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Legal Basis for Research

Primary use of data.

In advance of any data collection, Researchers must inform participants of the legal basis under GDPR.  

Personal Data

We advise researchers to rely on Article 6 (1)(e) GDPR quoted in full below:

It is a primary object and function of the University under the Irish Universities Act 1997, (section 12 (a),(j) and section 13 (b)) to promote and facilitate research.

Special Category Personal Data (or Sensitive Personal Data)

We advise researchers to rely on Article 9(2)(j) GDPR quoted in full below: 

Secondary Data Use – Legal Basis for Research

If researchers wish to use personal data for a secondary use, such use is presumed compatible with the original purpose – if the research is in the public interest (Article 5(1) GDPR). 

Researchers should carry out due diligence on any third party provider of data, and Data Transfer Agreements should be put in place to record any transfers into Trinity College Dublin. 

Legal Research Strategy

Preliminary analysis, organization, secondary sources, primary sources, updating research, identifying an end point, getting help, about this guide.

This guide will walk a beginning researcher though the legal research process step-by-step. These materials are created with the 1L Legal Research & Writing course in mind. However, these resources will also assist upper-level students engaged in any legal research project.

How to Strategize

Legal research must be comprehensive and precise.  One contrary source that you miss may invalidate other sources you plan to rely on.  Sticking to a strategy will save you time, ensure completeness, and improve your work product. 

Follow These Steps

Running Time: 3 minutes, 13 seconds.

Make sure that you don't miss any steps by using our:

• Legal Research Strategy Checklist

If you get stuck at any time during the process, check this out:

• Ten Tips for Moving Beyond the Brick Wall in the Legal Research Process, by Marsha L. Baum

Understanding the Legal Questions

A legal question often originates as a problem or story about a series of events. In law school, these stories are called fact patterns. In practice, facts may arise from a manager or an interview with a potential client. Start by doing the following:

• Read anything you have been given
• Analyze the facts and frame the legal issues
• Assess what you know and need to learn
• Note the jurisdiction and any primary law you have been given
• Generate potential search terms

Jurisdiction

Legal rules will vary depending on where geographically your legal question will be answered. You must determine the jurisdiction in which your claim will be heard. These resources can help you learn more about jurisdiction and how it is determined:

• Legal Treatises on Jurisdiction
• LII Wex Entry on Jurisdiction

This map indicates which states are in each federal appellate circuit:

Getting Started

Once you have begun your research, you will need to keep track of your work. Logging your research will help you to avoid missing sources and explain your research strategy. You will likely be asked to explain your research process when in practice. Researchers can keep paper logs, folders on Westlaw or Lexis, or online citation management platforms.

Organizational Methods

Tracking with paper or excel.

Many researchers create their own tracking charts.  Be sure to include:

• Search Date
• Topics/Keywords/Search Strategy
• Citation to Relevant Source Found
• Save Locations
• Follow Up Needed

Consider using the following research log as a starting place: 

• Sample Research Log

Tracking with Folders

Westlaw and Lexis offer options to create folders, then save and organize your materials there.

• Lexis Advance Folders
• Westlaw Edge Folders

Tracking with Citation Management Software

For long term projects, platforms such as Zotero, EndNote, Mendeley, or Refworks might be useful. These are good tools to keep your research well organized. Note, however, that none of these platforms substitute for doing your own proper Bluebook citations. Learn more about citation management software on our other research guides:

• Guide to Zotero for Harvard Law Students by Harvard Law School Library Research Services Last Updated Aug 9, 2024 408 views this year
• Zotero by Daniel Becker Last Updated Aug 30, 2024 27681 views this year

Types of Sources

There are three different types of sources: Primary, Secondary, and Tertiary.  When doing legal research you will be using mostly primary and secondary sources.  We will explore these different types of sources in the sections below.

Secondary sources often explain legal principles more thoroughly than a single case or statute. Starting with them can help you save time.

Secondary sources are particularly useful for:

• Learning the basics of a particular area of law
• Understanding key terms of art in an area
• Identifying essential cases and statutes

Consider the following when deciding which type of secondary source is right for you:

• Scope/Breadth
• Depth of Treatment
• Currentness/Reliability

For a deep dive into secondary sources visit:

• Secondary Sources: ALRs, Encyclopedias, Law Reviews, Restatements, & Treatises by Catherine Biondo Last Updated Apr 12, 2024 6646 views this year

Legal Dictionaries & Encyclopedias

Legal dictionaries.

Legal dictionaries are similar to other dictionaries that you have likely used before.

• Black's Law Dictionary
• Ballentine's Law Dictionary

Legal Encyclopedias

Legal encyclopedias contain brief, broad summaries of legal topics, providing introductions and explaining terms of art. They also provide citations to primary law and relevant major law review articles.  

Here are the two major national encyclopedias:

• American Jurisprudence (AmJur) (Westlaw)
• American Jurisprudence (Lexis)
• Corpus Juris Secundum (CJS)

Treatises are books on legal topics.  These books are a good place to begin your research.  They provide explanation, analysis, and citations to the most relevant primary sources. Treatises range from single subject overviews to deep treatments of broad subject areas.

It is important to check the date when the treatise was published. Many are either not updated, or are updated through the release of newer editions.

To find a relevant treatise explore:

• Legal Treatises by Subject by Catherine Biondo Last Updated Apr 12, 2024 6232 views this year

American Law Reports (ALR)

American Law Reports (ALR) contains in-depth articles on narrow topics of the law. ALR articles, are often called annotations. They provide background, analysis, and citations to relevant cases, statutes, articles, and other annotations. ALR annotations are invaluable tools to quickly find primary law on narrow legal questions.

This resource is available in both Westlaw and Lexis:

• American Law Reports on Westlaw (includes index)
• American Law Reports on Lexis

Law Reviews & Journals

Law reviews are scholarly publications, usually edited by law students in conjunction with faculty members. They contain both lengthy articles and shorter essays by professors and lawyers. They also contain comments, notes, or developments in the law written by law students. Articles often focus on new or emerging areas of law and may offer critical commentary. Some law reviews are dedicated to a particular topic while others are general. Occasionally, law reviews will include issues devoted to proceedings of panels and symposia.

Law review and journal articles are extremely narrow and deep with extensive references. 

To find law review articles visit:

• Law Journal Library on HeinOnline
• Law Reviews & Journals on LexisNexis
• Law Reviews & Journals on Westlaw

Restatements

Restatements are highly regarded distillations of common law, prepared by the American Law Institute (ALI). ALI is a prestigious organization comprised of judges, professors, and lawyers. They distill the "black letter law" from cases to indicate trends in common law. Resulting in a “restatement” of existing common law into a series of principles or rules. Occasionally, they make recommendations on what a rule of law should be.

Restatements are not primary law. However, they are considered persuasive authority by many courts.

Restatements are organized into chapters, titles, and sections.  Sections contain the following:

• a concisely stated rule of law,
• comments to clarify the rule,
• hypothetical examples,
• explanation of purpose, and
• exceptions to the rule  

To access restatements visit:

• American Law Institute Library on HeinOnline
• Restatements & Principles of the Law on LexisNexis
• Restatements & Principles of Law on Westlaw

Primary Authority

Primary authority is "authority that issues directly from a law-making body."   Authority , Black's Law Dictionary (11th ed. 2019).   Sources of primary authority include:

• Constitutions
• Statutes 

Regulations

Access to primary legal sources is available through:

• Bloomberg Law
• Free & Low Cost Alternatives

Statutes (also called legislation) are "laws enacted by legislative bodies", such as Congress and state legislatures.  Statute , Black's Law Dictionary (11th ed. 2019).

We typically start primary law research here. If there is a controlling statute, cases you look for later will interpret that law. There are two types of statutes, annotated and unannotated.

Annotated codes are a great place to start your research. They combine statutory language with citations to cases, regulations, secondary sources, and other relevant statutes. This can quickly connect you to the most relevant cases related to a particular law. Unannotated Codes provide only the text of the statute without editorial additions. Unannotated codes, however, are more often considered official and used for citation purposes.

For a deep dive on federal and state statutes, visit:

• Statutes: US and State Codes by Mindy Kent Last Updated Apr 12, 2024 4982 views this year
• 50 State Surveys

Want to learn more about the history or legislative intent of a law?  Learn how to get started here:

• Legislative History Get an introduction to legislative histories in less than 5 minutes.
• Federal Legislative History Research Guide

Regulations are rules made by executive departments and agencies. Not every legal question will require you to search regulations. However, many areas of law are affected by regulations. So make sure not to skip this step if they are relevant to your question.

To learn more about working with regulations, visit:

• Administrative Law Research by AJ Blechner Last Updated Apr 12, 2024 835 views this year

Case Basics

In many areas, finding relevant caselaw will comprise a significant part of your research. This Is particularly true in legal areas that rely heavily on common law principles.

Running Time: 3 minutes, 10 seconds.

Unpublished Cases

Up to  86% of federal case opinions are unpublished. You must determine whether your jurisdiction will consider these unpublished cases as persuasive authority. The Federal Rules of Appellate Procedure have an overarching rule, Rule 32.1  Each circuit also has local rules regarding citations to unpublished opinions. You must understand both the Federal Rule and the rule in your jurisdiction.

• Federal and Local Rules of Appellate Procedure 32.1 (Dec. 2021).
• Type of Opinion or Order Filed in Cases Terminated on the Merits, by Circuit (Sept. 2021).

Each state also has its own local rules which can often be accessed through:

• State Bar Associations
• State Courts Websites

First Circuit

• First Circuit Court Rule 32.1.0

Second Circuit

• Second Circuit Court Rule 32.1.1

Third Circuit

• Third Circuit Court Rule 5.7

Fourth Circuit

• Fourth Circuit Court Rule 32.1

Fifth Circuit

• Fifth Circuit Court Rule 47.5

Sixth Circuit

• Sixth Circuit Court Rule 32.1

Seventh Circuit

• Seventh Circuit Court Rule 32.1

Eighth Circuit

• Eighth Circuit Court Rule 32.1A

Ninth Circuit

• Ninth Circuit Court Rule 36-3

Tenth Circuit

• Tenth Circuit Court Rule 32.1

Eleventh Circuit

• Eleventh Circuit Court Rule 32.1

D.C. Circuit

• D.C. Circuit Court Rule 32.1

Federal Circuit

• Federal Circuit Court Rule 32.1

Finding Cases

Headnotes show the key legal points in a case. Legal databases use these headnotes to guide researchers to other cases on the same topic. They also use them to organize concepts explored in cases by subject. Publishers, like Westlaw and Lexis, create headnotes, so they are not consistent across databases.

Headnotes are organized by subject into an outline that allows you to search by subject. This outline is known as a "digest of cases." By browsing or searching the digest you can retrieve all headnotes covering a particular topic. This can help you identify particularly important cases on the relevant subject.

Running Time: 4 minutes, 43 seconds.

Each major legal database has its own digest:

• Topic Navigator (Lexis)
• Key Digest System (Westlaw)

Start by identifying a relevant topic in a digest.  Then you can limit those results to your jurisdiction for more relevant results.  Sometimes, you can keyword search within only the results on your topic in your jurisdiction.  This is a particularly powerful research method.

One Good Case Method

After following the steps above, you will have identified some relevant cases on your topic. You can use good cases you find to locate other cases addressing the same topic. These other cases often apply similar rules to a range of diverse fact patterns.

• in Lexis click "More Like This Headnote"
• in Westlaw click "Cases that Cite This Headnote"

to focus on the terms of art or key words in a particular headnote. You can use this feature to find more cases with similar language and concepts.  ​

Ways to Use Citators

A citator is "a catalogued list of cases, statutes, and other legal sources showing the subsequent history and current precedential value of those sources.  Citators allow researchers to verify the authority of a precedent and to find additional sources relating to a given subject." Citator , Black's Law Dictionary (11th ed. 2019).

Each major legal database has its own citator.  The two most popular are Keycite on Westlaw and Shepard's on Lexis.

• Keycite Information Page
• Shepard's Information Page

Making Sure Your Case is Still Good Law

This video answers common questions about citators:

For step-by-step instructions on how to use Keycite and Shepard's see the following:

Additional Shepard's Resources

• Shepard's Video Tutorial
• Shepard's Handout
• Shepard's Editorial Phrase Dictionary
• Shepard's Signal Indicators & Analysis Phrases
• Shepard's Citation Services User Guide
• Lexis+ Support and Training Additional online videos and handouts for Lexis+.

Additional KeyCite Resources

• How to Ensure I'm Citing Good Law (Westlaw Video)
• KeyCite Handout
• KeyCite Editorial Phrase Dictionary
• Understanding Next Generation KeyCite
• How to Check the Status of a Case with KeyCite
• Westlaw Precision Support Additional videos and handouts to support your Westlaw research.

Using Citators For

Citators serve three purposes: (1) case validation, (2) better understanding, and (3) additional research.

Case Validation

Is my case or statute good law?

• Parallel citations
• Prior and subsequent history
• Negative treatment suggesting you should no longer cite to holding.

Better Understanding

Has the law in this area changed?

• Later cases on the same point of law
• Positive treatment, explaining or expanding the law.
• Negative Treatment, narrowing or distinguishing the law.

Track Research

Who is citing and writing about my case or statute?

• Secondary sources that discuss your case or statute.
• Cases in other jurisdictions that discuss your case or statute.

Knowing When to Start Writing

For more guidance on when to stop your research see:

• Terminating Research, by Christina L. Kunz

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• Last Updated: Aug 27, 2024 5:19 PM
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Legal Research Basics: A Step-By-Step Guide to Brushing Up on Your Skills

Legal research is imperative to the practice of law. Depending on where you are in your legal career, there could be multiple reasons to brush up on the basics of legal research. You could be a: 

• Law student or recent graduate preparing for your career 
• Seasoned attorney aiming to brush up on the basics amidst ever-evolving legal research technology 
• Growing law firm preparing to train new attorneys or paralegals 

Regardless of which of these categories you align with most, reviewing the basics of legal research should become regular practice. After all, the importance of legal research cannot be overstated – pinpointing the best facts and knowledge for your case can make the difference between winning and losing.  

Use this article to review the basics and set yourself (and your firm) up for success. First, we’ll define legal research and its components. Then, we’ll walk you through a step-by-step process for conducting superior legal research. Finally, we’ll close with recommendations for tools that can help you become both an accurate and efficient legal researcher – which ultimately equips you with a reputation for success in the courtroom.  

What is Legal Research?

Legal research is defined as the process of identifying and retrieving information necessary to support legal decision-making. There are multiple reasons you might conduct legal research: 

• To find “good” case law that backs up your motion or brief  
• To provide legal counsel to clients  
• To provide a memo or brief for class (law students only)  
• To identify case law that refutes an opposing argument 
• To support the over-arching narrative of your case 

What is the Importance of Legal Research?

Legal research provides support for decision-making on complex issues, by providing specific facts and legal precedent that allow you to produce complete answers for clients. Quality legal research is critical to the practice of law.

Historically, attorneys combed through books and libraries for the perfect facts, cases, and issues; now, technology has largely replaced this process. While the prominence of ever-evolving technology has made the process more efficient (and, in many ways, easier), the sheer number of products and options available can be overwhelming.  

The Legal Research Process

Understanding that the legal research process can be overwhelming and time-consuming, we’ve broken the legal research process down into three key steps: 

• Understand the facts of your case 
• Gather sources of law 
• Check your citations for “good” law 

Each of these steps is detailed below, alongside a quick-view checklist.  

Step 1: Record the Facts of Your Case and Create a Research Plan  

Handling a legal task with authority requires confidence in the process. This is true in any practice, jurisdictional setting, or level of legal expertise. A good process should start by taking time to identify and understand the facts of your case. Ask yourself the following questions: 

• What is the legal issue at hand?  
• What are the details of the case?  
• What jurisdiction is most relevant?  
• Do you need state or federal case law? 

Record your facts in a case management tool before beginning – this can help you develop a course of action and narrow down where to start your research. While it may be tempting to skip this step, a commitment to this process saves you time in the long run by helping you efficiently juggle multiple clients. Not to mention, you will likely need what you’ve recorded to file a motion or brief. 

With the facts of the case recorded, you can begin your research. Because this will help you develop a plan for gathering your sources, we will briefly discuss creating a research plan before moving on to Step 2.  

Did you know? LexisNexis boasts a collection of state case law superior to its leading competitors. Easily filter by jurisdiction before or after your search.  

Creating a Research Plan  

Review the facts you recorded to determine what information you will need to build your case. When legal research first moved online, many attorneys felt the need to start with a free service like Google to identify terms of art before conducting a search in a legal research platform. However, this is no longer necessary. Research platforms like Lexis+ allow you to start your search with a natural language search or question and equip you to quickly comb both primary and secondary sources. Litigators, specifically, can use Fact and Issue Finder – integrated directly with Lexis+ – to help quickly identify the best terms of art for their search.  

Creating your research plan is less about planning where you will search and more about planning what you will search. You know your research can be conducted on one, fully integrated platform. So, what questions will you ask to get started? What legal issues do you need more information about? What filters will you need (jurisdiction, time period, etc.)?  

Once you know what you will search for, you are ready to gather sources.  

Step 2: Gather Sources of Law  

The next step in your process is to gather relevant sources of law. Below, we detail the difference between primary law and secondary law. Importantly, when gathering sources, start with secondary law materials. This helps ensure you are up-to-speed on what experts have to say about a topic before you begin your case law search. Why does this matter? Think about it as building your knowledge base before crafting an argument – you’ll be less likely to make mistakes and more inclined to spot case-winning primary law.  

What are Secondary Sources of Law?  

Secondary legal sources are materials that describe or interpret the law. They are educational resources that provide analysis of the law. These documents are cited by attorneys to persuade a court to reach a particular decision in a case, but which the court is not obligated to follow. Start with secondary sources to learn from legal experts that have already explored a given topic.  

Secondary sources may include: 

• Practice guides 
• Legal treatises 
• Law review articles 
• Scholarly journals 
• Legal news 
• Jury instructions 
• Legal dictionaries and encyclopedias 

What are Primary Sources of Law?  

A primary legal source is a formal document officially issued by the government that establishes the law on a particular matter, such as a case decision or legislative act. Primary sources are the law. This is the most authoritative step in the legal research process. You can support arguments with primary sources as they are not only authoritative, but precedential and controlling.  

Your primary sources may include: 

• Case law (federal and/or state) 
• Orders 
• Decisions 
• Statutes and regulations 
• Constitutions  
• Treatises 

Step 3: Check to See If You’re Using Good Law   

The final step in your research process should include a final check to ensure you have used “good” law – this means you are using case law that has been treated positively in court (as opposed to case law that has been overturned or brought into question). 

Check your case citations as you collect them, especially since legal research software can allow a quick view of how your case has been treated in court directly from your search results. However, it is best practice to review your citations once your research process is complete to check for any gaps, changes, or oversights.  

Read more about using good law and the process of " Shepardizing ."

Conduct Winning Legal Research  

Following this three-step process ensures you’re taking the right measures to find the most accurate, relevant and valuable data to achieve your objectives. Now that you’re ready to conduct winning legal research, take some time to review products and tools that can help you in your path to success.  

Getting Started with Legal Research Tools   

Legal research is key to drafting effective documents and building winning cases. Legal research solutions have evolved substantially – helping you conduct legal research with increased efficiency and accuracy . Below is a list of legal research tools to help you build a winning case:  

• Lexis +:  This is the premier LexisNexis fully integrated legal research platform. Features such as Shepard's At Risk ensures you’re citing only the most authoritative sources, with unprecedented visibility into whether a case is at risk of being overruled or undermined. Other Lexis+ features include, but aren’t limited to: 
• Brief Analysis: Get a clear picture of the contents of your legal brief to identify any missteps and bolster your arguments against opposing counsel. Simply upload and file and quickly evaluate the legal authority cited in your (or an opposing) brief in granular detail and receive recommendations for additional searches.  
• Litigation Analytics: Get the most accurate insights into judges, courts, attorneys, and law firms to ensure your success in litigation. Understand critical insights regarding caseloads, experience across case types, timing to key milestones, and damages by comparing federal districts and judges. 
• Shepard's ® Citations Service:  See if a case has been overturned, reaffirmed, questioned, or cited by later cases, or is at risk of negative treatment. Your research needs to provide precedential value. Using reversed or overruled authority doesn't qualify as "Good Law" and your research may be ineffectual or harmful to your case.  
• Practical Guidance: View professional insights on 20 different practice areas. Accomplish any task with practice notes, annotated templates, and checklists.  
• Legal News Hub: Receive up-to-the-minute, award-winning journalism and legal news from Law360 and Law360 Pulse anytime you need it — without having to leave the Lexis+ ecosystem. Stay current on critical developments across legal practice areas, with over 70 coverage areas spanning the practice and business of law. 

LexisNexis is here to support your firm in winning your next case. With Lexis+, all of your legal research needs are integrated into one platform as a true start-to-finish solution. Ready to learn more? Take a guided tour of Lexis+ today. 

Buy Now    Free Lexis+ Access

• Practical Guidance
• Legal Research
• Shepard's Citations Service

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Legal basis for processing data

This technical guidance has been produced for data protection officers, information governance officers and research governance managers. 

What is processing data?

Processing data includes doing any of the following to the data:

Organisations must have a valid, legal reason to process personal data. This is called a ‘legal basis’. This requirement is not new, however there are some important changes in the forthcoming legislation. Organisations have to record, and inform data subjects, what their legal basis for processing data is.

The legal basis that research organisations have used under the 1998 data protection legislation is most likely to support ‘legitimate interests’. Under GDPR, commercial companies and charitable research organisations will continue to use ‘legitimate interests’ as their legal basis.

However, public authorities (as defined in Freedom of Information legislation), when carrying out public tasks – such as research in NHS organisations, universities and Research Council institutes – will no longer be able to use ‘legitimate interests’. Instead, they will use ‘task in the public interest’ as their legal basis. Public authorities should document their justification for this, by reference to their public research purpose as established by statute or University Charter.

The new legislation does not introduce different standards between organisations that use ‘legitimate interests’ and organisations that use ‘task in the public interest’.

The legislation will also require research organisations to be explicit about which of the new legal bases they are using. Under the new legislation, you will need:

• a legal basis to process personal data; and
• an additional legal basis to process any ‘special category’ personal data (e.g. health information).

Legal basis and consent

Consent is an important part of the research process and is frequently sought for participation in research studies. One reason is to ensure that any disclosure of confidential information meets the requirements of the common law duty of confidentiality. Where consent is sought from research participants, they are normally told how information about them will be used.

Consent to participation in research is not the same as consent as the legal basis for processing under data protection legislation. An example is that a person is asked to consent to participate in research but is told that, if they agree to participate, data about them will be processed for a task in the public interest. The legal basis for data processing is not consent.

If you use consent as the legal basis for your processing and a participant withdraws their consent, you will not have a legal basis to process personal data about them. See the ICO guidance on consent  to understand the implications.

If you use 'task in the public interest', it does not automatically mean that the requirements of the common law duty of confidentiality have been met. The requirements of both data protection legislation and the common law duty of confidentiality must be satisfied. National guidance on confidentiality is unaffected by the GDPR (see the Information Governance Alliance’s GDPR guidance on consent  and information about the Confidentiality Advisory Group on the HRA website for more information).

Legal basis for processing personal data

Data controllers must already have a legal basis for processing personal data. However, the new data protection law makes some changes in this area. For example, organisations must now include the legal basis for processing in a ‘privacy notice’ (the information for data subjects about processing). This information should be given at the appropriate level. For example, the legal basis for a research organisation’s processing can be provided in corporate information but project-specific details about the purpose of the processing should belong in the participant information sheet for the individual research project. 

Legal basis for processing ‘special category’ personal data

‘Special category’ personal data is:

• data which reveals racial or ethnic origin, political opinions, religious or philosophical beliefs, trade union membership
• data concerning health (the physical or mental health of a person, including the provision of health care services)
• data concerning sex life or sexual orientation
• genetic or biometric data processed to uniquely identify a natural person.

‘Genetic data’ means personal data relating to the inherited or acquired genetic characteristics of a natural person which give unique information about the physiology or the health of that natural person and which result, in particular, from an analysis of a biological sample from the natural person in question.

Whether processed by a public authority or by a commercial organisation or charitable research organisation, special category personal data can be processed for research purposes, but only if processing such data is:

• necessary for archiving purposes, scientific or historical research purposes or statistical purposes,
• subject to appropriate safeguards ( Safeguards section ), and
• in the public interest.
• Privacy notice
• Terms & conditions
• Accessibility statement
• Feedback or concerns

The EU’s General Data Protection Regulation (GDPR) in a Research Context

• Open Access
• First Online: 22 December 2018

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• Christopher F. Mondschein 4 &
• Cosimo Monda 4  

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This chapter introduces the rational and regulatory mechanism underlying the EU data protection framework with specific focus on the EU’s General Data Protection Regulation (GDPR). It outlines the applicability of the research exemption included in the GDPR and discusses further or secondary use of personal data for research purposes.

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1 Introduction

The EU’s General Data Protection Regulation (GDPR). Footnote 1 has entered into force on 25 May 2018. Footnote 2 It replaces the EU’s previous legal framework that dates back to 1995; while retaining the overall regulatory approach of its predecessor, the GDPR also introduces a number of new compliance obligations , including higher sanctions than those available under the previous framework. Footnote 3 This Chapter introduces the key concepts of data protection law and specifically those of the GDPR to the readership in order to sensitize the readership to this matter. A basic understanding of the telos of the GDPR and the way it strives to achieve the regulatory goals set therein can help researchers understand what compliance tasks will become necessary. The importance of data protection and compliant research has become apparent: the lack of compliance will inevitably lead to problems with obtaining funding for research, especially through European Union grants. Footnote 4

This chapter will hardly succeed in making the reader an expert on data protection law or the GDPR, given that volumes of books could be filled on this topic. Nevertheless, awareness of the compliance goals and a basic understanding of the functioning of the GDPR can give researchers an edge in identifying and flagging issues at an early stage in their research endeavours. It also aids research organizations in assessing their internal procedures. Here, the presence of a supporting infrastructure for researchers that is able to support them in achieving legal compliance and through which issues can be address at an early stage is an important factor; researchers by themselves hardly can be expected to be GDPR experts.

Considering data protection issues at an early stage of a research project is of great importance specifically in the context of large-scale research endeavours that make use of personal data. In clinical settings, this often includes special categories of personal data , also referred to as sensitive data, that are collected from a wide array of sources (see Chap. 1 of this book) and which can be combined to gain novel insights. In this context, the development of clinical data standards – as described in Chap. 3 of this book – supporting the FAIR principles Footnote 5 and ensuring interoperability and shareability pose a potential risk for a data protection perspective, if legal compliance is not assured.

We approach these issues in the following manner:

we introduce the basic tenets of EU data protection law;

we give a broad overview of the GDPR and its principles, actors and mechanisms;

we contextualize the research exemption included in Article 89 of the GDPR.

2 Data Protection Law in the EU

EU data protection law stands on a dual footing: on the one hand, it strives to facilitate the free flow of personal data; on the other hand, it makes the free flow of personal data subject to conformity with legal requirements that are derived from the fundamental rights character of the right to privacy and the right to the protection of personal data of individuals. Footnote 6 The fundamental rights character of EU data protection law is anchored in the Charter of Fundamental Rights of the European Union (the Charter), which provides for the right to privacy (Article 7 of the Charter) and the right to the protection of personal data (Article 8 of the Charter). Footnote 7

The right to the protection of personal data demands that personal data be only processed in a lawful and transparent manner, following a set of principles that ensure that the data subject (i.e. the individual whose data is processed) can effectively make use of a number of rights vis-á-vis the entities processing his/her personal data. This is ensured through supervision by independent supervisory authorities at the national level.

The fundamental rights nature of this right necessitates a case-by-case analysis of each processing operation, balancing a wide array of fundamental rights and the interests of the data subject and other stakeholders. This explains the general complexity surrounding data protection when viewed through a regulatory compliance lens.

The GDPR operationalizes data protection under the dual footing described above. It retains many elements contained in its predecessor and adds certain elements, most notably a more severe sanctioning regime, the right to be forgotten and the mandatory assignment of a Data Protection Officer (DPO) for certain processing situations.

The GDPR takes an ‘omnibus’ approach, Footnote 8 meaning that it applies as a general law encompassing a wide scope of processing operations and actors (both public bodies and private organizations) and applies a wide definition of what constitutes the processing personal data. This can be contrasted with the US legal framework, which takes a sectoral approach, for example by separately regulating children’s privacy or insurance and health privacy, yet lacking an overall (federal) data protection law. Footnote 9

The EU legislator chose to continue the use of a principle- and rights-based approach for the GDPR, which takes a technological neutral perspective. This is connected with the omnibus nature of the GDPR: in order to retain its wide scope, the GDPR utilizes general principles from which compliance has to be deduced by the processing entities under a so-called ‘risk-based approach’; this means that organizations must self-assess their operations and take the necessary steps to comply with the GDPR on an on-going basis, a ensuring that the level of compliance is proportional to the level of risk inherent to the processing operations carry. This is not to say that there is no guidance, as there are various sources that aid with the interpretation of the principles such as guidance issued by supervising authorities, case law, established practices and so on that should be used for the legal assessment of processing operations. Where this is not the case, this approach introduces a sense of legal uncertainty and requires expertise to ensure compliance. This effect is in part amplified where new technologies or processing approaches are introduced: the GDPR takes a technological-neutral approach, stating that “in order to prevent creating a serious risk of circumvention, the protection of natural persons should be technologically neutral and should not depend on the techniques used.” Footnote 10 This potentially poses a factor of uncertainty.

The GDPR is said to introduce a higher level of harmonization of data protection law throughout the European Union. However, the fact that it contains a substantial number of opening clauses which create space for Member States to take decisions on the implementation of the GDPR at national level may undermine this attempt. Most notably, Member States may introduce specific derogation for the research exemptions under Article 89(2) GDPR, which may lead to a fragmentation of the rules governing research (see further below). It remains to be seen what level of harmonization will be reached as at the point of writing, not even all Member States have finalized the national laws implementing the GDPR. Footnote 11

A hallmark of the GDPR is the introduction of the principle of accountability . The principle of accountability calls for entities processing personal data to take a proactive and holistic stance towards compliance with the GDPR. An accountable organization is able to prove upon request that they have taken all necessary steps to be in compliance with the GDPR.

4 Scope of Application of the GDPR

Temporal scope.

The GDPR entered into force on 25 May 2018 (Article 99 GDPR). Any new processing operations started after this date must be considered to fall under the scope of the GDPR if they fulfil the material and territorial scope set out in Articles 4(7) and 4(8) GDPR respectively. Ongoing processing operations that were commenced before the entry into force of the GDPR are not grandfathered under the old legal regime and hence the GDPR also applies to these processing operations. Regarding the reuse data collected prior to the entry into force of the GDPR, an assessment whether the lawfulness criteria of the GDPR are still fulfilled is necessary (especially regarding the collection of consent).

Material Scope

The GDPR applies to both public bodies as well as private organizations. However, distinct rules for the EU institutions, bodies and agencies exist (Article 2(3) GDPR). The GDPR applies to the processing of personal data (Article 2 GDPR). Footnote 12 Two notions have to be considered here: (i) the notion of personal data and (ii) the notion of processing. The GDPR makes use of four distinct categories to make sense of the notion of personal data and to delineate legal obligations for the processing of these data:

Pseudonymous data

Anonymous data

The notion of personal data in this context possesses a wide scope: it encompasses any information relating to an identified or identifiable individual. This includes names, identification numbers, location data and so on. An example of the wide scope of this notion is that dynamic IP addresses Footnote 13 fall under the definition of personal data as there are means to potentially identify the data subject through legal means that are realistic to achieve. When looking at the data sources described in Chap. 1 of this book, it becomes clear that in almost any context of clinical data science, personal data as defined by the GDPR is used.

According to Article 9 GDPR, special categories of personal data , also referred to as ‘sensitive personal data’ , include (i) racial or ethnic origin, (ii) political opinions, (iii) religious or philosophical beliefs, (iv) trade union membership, (v) genetic data, (vi) biometric data, (vii) data concerning health, (viii) sex life or sexual orientation. These data carry a higher degree of risk for the data subject, thus necessitating further compliance steps for any entity processing them. Data points that can be used as proxies for certain characteristics fall within in the scope of the definition of special categories of personal data. For example, certain dietary requirements in passenger name records were deemed to be sensitive data as data subjects’ religious beliefs could be inferred from them. Footnote 14 In the research context, Article 9(1)(j) GDPR offers derogations that may be introduced by virtue of EU or Member State’s national law. However, Member States may also maintain or introduce hurdles in the form of specific limitations to the processing of genetic, biometric or health data (Article 9(4) GDPR). Hence, Member States have leeway to open or restrict the processing of these categories of data under the GDPR, which is something that has a potentially large impact on the way research is conducted.

Pseudonymization of personal data refers to the act of altering personal data to the extent that the data subject cannot be directly identied without having further information, which is stored separately (Article 4(4) GDPR). The Article 29 WP gives a number of examples for pseudonymisation techniques, including where data is (i) encrypted with a secret key; (ii) hashing and salting data; (iii) keyed-hash functions with stored key; (iv) deterministic encryption or keyed-hash functions with deletion of the key; or (v) tokenization. Footnote 15 It is important to note that pseudonymised personal data still falls within the scope of the GDPR and it is viewed as a security safeguard under the notion of technical and organizational measures (Article 32(1)(a) GDPR) but these technologies cannot be used to circumvent compliance obligations pursuant to the GDPR (see Recitals 26 and 28 GDPR).

The GDPR does not contain a definition of what constitutes anonymous data . However, the fifth and sixth sentence of Recital 26 provide that the “principles of data protection should (…) not apply to anonymous information, namely information which does not relate to an identified or identifiable natural person or to personal data rendered anonymous in such a manner that the data subject is not or no longer identifiable. This Regulation does not therefore concern the processing of such anonymous information, including for statistical or research purposes.” Hence, the GDPR does not apply to anonymous data (Fig. 5.1 ).

Categories of personal data under the GDPR

This leaves the question where to draw the line between anonymous and pseudonymous data, thus determining when the GDPR applies, and when not. Spindler and Schmeichel highlight the tension between an absolute approach and a relative approach towards encrypted data and the identifiability of the data subject. Footnote 16 The former qualifies that the criterium for identifiability for encrypted data is fulfilled as long as even the remotest possibility of identifying the data subject based on the encrypted data exists, whereas the latter considers the scope of identifiability somewhat narrower, relying on the existence of a realistic opportunity of identifying the data subject. From a legal perspective, it remains to be seen how technological advancements such as fully homomorphic encryption (FHE) or secure multi-party computing (SMC) will be received, albeit it being unlikely that utilizing these technologies will create an exemption to the application of the GDPR due to the wide interpretation of the scope of personal data. Footnote 17

When contemplating secondary use of data for research, one must take into account that the combination of different data points from different categories might lead to a shift in the classification of a processing operation. Here, a functional approach is required to make an assessment of the legal nature of the data processed, which is important in a research setting, especially when applying a Big Data approach and obtaining data from a wide array of sources for secondary use. Here, the temporal aspect of technological change must also be taken into account by asking what changes can be realistically expected in the future and how these changes might impact the processing operation.

In summary, the GDPR grants the notion of personal data a wide scope and it is difficult to argue that the GDPR does not apply by virtue of data not qualifying as personal data. The legal definition of pseudonymization under the GDPR is considerably far-ranging and circumventing compliance obligations under the GDPR by virtue of utilizing anonymous data is rather unlikely, as the usefulness of data for research purposes stands in contrast to the stringent criteria of anonymisation under the GDPR.

The Notion of Processing

Article 4(2) GDPR refers to processing as “[a]ny operation or set of operations which is performed on personal data or on sets of personal data, whether or not by automated means, such as collection, recording, organisation, structuring, storage, adaptation or alteration, retrieval, consultation, use, disclosure by transmission, dissemination or otherwise making available, alignment or combination, restriction, erasure or destruction.” This complements the broad definition the GDPR gives to the notion of personal data. In short, the notion of processing covers everything one does with personal data.

Territorial Scope

By virtue of Article 3 of the GDPR, the GDPR applies to all processing operations of controllers or processors that are established within the EU. Here, it is not important whether the processing activities take place within the EU or not; the connecting factor triggering the application of the GDPR is the fact that the entities have a legal establishment in the EU. Next to that, the GDPR applies where personal data of data subjects located within the EU is processed by entities without an establishment in the EU if (i) it pertains to offering goods or services to data subjects within the EU, independent of whether payment is required, or (ii) the behaviour of data subjects within the EU is monitored. Lastly, the GDPR might apply where public international law so dictates. It is important to highlight that the applicability of the GDPR is not linked to nationality of a Member State or to EU citizenship but applies to all data subjects located within the EU. Within the research context it is also important to highlight that datasets imported to the EU for further processing fall within the scope of the GDPR.

5 Key Concepts of the GDPR

Controller and processor.

The notions of controller and processor are used to delineate and assign the tasks, responsibilities and liability of entities that processes personal data under the GDPR. The notions were already present in the 1995 Directive; however, the GDPR has assigned more responsibilities to data processors. The controller is the entity which decides (or jointly together with another controller) on the purpose and the means of the processing (Article 4(7) GDPR). The processor is the entity that processes the data on behalf of the controller (Article 4(8) GDPR). These notions are used to identify obligations and liability of entities processing personal data. Numerous different combinations of controllership and processor relations are possible (controller and processor are one entity; controller and processors are separate entities; joint controllers; sub-processors; etc.). Here, it is best map the dataflow and check which entities have what role. It is important to note that as soon as a processor deviates from the instructions of a controller, the processor becomes a controller and incurs the higher level of responsibilities and liability attached to this notion. The setup and due diligence in identifying the roles in this context is of utmost importance prior to starting data processing operations.

Principles Relating to Lawful Processing

Article 5 GDPR lays down the principles allowing for lawful processing of personal data . These principles are:

Lawfulness, fairness and transparency: processing of personal data is lawful when it is based on one of the six legal bases listed in Article 6 GDPR. The principles of fairness and transparency relate to the fact that data subjects must be informed in a comprehensive manner about the purpose and scope of the processing as laid down is Articles 12–14 GDPR.

Purpose limitation: In line with the principle of transparency, data can only be processed for a specific purpose, which has to be communicated to the data subject. In the context of research, Article 89 GDPR provides for certain derogations if the requirements under that article are fulfilled, allowing for further processing (see further below).

Data minimisation: this principle requires controllers to minimize the data they collect and keep.

Accuracy: the controller is obliged to ensure the accuracy of the data.

Storage limitation: this principle requires controllers to specify the time limit for after which data is deleted. In the context of research, Article 89 GDPR provides for certain derogations if the requirements under that article are fulfilled (see further below).

Integrity and confidentiality: this principle requires that the integrity and confidentiality of personal data is ensured. It links with the obligations of data security, having in place adequate technical and organizational measures as well as the requirement to report data breaches to the supervisory authority and/or data subjects under certain circumstances as specified in Articles 33–34 GDPR.

Legal Basis

In order to be able to process personal data in a lawful manner, the controller must specify a legal basis for the data processing operation . There is a closed list of six legal bases to be found in Article 6 GDPR:

Consent: to be a lawful legal basis, consent by the data subject must fulfil the conditions listed in Article 7 GDPR. Consent must be (i) freely given, (ii) specific, (iii) informed, (iv) unambiguous, (v) and the age of consent must be fulfilled (this can vary in Member States from 13 to 16 years). Footnote 18 The consent must be given through a clear affirmative act (for example, pre-ticked boxes on a consent form are prohibited). The burden of proof to demonstrate that consent was lawfully obtained lies with the controller. Hence, good documentation and archiving of consent forms is required.

Performance of a Contract

Compliance with a legal obligation

Vital interest of the data subject: the scope of vital interest must be interpreted narrowly. This legal basis for example pertains to life-threatening situations in which a data subject cannot consent to the transfer of vital medical data.

Performance of a task carried out in the public interest or in the exercise of official authority vested in the controller

Legitimate interest of the controller or by a third party: this legal basis requires an assessment of the necessity and the purpose of the processing operation as well as a balancing test between the interests of the data subject against those of the controller and third parties: this means that the legitimate interest of the controller and that of any stakeholder must be weighed against the interests and fundamental rights – especially data protection and privacy – of the data subject. The outcome of the balancing exercise must be that the legitimate interest of the controller or any third party outweighs the interests and fundamental rights of the data subject in order for the processing to be lawful under this legal basis. Footnote 19 This legal basis is not available to public authorities when fulfilling a public task.

In case the same personal data is collected for different purposes, this must be specified in a transparent way and communicated to the data subject. A granular approach is necessary in order to give effect to the data subject rights.

Regarding the choice of a legal basis, generally, consent and legitimate interest may seem as an attractive option, yet, choosing either entails a number of caveats which must be addressed. As outlined above, legitimate interest requires a prior assessment and weighing of interests and front-loads the risk (it is up to the controller to make the assessment and this assessment might be challenged at a later time, hence, when dealing with complex situations and uncertainty the risk level is increased). Consent might seem as an attractive legal basis in many situations due to the perceived ease with which it can be applied; however, consent is a volatile legal basis in the sense that consent can be withdrawn by the data subject at any time. In practice, this necessitates a consent tracking and management solution as the controller must also be able to prove that valid consent was given by the data subject. If possible, other legal bases should be given priority over consent – however, for the purpose of research, consent will most likely be the only choice as a legal basis.

Sensitive Data and Explicit Consent

Where sensitive data are processed, the GDPR requires explicit consent from the data subject (Article 9(2)(a) GDPR). Explicit consent requires a stronger affirmative action by the data subject: “The term explicit refers to the way consent is expressed by the data subject. It means that the data subject must give an express statement of consent. An obvious way to make sure consent is explicit would be to expressly confirm consent in a written statement. Where appropriate, the controller could make sure the written statement is signed by the data subject, in order to remove all possible doubt and potential lack of evidence in the future.” Footnote 20 However, the controller can also rely on other means such as a two-step verification or the “data subject may be able to issue the required statement by filling in an electronic form, by sending an email, by uploading a scanned document carrying the signature of the data subject, or by using an electronic signature”. Footnote 21

Data Subject Rights

Data subjects have a number of rights vis-à-vis entities processing personal data.

Right to transparent information, communication and modalities to exercise rights

Right to information relating the processing (both where data is obtained by first and third parties)

Right to access of one’s personal data

Right to rectification, erasure and restriction of processing

Right to data portability

Right to object

In order to be accountable, entities processing personal data must fulfil a set of compliance criteria . Most fundamentally, they must adhere to the data protection principles when processing personal data. In relation to the data subject, the entities processing personal data must enable and effectuate data subject rights; this includes responding to data subject requests for access and informing data subjects on the processing in a fair and transparent manner. According to Article 30 GDPR, controllers and processor are required to keep documentation of the processing operations and must be able to demonstrate compliance on request of the supervisory authority. In line with the risk-based approach taken by the GDPR, it might become necessary to consult the supervisory authority prior to commencing a risky processing operation (Article 36 GDPR). In case a processing operation is deemed to have a high risk, the controller must conduct a data protection impact assessments (DPIAs) prior to commencing processing (Article 35 GDPR). Processing operations that potentially have a high risk attached to them include operations where new technologies are used (e.g. Big Data approaches), and based on factors such as the nature, the scope, the context and purpose of the processing. Article 35 GDPR specifically mentions the processing and systematic and extensive evaluation of persons, including profiling as well as the large-scale monitoring of public areas. Important for the research context is that the large-scale processing of sensitive data requires a DPIA (Article 35(3)(b) GDPR). Such risky operation potentially must be notified to the supervisory authority. In line with the principle of integrity and confidentiality, controllers and processors must ensure security of the personal data (Article 32 GDPR): the extent of the technical and organizational measures that will be required to secure personal data depends on a number of factors as the entities processing personal data must take “into account the state of the art, the costs of implementation and the nature, scope, context and purposes of processing as well as the risk of varying likelihood and severity for the rights and freedoms of natural persons”. Next to this, the GDPR introduces the notions of privacy by design and privacy by default (Article 25 GDPR).

Appointment of a DPO

Controllers and processors must appoint a DPO under certain conditions (Article 37 GDPR): (i) In case the processing operation is carried out by a public body, (ii) “the core activities of the controller or the processor consist of processing operations which, by virtue of their nature, their scope and/or their purposes, require regular and systematic monitoring of data subjects on a large scale”, (iii) the processing of special categories of personal data (Article 9 GDPR) or data relating to criminal offences (Article 20 GDPR). The Article 29 WP issued guidelines on these matters. Footnote 22 An example to contrast where the designation of a DPO becomes necessary in the medical field: a DPO is necessary for processing of patient data in the regular course of business by a hospital; a DPO is not necessary where patient data is processed by an individual physician; where there is a joint practice of physicians, the appointment of a DPO becomes necessary. Footnote 23

Regarding the position of the DPO, it is important to note that the DPO has an advisory function and is not personally responsible for non-compliance with the GDPR. Regarding the appointment of a DPO, a possible conflict of interest must be avoided where the DPO also holds another position in the organization; to that extent, a DPO cannot at the same time hold a leadership role (for example, “chief executive, chief operating, chief financial, chief medical officer, head of marketing department, head of Human Resources or head of IT departments”). Footnote 24

Transfers to Third Countries

The general approach regarding the transfer of personal data from the EU to any third country is that it is prohibited unless there is one of the following measures in place:

Adequacy decision

Binding Corporate Rules (BCRs)

Model Contract Clauses

Explicit Consent

(Derogations)

Since this provision functions as a prohibition with a closed list of exemptions, any transfer of personal data from the EU to a third country must fall within the scope of one of these exemptions in order to be deemed lawful (Fig. 5.2 ).

ECPC GDPR cheat sheet

6 The GDPR’s Research Exemption

The GDPR acknowledges the need to facilitate different types of research, citing scientific and historical research, statistical research, and archiving in the public interest (Article 89 GDPR).

The GDPR does not contain a formal definition of what constitutes scientific research. It applies a wide definition to the notion of research, stating that “the processing of personal data for scientific research purposes should be interpreted in a broad manner including for example technological development and demonstration, fundamental research, applied research and privately funded research.” Footnote 25 In the clinical research context, the relation between the GDPR and the Clinical Trials Regulation (CTR) Footnote 26 has to be specified: the CTR contains specific rules for a wide variety of clinical trial settings (Article 2(2)(1)–(4) CTR). In this context, the CTR requirement to collect informed consent for clinical trials falling within the scope of the CTR applies as lex specials to the GDPR. The CTR allows for broad consent for clinical trials that fall within the scope of the CTR and if so permitted at in the Member States. Footnote 27

Regarding the secondary or further use of data collected during clinical trials, the CTR states that “[i]t is appropriate that universities and other research institutions, under certain circumstances that are in accordance with the applicable law on data protection, be able to collect data from clinical trials to be used for future scientific research, for example for medical, natural or social sciences research purposes. In order to collect data for such purposes it is necessary that the subject gives consent to use his or her data outside the protocol of the clinical trial and has the right to withdraw that consent at any time. It is also necessary that research projects based on such data be made subject to reviews that are appropriate for research on human data, for example on ethical aspects, before being conducted.” Footnote 28 Here, the CTR makes reference to EU data protection law as the framework for further processing of personal data, now being the GDPR.

The GDPR adds to this by the stating in Recital 33 GDPR that “it is often not possible to fully identify the purpose of personal data processing for scientific research purposes at the time of data collection. Therefore, data subjects should be allowed to give their consent to certain areas of scientific research when in keeping with recognised ethical standards for scientific research . Data subjects should have the opportunity to give their consent only to certain areas of research or parts of research projects to the extent allowed by the intended purpose.” Footnote 29

The GDPR provides for a research exemption in Article 89 GDPR, inter alia for scientific and research purposes. The exemption under the GDPR relies largely on the same discretionary framework as in the 1995 Directive.

As noted above, the scope of the notion of research under the GDPR is wide. Article 89 GDPR functions by setting a baseline in that requires that any derogation is subject to the existence of appropriate safeguards for the rights and freedoms of data subjects. Here, the GDPR stresses that safeguards shall include:

Data minimization;

Technical and organizational measures;

Privacy by Design and by Default;

Pseudonymization/further processing.

The respect of relevant and recognised ethical standards as well as the requirements for obtaining ethical approvals are part of these safeguards. Footnote 30 This means that any research project has to fulfil the recognized quality standards and processes required for conducting research as this is inextricably linked to the research exemption.

If these safeguards are in place, derogations to the following points may be applied:

Further processing and storage limitation (Articles 5(1)(b) and (e) GDPR);

Processing of special categories of data (Article 9(2)(j) GDPR);

Information provided by third parties (Article 14(5)(b) GDPR);

Right to erasure (Article 17(3)(d) GDPR);

Right to object (Article 21(6) GDPR).

It is important to note that if any derogation to the points listed above is applied, this must be done by taking into account the principles of proportionality and necessity . Such assessment must be conducted before the derogations are applied and must be documented.

Next to the derogations listed above, EU or Member State law may allow for derogations on the following points:

The rights to access;

The right to rectification;

The right to restrict processing;

The right to object.

The application is restricted by the requirements to also apply the safeguards mentioned above. A further qualifier is added in that any derogation must be justified by the fact that the full application of any of the rights listed rights listed above “are likely to render impossible or seriously impair the achievement of the specific purposes” and that such derogations “are necessary for the fulfilment of those purposes”. Footnote 31

Lastly, where processing personal data serves multiple purposes, one of which falling within the ambit of derogations for research as per Article 89 GDPR, the processing operations that do not fall within the scope research cannot benefit from these derogations.

It becomes obvious that the research exemption in the GDPR is quite undefined and leaves much space for interpretation by Member States. This may have an adverse effect on the scope of research that can be conducted in different Member States and may impair the function of a European Research Area. Footnote 32 Part of the problematic lies in the fact that the EU does not possess the competency to create fully harmonized rules for health and research. Footnote 33

7 Contentious Issues for Research Under the GDPR

A number of contentious issues regarding to the GDPR and research remain that we wish to discuss:

Modes of consent in a research context: the scope of valid consent for research purposes under the GDPR is a contested issue. Generally, modes of consent often discussed in a research context include (i) specific, informed consent, (ii) democratic consent, (iii) dynamic consent management, (iv) sectoral consent, and (v) open/general/broad/blanket consent. Footnote 34 Broad consent requires a single affirmative action that will allow the data to be utilized for research purposes in general and without a strict temporal limitation. Especially, applying the notion of broad consent to any further processing for research purposes is a contested issue, as it clashes with the principle of purpose limitation and storage limitation. In the context of the research exemption of the GDPR, the lack of specificity arguably goes against the spirit of the GDPR and the text states that “[d]ata subjects should have the opportunity to give their consent only to certain areas of research or parts of research projects” (Recital 33 GDPR) under certain conditions. Footnote 35 A further factor of uncertainty is that the acceptance of broad consent in the research context is largely dependent on the Member State’s national implementation and in this respect may lead to a divergence within the EU. This may have a negative impact on the creation of a European Research Area as the utility of research data might vary tremendously within the EU.

Research purposes as a legitimate interest: it is debated whether the legitimate interest legal basis (Article 9(1)(f) GDPR) is suitable for research purposes – bypassing the consent of the data subject when applied correctly. It is argued that the interpretation of the Article 29 WP in their Opinion on legitimate interest opens this possibility, referring to processing for research purposes – specifically marketing research – as potentially falling within the scope of the legitimate interest legal basis. Footnote 36 This is echoed in the GDPR in Recital 47, linking direct marketing and the legitimate interest legal basis. At the same time, the balancing test required “would need careful assessment including whether a data subject can reasonably expect at the time and in the context of the collection of the personal data that processing for that purpose may take place.” Footnote 37 The link between research and the legitimate interest legal basis is somewhat weak. Further, the lack of experience with the legal basis and the rather unclear scope of the balancing test lead to a rather high degree of legal uncertainty as the risk assessment has to be conducted by the controller prior to the processing and any mistake, especially in the research context, might have dire consequences.

8 Checklists

Prior to commencing a processing operation, one should assess the following points as a starting point:

What kind of information is being processed (sensitive or general)?

What is your purpose – what are you trying to achieve?

Can you reasonably achieve it in a different way?

Do you have a choice over whether or not to process the data?

Are you a public authority?

When deciding to make use of the legitimate interest legal basis:

Who does the processing benefit?

What kind of impact could processing have on the data subject?

Are they vulnerable?

Would individuals expect this processing to take place?

What is your relationship with the individual?

Are some of the individuals concerned likely to object?

Are you able to stop the processing at any time on request?

For the application of the research exemption :

Are the conditions of Article 89 GDPR met?

Would the application of any right from with there is a derogation seriously compromise the purpose and the use of the derogations are necessary and proportional for achieving the purpose?

Check if there are further requirements/derogations in EU or national law?

Is the process and reasoning documented?

9 Conclusion

The GDPR requires that entities processing personal data define the personal data they wish to process as well as the purpose of the data processing operation. Processing of personal data is subject to lawfulness and entities processing data must meet compliance obligations. Entities processing personal data must facilitate the fulfilment of data subject’s rights. Operating on this baseline, the processing of personal data for research purposes requires specific safeguards to ensure compliance with the GDPR. As outlined above, the secondary or further use of personal data for research is possible under certain circumstances set out in the GDPR. In this respect, it is important to reflect on the growing scale and complexity of systems applied in research and compare this to compliance aspects. The underlying regulatory ideal is to scale compliance to ensure that potential externalities created by the processing of personal data are internalized by the entities conducting these processing operations. Footnote 38

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) (Text with EEA relevance), [2016] OJ L 119/1.

Article 99 GDPR.

Directive 95/46/EC of the European Parliament and of the Council of 24 October 1995 on the protection of individuals with regard to the processing of personal data and on the free movement of such data, [1995] OJ L 281/31.

See Frischhut [ 1 ]. In the context of the Horizon 2020 framework, data protection plays a crucial role in the ethics assessment, see European Commission DG Research & Innovation, ‘Horizon 2020 Programme: Guidance. How to complete your ethics self-assessment’. Version 5.3. 21 February 2018, http://ec.europa.eu/research/participants/data/ref/h2020/grants_manual/hi/ethics/h2020_hi_ethics-self-assess_en.pdf

Wilkinson et al. [ 2 , 3 ].

Article 1(2) and (3) GDPR. Lynskey [ 4 ], Ch. 3.

For the distinction between the two rights, especially for Big Data application in the health sector, see Mostert et al. [ 5 ].

Lynskey [ 4 ], p. 15 ff.

Schwartz and Pfeifer [ 6 ].

Recital 15 GDPR.

See e.g. Alston & Bird, ‘GDPR Tracker’, https://files.alston.com/files/Uploads/gdprtracker/index.html (last visited: 03.07.2018).

Article 29 WP Opinion on the concept of personal data, WP136, 20.6.2007.

Case C-582/12 Breyer , EU:C:2016:779.

Opinion 1/15 EU-Canada PNR , EU:C:2016:656.

Article 29 WP Opinion on anonymisation techniques, WP216, 10.4.2014, p. 20.

Spindler and Schmechel [ 7 ].

Spindler and Schmechel [ 7 ], p. 174–176.

See further Article 29 WP, Guidelines on consent under Regulation 2016/679, WP259 rev.01, 10.4.2018. Kosta [ 8 ].

Article 29 WP Opinion on the notion of legitimate interests of the data controller under Article 7 of Directive 95/46/EC, WP217, 9.4.2014.

Article 29 WP, Guidelines on consent under Regulation 2016/679, WP259 rev.01, 10.4.2018, p. 18.

Article 29 WP, Guidelines on consent under Regulation 2016/679, WP259 rev.01, 10.4.2018, p. 18–19.

Article 29 WP, Guidelines on Data Protection Officers (‘DPOs’), WP243 rev.01, 5.4.2018.

Article 29 WP, Guidelines on Data Protection Officers (‘DPOs’), WP243 rev.01, 5.4.2018, p. 16.

Article 29 WP, Guidelines on Data Protection Officers (‘DPOs’), WP243 rev.01, 5.4.2018, p. 24.

Recital 159 GDPR.

Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC Text with EEA relevance, [2014] OJ L 185/1.

Chassang [ 9 ], p. 10.

Recital 29 CTR.

Emphasis added.

Chassang [ 9 ], p. 11.

Article 89(2) GDPR.

Pormeister [ 10 ], p. 145–146.

Hallinan and Friedewald [ 11 ], p. 4–5.

Rumbold and Pierscionek [ 12 ].

G. Maldoff, ‘How GDPR changes the rules for research’, IAPP, https://iapp.org/news/a/how-gdpr-changes-the-rules-for-research/ (last visited 3.7.2018).

Recital 49 GDPR.

Baldwin et al. [ 13 ], p. 18.

Frischhut M. “EU”: short for “ethical” union?: the role of ethics in European Union Law. Heidelberg J Int Law. 2015;75(3):531–77.

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Lynskey O. The foundations of EU data protection law. Oxford: OUP; 2015.

Mostert M, Bredenoord AL, van der Slootb B, van Delden JJM. From privacy to data protection in the: implications for big data health research. Eur J Health Law. 2017;25:43–55. https://doi.org/10.1163/15718093-12460346 .

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Rumbold JMM, Pierscionek B. The effect of the general data protection regulation on medical research. J Med Internet Res. 2017;19(2):e47. https://doi.org/10.2196/jmir.7108 .

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Mondschein, C.F., Monda, C. (2019). The EU’s General Data Protection Regulation (GDPR) in a Research Context. In: Kubben, P., Dumontier, M., Dekker, A. (eds) Fundamentals of Clinical Data Science. Springer, Cham. https://doi.org/10.1007/978-3-319-99713-1_5

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The ‘legal basis’ is the foundation for data processing under the General Data Protection Regulation (GDPR). This means that when an organisation wants to process personal data, there is a need to identify specific legal grounds for the processing.  ‌ ‌In other words: on what grounds is the organisation processing your data?

The informed consent as legal and ethical basis of research data production

FORS Guide Nº 05

Kruegel, S. (2019). The informed consent as legal and ethical basis of research data production . FORS Guide No. 05, Version 1.0. Lausanne: Swiss Centre of Expertise in the Social Sciences FORS. doi:10.24449/FG-2019-00005

The trend toward and the obligation for sharing and long-term preservation of research data is in conflict with increasingly restrictive data protection legislation and practices on personal data in Europe, such as the General Data Protection Regulation (GDPR). Quali-tative research data, in particular, often cannot be completely de-identified without compromising the usability of the data. In consequence, the informed consent plays a crucial role in forming the basis of ethical and legal research to allow for the processing (collecting, storing, re-use) of data collected at considerable expense. This guide is con-cerned with the definition of the concept, the legislation governing it, and the best practices for drafting and obtaining informed consent from a social science perspective.

• The adequate informing of participants in research data production and their consent to participation and the further use of the data lays the groundwork for legal and ethical research.
• As the Swiss data protection legislations are currently being revised and the European General Data Protection Regulation (GDPR, art. 3, Territorial scope) extends by the rule of extraterritoriality to certain cases of Swiss research, if in doubt, chose the stricter standard, which is the GDPR.
• The consent form should contain or be preceded by a procedure of informing the potential respondent of the aim of the research and the risk and benefits of a potential participation.
• There is a wide range of forms that informed consent can take: The sensitivity of the data collected, the disclosure risk and confidentiality, the anonymisation potential, and the respondent population determine the degree of formality of the informed consent procedure and the elaborateness of the information divulged to respondents. As a general rule: The more sensitive the data and the higher the risk of disclosure, the more extended and/or formal the consent and information procedure should be.
• It is good practice to draft consent forms that allow for future scientific use of the data beyond the primary research team. If applicable, use the broad or unspecified consent approach, which allows for long-term preservation in a in a secure environment such as the repository of FORS and unspecified scientific re-use of data in keeping with the recognised ethical standards for scientific research.
• Include in the consent form the procedure followed to protect the identity, confidentiality and the personal data of the participant (anonymization/ pseudonymisation, access conditions, user contract, embargo, etc.). Avoid the termino-logies of “fully anonymised” or “strictly confidential”, since these features are hard to achieve in practice.
• Avoid setting an expiration date of the consent, and avoid committing to the destruction of the data after use by the primary research team.
• Best practice consent is sought before and after the data collection.
• Consent can also be sought retrospectively, and in some well-specified cases certain data can be released without consent form.
• The following features constitute the minimal content of information provided to the participant either on the consent form or on a separate information sheet (Universität Zürich, n.d.): a) Research project title, key features and link to project website; b) Names of researchers, affiliated institutions and contact information; c) Short, comprehensive summary of the project aims and purposes d) Benefits, potential risks and disadvantages arising from participation; e) Funding sources, if applicable; f) Implications of participation, e.g. duration of interview; g) Confirmation that the participation is voluntary, that the participant has read and understood the information given and had been given the occasion to ask questions; h) The fact that that the participant has a right to see and correct the personal data; i) Specifications regarding data protection measures (anonymisation, pseudonymisation, etc.) and procedures to secure the confidentiality and protect the personal data of the participant; j) If necessary, the future use of the data, e.g. storing in a secure environment and access for scientific researchers for secondary analysis, conditions of use and access; k) Confirmation that the participant can withdraw from the participation or consent at all times without stating the reasons (best outline these procedures of withdrawal); l) Confirmation that the participant will receive a copy of the consent form; m) Date and signature of both participant and researcher/interviewer.

Copyright: © the authors 2019. This work is licensed under a Creative Commons Attribution 4.0 International License (CC BY 4.0)

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Legal and ethical issues in research

Camille yip.

1 Department of Women's Anaesthesia, KK Women's and Children's Hospital, Bukit Timah, Singapore

Nian-Lin Reena Han

2 Division of Clinical Support Services, KK Women's and Children's Hospital, Bukit Timah, Singapore

Ban Leong Sng

3 Anesthesiology and Perioperative Sciences Academic Clinical Program, Duke-NUS Medical School, Singapore

Legal and ethical issues form an important component of modern research, related to the subject and researcher. This article seeks to briefly review the various international guidelines and regulations that exist on issues related to informed consent, confidentiality, providing incentives and various forms of research misconduct. Relevant original publications (The Declaration of Helsinki, Belmont Report, Council for International Organisations of Medical Sciences/World Health Organisation International Guidelines for Biomedical Research Involving Human Subjects, World Association of Medical Editors Recommendations on Publication Ethics Policies, International Committee of Medical Journal Editors, CoSE White Paper, International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use-Good Clinical Practice) form the literature that are relevant to the ethical and legal aspects of conducting research that researchers should abide by when conducting translational and clinical research. Researchers should note the major international guidelines and regional differences in legislation. Hence, specific ethical advice should be sought at local Ethics Review Committees.

INTRODUCTION

The ethical and legal issues relating to the conduct of clinical research involving human participants had raised the concerns of policy makers, lawyers, scientists and clinicians for many years. The Declaration of Helsinki established ethical principles applied to clinical research involving human participants. The purpose of a clinical research is to systematically collect and analyse data from which conclusions are drawn, that may be generalisable, so as to improve the clinical practice and benefit patients in future. Therefore, it is important to be familiar with Good Clinical Practice (GCP), an international quality standard that is provided by the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH),[ 1 ] or the local version, GCP of the Central Drugs Standard Control Organization (India's equivalent of US Food and Drug Administration)[ 2 ] and local regulatory policy to ensure that the research is conducted both ethically and legally. In this article, we will briefly review the legal and ethical issues pertaining to recruitment of human subjects, basic principles of informed consent and precautions to be taken during data and clinical research publications. Some of the core principles of GCP in research include defining responsibilities of sponsors, investigators, consent process monitoring and auditing procedures and protection of human subjects.[ 3 ]

ISSUES RELATED TO THE RESEARCH PARTICIPANTS

The main role of human participants in research is to serve as sources of data. Researchers have a duty to ‘protect the life, health, dignity, integrity, right to self-determination, privacy and confidentiality of personal information of research subjects’.[ 4 ] The Belmont Report also provides an analytical framework for evaluating research using three ethical principles:[ 5 ]

• Respect for persons – the requirement to acknowledge autonomy and protect those with diminished autonomy
• Beneficence – first do no harm, maximise possible benefits and minimise possible harms
• Justice – on individual and societal level.

Mistreatment of research subjects is considered research misconduct (no ethical review approval, failure to follow approved protocol, absent or inadequate informed consent, exposure of subjects to physical or psychological harm, exposure of subjects to harm due to unacceptable research practices or failure to maintain confidentiality).[ 6 ] There is also scientific misconduct involving fraud and deception.

Consent, possibility of causing harm

Based on ICH definition, ‘informed consent is a process by which a subject voluntarily confirms his or her willingness to participate in a particular trial, after having been informed of all aspects of the trial that are relevant to the subject's decision to participate’. As for a standard (therapeutic) intervention that carries certain risks, informed consent – that is voluntary, given freely and adequately informed – must be sought from participants. However, due to the research-centred, rather than patient-centred primary purpose, additional relevant information must be provided in clinical trials or research studies in informed consent form. The essential components of informed consent are listed in Table 1 [Adapted from ICH Harmonised Tripartite Guideline, Guideline for Good Clinical Practice E6(R1)].[ 1 ] This information should be delivered in the language and method that individual potential subjects can understand,[ 4 ] commonly in the form of a printed Participant Information Sheet. Informed consent is documented by means of written, signed and dated informed consent form.[ 1 ] The potential subjects must be informed of the right to refuse to participate or withdraw consent to participate at any time without reprisal and without affecting the patient–physician relationship. There are also general principles regarding risk assessment, scientific requirements, research protocols and registration, function of ethics committees, use of placebo, post-trial provisions and research publication.[ 4 ]

Essential components of an informed consent

Special populations

Informed consent may be sought from a legally authorised representative if a potential research subject is incapable of giving informed consent[ 4 ] (children, intellectual impairment). The involvement of such populations must fulfil the requirement that they stand to benefit from the research outcome.[ 4 ] The ‘legally authorised representative’ may be a spouse, close relative, parent, power of attorney or legally appointed guardian. The hierarchy of priority of the representative may be different between different countries and different regions within the same country; hence, local guidelines should be consulted.

Special case: Emergency research

Emergency research studies occur where potential subjects are incapacitated and unable to give informed consent (acute head trauma, cardiac arrest). The Council for International Organisations of Medical Sciences/World Health Organisation guidelines and Declaration of Helsinki make exceptions to the requirement for informed consent in these situations.[ 4 , 7 ] There are minor variations in laws governing the extent to which the exceptions apply.[ 8 ]

Reasonable efforts should have been made to find a legal authority to consent. If there is not enough time, an ‘exception to informed consent’ may allow the subject to be enrolled with prior approval of an ethical committee.[ 7 ] Researchers must obtain deferred informed consent as soon as possible from the subject (when regains capacity), or their legally authorised representative, for continued participation.[ 4 , 7 ]

Collecting patient information and sensitive personal information, confidentiality maintenance

The Health Insurance Portability and Accountability Act has requirements for informed consent disclosure and standards for electronic exchange, privacy and information security. In the UK, generic legislation is found in the Data Protection Act.[ 9 ]

The International Committee of Medical Journal Editors (ICMJE) recommendations suggest that authors must ensure that non-essential identifying information (names, initials, hospital record numbers) are omitted during data collection and storage wherever possible. Where identifying information is essential for scientific purposes (clinical photographs), written informed consent must be obtained and the patient must be shown the manuscript before publication. Subjects should also be informed if any potential identifiable material might be available through media access.

Providing incentives

Cash or other benefits ‘in-kind’ (financial, medical, educational, community benefits) should be made known to subjects when obtaining informed consent without emphasising too much on it.[ 7 ] Benefits may serve as appreciation or compensation for time and effort but should not result in the inducement to participation.[ 10 ] The amount and nature of remuneration should be compared to norms, cultural traditions and are subjected to the Ethical Committee Review.[ 7 ]

ISSUES RELATED TO THE RESEARCHER

Legal issues pertaining to regulatory bodies.

Various regulatory bodies have been constituted to uphold the safety of subjects involved in research. It is imperative to obtain approval from the appropriate regulatory authorities before proceeding to any research. The constitution and the types of these bodies vary nation-wise. The researchers are expected to be aware of these authorities and the list of various bodies pertinent to India are listed in the article “Research methodology II” of this issue.

Avoiding bias, inappropriate research methodology, incorrect reporting and inappropriate use of information

Good, well-designed studies advance medical science development. Poorly conducted studies violate the principle of justice, as there are time and resources wastage for research sponsors, researchers and subjects, and undermine the societal trust on scientific enquiry.[ 11 ] The Guidelines for GCP is an international ethical and scientific quality standard for designing, conducting, recording and reporting trials.[ 1 ]

Fraud in research and publication

De novo data invention (fabrication) and manipulation of data (falsification)[ 6 ] constitute serious scientific misconduct. The true prevalence of scientific fraud is difficult to measure (2%–14%).[ 12 ]

Plagiarism and its checking

Plagiarism is the use of others' published and unpublished ideas or intellectual property without attribution or permission and presenting them as new and original rather than derived from an existing source.[ 13 ] Tools such as similarity check[ 14 ] are available to aid researchers detect similarities between manuscripts, and such checks should be done before submission.[ 15 ]

Overlapping publications

Duplicate publications violate international copyright laws and waste valuable resources.[ 16 , 17 ] Such publications can distort evidence-based medicine by double-counting of data when inadvertently included in meta-analyses.[ 16 ] This practice could artificially enlarge one's scientific work, distorting apparent productivity and may give an undue advantage when competing for research funding or career advancement.[ 17 ] Examples of these practices include:

Duplicate publication, redundant publication

Publication of a paper that overlaps substantially with one already published, without reference to the previous publication.[ 11 ]

Salami publication

Slicing of data from a single research process into different pieces creating individual manuscripts from each piece to artificially increase the publication volume.[ 16 ]

Such misconduct may lead to retraction of articles. Transparent disclosure is important when submitting papers to journals to declare if the manuscript or related material has been published or submitted elsewhere, so that the editor can decide how to handle the submission or to seek further clarification. Further information on acceptable secondary publication can be found in the ICMJE ‘Recommendations for the Conduct, Reporting, Editing, and Publishing of Scholarly Work in Medical Journals’.

Usually, sponsors and authors are required to sign over certain publication rights to the journal through copyright transfer or a licensing agreement; thereafter, authors should obtain written permission from the journal/publisher if they wish to reuse the published material elsewhere.[ 6 ]

Authorship and its various associations

The ICMJE recommendation lists four criteria of authorship:

• Substantial contributions to the conception of design of the work, or the acquisition, analysis or interpretation of data for the work
• Drafting the work or revising it critically for important intellectual content
• Final approval of the version to be published
• Agreement to be accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved.

Authors and researchers have an ethical obligation to ensure the accuracy, publication and dissemination of the result of research,[ 4 ] as well as disclosing to publishers relevant corrections, retractions and errata, to protect scientific integrity of published evidence. Every research study involving human subjects must be registered in a publicly accessible database (e.g., ANZCTR [Australia and NZ], ClinicalTrials.gov [US and non-US], CTRI [India]) and the results made publicly available.[ 4 ] Sponsors of clinical trials must allow all study investigators and manuscript authors access to the full study data set and the right to use all study data for publication.[ 5 ] Source documents (containing trial data) and clinical study report (results and interpretation of trial) form part of the essential documentation that must be retained for a length of time prescribed by the applicable local legislation.[ 1 ] The ICMJE is currently proposing a requirement of authors to share with others de-identified individual patient data underlying the results presented in articles published in member journals.[ 18 ]

Those who have contributed to the work but do not meet all four criteria should be acknowledged; some of these activities include provision of administrative support, writing assistance and proofreading. They should have their written permission sought for their names to be published and disclose any potential conflicts of interest.[ 6 ] The Council of Scientific Editors has identified several inappropriate types of authorship, such as guest authorship, honorary or gift authorship and ghost authorship.[ 6 ] Various interventions should be put in place to prevent such fraudulent practices in research.[ 19 ] The list of essential documents for the conduct of a clinical trial is included in other articles of the same issue.

The recent increase in research activities has led to concerns regarding ethical and legal issues. Various guidelines have been formulated by organisations and authorities, which serve as a guide to promote integrity, compliance and ethical standards in the conduct of research. Fraud in research undermines the quality of establishing evidence-based medicine, and interventions should be put in place to prevent such practices. A general overview of ethical and legal principles will enable research to be conducted in accordance with the best practices.

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How to do legal research in 3 steps

Knowing where to start a difficult legal research project can be a challenge. But if you already understand the basics of legal research, the process can be significantly easier — not to mention quicker.

Solid research skills are crucial to crafting a winning argument. So, whether you are a law school student or a seasoned attorney with years of experience, knowing how to perform legal research is important — including where to start and the steps to follow.

What is legal research, and where do I start? 

Black's Law Dictionary defines legal research as “[t]he finding and assembling of authorities that bear on a question of law." But what does that actually mean? It means that legal research is the process you use to identify and find the laws — including statutes, regulations, and court opinions — that apply to the facts of your case.

In most instances, the purpose of legal research is to find support for a specific legal issue or decision. For example, attorneys must conduct legal research if they need court opinions — that is, case law — to back up a legal argument they are making in a motion or brief filed with the court.

Alternatively, lawyers may need legal research to provide clients with accurate legal guidance . In the case of law students, they often use legal research to complete memos and briefs for class. But these are just a few situations in which legal research is necessary.

Why is legal research hard?

Each step — from defining research questions to synthesizing findings — demands critical thinking and rigorous analysis.

1. Identifying the legal issue is not so straightforward. Legal research involves interpreting many legal precedents and theories to justify your questions. Finding the right issue takes time and patience.

2. There's too much to research. Attorneys now face a great deal of case law and statutory material. The sheer volume forces the researcher to be efficient by following a methodology based on a solid foundation of legal knowledge and principles.

3. The law is a fluid doctrine. It changes with time, and staying updated with the latest legal codes, precedents, and statutes means the most resourceful lawyer needs to assess the relevance and importance of new decisions.

Legal research can pose quite a challenge, but professionals can improve it at every stage of the process . 

Step 1: Key questions to ask yourself when starting legal research

Before you begin looking for laws and court opinions, you first need to define the scope of your legal research project. There are several key questions you can use to help do this.

What are the facts?

Always gather the essential facts so you know the “who, what, why, when, where, and how” of your case. Take the time to write everything down, especially since you will likely need to include a statement of facts in an eventual filing or brief anyway. Even if you don't think a fact may be relevant now, write it down because it may be relevant later. These facts will also be helpful when identifying your legal issue.

What is the actual legal issue?

You will never know what to research if you don't know what your legal issue is. Does your client need help collecting money from an insurance company following a car accident involving a negligent driver? How about a criminal case involving excluding evidence found during an alleged illegal stop?

No matter the legal research project, you must identify the relevant legal problem and the outcome or relief sought. This information will guide your research so you can stay focused and on topic.

What is the relevant jurisdiction?

Don't cast your net too wide regarding legal research; you should focus on the relevant jurisdiction. For example, does your case deal with federal or state law? If it is state law, which state? You may find a case in California state court that is precisely on point, but it won't be beneficial if your legal project involves New York law.

Where to start legal research: The library, online, or even AI?

In years past, future attorneys were trained in law school to perform research in the library. But now, you can find almost everything from the library — and more — online. While you can certainly still use the library if you want, you will probably be costing yourself valuable time if you do.

When it comes to online research, some people start with free legal research options , including search engines like Google or Bing. But to ensure your legal research is comprehensive, you will want to use an online research service designed specifically for the law, such as Westlaw . Not only do online solutions like Westlaw have all the legal sources you need, but they also include artificial intelligence research features that help make quick work of your research

Step 2: How to find relevant case law and other primary sources of law

Now that you have gathered the facts and know your legal issue, the next step is knowing what to look for. After all, you will need the law to support your legal argument, whether providing guidance to a client or writing an internal memo, brief, or some other legal document.

But what type of law do you need? The answer: primary sources of law. Some of the more important types of primary law include:

• Case law, which are court opinions or decisions issued by federal or state courts
• Statutes, including legislation passed by both the U.S. Congress and state lawmakers
• Regulations, including those issued by either federal or state agencies
• Constitutions, both federal and state

Searching for primary sources of law

So, if it's primary law you want, it makes sense to begin searching there first, right? Not so fast. While you will need primary sources of law to support your case, in many instances, it is much easier — and a more efficient use of your time — to begin your search with secondary sources such as practice guides, treatises, and legal articles.

Why? Because secondary sources provide a thorough overview of legal topics, meaning you don't have to start your research from scratch. After secondary sources, you can move on to primary sources of law.

For example, while no two legal research projects are the same, the order in which you will want to search different types of sources may look something like this:

• Secondary sources . If you are researching a new legal principle or an unfamiliar area of the law, the best place to start is secondary sources, including law journals, practice guides , legal encyclopedias, and treatises. They are a good jumping-off point for legal research since they've already done the work for you. As an added bonus, they can save you additional time since they often identify and cite important statutes and seminal cases.
• Case law . If you have already found some case law in secondary sources, great, you have something to work with. But if not, don't fret. You can still search for relevant case law in a variety of ways, including running a search in a case law research tool.

Once you find a helpful case, you can use it to find others. For example, in Westlaw, most cases contain headnotes that summarize each of the case's important legal issues. These headnotes are also assigned a Key Number based on the topic associated with that legal issue. So, once you find a good case, you can use the headnotes and Key Numbers within it to quickly find more relevant case law.

• Statutes and regulations . In many instances, secondary sources and case law list the statutes and regulations relevant to your legal issue. But if you haven't found anything yet, you can still search for statutes and regs online like you do with cases.

Once you know which statute or reg is pertinent to your case, pull up the annotated version on Westlaw. Why the annotated version? Because the annotations will include vital information, such as a list of important cases that cite your statute or reg. Sometimes, these cases are even organized by topic — just one more way to find the case law you need to support your legal argument.

Keep in mind, though, that legal research isn't always a linear process. You may start out going from source to source as outlined above and then find yourself needing to go back to secondary sources once you have a better grasp of the legal issue. In other instances, you may even find the answer you are looking for in a source not listed above, like a sample brief filed with the court by another attorney. Ultimately, you need to go where the information takes you.

Step 3: Make sure you are using ‘good’ law

One of the most important steps with every legal research project is to verify that you are using “good" law — meaning a court hasn't invalidated it or struck it down in some way. After all, it probably won't look good to a judge if you cite a case that has been overruled or use a statute deemed unconstitutional. It doesn't necessarily mean you can never cite these sources; you just need to take a closer look before you do.

The simplest way to find out if something is still good law is to use a legal tool known as a citator, which will show you subsequent cases that have cited your source as well as any negative history, including if it has been overruled, reversed, questioned, or merely differentiated.

For instance, if a case, statute, or regulation has any negative history — and therefore may no longer be good law — KeyCite, the citator on Westlaw, will warn you. Specifically, KeyCite will show a flag or icon at the top of the document, along with a little blurb about the negative history. This alert system allows you to quickly know if there may be anything you need to worry about.

Some examples of these flags and icons include:

• A red flag on a case warns you it is no longer good for at least one point of law, meaning it may have been overruled or reversed on appeal.
• A yellow flag on a case warns that it has some negative history but is not expressly overruled or reversed, meaning another court may have criticized it or pointed out the holding was limited to a specific fact pattern.
• A blue-striped flag on a case warns you that it has been appealed to the U.S. Supreme Court or the U.S. Court of Appeals.
• The KeyCite Overruling Risk icon on a case warns you that the case may be implicitly undermined because it relies on another case that has been overruled.

Another bonus of using a citator like KeyCite is that it also provides a list of other cases that merely cite your source — it can lead to additional sources you previously didn't know about.

Perseverance is vital when it comes to legal research

Given that legal research is a complex process, it will likely come as no surprise that this guide cannot provide everything you need to know.

There is a reason why there are entire law school courses and countless books focused solely on legal research methodology. In fact, many attorneys will spend their entire careers honing their research skills — and even then, they may not have perfected the process.

So, if you are just beginning, don't get discouraged if you find legal research difficult — almost everyone does at first. With enough time, patience, and dedication, you can master the art of legal research.

Thomson Reuters originally published this article on November 10, 2020.

Related insights

Westlaw tip of the week: Checking cases with KeyCite

Why legislative history matters when crafting a winning argument

Case law research tools: The most useful free and paid offerings

Request a trial and experience the fastest way to find what you need

• Fowler School of Law
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Legal Research Basics

Introduction, step 1: preliminary analysis, step 2: create a research plan, step 3: consult secondary sources, step 4: search for primary authority – statutes, regulations, and cases, step 5: evaluate your search strategy and results as you go, step 6: update & final check.

• Secondary Sources
• Primary Law - Mandatory v. Persuasive Authority
• Court Structure
• Regulations
• Legislative History
• Legal Citations
• Boolean Operators
• Free Sources of Legal Information

Whenever you conduct legal research, it is essential that you follow a process. Many researchers simply throw words into Westlaw or Lexis+ and try their best to sift through the thousands of results, without first coming up with a research plan. They end up lost, confused, and frustrated. Taking the time to develop a research plan (and having the discipline to follow it) will make your research more efficient and productive. The major steps of the research process are detailed below.

• Relevant and material facts (Who? What? Where? When?)
• Parties (who is the Plaintiff and who is the Defendant?)
• Jurisdiction(s) – Is the issue resolved under federal, state (which state?), or both?
• Area(s) of law
• Primary legal issues: what are you trying to resolve?
• Legal concepts, terms of art, possible legal theories, and defenses
• What entities have authority?
• What types of law do you expect to find (e.g., statutes, regulations, case law)?
• How familiar are you with the area of law? What do you know about the issues?
• Create a list of general and specific search terms (unique or distinctive facts) and legal concepts (include synonyms and related terms).
• Decide where to begin (usually secondary sources).
• Identify primary authority sources to search (federal, state, or both; statutes, regulations, and cases).
• Locate the sources you wish to search, choose the format, understand the scope and coverage of the resource and how to navigate / search (table of contents, index, full-text search conventions).
• Identify one or more secondary sources relevant to your issue.
• Find the relevant sections using the index, table of contents, or search features.
• Read all the relevant sections. Take notes as you go.
• Note any citations to primary law. Repeat this until you have a good understanding of the issue.

If you don't know what secondary source to use, consult our list of Recommended Treatises . You can also contact your Research Librarians if you need assistance getting started. 

• Search for statutes first (enacted laws control before case law).
• Search for administrative regulations related to relevant statutes.
• Search for case law interpreting the statute(s).
• If there are no applicable statutes or regulations, look for mandatory case law (See Mandatory v. Persuasive Authority for more detail).
• Search for persuasive authority if there is no mandatory authority, or to find contrary authority (it can be good to know what authority the other side is going to use to make their case).
• Identify new search terms and legal concepts.
• Refine research strategy to incorporate findings.
• Try utilizing a research log to track what terms you've already used, in what combination, and where you searched them.
• Add more terms, use more specific terms, set filters, adjust proximity connectors (e.g., AND instead of OR, /s instead of /p).
• Use fewer terms, use synonyms for original terms, use broader terms, remove filters, adjust proximity connectors (e.g., OR instead of AND, /p instead of /s).
• Periodically consult your notes/facts to ensure you are staying on track.
• Consider other relevant sources (e.g., surrounding sections of statutes, definitions, related authority).
• Make sure you have addressed all issues completely.
• Update all primary authority you are relying on or citing to make sure it is still good law (using KeyCite and/or Shepard’s).
• Proofread your work.
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Writing a law school research paper or law review note

• Books and articles

Basics of Format & Content

Research papers are not as strictly structured as legal memos, briefs, and other documents that you've learned about in legal writing and drafting courses. For example, there is no prescribed content/format similar to to the Questions Presented, Brief Answers, etc. that you learned for a legal memo.

A general approach to thinking about the content of a research paper is:

• Introduction in which you give some background and a clear statement of your thesis
• Status quo -- what is the existing law and why is it a problem
• Proposals for change

See this blog post by Jonathan Burns , an IU McKinney alum, for more on basic content.

If you're writing for a law review or seminar, you should get formatting instructions regarding things like margins, font size, line spacing. If you don't, or if you're doing an independent study, here are some basic guidelines to follow:

• Times New Roman or similar, 12 pt font.
• Double spaced lines.
• One inch margins all around.
• Footnotes in academic Bluebook style (use the rules on the main white pages instead of the light blue pages at the front of the Bluebook).
• Footnotes in same font as text, 10 pt font.
• Use Roman numerals and/or letters on headings and subheadings or style the fonts so that the difference between headings and subheadings is clear.   
• Page numbers in the footer, preferably centered, especially on first page. You could do bottom center on first page and then upper right in the header thereafter. Use the header and footer functions for this. If you don't know how to use headers and footers in Word, here is help:  https://edu.gcfglobal.org/en/word2016/headers-and-footers/1/ . 

Headings and subheadings

Research papers should have headings and subheadings. These help your reader follow your logic--and a logical structure is very important. Headings and subheadings can also help you keep your thoughts organized. Just don't overuse them--you don't want every paragaph to have a subheading. 

Road map paragraph

Often, research papers will also include a paragraph at the end of the introduction that narrates the road map the paper will follow.   Here is an example of this kind of paragraph:

"The section that follows [this introduction] sets the stage by recounting two scenarios from the Indiana University Robert H. McKinney School of Law, with discussion of the knowledge and implementation of accessibility features in online instructional materials. The next section provides an overview of various impairments and their effects on a user's experience of the online environment. Next is a review of the laws relevant to accessibility with attention to their potential application to online instruction, along with standards used to guide accessibility compliance. The article then explores the concept of universal design and its guiding principles, followed by a discussion of how to use the universal design principles to organize and better understand accessibility standards and practices. The final section briefly summarizes the discussion and encourages law librarians and professors to become knowledgeable and skilled in universal design for online materials to benefit all their students."

Table of Contents

A table of contents can also be helpful, though it's not necessary. If you add a table of contents to your papers, put it right at the beginning, before the introduction. Here's part of the table of contents for the same paper the paragraph above was taken from--it really just lays out the heading and subheadings with page numbers: 

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• Last Updated: Jul 29, 2022 11:08 AM
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How to write a legal research paper: All you need to know

This article on “How to write a legal research paper: All you need to know” was written by Vridhi Rai, an intern at Legal Upanishad.

Introduction:

Law is all about analysis, critical thinking, and interpretation. Your capability to put together the analysis of the study of the issues in written form is essential in the practice of law. The research paper is one such way to express your creative and analytic thought process, your vision of the theme, and the originality of your content. The word ‘research’ means a systematic examination of material facts. It can be complex and daunting for law students. But research helps in enhancing your knowledge and cultivating your writing skills. This article will help you understand what is research paper all about and how to write a research paper.

What is a research paper?

A research paper is a piece of academic writing which is based on an author’s original composition in the research and the findings on a given theme or topic. The writing should be owned by the author himself or herself. A good research paper strives to convey the information traced by the author crisply and concisely. The paper is written to examine the theme or the provisions, present your stand on it, and showcase evidence in support in a systematic manner. The true nature of the paper shows you the purpose of the theme or topic. 

What is the aim of the legal research paper?

The aim of the legal research paper can be a subjective question since the writing will indicate what the intended outcome is. There are kinds of writings that would pave a way for courts because it geared toward a certain kind of doctrinal analysis of the court’s interaction with theory and practice. The writings are done for better interpretation of the law. It could also be used to influence policy-making and generate debates. The author has a specific objective and intended audience in mind to serve.

How to write a legal research paper?

Step-1 choose a theme or topic:.

The foremost step in writing a  legal research paper is to select a theme or topic for the research. Select topics that catch your attention or interest. You can pick topics addressing contemporary issues or topics for the intended audience you wish to cater to. It should be novel, innovative, and interesting. While choosing a topic, read pertinent issues from different sources.  You can follow legal news to search for pertinent topics.

In case, you find difficulty selecting a topic, it will be wonderful for you to approach your professors, colleagues, and friends for consultation. Also, never feel hesitant to change the theme or topic of the research, if you feel it is not the right topic or you will not able to research the topic effectively.

Step-2 Research on your topic:

Now, your next task is to research the topic extensively on your selected topic from credible sources. You can refer to different sources by reading legal research pieces from books to online sites like SCC online, Manupatra, and Kluwer Arbitration. Always remember don’t just goggle. Use conventional sources like books and articles, these will give you a broader perspective. Read as much as you can. Reading helps you understand the nitty-gritty of the law provisions. Please beware of the research as this task can be very monotonous. You might lose motivation to perform this task. But hang in there and stay motivated to find interesting facts.

Step-3 Examine and Make a plan:

After researching, your very next step is to examine and make a plan to execute writing a legal research paper. Your research will be comprehensive with ideas. Please develop a detailed outline. Try adding notes to your research work. It can be possible that you might end up adding too much information to your paper. Highlight the key findings from your study. At this stage you are required to identify the goal of your research work, it can be either argumentative or analytic. You have to determine the masses you are wishing to address. The focus and the tone of the paper should b according to the audience you are intending to reach.

To get your Legal Research Paper written by an expert. Contact us.

Step-4 writing the paper:.

The next step is to draft the research paper. Make a final outline of the research work. The outline must have the points to describe the overview of the paper. The basic mantra of legal research is the structure of the paper. The research paper writing should be creative, clear, concise, and comprehensive. The language of your research paper should be easy to interpret. The legal terminologies and material facts are generally very sophisticated and complex. The facts, you are mentioning must be backed by shreds of evidence.

The format of the legal research paper:

The paper should have a proper format that consists of writing styles, referencing styles, page numbering, spacing, and margins. It should also include the headlines, sub-headlines, citations, or credits to the authors and the scholars.

The content of the legal research paper:

The content consists of the following:

Acknowledgment : the content of the paper should include an acknowledgment section that appreciates all the contributors to the research paper for their efforts and encouragement.

Table of contents: it includes the list of the things that you have written in your research paper.

Scope of the research: the scope or object of the research includes the reason for your study. It shows you the skeleton of your research paper. You have stated the problem or issue of the paper.

A literature survey or the sources used in the study: it includes the sources you have referred to in your study. It can be primary or secondary resources. The primary resources include books, statutes, and case laws. The secondary sources include the material you have collected from law articles, journals, and compendiums online or offline.

The hypothesis of the research: the hypothesis is the idea that is suggested to explain the objective of the research conducted by the researcher. It conveys the expectations of the researcher on what basis he started studying the issues, he raised in his paper.

Abstract : abstract shows the gist of the theme you have mentioned in your study. It is like the summary of the findings in your research regarding the theme. It should be written clearly and concisely.

Introduction: the introduction should be well-written to attract the attention of the audience toward the theme you mentioned in your thesis. A glance over the initial paragraphs gives an insight to the readers of your work. The introduction determines whether the research paper is worth reading or not. It should express the research problem, the purpose of your thesis, and background details about the issue you are referring to. It should be short, crisp, and comprehensive.

The main body of the study: the main focus of the paper is the main body of the thesis. The body should be divided into paragraphs along with sub-headings for a better understanding of the facts. Each paragraph should draw the main points of your study. It should begin with the topic’s sentences and should conclude extensively. In the main body, you can add the case laws and judgments.  

The conclusion of the study: the finale of the study should include a summary of the main pointers discussed in the study, it should express your stand or viewpoint towards the research problem. The concluding para of your research can be affirmative or negative in tone. In the end, you can add some suggestive measures to your study.

References or bibliography: at the end of the paper mention the references or the sources links or sites from which you have researched the material facts.

Step – 5 edit and proofread the final draft of the research paper:

Use proper grammar, punctuation, and spelling. Proofreading will help you to find errors in your content. If you need, to make changes to the paper, check and find the logic and legality of the statement. At this stage, you check the plagiarism of your content.

The things that should be considered carefully before drafting the paper:

you need to check the validity of the judgments before mentioning them in the research paper. The validity of the bills mentioned in your study should be carefully considered. The errors related to applicability or jurisdictions should be carefully verified.

Conclusion:

Legal research is not an easy task to perform. It takes a lot of time to conduct it. Constant hard work, attention, motivation, and patience are the factors required to examine and analyze the details. It can be boring. But it will help you in brushing your skills. Your efforts and dedication toward finding more and more material facts will help in shaping you into a good researcher.

It is beneficial for law students for interpreting law provisions, policies, and judgments. It can be used as a medium to influence policy-making procedures and as a tool to aware the masses. Publication of your research papers will act as a stimulating force to your law career. It will help you build your confidence and help them transform into law professionals.

References:

• How to write a legal research paper: guide: how to write a winning research paper?- Legal Desire. Retrieved: https://legaldesire.com/guide-how-to-write-a-winning-research-paper/
• A helpful guide on writing a law research paper- Writing help. Retrieved: https://howtowrite.customwritings.com/post/law-research-paper-guide/
• How to begin with writing a legal research paper- Manupatra- youtube channel-(video file)
• How to write a legal research paper law?|research paper- Eminent law classes-(Video file)
• The aim of writing a legal research paper- the art of writing a legal research paper-Rohini Sen-letter of the law-(video file)

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1 Introduction: Legal Research Methodology, Purposes, and Footsteps

• Published: January 2020
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The first chapter introduces the subject by explaining key words like research, legal research, method, and methodology. By linking knowledge with research, it brings out the purposive character of knowledge influencing research. It lists various objectives of legal research such as exploration, description, historical explanation, law reform, prediction, and publication, briefly explaining each. It traces the historical development of legal research in India thorugh ancient, medieval, colonial, and modern times. It finds that legal research became systematic and wide spread only along with orderly growth of legal education. Finally, it catalogues diverse methods of legal research under the categories of doctrinal, non-doctrinal, and integrated methods of legal research. Reader gets a basic idea about legal research, its past, present, and future potentiality and a glimpse of its wider canvas.

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What is legal basis?  

Insight from top 3 papers.

Legal basis refers to the foundation or framework upon which laws and regulations are established and implemented. It provides the authority and justification for the existence and enforcement of legal rules and policies. The legal basis can vary depending on the specific context and jurisdiction. In the field of countering crime in penal enforcement institutions, the legal basis is defined by criminal law and criminal procedure means [1] . In the context of entrepreneurial activity, the legal basis includes laws and regulations that govern business contracts, labor relations, and protection of entrepreneurs' rights and interests [2] [3] . In the realm of innovation governance, the legal basis involves the rules, processes, and policies that influence the innovation process and its dissemination, with both private firms and government playing a role [4] . In the European Union, legal basis refers to the instruments of secondary EU law and the choices made by institutions to give effect to policies, with the aim of ensuring legal certainty [5] .

Source Papers (3)

Related Questions

A legal principle is a fundamental value or guiding norm that underpins the creation, interpretation, and application of legal rules within a legal system. These principles serve as the foundational ideas that inform the law's purpose and social orientation, acting as a framework for legal reasoning and decision-making. They are operationalized through specific legal rules, which cannot encompass all possible factual scenarios; thus, principles help clarify the application of these rules in diverse contexts. Legal principles, such as the inviolability of judges, illustrate their role in establishing the status and independence of legal actors, thereby ensuring justice and societal respect for the judiciary. Furthermore, adherence to these principles fosters predictability and stability in legislation, essential for effective governance and social order. Overall, legal principles are integral to the coherence and functionality of the legal system, guiding both legislative processes and law enforcement activities.

NATO's legal basis stems from its role as a security organization formalized after World War II, serving as a framework for the US commitment to European security . NATO's involvement in armed conflicts, such as the intervention in Libya during the Arab Spring, required adherence to international humanitarian law (IHL) and human rights law (IHRL) while navigating the complexities of self-defence criteria . The organization's actions are constrained by the UN Charter, which limits the use of force to self-defence under Article 51 or through Security Council authorization under Chapter VII . NATO's regulatory and legal framework continues to evolve, with suggestions for refining domestic legal frameworks in member states like Ukraine to enhance national security strategies .

Hygiene is not an appropriate basis for the law due to the lack of legal support and conceptual apparatus in the field of cyber hygiene, leading to insufficient protection against cybercrimes . Additionally, the industrial hygiene field faces challenges as industrial hygienists must navigate an ever-expanding definition of their responsibilities and potential liabilities within the legal system . Furthermore, deficiencies in hygienic procedures in medical practices highlight the need for increased hygiene control tasks under new infection control laws, emphasizing the legal complexities surrounding hygiene enforcement . The historical perspective reveals that while some efforts have been made to regulate hygiene in certain sectors, there is a general lack of scientific knowledge dissemination and legal enforcement to ensure optimal hygienic conditions for workers .

The legal basis for bioplastics is currently lacking clear and unified opinion throughout the EU . This absence of regulation on bioplastics production and usage hinders its recognition and adoption . However, there is an initiative by major companies to manufacture bioplastics and expand their usage in packaging . To improve and expedite the processes related to bioplastics manufacture, usage, and waste management in Europe and Lithuania, recommendations have been presented . These recommendations aim to update and adapt the legal laws to include regulations on bioplastics . Despite the slow progress, the search for alternative materials for traditional plastics, such as bioplastics, is driven by the limited reserves of fossil organic sources and the need for waste treatment and recycling . The goal is to find bioplastics that have similar properties to traditional plastics and the ability to biodegrade .

A legal right is a concept that is difficult to define, but it generally refers to a claim of entitlement to certain freedoms, goods, or conditions that can be enforced. There are different approaches to defining legal rights, including viewing them as an ethical phenomenon or value system, as a set of norms, or as a social-material category . Legal rights are not innate, but generated by society and change with the growth of human ability and the development of society. Human rights are considered the most basic rights, to which all other rights are attached . A legal right is a system of autonomy that allocates autonomy within a defined sphere to one party in the event of conflict or confrontation with other parties . There are also legal doctrines that allow for rights to do wrong, such as diplomatic immunity, which demonstrate that such rights can be conceptually coherent and normatively valuable .

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