the need to balance innovation and human rights, without either of them excluding the other.

Most Ethical Review Boards required specific and explicit information on funding sources, aiming at ensuring the impartiality of research. By validating that funding is secured through objective and impartial sources, and that adequate measures are in place, it is ensured that the results are unbiased and trustworthy.

In most pilots, a long list of supporting documents was requested, further exaggerating the bureaucratic element of the procedure. Such documents most frequently included the detailed research protocol, the patient information leaflet, and the consent forms, as well as documentation regarding funding and insurance. In many of the pilots, the researchers’ curriculum vitae was also requested, along with a formal declaration of assumption of responsibility with regard to the project.

Despite the above, there remained a minimum of information that was required in the majority of the pilots. In particular, those common elements that were requested regarding the research were:

The research classification as a research or clinical trial;

The introduction of the research team;

The description of the research, its objectives and expected outcomes;

The research’s duration;

The methodology for data collection and analysis;

The description of the intended participants’ characteristics;

The number of participants.

Taking the above into consideration, our proposal for a Unified Ethics Application Form has focused on three main elements: (i) compliance with all of the pilots’ procedures, (ii) simplification, (iii) an easy-to-fill application format that thoroughly guides the researcher as to the information they have to provide in order to proceed to the submission of their research project for an Ethical Approval. By creating three primary sections that differentiate the information between general, research description and ethical considerations, and additional ad hoc information, there is a two-fold benefit for the organisation; on one hand, the competent Committee can more easily mark which of the additional information it deems necessary to examine, and, on the other, the researcher is in a better position to intuitively fill in the required information, avoiding repetitions.

Finally, by establishing a common form along pilot sites, as proposed above, the procedures for validating the Ethical Approvals within the research project are also facilitated. Thanks to their simplicity and unified approach, the documents can be easily translated and shared with the project’s management and legal team to serve as the baseline for the design of further compliance activities, including the performance of a Data Protection Impact Assessment (DPIA), risk and conformity assessments, as required by relevant legislation in each case. As a result and considering the Ethical Approval’s importance for the demonstration of compliance, the project’s activities towards regulatory and ethical compliance become more easily auditable, traceable, and transparent.

As already discussed, the GATEKEEPER LSP is a federation of multicentre longitudinal cohort studies, aiming at demonstrating the effectiveness and the cost-effectiveness of Key Enabling Technologies (KETs) such as AI, big-data, and Internet of Things (IoT) for the prevention of adverse events and the management of health in later life. Therefore, while respecting shared principles, each pilot was obliged to follow the procedures requested by their LERBs for submitting their ethical approvals and preparing the required documentation, in alignment with the official forms and in the languages locally requested, leading to a lack of homogeneity and an increase in complexity. This situation demonstrated the fundamental importance of Ethical and Legal management in support of each pilot and the need for a unified strategy in this kind of project (LSP), which can speed up the process of the ethical application and approval, ensuring adherence to commonly recognised regulatory and ethical references.

This paper not only presents the process of managing the ethical and regulatory aspects of an LSP project that is a rarity in the international research landscape and can be considered a reference model for future similar research projects on technology on human health but it also proposes a unified ethical and legal framework that can be considered an exemplary tool to standardise procedures, overcome the existing situation, and speed up the procedural hurdles that could jeopardise the success of a research project, particularly on a large scale.

The lack of existing information on LSP projects and in particular on the management of ethical issues, as well as the need to overcome local particularisms to tend to a unique perspective among the partners of a research project, make this work unique and worthy of further studies.

Top down and bottom-up approaches

In order to provide a clear picture of all the tools assessed for the deployment of the ethical and legal management of the GATEKEEPER project, the process was divided into two main phases as described in Fig. 2 .

Workflow for establishing the unified ethical-legal framework.

Phase 1 : Preparation and deployment of the ethical action – top-down approach:

A Scoping review of existing regulations and guidelines was performed on the internet and specific websites (e.g., EU, WHO) on the theme of ethics and legal requirements for the use of AI and medical technologies in research projects 6 .

During the early stages of the project, an Ethical Risk Assessment was performed (and prevised some Mitigation Strategies). As stated previously, one of the aims of GATEKEEPER is to be able to contribute to its field of innovation and research by producing and ethical impact assessment model that could be deployed to evaluate e-health processes and products. In order to do so, a data protection and ethical assessment template was co-created and filled with the pilot representatives.

A Scoping Literature Review was performed on PubMed and it aimed at gathering knowledge relative to the management of the ethics of LSP projects. The search string, i.e., “(ethic* OR bioethics*) AND (“large scale pilot*”)” returned only 4 publications, out of which 2 were excluded because out of topic 24 . Considering the scarce number of papers extracted from the systematic approach, a scoping search on the web was also performed and a few more papers and documents on the topic were added (Supplementary Table 3 ).

With the aim of mapping the local ethical application procedure of each pilot, specific actions were performed (with the continuous support of the pilots’ sites to ethical and legal expert staff). In particular a Questionnaire on the ethical procedure steps required by each Ethical Committee per different pilot site (Supplementary Note 2 ) was created and handed out to the pilot representatives.

After obtaining information on the procedure to be followed per each pilot site, the collection of Ethical submissions started. In that stage, each pilot representative was supported in the writing and preparation of the document submitted to their reference ethical committee and for possible amendments, when needed.

Given the difference within the documents related to the ethical submission in terms of templates and languages (each pilot sent to the GK Management the original version of the submission in their own local language), it was decided to request that all pilot representatives fill in the WHO model of “Recommended format for a ‘research protocol’” ( https://www.who.int/groups/research-ethics-review-committee/recommended-format-for-a-research-protocol/ ) in the English language, which was named English Summary.

Phase 2: Analysis at the late stages of the project and proposal of the unique framework – bottom-up approach.

Taking the above into consideration, and in order to reach the proposal for a common Ethical Approval framework for health-related research activities, described below, a bottom-up approach was adopted. Benefiting from the procedures followed by partners within the GATEKEEPER project to secure the respective Ethical Approval and be able to perform their research tasks, a set of similarities and differences was identified. Said observations served as the baseline for a common Ethical Approval framework that could significantly facilitate the relevant procedures, without compromising adequate examination of each case ad-hoc.

In particular, in order to achieve the above-described objectives, the following procedure was performed:

The first step required to be able to compare the relevant procedures followed by each pilot for their Ethical Approval was the translation of all Ethical Approval application forms from their original language into English, since each Ethical Review Board performs all related activities in the official language of the region where it is based.

After their translation, a comparative analysis was performed in-depth, aiming at extracting any similarities and/or discrepancies in the approaches followed in each pilot’s case. The extensive analysis extracted, compiled, and compared all information provided across the pilot sites for their respective Ethical Approvals.

In order to ensure that the observations could be safely monitored and validated, while leaving room for reflection, an extensive comparative table was created (Supplementary Table 6 ). Said table provided a complete overview of all aspects regarding the Ethical Approval procedure, as was described in each application form, ranging from the form’s required format to the necessary supporting documentation. The table demonstrates all the unique Ethical Approval Forms that were requested in the context of the Pilots and has excluded the Ethical Approval Forms that were submitted in the same body using the same form for different RUCs. A shorter version of the comparative table (Table 2 ) can be found below, where the requirements are marked with a mark ( ✓ ), while the mark including the plus symbol ( ✓  + ) indicates the requirement that researchers provide more extensive information on the topic.

Where an element was requested in at least six ethical approval forms, this was translated in a generally applicable requirement and information that would be required.

Nonetheless, and in order to achieve the representation of all pilot sites, the remaining requirements that were required in five or less ethical approval forms, were handled in the following manner, namely they were:

Clustered, where possible based on the level of similarity, in one requirement (eg. Information on the inclusion of minors and on the inclusion of imprisoned individuals were taken into consideration in the requirement to report the inclusion of vulnerable groups); or

Reported in a simple yes/no manner, requiring that these elements are merely reported, not imposing any obligation to that end, unless otherwise required by the organisation’s internal procedures (eg. Information on whether a DPO has been appointed or whether a DPIA has been performed); or

Marked with an asterisk, meaning that the requirement may only be applicable under certain circumstances and in certain jurisdictions.

The above-described process underlined the need for further actions to propose a harmonised approach to the procedures followed by the pilots for the demonstration of their compliance with the applicable ethical and legal requirements, which is required in order to obtain the Ethical Approval and proceed with their research activities.

Reporting summary

Further information on research design is available in the Nature Research Reporting Summary linked to this article.

Data availability

The datasets used and/or analysed during the current study available from the corresponding author on reasonable request.

Ienca, M., Schneble, C., Kressig, R. W. & Wangmo, T. Digital health interventions for healthy ageing: a qualitative user evaluation and ethical assessment. BMC Geriatr. 21 , 412 (2021).

Article   PubMed   PubMed Central   Google Scholar  

Awad, A. et al. Connected healthcare: Improving patient care using digital health technologies. Adv. Drug Deliv. Rev. 178 , 113958 (2021).

Article   CAS   PubMed   Google Scholar  

Gaiduk, M., Seepold, R., Martínez Madrid, N. & Ortega, J. Digital health and care study on elderly monitoring. Sustainability 13 , 13376 (2021).

Article   Google Scholar  

Lang, T. Advancing global health research through digital technology and sharing data. Science 331 , 714–717 (2011).

de Batlle, J. et al. GATEKEEPER’s strategy for the multinational large-scale piloting of an ehealth platform: tutorial on how to identify relevant settings and use cases. J. Med Internet Res 25 , e42187 (2023).

Annicchino, P. et al. D1.10 Legal, Ethics and Privacy Protection (LEPP) Management. (2022).

Maccaro, A. et al. Ethics and biomedical engineering for well-being: a cocreation study of remote services for monitoring and support. Sci. Rep. 13 , 14322 (2023).

Article   CAS   PubMed   PubMed Central   Google Scholar  

Murphy, K. et al. Artificial intelligence for good health: a scoping review of the ethics literature. BMC Med. Ethics 22 , 14 (2021).

Raab, C. D. Information privacy, impact assessment, and the place of ethics. Comput. Law Secur. Rev. 37 , 105404 (2020).

World Commission on the Ethics of Scientific Knowledge and Technology. Report of the World Commission on the Ethics of Scientific Knowledge and Technology (COMEST) on the Ethical Implications of the Internet of Things (IoT) . https://unesdoc.unesco.org/ark:/48223/pf0000375304 (2021).

Lipford, H. R., Tabassum, M., Bahirat, P., Yao, Y. & Knijnenburg, B. P. Privacy and the Internet of Things. In Modern Socio-Technical Perspectives on Privacy (eds. Knijnenburg, B. P. et al.) 233–264 (Springer International Publishing, Cham, 2022). https://doi.org/10.1007/978-3-030-82786-1_11 .

European Parliament, E. C. Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 on the Protection of Natural Persons with Regard to the Processing of Personal Data and on the Free Movement of Such Data, and Repealing Directive 95/46/EC (General Data Protection Regulation) . OJ L 119 (2016).

European Commission. Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on the European Health Data Space . (2022).

High-Level Expert Group on Artificial Intelligence. Ethics Guidelines for Trustworthy AI . https://digital-strategy.ec.europa.eu/en/library/ethics-guidelines-trustworthy-ai (2019).

Beauchamp, T. L. & Childress, J. F. Principles of Biomedical Ethics . (Oxford University Press, New York, 2009).

OECD. The OECD Privacy Framework. (2013) https://www.oecd.org/sti/ieconomy/oecd_privacy_framework.pdf .

Nowell, J. Guide to ethical approval. BMJ b450 (2009) https://doi.org/10.1136/bmj.b450 .

Rikkert, M. G. M. O., Lauque, S., Frölich, L., Vellas, B. & Dekkers, W. The practice of obtaining approval from medical research ethics committees: a comparison within 12 European countries for a descriptive study on acetylcholinesterase inhibitors in Alzheimer’s dementia. Eur. J. Neurol. 12 , 212–217 (2005).

Article   PubMed   Google Scholar  

Hultgren, A. K., Erling, E. J. & Chowdhury, Q. H. Ethics in language and identity research. in The Routledge handbook of language and identity 257–271 (Routledge, 2016).

Dixon-Woods, M. et al. Can an ethics officer role reduce delays in research ethics approval? A mixed-method evaluation of an improvement project. BMJ Open 6 , e011973 (2016).

Christie, D. R. H., Gabriel, G. S. & Dear, K. Adverse effects of a multicentre system for ethics approval on the progress of a prospective multicentre trial of cancer treatment: how many patients die waiting? Intern. Med. J. 37 , 680–686 (2007).

Gold, J. L. & Dewa, C. S. Institutional review boards and multisite studies in health services research: is there a better way? Health Serv. Res. 40 , 291–308 (2005).

Maccaro, A. et al. Pandemic preparedness: a scoping review of best and worst practices from COVID-19. Healthcare 11 , 2572 (2023).

Nalin, M. et al. The European cross-border health data exchange roadmap: Case study in the Italian setting. J. Biomed. Inform. 94 , 103183 (2019).

Download references

Acknowledgements

The authors would like to express their sincerest gratitude to all the partners and participants of the GATEKEEPER project. In particular within the GATEKEEPER CONSORTIUM a special thanks goes to Maria Fernanda Cabrera, Maria Teresa Arredondo, Paula Curras, Jorge Posada, German Gutierrez, Sergio Guillen, Silvio Pagliara, Rosana Angles Barbastro, Maria Teresa Hurtado, Janire Orcajo Lago, Jon Eneko Idoyaga Uribarrena, Ane Fullaondo, Irati Erreguerena, Maria Krini, Yannis Manios, Eva Karaglani, Maria Vlachava, Jorge E. Dafoulas, Ioanna Drympeta, Alessio Antonini, Pasquale Innominato, Przemyslaw Kardas, Pawel Lewek, Ewelina Łojewska, Franco Mercalli, Francesco Giuliani, Julia Shellong and Kai Gand. This project has received funding from the European Union’s Horizon 2020 research and innovation program (under grant 857223), cofounded by the European Regional Development Fund (ERDF), “A way to make Europe.” The funder played no role in study design, data collection, analysis and interpretation of data, or the writing of this manuscript. Alessia Maccaro received further support from UKRI Innovate UK grant (grant number 10031483).

Author information

Authors and affiliations.

Applied Biomedical Signal Processing Intelligent eHealth Lab, University of Warwick, CV47AL, Coventry, UK

Alessia Maccaro & Davide Piaggio

UDG Alliance (UDGA), 15 rue Fort Barreau, 1201, Geneva, Switzerland

Vasiliki Tsiompanidou & Adrian Quesada Rodriguez

Life Supporting Technologies-LifeSTech, Universidad Politécnica de Madrid, 28040, Madrid, Spain

Alba M. Gallego Montejo, Gloria Cea Sánchez & Giuseppe Fico

Group of Translational Research in Respiratory Medicine, IRBLleida, Hospital Universitari Arnau de Vilanova and Santa Maria, Centro de Investigación Biomédica en Red de Enfermedades Respiratorias (CIBERES), Lleida, Spain

Jordi de Batlle

European Alliance of Medical and Biological Engineering and Science (EAMBES), Rome, Italy

Giuseppe Fico

University Campus Bio-Medico, Via Alvaro del Portillo 21, 00128, Rome, Italy

Leandro Pecchia

Fondazione Policlinico Universitario Campus Bio-Medico, Via Alvaro del Portillo, 200, 00128, Roma, Italy

You can also search for this author in PubMed   Google Scholar

Contributions

Conceptualization: A.M., V.T., D.P., A.G.M., G.C.S., J.d.B., G.F., Consortium & L.P.; Methodology: A.M., V.T.; Formal Analysis: A.M., V.T., A.Q.R.; investigation: A.M., V.T.; Resources, L.P., G.F.; Data Curation, A.M., V.T., A.G.M., G.C.S.; Writing-original draft, A.M., V.T.; Writing- review and editing, A.M., V.T., D.P., A.G.M., G.C.S., J.d.B., G.F., Consortium & L.P.; Visualization: L.P., A.Q.R., G.F.; Supervision: D.P., J.d.B., A.G.M., G.C.S.; Funding acquisition: L.P., G.F. The authors read and approved the final manuscript and are accountable for all the aspects of the work in ensuring that questions related to accuracy or integrity of any part of the work are appropriately investigated and resolved.

Corresponding author

Correspondence to Alessia Maccaro .

Ethics declarations

Competing interests.

The authors declare no competing interests.

Additional information

Publisher’s note Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Supplementary information

Supplementary material, reporting summary, rights and permissions.

Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article’s Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article’s Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/ .

Reprints and permissions

About this article

Cite this article.

Maccaro, A., Tsiompanidou, V., Piaggio, D. et al. Towards a common European ethical and legal framework for conducting clinical research: the GATEKEEPER experience. npj Digit. Med. 7 , 95 (2024). https://doi.org/10.1038/s41746-024-01092-x

Download citation

Received : 05 December 2023

Accepted : 29 March 2024

Published : 13 April 2024

DOI : https://doi.org/10.1038/s41746-024-01092-x

Share this article

Anyone you share the following link with will be able to read this content:

Sorry, a shareable link is not currently available for this article.

Provided by the Springer Nature SharedIt content-sharing initiative

Quick links

• Explore articles by subject
• Guide to authors
• Editorial policies

Sign up for the Nature Briefing newsletter — what matters in science, free to your inbox daily.

WMU nursing students lead hospital study that could change future of pressure-wound monitoring

Students Maddie Bies, Jordyn Swenson and David Le are making an impact at Ascension Borgess Hospital with a project for their nursing leadership and management course.

Dave Neuman prepares WMU student volunteers for their work on the IPUP Survey.

Students walk from Ascension Borgess's Navigation Center to the hospital where they will begin observing patients.

Western's student leaders gathered the largest number of student volunteers to date for the IPUP Survey at Ascension Borgess Hospital.

Maddie Bees helps fellow nursing students enter information into the computer system.

Students learn charting skills and interact with patients while conducting the IPUP Survey.

KALAMAZOO, Mich.—An innovative effort is underway to better detect and prevent pressure wounds at Ascension Borgess Hospital, and Western Michigan University nursing students are leading the charge.

"This is cutting-edge work," says Dave Neuman , wound ostomy coordinator at Ascension Borgess.  

Students Maddie Bies , David Le and Jordyn Swenson are conducting research and compiling data to help the hospital determine if a new pressure ulcer risk assessment scale could lead to better patient care. Neuman emphasized the potential impact of the Western team's work in an email to their professor, Dr. Kelley Pattison .

Currently, the Braden Scale is the industry standard in terms of scoring risk factors for ulcers. But scoring is subjective and can vary depending on who is filling out the chart. The Shieh Score is a new tool developed to be more objective.

"We tell them all the time how important charting and documentation is … but this really gives them examples and will help their skills after graduation," says Jaime Neary, faculty specialist II of nursing.

"What the Western Michigan University students are doing is retrospectively analyzing our internal data utilizing the Shieh scale to see if we could have captured more patients who would have been pressure injury risks who were not labeled as risks," Neuman says.

The students are working with Neuman and his colleague Tammy Austin , a wound nurse and preceptor, through a nursing leadership and management class that all Bronson School of Nursing students take in their final semester before graduation. It pairs students with a nurse leader in the community to do a project related to patient safety and quality.

"The fact that we're last-year nursing students on the forefront of this effort is pretty phenomenal," says Le, of Portage. "I really love research, and this project reflects how much care has evolved—and we're adding to it. I know we're just at the beginning, but it's crazy to think that one day maybe hospitals will be using this Shieh scale."

"Health care is ever-changing; nursing is ever-changing. We're always researching and updating our practices," adds Swenson, of Homer Glen, Illinois. "I like seeing this new scale and seeing how well it's working so far. … I'm really excited to see where this goes and see how it's implemented into this hospital and possibly throughout the country."

The results of the research are being presented to hospital leadership and could potentially lead to the Shieh Score being adopted not just locally but systemwide within Ascension.

"The initial data from the students' research is already so compelling that nursing leadership is excited about the possibilities," says Neuman.

It's also opening up potential future career possibilities for the students, who admit they'd never considered research or community nursing before this project.

"It's really cool because we're getting to step into not just the clinical side of nursing that we've been so used to, we're able to dig into the research and continuing education aspect," says Bies, of Kingsley, Michigan, who plans to start her career as a patient care nurse. "This has opened the doors and shown that this is a part of nursing and this is an option for me."

UNIQUE EXPERIENCE

Bies, Le and Swenson also recently led the annual International Pressure Ulcer/Injury Prevention (IPUP) Survey at Ascension Borgess, which is conducted by more than 1,000 facilities around the globe to assess the number and severity of pressure wounds in health care systems. The Western team coordinated a group of two dozen fellow nursing students to staff the daylong effort.

"To the best of my knowledge, this is the only student-run operation in the nation. 

We've been doing this in collaboration with Western for about five or six years now, and it's been fantastically successful," says Neuman.

Bies, Swenson and Le

Six years ago, a Western nursing student in the same course created the student-led survey as her project, and it has grown every year. This year's student volunteer group was the largest the hospital has seen.

"I've had nothing but excellent students from Western in my entire tenure here," Neuman says. "It says a lot about our student externs and the buy-in from the University. It's just a great partnership."

"Every year it gets better," Austin adds. "This group is the best we've had yet. They're absolutely phenomenal."

It also allows students to gain resume-worthy experience that could give them a leg up when they begin applying for jobs.

"We're really honing in on advancing their assessment skills. When they do these surveys, they're finding that the pressure ulcers are not always properly charted, so it's giving them a lot of practice for assessment skills and communication skills in explaining what they are doing to patients," says Jaime Neary , faculty specialist II of nursing. "We tell them all the time how important charting and documentation is … but this really gives them examples and will help their skills after graduation."

The opportunity to focus on patient care and have a measurable impact at the hospital reinforces the reason the students chose Western to explore this profession in the first place.

"I want something where every day I walk away knowing that I made a difference in someone's life," Bies says. "Nursing truly fulfills that passion for me in caring for others."

For more WMU news, arts and events , visit WMU News online.

University of Missouri

• Faculty Directory
• Staff Directory
• Calendar & Events

Mizzou Engineering

Show me success: students showcase work during show me research week.

April 12, 2024

Judging from the innovative projects and research they presented this week, it’s evident that engineering students at Mizzou are getting ready to change the world.

Show Me Research Week , held in April, gives students an opportunity to present the work that they conduct throughout the year in front of judges and other interested students and members of the Mizzou community. This year, more than 60 engineering students chose to present work as part of the Research and Creative Achievements Symposium.

One presenter, mechanical engineering student Sarah Muller, has been working on research with Associate Professor Roger Fales for the last four years to create a device (currently in clinical trials) that monitors and automatically adjusts oxygen levels for pre-mature babies. Over the years she’s become a regular presenter at Mizzou’s undergraduate research forums.

“I’m an engineer. I never thought I would want to do something in a hospital, but I’ve always wanted to do something that helps people and impacts the world in a positive way,” Muller said. “I’ve worked on this project for four years and presented work at research forums for the last four semesters. It’s a cool way to network with people and showcase my work.”

Since last year’s inaugural event, the symposium grew by more than 120 students across academic units and expanded to span over three days of poster and oral presentations in Memorial Union.  

For engineering undergraduates, the opportunity to present research is a great way to prepare for life as a graduate student. Olivia Heyne, originally from North English, Iowa, is now a biomedical engineering sophomore at Mizzou planning to continue her education.  

“I wasn’t initially thinking about graduate school, but I am now,” she said. “I love the lab environment. I love being able to do all this hands-on research. I also work at the hospital and have been able to meet with patients and being able to see the impacts of research like mine—even though I’m not a frontline health care worker—has been really rewarding.”

And even if one isn’t planning on continuing their education, biomedical engineering senior Nate Forck recommends other students get involved. 

“You should get into a lab,” he said. “If you’re in STEM, you should be looking for that lab experience. I definitely recommend it. You will meet a lot of people and learn a lot of stuff, just about every day.” 

For sophomore Brady Danek, the in-lab work he’s done has prepared him for becoming a scientist in addition to his engineering coursework. 

“I enjoyed the hand on experience, actually being in the lab, feeling like a real scientist,” he said. “I’m not just sitting at a desk taking in information, or reading off a whiteboard. I’m finding things out for myself.” 

Exercise your creativity and fuel your passion for discovery by engaging in research as an undergraduate. Choose Mizzou Engineering !  

• Missouri Compacts - Research and Creative Works
• Missouri Compacts - Student Success
• Undergraduate Research

• Madison, Wisconsin
• SCHOOL OF MEDICINE AND PUBLIC HEALTH/FAMILY MEDICINE-GEN
• Partially Remote
• Staff-Full Time
• Opening at: Apr 12 2024 at 16:00 CDT
• Closing at: Apr 29 2024 at 23:55 CDT

Job Summary:

This Researcher position will support the research program of Rachel Grob, MA, PhD and will provide research expertise to fundamental and applied scientific research and solve problems in research development and applications to support the advancement of the Qualitative and Health Experiences Research (Q-HER) Lab. Responsibilities will include overall research support, assisting in grant submissions, developing reports, conducting literature reviews, co-authoring publications, project management, leading dissemination and implementation for various projects including working with and overseeing work with data in video and audio as well as transcript formats. This position may supervise student workers.

Responsibilities:

• 20% Collects and analyzes basic research data, conducts experiments and interviews, and documents results according to established policies and procedures
• 20% Conducts literature reviews, prepares reports and materials, and disseminates information to appropriate entities and assists with publications
• 10% Trains individuals and groups on equipment operations, research protocols, and techniques within a specialized laboratory or research area
• 20% Assists with the development of research methodologies and procedures
• 5% Identifies concerns and recommends solutions to leadership
• 5% Assists in developing grant applications and proposals to secure research funding
• 10% Helps prepare, organize, and maintain video, audio, and text clips for the study team
• 10% Provides operational guidance on day-to-day activities of unit or program staff and/or student workers

Institutional Statement on Diversity:

Diversity is a source of strength, creativity, and innovation for UW-Madison. We value the contributions of each person and respect the profound ways their identity, culture, background, experience, status, abilities, and opinion enrich the university community. We commit ourselves to the pursuit of excellence in teaching, research, outreach, and diversity as inextricably linked goals. The University of Wisconsin-Madison fulfills its public mission by creating a welcoming and inclusive community for people from every background - people who as students, faculty, and staff serve Wisconsin and the world. For more information on diversity and inclusion on campus, please visit: Diversity and Inclusion

Required Master's Degree Preferred focus in Public Health or related field

Qualifications:

- Minimum two years of experience in public health or social research environment required. Graduate and/or student experience will be considered. - Experience working with health experiences data in multiple formats preferred. - Experience providing staff or student support within a multidisciplinary team is desirable. - One year of experience in qualitative or mixed-methods research is preferred, including any related experience in dissemination and implementation. - Ability to communicate effectively (verbal and written). - Proficiency with Microsoft Office Suite, MAXQDA software, and/or Abode premier software. - Detail-oriented with excellent interpersonal, problem-solving and organization skills.

License/Certification:

Required Drivers License - Valid and Meets UW Risk Management Standards Travel is required. Must provide a valid driver's license. Employees may use their own transportation or receive approval for University Car Fleet usage. Employment is conditional pending the results of a Pre-hire Driver Authorization Check. See https://businessservices.wisc.edu/managing-risk/driver-authorization-and-insurance/driver-authorization/#become-authorized-driver (click on "Become an authorized driver;" then click on "Required criteria").

Full or Part Time: 80% - 100% This position may require some work to be performed in-person, onsite, at a designated campus work location. Some work may be performed remotely, at an offsite, non-campus work location.

Appointment Type, Duration:

Ongoing/Renewable

Minimum $42,226 ANNUAL (12 months) Depending on Qualifications The starting salary for the position is $42,226 but is negotiable based on experience and qualifications. Employees in this position can expect to receive benefits such as generous vacation, holidays, and sick leave; competitive insurances and savings accounts; retirement benefits. Benefits information can be found at: https://hr.wisc.edu/benefits/ SMPH Academic Staff Benefits flyer: https://uwmadison.box.com/s/r50myohfvfd15bqltljn0g4laubuz7t0

Additional Information:

The University of Wisconsin Department of Family Medicine and Community Health (DFMCH) is a large, tier-one clinical department in the UW School of Medicine and Public Health that offers outstanding educational and research programs. UW DFMCH has 204 faculty, 211 adjunct faculty, and 170 staff located throughout the state transforming health care for all. There are over 160 residents in our sponsored and academic partner programs, with the Madison residency program ranking ninth in the nation for 2023. More than 400 medical students train in the department each year. In fiscal year 2023, our physicians and residents practicing at 17 clinics throughout the state managed over 403,900 patient visits - an integral part of the department's success that demonstrates its commitment to patient care. Research funding from the NIH and other state, federal and private sources exceeded $6.7 million in fiscal year 2023 and supported major research projects in pain management, opioid prescription guidelines, mobile health for alcohol use disorder treatment, management of sinusitis, and infectious disease surveillance. Learn more about our department's work by visiting https://www.fammed.wisc.edu/ DFMCH has a Diversity, Equity, and Inclusion (DEI) Committee that was formed in 2015. The committee's vision is for DFMCH to be a place where everyone feels engaged, included, and has a sense of belonging; a place that reflects the community we serve at all levels. Learn about our DEI commitment here: https://www.fammed.wisc.edu/diversity/ University sponsorship is not available for this position. The selected applicant will be responsible for ensuring their continuous eligibility for employment in the United States on or before the effective date of the appointment. UW-Madison is not an E-Verify employer, and therefore, is not eligible to employ F1-OPT STEM Extension participants. This position has been identified as a position of trust with access to vulnerable populations. The selected candidate will be required to pass an initial caregiver check to be eligible for employment under the Wisconsin Caregiver Law and then every two years.

How to Apply:

To apply for this position, please click on the "Apply Now" button. You will be asked to upload a current resume/CV and a cover letter briefly describing your qualifications and experience. Finalists may be asked to complete and submit results from a brief exercise coding a small amount of qualitative data (instructions will be included).

Paige Steinert [email protected] 608-890-1740 Relay Access (WTRS): 7-1-1. See RELAY_SERVICE for further information.

Official Title:

Researcher I(RE040)

Department(s):

A53-MEDICAL SCHOOL/FAMILY MED/RES GRANTS

Employment Class:

Academic Staff-Renewable

Job Number:

The university of wisconsin-madison is an equal opportunity and affirmative action employer..

You will be redirected to the application to launch your career momentarily. Thank you!

Frequently Asked Questions

Applicant Tutorial

Disability Accommodations

Pay Transparency Policy Statement

Refer a Friend

You've sent this job to a friend!

Website feedback, questions or accessibility issues: [email protected] .

Learn more about accessibility at UW–Madison .

© 2016–2024 Board of Regents of the University of Wisconsin System • Privacy Statement