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Understanding Scientific and Research Ethics

How to pass journal ethics checks to ensure a smooth submission and publication process

Reputable journals screen for ethics at submission—and inability to pass ethics checks is one of the most common reasons for rejection. Unfortunately, once a study has begun, it’s often too late to secure the requisite ethical reviews and clearances. Learn how to prepare for publication success by ensuring your study meets all ethical requirements before work begins.

The underlying principles of scientific and research ethics

Scientific and research ethics exist to safeguard human rights, ensure that we treat animals respectfully and humanely, and protect the natural environment.

The specific details may vary widely depending on the type of research you’re conducting, but there are clear themes running through all research and reporting ethical requirements:

Documented 3rd party oversight

• Consent and anonymity
• Full transparency

If you fulfill each of these broad requirements, your manuscript should sail through any journal’s ethics check.

If your research is 100% theoretical, you might be able to skip this one. But if you work with living organisms in any capacity—whether you’re administering a survey, collecting data from medical records, culturing cells, working with zebrafish, or counting plant species in a ring—oversight and approval by an ethics committee is a prerequisite for publication. This oversight can take many different forms:

For human studies and studies using human tissue or cells, obtain approval from your institutional review board (IRB). Register clinical trials with the World Health Organization (WHO) or International Committee of Medical Journal Editors (ICMJE). For animal research consult with your institutional animal care and use committee (IACUC). Note that there may be special requirements for non-human primates, cephalopods, and other specific species, as well as for wild animals. For field studies , anthropology and paleontology , the type of permission required will depend on many factors, like the location of the study, whether the site is publicly or privately owned, possible impacts on endangered or protected species, and local permit requirements. 

TIP: You’re not exempt until your committee tells you so

Even if you think your study probably doesn’t require approval, submit it to the review board anyway. Many journals won’t consider retrospective approvals. Obtaining formal approval or an exemption up front is worth it to ensure your research is eligible for publication in the future.

TIP: Keep your committee records close

Clearly label your IRB/IACUC paperwork, permit numbers, and any participant permission forms (including blank copies), and keep them in a safe place. You will need them when you submit to a journal. Providing these details proactively as part of your initial submission can minimize delays and get your manuscript through journal checks and into the hands of reviewers sooner.

Consent & anonymity

Obtaining consent from human subjects.

You may not conduct research on human beings unless the subjects understand what you are doing and agree to be a part of your study. If you work with human subjects, you must obtain informed written consent from the participants or their legal guardians. 

There are many circumstances where extra care may be required in order to obtain consent. The more vulnerable the population you are working with the stricter these guidelines will be. For example, your IRB may have special requirements for working with minors, the elderly, or developmentally delayed participants. Remember that these rules may vary from country to country. Providing a link to the relevant legal reference in your area can help speed the screening and approval process.

TIP: What if you are working with a population where reading and writing aren’t common?

Alternatives to written consent (such as verbal consent or a thumbprint) are acceptable in some cases, but consent still has to be clearly documented. To ensure eligibility for publication, be sure to:

• Get IRB approval for obtaining verbal rather than written consent
• Be prepared to explain why written consent could not be obtained
• Keep a copy of the script you used to obtain this consent, and record when consent was obtained for your own records

Consent and reporting for human tissue and cell lines

Consent from the participant or their next-of-kin is also required for the use of human tissue and cell lines. This includes discarded tissue, for example the by-products of surgery.  

When working with cell lines transparency and good record keeping are essential. Here are some basic guidelines to bear in mind:

• When working with established cell lines , cite the published article where the cell line was first described.
• If you’re using repository or commercial cell lines ,  explain exactly which ones, and provide the catalog or repository number. 
• If you received a cell line from a colleague , rather than directly from a repository or company, be sure to mention it. Explain who gifted the cells and when.
• For a new cell line obtained from a colleague there may not be a published article to cite yet, but the work to generate the cell line must meet the usual requirements of consent—even if it was carried out by another research group. You’ll need to provide a copy of your colleagues’ IRB approval and details about the consent procedures in order to publish the work.

Finally, you’re obliged to keep your human subjects anonymous and to protect any identifying information in photos and raw data. Remove all names, birth dates, detailed addresses, or job information from files you plan to share. Blur faces and tattoos in any images. Details such as geography (city/country), gender, age, or profession may be shared at a generalized level and in aggregate. Read more about standards for de-identifying datasets in The BMJ .

TIP: Anonymity can be important in field work too

Be careful about revealing geographic data in fieldwork. You don’t want to tip poachers off to the location of the endangered elephant population you studied, or expose petroglyphs to vandalism.

Full Transparency

No matter the discipline, transparent reporting of methods, results, data, software and code is essential to ethical research practice. Transparency is also key to the future reproducibility of your work.

When you submit your study to a journal, you’ll be asked to provide a variety of statements certifying that you’ve obtained the appropriate permissions and clearances, and explaining how you conducted the work. You may also be asked to provide supporting documentation, including field records and raw data. Provide as much detail as you can at this stage. Clear and complete disclosure statements will minimize back-and-forth with the journal, helping your submission to clear ethics checks and move on to the assessment stage sooner.

TIP: Save that data

As you work, be sure to clearly label and organize your data files in a way that will make sense to you later. As close as you are to the work as you conduct your study, remember that two years could easily pass between capturing your data and publishing an article reporting the results. You don’t want to be stuck piecing together confusing records in order to create figures and data files for repositories.

Read our full guide to preparing data for submission .

Keep in mind that scientific and research ethics are always evolving. As laws change and as we learn more about influence, implicit bias and animal sentience, the scientific community continues to strive to elevate our research practice.

A checklist to ensure you’re ethics-check ready

Before you begin your research

Obtain approval from your IRB, IACUC or other approving body

Obtain written informed consent from human participants, guardians or next-of-kin

Obtain permits or permission from property owners, or confirm that permits are not required

Label and save all of records

As you work

Adhere strictly to the protocols approved by your committee

Clearly label your data, and store it in a way that will make sense to your future self

As you write, submit and deposit your results

Be ready to cite specific approval organizations, permit numbers, cell lines, and other details in your ethics statement and in the methods section of your manuscript

Anonymize all participant data (including human and in some cases animal or geographic data)

If a figure does include identifying information (e.g. a participant’s face) obtain special consent

The contents of the Peer Review Center are also available as a live, interactive training session, complete with slides, talking points, and activities. …

The contents of the Writing Center are also available as a live, interactive training session, complete with slides, talking points, and activities. …

There’s a lot to consider when deciding where to submit your work. Learn how to choose a journal that will help your study reach its audience, while reflecting your values as a researcher…

An Introduction to Research Ethics and Scientific Integrity

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This chapter outlines the aims for the handbook. A main aim is to be a first point of contact for contemporary information, issues, and challenges in the fields of research ethics and scientific integrity. It is aimed at researchers, reviewers, and policymakers to help them pursue the best ways forward in seeking ethics and integrity in all research across disciplines, methods, subjects, participants, and contexts. The authors form a global network of scholars, practitioners, and researchers with a range of experience and insights that scope a challenging field but one that is vital to the maintenance of research standards and public confidence in science. Fact-based policymaking remains under threat from political and ideological pressures. Scientists and researchers in all disciplines and professions hold a clear responsibility to protect their subjects, research participants, and society from pressures, interests, and prejudices that risk undermining the value of their work. This overview outlines how the handbook is constructed and how readers might gain from it.

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Cadwalladr C (2018) Our Cambridge Analytica scoop shocked the world. But the whole truth remains elusive, The Guardian , 23rd December Accessed at: https://www.theguardian.com/uk-news/2018/dec/23/cambridge-analytica-facebook-scoop-carole-cadwalladr-shocked-world-truth-still-elusive

Cadwalladr C (2019) Cambridge Analytica a year on: ‘a lesson in institutional failure’, The Guardian, 17 March, accessed at: https://www.theguardian.com/uk-news/2019/mar/17/cambridge-analytica-year-on-lesson-in-institutional-failure-christopher-wylie

Cohen S, Young J (1973) The manufacture of news: a reader. Sage, London

Google Scholar  

Collingridge D (1980) The social control of technology. Frances Pinter, London

ESOMAR (2016) https://www.esomar.org/what-we-do/code-guidelines

Evans RJ (2002) Telling lies about Hitler: the holocaust, history and the David Irving trial. Verso, London

Fuhrman J (2013) Super immunity. HarperCollins, London

Goldacre B (2001) Bad pharma. HarperCollins, London

Gross J (2018) Poland’s death camp law is designed to falsify history, Financial Times, February 6, accessed at: https://www.ft.com/content/1c183f56-0a6a-11e8-bacb-2958fde95e5e

Hutton W, Adonis A (2018) Saving Britain: how we must change to prosper in Europe. Abacus, London

Ioris AAR (2015) Cracking the nut of agribusiness and global food insecurity: in search of a critical agenda of research. Geoforum 63:1–4. https://doi.org/10.1016/j.geoforum.2015.05.004

Article   Google Scholar  

Iphofen R (2017) Epistemological metaphors: orders of knowledge and control in the Encyclopedist myths of cyberspace. International Journal of Humanities and Cultural Studies. (ISSN 2356-5926) 4(2):122–141. https://www.ijhcs.com/index.php/ijhcs/article/view/3128

Levitt SD, Dubner SJ (2005) Freakonomics: a rogue economist explores the hidden side of everything. Allen Lane, London

Levitt SD, Dubner SJ (2009) SuperFreakonomics: global cooling, patriotic prostitutes, and why suicide bombers should buy life insurance. Harper Collins, New York

Portes R (2017) Who needs experts? The London Business Review, 9th May. Accessed at: https://www.london.edu/faculty-and-research/lbsr/who-needs-experts

Posner M (2006) Social sciences under attack in the UK (1981–1983), La revue pour l’histoire du CNRS [], 7|2002, 20 October 2006, 09 January 2017. http://histoire-cnrs.revues.org/547 ; https://doi.org/10.4000/histoire-cnrs.547

Schrag Z (2010) Ethical Imperialism: Institutional Review Boards and the Social Sciences, 1965–2009. The John Hopkins University Press, Baltimore

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Iphofen, R. (2019). An Introduction to Research Ethics and Scientific Integrity. In: Iphofen, R. (eds) Handbook of Research Ethics and Scientific Integrity. Springer, Cham. https://doi.org/10.1007/978-3-319-76040-7_62-1

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A STUDY OF ETHICAL PRINCIPLES FOR RESEARCH SCIENTISTS: AN ANALYSIS OF THE ETHICAL BEHAVIOR OF RESEARCH SCIENTISTS AND ITS IMPLICATIONS FOR HIGHER EDUCATION

Since the beginning of the nuclear age and recent advances in biology, concern has been growing among the general populace about the possibility of unethical behavior by research scientists, and about the misapplication of natural science discoveries. Scrutiny of the available literature reveals conflicting views regarding ethical responsibility of research scientists and a lack of understanding regarding by what sources of knowledge research scientists became aware of ethical principles for research ethics. The major purpose of this study was twofold: to determine the pattern of ethical behavior of research scientists, and to explore their sources of knowledge of ethical principles. As a supportive effort, this study inquired into the attitude of research scientists toward ethical principles, and their perception of the ethical behavior of other scientists. An ultimate purpose was to make recommendations for higher education. To determine the ethical behavior of research scientists, ethical principles were selected from the literature. The basis for the selection of ethical principles was concern for human worth and general applicability to research scientists. The randomly selected sample was limited to 300 research scientists in biology, chemistry, geology and physics. Of the 300, eighty-six indicated themselves to be ineligible because of retirements or transfers to administration; three were no longer working in the United States; one was dead; and eight had moved leaving no forwarding addresses. Of the remaining 202 members, 135 filled out and returned the questionnaire (a 66.8 percent return of eligible questionnaires). Research scientists' attitude toward ethical principles has been documented as a result of this study. Research scientists in general strongly believe that ethical principles are very important. Majorities of the research scientists, ranging from 52.6 percent to 94.8 percent, have rated ten of the eleven selected principles as "very important." The only principle having failed to be regarded as very important by a majority was that of "considering ethical implications as important as scientific implications.". Perhaps the most significant finding is that research scientists are generally adhering to ethical principles mostly from the beginning of their career. Each of the eleven principles is being observed by majorities of 62.9 percent to 97 percent. Naturally, there are disparities between attitude and behavior, but the significance of the disparities is negligible. The perception of research scientists regarding ethical behavior of other scientists reinforces the validity of the finding that research scientists are generally adhering to ethical principles. It is interesting to note that research scientists tend to be more doubtful about the ethical behavior of other scientists than about themselves. "Conscience" was identified as the single greatest source of awareness of ethical principles for the respondents. Teaching in science course work had also significant influence. Another important but less significant source was science publication. Only about 10 percent indicated that they have ever benefited from higher education for their background on research ethics. In contrast, 43 percent cited independent reading as their sole background. For six of the ethical principles, more than 10 percent did not begin adhering to them until becoming aware of them later in their career. It has been determined that research scientists are generally concerned with and, more importantly, are in fact adhering to ethical principles whenever applicable to their situation; and "conscience" is the single greatest source of awareness for research scientists of ethical principles.

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Introduction: What is Research Ethics?

Research Ethics is defined here to be the ethics of the planning, conduct, and reporting of research. This introduction covers what research ethics is, its ethical distinctions, approaches to teaching research ethics, and other resources on this topic.

What is Research Ethics

Why Teach Research Ethics

Animal Subjects

Biosecurity

Collaboration

Conflicts of Interest

Data Management

Human Subjects

Peer Review

Publication

Research Misconduct

Social Responsibility

Stem Cell Research

Whistleblowing

Descriptions of educational settings , including in the classroom, and in research contexts.

Case Studies

Other Discussion Tools

Information about the history and authors of the Resources for Research Ethics Collection

What is Research Ethics?

Research Ethics is defined here to be the ethics of the planning, conduct, and reporting of research. It is clear that research ethics should include:

• Protections of human and animal subjects

However, not all researchers use human or animal subjects, nor are the ethical dimensions of research confined solely to protections for research subjects. Other ethical challenges are rooted in many dimensions of research, including the:

• Collection, use, and interpretation of research data
• Methods for reporting and reviewing research plans or findings
• Relationships among researchers with one another
• Relationships between researchers and those that will be affected by their research
• Means for responding to misunderstandings, disputes, or misconduct
• Options for promoting ethical conduct in research

The domain of research ethics is intended to include nothing less than the fostering of research that protects the interests of the public, the subjects of research, and the researchers themselves.

Ethical Distinctions

In discussing or teaching research ethics, it is important to keep some basic distinctions in mind.

• It is important not to confuse moral claims about how people ought to behave with descriptive claims about how they in fact do behave. From the fact that gift authorship or signing off on un-reviewed data may be "common practice" in some contexts, it doesn't follow that they are morally or professionally justified. Nor is morality to be confused with the moral beliefs or ethical codes that a given group or society holds (how some group thinks people should live). A belief in segregation is not morally justified simply because it is widely held by a group of people or given society. Philosophers term this distinction between prescriptive and descriptive claims the 'is-ought distinction.'  
• A second important distinction is that between morality and the law. The law may or may not conform to the demands of ethics (Kagan, 1998). To take a contemporary example: many believe that the law prohibiting federally funded stem cell research is objectionable on moral (as well as scientific) grounds, i.e., that such research can save lives and prevent much human misery. History is full of examples of bad laws, that is laws now regarded as morally unjustifiable, e.g., the laws of apartheid, laws prohibiting women from voting or inter-racial couples from marrying.  
• It is also helpful to distinguish between two different levels of discussion (or two different kinds of ethical questions): first-order or "ground-level" questions and second-order questions.  
• First-order moral questions concern what we should do. Such questions may be very general or quite specific. One might ask whether the tradition of 'senior' authorship should be defended and preserved or, more generally, what are the principles that should go into deciding the issue of 'senior' authorship. Such questions and the substantive proposals regarding how to answer them belong to the domain of what moral philosophers call 'normative ethics.'  
• Second-order moral questions concern the nature and purpose of morality itself. When someone claims that falsifying data is wrong, what exactly is the standing of this claim? What exactly does the word 'wrong' mean in the conduct of scientific research? And what are we doing when we make claims about right and wrong, scientific integrity and research misconduct? These second-order questions are quite different from the ground-level questions about how to conduct one's private or professional life raised above. They concern the nature of morality rather than its content, i.e., what acts are required, permitted or prohibited. This is the domain of what moral philosophers call 'metaethics' (Kagan, 1998).

Ethical Approaches

Each of these approaches provides moral principles and ways of thinking about the responsibilities, duties and obligations of moral life. Individually and jointly, they can provide practical guidance in ethical decision-making.

• One of the most influential and familiar approaches to ethics is deontological ethics, associated with Immanuel Kant (1742-1804). Deontological ethics hold certain acts as right or wrong in themselves, e.g., promise breaking or lying. So, for example, in the context of research, fraud, plagiarism and misrepresentation are regarded as morally wrong in themselves, not simply because they (tend to) have bad consequences. The deontological approach is generally grounded in a single fundamental principle: Act as you would wish others to act towards you OR always treat persons as an end, never as a means to an end.  
• From such central principles are derived rules or guidelines for what is permitted, required and prohibited. Objections to principle-based or deontological ethics include the difficulty of applying highly general principles to specific cases, e.g.: Does treating persons as ends rule out physician-assisted suicide, or require it? Deontological ethics is generally contrasted to consequentialist ethics (Honderich, 1995).  
• According to consequentialist approaches, the rightness or wrongness of an action depends solely on its consequences. One should act in such a way as to bring about the best state of affairs, where the best state of affairs may be understood in various ways, e.g., as the greatest happiness for the greatest number of people, maximizing pleasure and minimizing pain or maximizing the satisfaction of preferences. A theory such as Utilitarianism (with its roots in the work of Jeremy Bentham and John Stuart Mill) is generally taken as the paradigm example of consequentialism. Objections to consequentialist ethics tend to focus on its willingness to regard individual rights and values as "negotiable." So, for example, most people would regard murder as wrong independently of the fact that killing one person might allow several others to be saved (the infamous sacrifice of an ailing patient to provide organs for several other needy patients). Similarly, widespread moral opinion holds certain values important (integrity, justice) not only because they generally lead to good outcomes, but in and of themselves.
• Virtue ethics focuses on moral character rather than action and behavior considered in isolation. Central to this approach is the question what ought we (as individuals, as scientists, as physicians) to be rather than simply what we ought to do. The emphasis here is on inner states, that is, moral dispositions and habits such as courage or a developed sense of personal integrity. Virtue ethics can be a useful approach in the context of RCR and professional ethics, emphasizing the importance of moral virtues such as compassion, honesty, and respect. This approach has also a great deal to offer in discussions of bioethical issues where a traditional emphasis on rights and abstract principles frequently results in polarized, stalled discussions (e.g., abortion debates contrasting the rights of the mother against the rights of the fetus).  
• The term 'an ethics of care' grows out of the work of Carol Gilligan, whose empirical work in moral psychology claimed to discover a "different voice," a mode of moral thinking distinct from principle-based moral thinking (e.g., the theories of Kant and Mill). An ethics of care stresses compassion and empathetic understanding, virtues Gilligan associated with traditional care-giving roles, especially those of women.  
• This approach differs from traditional moral theories in two important ways. First, it assumes that it is the connections between persons, e.g., lab teams, colleagues, parents and children, student and mentor, not merely the rights and obligations of discrete individuals that matter. The moral world, on this view, is best seen not as the interaction of discrete individuals, each with his or her own interests and rights, but as an interrelated web of obligations and commitment. We interact, much of the time, not as private individuals, but as members of families, couples, institutions, research groups, a given profession and so on. Second, these human relationships, including relationships of dependency, play a crucial role on this account in determining what our moral obligations and responsibilities are. So, for example, individuals have special responsibilities to care for their children, students, patients, and research subjects.  
• An ethics of care is thus particularly useful in discussing human and animal subjects research, issues of informed consent, and the treatment of vulnerable populations such as children, the infirm or the ill.  
• The case study approach begins from real or hypothetical cases. Its objective is to identify the intuitively plausible principles that should be taken into account in resolving the issues at hand. The case study approach then proceeds to critically evaluate those principles. In discussing whistle-blowing, for example, a good starting point is with recent cases of research misconduct, seeking to identify and evaluate principles such as a commitment to the integrity of science, protecting privacy, or avoiding false or unsubstantiated charges. In the context of RCR instruction, case studies provide one of the most interesting and effective approaches to developing sensitivity to ethical issues and to honing ethical decision-making skills.  
• Strictly speaking, casuistry is more properly understood as a method for doing ethics rather than as itself an ethical theory. However, casuistry is not wholly unconnected to ethical theory. The need for a basis upon which to evaluate competing principles, e.g., the importance of the well-being of an individual patient vs. a concern for just allocation of scarce medical resources, makes ethical theory relevant even with case study approaches.  
• Applied ethics is a branch of normative ethics. It deals with practical questions particularly in relation to the professions. Perhaps the best known area of applied ethics is bioethics, which deals with ethical questions arising in medicine and the biological sciences, e.g., questions concerning the application of new areas of technology (stem cells, cloning, genetic screening, nanotechnology, etc.), end of life issues, organ transplants, and just distribution of healthcare. Training in responsible conduct of research or "research ethics" is merely one among various forms of professional ethics that have come to prominence since the 1960s. Worth noting, however, is that concern with professional ethics is not new, as ancient codes such as the Hippocratic Oath and guild standards attest (Singer, 1986).
• Adams D, Pimple KD (2005): Research Misconduct and Crime: Lessons from Criminal Science on Preventing Misconduct and Promoting Integrity. Accountability in Research 12(3):225-240.
• Anderson MS, Horn AS, Risbey KR, Ronning EA, De Vries R, Martinson BC (2007): What Do Mentoring and Training in the Responsible Conduct of Research Have To Do with Scientists' Misbehavior? Findings from a National Survey of NIH-Funded Scientists . Academic Medicine 82(9):853-860.
• Bulger RE, Heitman E (2007): Expanding Responsible Conduct of Research Instruction across the University. Academic Medicine. 82(9):876-878.
• Kalichman MW (2006): Ethics and Science: A 0.1% solution. Issues in Science and Technology 23:34-36.
• Kalichman MW (2007): Responding to Challenges in Educating for the Responsible Conduct of Research, Academic Medicine. 82(9):870-875.
• Kalichman MW, Plemmons DK (2007): Reported Goals for Responsible Conduct of Research Courses. Academic Medicine. 82(9):846-852.
• Kalichman MW (2009): Evidence-based research ethics. The American Journal of Bioethics 9(6&7): 85-87.
• Pimple KD (2002): Six Domains of Research Ethics: A Heuristic Framework for the Responsible Conduct of Research. Science and Engineering Ethics 8(2):191-205.
• Steneck NH (2006): Fostering Integrity in Research: Definitions, Current Knowledge, and Future Directions. Science and Engineering Ethics 12:53-74.
• Steneck NH, Bulger RE (2007): The History, Purpose, and Future of Instruction in the Responsible Conduct of Research. Academic Medicine. 82(9):829-834.
• Vasgird DR (2007): Prevention over Cure: The Administrative Rationale for Education in the Responsible Conduct of Research. Academic Medicine. 82(9):835-837.
• Aristotle. The Nichomachean Ethics.
• Beauchamp RL, Childress JF (2001): Principles of Biomedical Ethics, 5th edition, NY: Oxford University Press.
• Bentham, J (1781): An Introduction to the Principles of Morals and Legislation.
• Gilligan C (1993): In a Different Voice: Psychological Theory and Women's Development. Cambridge: Harvard University Press.
• Glover, Jonathan (1977): Penguin Books.
• Honderich T, ed. (1995): The Oxford Companion to Philosophy, Oxford and New York: Oxford University Press.
• Kagan S (1998): Normative Ethics. Westview Press.
• Kant I (1785): Groundwork of the Metaphysics of Morals.
• Kant I (1788): Critique of Practical Reason.
• Kant I (1797): The Metaphysics of Morals.
• Kant I (1797): On a Supposed right to Lie from Benevolent Motives.
• Kuhse H, Singer P (1999): Bioethics: An Anthology. Blackwell Publishers.
• Mill JS (1861): Utilitarianism.
• Rachels J (1999): The Elements of Moral Philosophy, 3rd edition, Boston: McGraw-Hill.
• Regan T (1993): Matters of Life and Death: New Introductory Essays in Moral Philosophy, 3rd edition. New York: McGraw-Hill. The history of ethics.
• Singer P (1993): Practical Ethics, 2nd ed. Cambridge University Press.

The Resources for Research Ethics Education site was originally developed and maintained by Dr. Michael Kalichman, Director of the Research Ethics Program at the University of California San Diego. The site was transferred to the Online Ethics Center in 2021 with the permission of the author.

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This material is based upon work supported by the National Science Foundation under Award No. 2055332. Any opinions, findings, and conclusions or recommendations expressed in this material are those of the author(s) and do not necessarily reflect the views of the National Science Foundation.

Ethical Considerations In Psychology Research

Saul Mcleod, PhD

Editor-in-Chief for Simply Psychology

BSc (Hons) Psychology, MRes, PhD, University of Manchester

Saul Mcleod, PhD., is a qualified psychology teacher with over 18 years of experience in further and higher education. He has been published in peer-reviewed journals, including the Journal of Clinical Psychology.

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Olivia Guy-Evans, MSc

Associate Editor for Simply Psychology

BSc (Hons) Psychology, MSc Psychology of Education

Olivia Guy-Evans is a writer and associate editor for Simply Psychology. She has previously worked in healthcare and educational sectors.

On This Page:

Ethics refers to the correct rules of conduct necessary when carrying out research. We have a moral responsibility to protect research participants from harm.

However important the issue under investigation, psychologists must remember that they have a duty to respect the rights and dignity of research participants. This means that they must abide by certain moral principles and rules of conduct.

What are Ethical Guidelines?

In Britain, ethical guidelines for research are published by the British Psychological Society, and in America, by the American Psychological Association. The purpose of these codes of conduct is to protect research participants, the reputation of psychology, and psychologists themselves.

Moral issues rarely yield a simple, unambiguous, right or wrong answer. It is, therefore, often a matter of judgment whether the research is justified or not.

For example, it might be that a study causes psychological or physical discomfort to participants; maybe they suffer pain or perhaps even come to serious harm.

On the other hand, the investigation could lead to discoveries that benefit the participants themselves or even have the potential to increase the sum of human happiness.

Rosenthal and Rosnow (1984) also discuss the potential costs of failing to carry out certain research. Who is to weigh up these costs and benefits? Who is to judge whether the ends justify the means?

Finally, if you are ever in doubt as to whether research is ethical or not, it is worthwhile remembering that if there is a conflict of interest between the participants and the researcher, it is the interests of the subjects that should take priority.

Studies must now undergo an extensive review by an institutional review board (US) or ethics committee (UK) before they are implemented. All UK research requires ethical approval by one or more of the following:

• Department Ethics Committee (DEC) : for most routine research.
• Institutional Ethics Committee (IEC) : for non-routine research.
• External Ethics Committee (EEC) : for research that s externally regulated (e.g., NHS research).

Committees review proposals to assess if the potential benefits of the research are justifiable in light of the possible risk of physical or psychological harm.

These committees may request researchers make changes to the study’s design or procedure or, in extreme cases, deny approval of the study altogether.

The British Psychological Society (BPS) and American Psychological Association (APA) have issued a code of ethics in psychology that provides guidelines for conducting research.  Some of the more important ethical issues are as follows:

Informed Consent

Before the study begins, the researcher must outline to the participants what the research is about and then ask for their consent (i.e., permission) to participate.

An adult (18 years +) capable of being permitted to participate in a study can provide consent. Parents/legal guardians of minors can also provide consent to allow their children to participate in a study.

Whenever possible, investigators should obtain the consent of participants. In practice, this means it is not sufficient to get potential participants to say “Yes.”

They also need to know what it is that they agree to. In other words, the psychologist should, so far as is practicable, explain what is involved in advance and obtain the informed consent of participants.

Informed consent must be informed, voluntary, and rational. Participants must be given relevant details to make an informed decision, including the purpose, procedures, risks, and benefits. Consent must be given voluntarily without undue coercion. And participants must have the capacity to rationally weigh the decision.

Components of informed consent include clearly explaining the risks and expected benefits, addressing potential therapeutic misconceptions about experimental treatments, allowing participants to ask questions, and describing methods to minimize risks like emotional distress.

Investigators should tailor the consent language and process appropriately for the study population. Obtaining meaningful informed consent is an ethical imperative for human subjects research.

The voluntary nature of participation should not be compromised through coercion or undue influence. Inducements should be fair and not excessive/inappropriate.

However, it is not always possible to gain informed consent.  Where the researcher can’t ask the actual participants, a similar group of people can be asked how they would feel about participating.

If they think it would be OK, then it can be assumed that the real participants will also find it acceptable. This is known as presumptive consent.

However, a problem with this method is that there might be a mismatch between how people think they would feel/behave and how they actually feel and behave during a study.

In order for consent to be ‘informed,’ consent forms may need to be accompanied by an information sheet for participants’ setting out information about the proposed study (in lay terms), along with details about the investigators and how they can be contacted.

Special considerations exist when obtaining consent from vulnerable populations with decisional impairments, such as psychiatric patients, intellectually disabled persons, and children/adolescents. Capacity can vary widely so should be assessed individually, but interventions to improve comprehension may help. Legally authorized representatives usually must provide consent for children.

Participants must be given information relating to the following:

• A statement that participation is voluntary and that refusal to participate will not result in any consequences or any loss of benefits that the person is otherwise entitled to receive.
• Purpose of the research.
• All foreseeable risks and discomforts to the participant (if there are any). These include not only physical injury but also possible psychological.
• Procedures involved in the research.
• Benefits of the research to society and possibly to the individual human subject.
• Length of time the subject is expected to participate.
• Person to contact for answers to questions or in the event of injury or emergency.
• Subjects” right to confidentiality and the right to withdraw from the study at any time without any consequences.

Debriefing after a study involves informing participants about the purpose, providing an opportunity to ask questions, and addressing any harm from participation. Debriefing serves an educational function and allows researchers to correct misconceptions. It is an ethical imperative.

After the research is over, the participant should be able to discuss the procedure and the findings with the psychologist. They must be given a general idea of what the researcher was investigating and why, and their part in the research should be explained.

Participants must be told if they have been deceived and given reasons why. They must be asked if they have any questions, which should be answered honestly and as fully as possible.

Debriefing should occur as soon as possible and be as full as possible; experimenters should take reasonable steps to ensure that participants understand debriefing.

“The purpose of debriefing is to remove any misconceptions and anxieties that the participants have about the research and to leave them with a sense of dignity, knowledge, and a perception of time not wasted” (Harris, 1998).

The debriefing aims to provide information and help the participant leave the experimental situation in a similar frame of mind as when he/she entered it (Aronson, 1988).

Exceptions may exist if debriefing seriously compromises study validity or causes harm itself, like negative emotions in children. Consultation with an institutional review board guides exceptions.

Debriefing indicates investigators’ commitment to participant welfare. Harms may not be raised in the debriefing itself, so responsibility continues after data collection. Following up demonstrates respect and protects persons in human subjects research.

Protection of Participants

Researchers must ensure that those participating in research will not be caused distress. They must be protected from physical and mental harm. This means you must not embarrass, frighten, offend or harm participants.

Normally, the risk of harm must be no greater than in ordinary life, i.e., participants should not be exposed to risks greater than or additional to those encountered in their normal lifestyles.

The researcher must also ensure that if vulnerable groups are to be used (elderly, disabled, children, etc.), they must receive special care. For example, if studying children, ensure their participation is brief as they get tired easily and have a limited attention span.

Researchers are not always accurately able to predict the risks of taking part in a study, and in some cases, a therapeutic debriefing may be necessary if participants have become disturbed during the research (as happened to some participants in Zimbardo’s prisoners/guards study ).

Deception research involves purposely misleading participants or withholding information that could influence their participation decision. This method is controversial because it limits informed consent and autonomy, but can provide otherwise unobtainable valuable knowledge.

Types of deception include (i) deliberate misleading, e.g. using confederates, staged manipulations in field settings, deceptive instructions; (ii) deception by omission, e.g., failure to disclose full information about the study, or creating ambiguity.

The researcher should avoid deceiving participants about the nature of the research unless there is no alternative – and even then, this would need to be judged acceptable by an independent expert. However, some types of research cannot be carried out without at least some element of deception.

For example, in Milgram’s study of obedience , the participants thought they were giving electric shocks to a learner when they answered a question wrongly. In reality, no shocks were given, and the learners were confederates of Milgram.

This is sometimes necessary to avoid demand characteristics (i.e., the clues in an experiment that lead participants to think they know what the researcher is looking for).

Another common example is when a stooge or confederate of the experimenter is used (this was the case in both the experiments carried out by Asch ).

According to ethics codes, deception must have strong scientific justification, and non-deceptive alternatives should not be feasible. Deception that causes significant harm is prohibited. Investigators should carefully weigh whether deception is necessary and ethical for their research.

However, participants must be deceived as little as possible, and any deception must not cause distress.  Researchers can determine whether participants are likely distressed when deception is disclosed by consulting culturally relevant groups.

Participants should immediately be informed of the deception without compromising the study’s integrity. Reactions to learning of deception can range from understanding to anger. Debriefing should explain the scientific rationale and social benefits to minimize negative reactions.

If the participant is likely to object or be distressed once they discover the true nature of the research at debriefing, then the study is unacceptable.

If you have gained participants’ informed consent by deception, then they will have agreed to take part without actually knowing what they were consenting to.  The true nature of the research should be revealed at the earliest possible opportunity or at least during debriefing.

Some researchers argue that deception can never be justified and object to this practice as it (i) violates an individual’s right to choose to participate; (ii) is a questionable basis on which to build a discipline; and (iii) leads to distrust of psychology in the community.

Confidentiality

Protecting participant confidentiality is an ethical imperative that demonstrates respect, ensures honest participation, and prevents harms like embarrassment or legal issues. Methods like data encryption, coding systems, and secure storage should match the research methodology.

Participants and the data gained from them must be kept anonymous unless they give their full consent.  No names must be used in a lab report .

Researchers must clearly describe to participants the limits of confidentiality and methods to protect privacy. With internet research, threats exist like third-party data access; security measures like encryption should be explained. For non-internet research, other protections should be noted too, like coding systems and restricted data access.

High-profile data breaches have eroded public trust. Methods that minimize identifiable information can further guard confidentiality. For example, researchers can consider whether birthdates are necessary or just ages.

Generally, reducing personal details collected and limiting accessibility safeguards participants. Following strong confidentiality protections demonstrates respect for persons in human subjects research.

What do we do if we discover something that should be disclosed (e.g., a criminal act)? Researchers have no legal obligation to disclose criminal acts and must determine the most important consideration: their duty to the participant vs. their duty to the wider community.

Ultimately, decisions to disclose information must be set in the context of the research aims.

Withdrawal from an Investigation

Participants should be able to leave a study anytime if they feel uncomfortable. They should also be allowed to withdraw their data. They should be told at the start of the study that they have the right to withdraw.

They should not have pressure placed upon them to continue if they do not want to (a guideline flouted in Milgram’s research).

Participants may feel they shouldn’t withdraw as this may ‘spoil’ the study. Many participants are paid or receive course credits; they may worry they won’t get this if they withdraw.

Even at the end of the study, the participant has a final opportunity to withdraw the data they have provided for the research.

Ethical Issues in Psychology & Socially Sensitive Research

There has been an assumption over the years by many psychologists that provided they follow the BPS or APA guidelines when using human participants and that all leave in a similar state of mind to how they turned up, not having been deceived or humiliated, given a debrief, and not having had their confidentiality breached, that there are no ethical concerns with their research.

But consider the following examples:

a) Caughy et al. 1994 found that middle-class children in daycare at an early age generally score less on cognitive tests than children from similar families reared in the home.

Assuming all guidelines were followed, neither the parents nor the children participating would have been unduly affected by this research. Nobody would have been deceived, consent would have been obtained, and no harm would have been caused.

However, consider the wider implications of this study when the results are published, particularly for parents of middle-class infants who are considering placing their young children in daycare or those who recently have!

b)  IQ tests administered to black Americans show that they typically score 15 points below the average white score.

When black Americans are given these tests, they presumably complete them willingly and are not harmed as individuals. However, when published, findings of this sort seek to reinforce racial stereotypes and are used to discriminate against the black population in the job market, etc.

Sieber & Stanley (1988) (the main names for Socially Sensitive Research (SSR) outline 4 groups that may be affected by psychological research: It is the first group of people that we are most concerned with!

• Members of the social group being studied, such as racial or ethnic group. For example, early research on IQ was used to discriminate against US Blacks.
• Friends and relatives of those participating in the study, particularly in case studies, where individuals may become famous or infamous. Cases that spring to mind would include Genie’s mother.
• The research team. There are examples of researchers being intimidated because of the line of research they are in.
• The institution in which the research is conducted.

salso suggest there are 4 main ethical concerns when conducting SSR:

• The research question or hypothesis.
• The treatment of individual participants.
• The institutional context.
• How the findings of the research are interpreted and applied.

Ethical Guidelines For Carrying Out SSR

Sieber and Stanley suggest the following ethical guidelines for carrying out SSR. There is some overlap between these and research on human participants in general.

Privacy : This refers to people rather than data. Asking people questions of a personal nature (e.g., about sexuality) could offend.

Confidentiality: This refers to data. Information (e.g., about H.I.V. status) leaked to others may affect the participant’s life.

Sound & valid methodology : This is even more vital when the research topic is socially sensitive. Academics can detect flaws in methods, but the lay public and the media often don’t.

When research findings are publicized, people are likely to consider them fact, and policies may be based on them. Examples are Bowlby’s maternal deprivation studies and intelligence testing.

Deception : Causing the wider public to believe something, which isn’t true by the findings, you report (e.g., that parents are responsible for how their children turn out).

Informed consent : Participants should be made aware of how participating in the research may affect them.

Justice & equitable treatment : Examples of unjust treatment are (i) publicizing an idea, which creates a prejudice against a group, & (ii) withholding a treatment, which you believe is beneficial, from some participants so that you can use them as controls.

Scientific freedom : Science should not be censored, but there should be some monitoring of sensitive research. The researcher should weigh their responsibilities against their rights to do the research.

Ownership of data : When research findings could be used to make social policies, which affect people’s lives, should they be publicly accessible? Sometimes, a party commissions research with their interests in mind (e.g., an industry, an advertising agency, a political party, or the military).

Some people argue that scientists should be compelled to disclose their results so that other scientists can re-analyze them. If this had happened in Burt’s day, there might not have been such widespread belief in the genetic transmission of intelligence. George Miller (Miller’s Magic 7) famously argued that we should give psychology away.

The values of social scientists : Psychologists can be divided into two main groups: those who advocate a humanistic approach (individuals are important and worthy of study, quality of life is important, intuition is useful) and those advocating a scientific approach (rigorous methodology, objective data).

The researcher’s values may conflict with those of the participant/institution. For example, if someone with a scientific approach was evaluating a counseling technique based on a humanistic approach, they would judge it on criteria that those giving & receiving the therapy may not consider important.

Cost/benefit analysis : It is unethical if the costs outweigh the potential/actual benefits. However, it isn’t easy to assess costs & benefits accurately & the participants themselves rarely benefit from research.

Sieber & Stanley advise that researchers should not avoid researching socially sensitive issues. Scientists have a responsibility to society to find useful knowledge.

• They need to take more care over consent, debriefing, etc. when the issue is sensitive.
• They should be aware of how their findings may be interpreted & used by others.
• They should make explicit the assumptions underlying their research so that the public can consider whether they agree with these.
• They should make the limitations of their research explicit (e.g., ‘the study was only carried out on white middle-class American male students,’ ‘the study is based on questionnaire data, which may be inaccurate,’ etc.
• They should be careful how they communicate with the media and policymakers.
• They should be aware of the balance between their obligations to participants and those to society (e.g. if the participant tells them something which they feel they should tell the police/social services).
• They should be aware of their own values and biases and those of the participants.

Arguments for SSR

• Psychologists have devised methods to resolve the issues raised.
• SSR is the most scrutinized research in psychology. Ethical committees reject more SSR than any other form of research.
• By gaining a better understanding of issues such as gender, race, and sexuality, we are able to gain greater acceptance and reduce prejudice.
• SSR has been of benefit to society, for example, EWT. This has made us aware that EWT can be flawed and should not be used without corroboration. It has also made us aware that the EWT of children is every bit as reliable as that of adults.
• Most research is still on white middle-class Americans (about 90% of research is quoted in texts!). SSR is helping to redress the balance and make us more aware of other cultures and outlooks.

Arguments against SSR

• Flawed research has been used to dictate social policy and put certain groups at a disadvantage.
• Research has been used to discriminate against groups in society, such as the sterilization of people in the USA between 1910 and 1920 because they were of low intelligence, criminal, or suffered from psychological illness.
• The guidelines used by psychologists to control SSR lack power and, as a result, are unable to prevent indefensible research from being carried out.

American Psychological Association. (2002). American Psychological Association ethical principles of psychologists and code of conduct. www.apa.org/ethics/code2002.html

Baumrind, D. (1964). Some thoughts on ethics of research: After reading Milgram’s” Behavioral study of obedience.”.  American Psychologist ,  19 (6), 421.

Caughy, M. O. B., DiPietro, J. A., & Strobino, D. M. (1994). Day‐care participation as a protective factor in the cognitive development of low‐income children.  Child development ,  65 (2), 457-471.

Harris, B. (1988). Key words: A history of debriefing in social psychology. In J. Morawski (Ed.), The rise of experimentation in American psychology (pp. 188-212). New York: Oxford University Press.

Rosenthal, R., & Rosnow, R. L. (1984). Applying Hamlet’s question to the ethical conduct of research: A conceptual addendum. American Psychologist, 39(5) , 561.

Sieber, J. E., & Stanley, B. (1988). Ethical and professional dimensions of socially sensitive research.  American psychologist ,  43 (1), 49.

The British Psychological Society. (2010). Code of Human Research Ethics. www.bps.org.uk/sites/default/files/documents/code_of_human_research_ethics.pdf

Further Information

• MIT Psychology Ethics Lecture Slides

BPS Documents

• Code of Ethics and Conduct (2018)
• Good Practice Guidelines for the Conduct of Psychological Research within the NHS
• Guidelines for Psychologists Working with Animals
• Guidelines for ethical practice in psychological research online

APA Documents

APA Ethical Principles of Psychologists and Code of Conduct

Related Articles

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Qualitative Data Coding

What Is a Focus Group?

Cross-Cultural Research Methodology In Psychology

What Is Internal Validity In Research?

Research Methodology , Statistics

What Is Face Validity In Research? Importance & How To Measure

Criterion Validity: Definition & Examples

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Structured Ethics Appendix

Social science researchers engaged in primary data collection often consider a range of ethical issues during the planning of their research, but such considerations are rarely articulated upfront or in subsequent articles generated from the research. We believe that building explicit steps for this can lead to better research, better communications about research, and thus better impact of research as well. To facilitate this, we propose authors include a structured ethics appendix in working papers and published online appendices, and we provide a framework below for guidance.

We consider this a living document, and plan to update it periodically upon receiving feedback and observing usage. Please email us at [email protected] and [email protected] if you have any suggestions. If you have included such an appendix in a working or published paper, please let us know so that we can observe usage as part of our effort to maintain, update and improve these guidelines.

Structured Ethics Appendix Questions: Brief Explanations

For a more complete discussion of each item, see Asiedu et al. (2021) .

1. Policy Equipoise

If there is no reasonable expectation that one arm of the study produces more benefits to participants than any other arm or than the best possible alternative policy, then randomization is ethically unproblematic. If not, then excluding some participants from the superior treatment arm can only be justified by scarcity. Scarcity conditions are two-fold: (1) resources are not sufficient, given constraints, to include all participants in the superior treatment arm; (2) no ex-ante identifiable participants are excluded from the superior arm and have a greater claim to those resources than any participant assigned to the superior arm. See MacKay 2018, 2020 for more complete discussions of policy equipoise.

2. Role of researchers with respect to implementation

A researcher should be considered “active” if, for example, the implementing staff are employed by an institution at which the PI is employed, and the staff report either directly or indirectly to the PI at this institution with regard to this project. Or if researchers control funding for implementation, or have direct decision-making power over key implementation decisions.

Some key factors that help illuminate whether the researchers are “active” or not (here “researchers” are defined as the PIs and the staff that report directly or indirectly to the PIs): Did researchers directly provide any of the interventions, or parts thereof, to participants? Did researchers interact directly with participants and implicitly endorse one or more of the interventions?

3. Potential harms to participants or nonparticipants from the interventions or policies

It may be important to consider whether the researchers are “active” (see above) or not for this discussion. If the researchers are “active”, then they are responsible for the potential harms, and thus a robust discussion is appropriate. If the researchers are not “active”, then while they may not be responsible for potential harms, a discussion of this would be appropriate here.

There will almost always be some potential harms, if nothing else because of complementary investments such as time that participants in an intervention necessarily redirect from one activity to another. Quantifying these risks and complementary investments may be difficult ex-ante, but a discussion of what they are here would help the reader assess their likely importance relative to the potential benefits of the tested intervention. Also note that measuring any harms ex-post may be the exact reason for the study, particularly when the intervention is common.

If risks to nonparticipants exist, discuss the mechanisms through which the risk arises from the study and provide an estimate of the magnitude of the risk and the probability of harm.

4. Potential harms to research participants or research staff from data collection (e.g., surveying, privacy, data management) or research protocols (e.g., random assignment)

Example of sub-questions to consider as part of the broad question: Are there any risks that could ensue because of the data collection process or storage, e.g. discomfort to being asked certain questions or breach of confidentiality? If so, what are the mitigation strategies? Are there costs to the participant for the data collection process, such as their time, and if so, what is the strategy or rationale for offsetting this cost?

Because these are all issues covered by most IRB processes, a sufficient explanation for a “yes” response may be to provide the IRB approval numbers for all IRBs that have approved the project. However, if there are particular issues that are important to discuss, please do so here.

Harms to research staff could include, e.g., exposure to political violence, exposure to unusual levels of a communicable disease, mistrust due to lack of perceived lack of community consent, or emotional wellbeing from surveying about difficult subject matters. This would not include, e.g., traffic accidents.

5. Financial and reputational conflicts of interest

We define financial conflicts of interest as that used by the researcher’s institutional (e.g., their university) guidelines. We define a reputational conflict of interest as one in which prior writing or advocacy could be contradicted by specific results pursued in this study, and such contradiction would pose reputational risks to the author.

6. Intellectual freedom

This could include, for example, approval of release of the paper and restrictions on data release, but does not include things such as a “comment period” during which interested parties have a right to review and provide comments prior to release but not to control the outputs of the study.

7. Feedback to participants or communities

Engaging in post-study feedback is a way of acknowledging the agency of participants and communities, and is thus a desired practice. However, it may be impractical due to costs, timing, challenges communicating the results, or potential harms if such communication may itself change behavior in undesirable ways.

8. Foreseeable misuse of research results

In settings with strong imbalances of power between interested parties, there may be foreseeable risks that a powerful party could use deliberately selected research findings to their advantage and to the harm of participants or non-participants, including for general public policy. For example, if the research might reveal the vulnerability of some that can be exploited for the gain of the more powerful party, what steps does the researcher plan to mitigate this risk?

9. Other Ethics Issues to Discuss

Are there any other issues to discuss?

Sample 1: Tying Odysseus to the Mast

Sample 2: A Better Vision for Development

Sample 3: Randomizing Religion

Sample 4: Agricultural Decisions after Relaxing Credit and Risk Constraints

Archive of Prior Versions

Version 1.0, november 2020:, version 2.0, january 2021:.

Please email us if you have any suggestions. If you have included such an appendix in a working or published paper, please let us know so that we can observe usage as part of our effort to maintain, update and improve these guidelines.

Email Dean Karlan and Chris Udry

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• Letter to the Editor
• Open access
• Published: 03 June 2024

Mapping the global research landscape on molecular mimicry: a visualization and bibliometric study

• Sa’ed H. Zyoud   ORCID: orcid.org/0000-0002-7369-2058 1 , 2  

Journal of Translational Medicine volume  22 , Article number:  531 ( 2024 ) Cite this article

Metrics details

To the Editor,

This letter represents my interest in participating in the recently released Journal of Translational Medicine Collection on Molecular Mimicry in Human diseases. A better understanding of many human diseases is possible, and new therapeutic approaches based on molecular mimicry have been developed. Damian first described “molecular mimicry” in 1964. This theory suggests that pathogenic microbes may escape the immune system by expressing antigens that are closely related to those found in human hosts [ 1 ]. Since then, growing data from experimental and epidemiological studies have supported the connection between autoimmune and infectious diseases. This suggests that molecular mimicry and the resulting cross-reactivity are very important [ 2 ]. A better understanding of molecular mimicry in this environment will greatly influence the diagnosis, prevention, and treatment of these diseases [ 3 ].

Numerous disciplines have employed bibliometric analysis to identify and emphasize the most significant countries, institutions, journals, and citations [ 4 , 5 ]. The application of mathematical and statistical techniques to quantitatively analyze and characterize published literature, provide evidence to support the formation of future research hotspots, master the discipline’s development trend, track the frontier of scientific research, improve the efficiency of scientific research, and propose research directions is known as bibliometrics [ 6 ]. It also summarizes the state of affairs and highlights hotspots in particular research fields. On the other hand, no bibliometric analysis of molecular mimicry has been performed. Therefore, the objective of this study was to conduct an in-depth review of the scientific advances in molecular mimicry. Consequently, the purpose of this bibliometric analysis was to investigate molecular mimicry research trends and to pinpoint potential future research hotspots. Furthermore, by offering references and concepts for further research on molecular mimicry pathogenicity, autoimmunity, and clinical applications, this study contributes significantly to the body of knowledge.

The current study uses the Scopus database, which is widely regarded among researchers for the purposes of high-quality bibliometric studies [ 7 ], although a significant number of databases are used for evaluative research at the global level [ 8 ]. The largest abstract and citation database of peer-reviewed research literature in the world, Scopus, is a trusted source for locating biomedical research, including MEDLINE documents. Because I am more interested in molecular mimicry as a novel idea in study than in related subjects, I used the terms “molecular mimicry” and its synonyms as my key words. The MeSH terms in PubMed and the findings of earlier studies on molecular mimicry were used to determine the relevant keywords [ 3 , 9 , 10 , 11 ]. The date of data mining was May 14, 2024. The main focus was on journal articles that used “molecular mimicry” to identify objects based on searches conducted in the fields of titles and abstracts.

To understand research trends, a quantitative analysis of the obtained articles was carried out. A comprehensive picture of global research production was obtained by analyzing important indicators such as publication rates, the distribution of articles in journals, and institutional and geographical origins. The VOSviewer software (version 1.6.20) was used to create visual maps based on the most common terms in the title of the article and the abstract, further clarifying research areas and emerging themes [ 12 ]. This visualization approach offers important new perspectives on current hot topics of research and suggests possible paths for molecular mimicry.

Our search strategy identified 3,391 articles on molecular mimicry published between 1965 and 2023. Most of the research articles were of original type (63.78%, n  = 2117), followed by reviews (30.94%, n  = 1027) and other types (7.44%, n  = 247), such as letters and editorials. As shown in Fig.  1 , there was a strong positive correlation ( r  = 0.876, p  < 0.001) between the publication year and the number of articles on molecular mimicry. Initially (1965–1990), there were few publications (annual average of approximately 7). However, from 1991 onward, there was a significant increase in publications (annual average of approximately 97), reaching a peak of 182 articles in 2023.

Annual number of publications related to molecular mimicry from 1965 to 2023

A worldwide review of publications on molecular mimicry research indicates a concentration in the US. With 1186 articles (34.97%) among the 94 contributing nations, the USA took the lead, followed by the UK (316, 9.32%), Italy (310, 9.14%), and other countries (Table  1 ). The National Institutes of Health (NIH) published 73 articles (2.15%), followed by Tel Aviv University ( n  = 56; 1.65%). American institutions dominate the field. King’s College London is another notable contributor ( n  = 53; 1.56%). The Journal of Autoimmunity (70 articles, 2.06%), Journal of Immunology (70 articles, 2.06%), Frontiers in Immunology (52 articles, 1.53%), and Autoimmunity Reviews (50 articles, 1.47%) are the most active journals that publish research on molecular mimicry.

The most cited article by Wucherpfennig and Strominger [ 13 ], published in Cell in 1995, investigated the role of molecular mimicry in T-cell-mediated autoimmunity. This study tested 129 peptides on seven myelin basic protein-specific T-cell clones from multiple sclerosis patients. Although only one peptide was identified as a molecular mimic, seven viral peptides and one bacterial peptide activated three of the clones. This finding suggested that a single T-cell receptor can recognize distinct but structurally related peptides from multiple pathogens, potentially contributing to the development of autoimmunity.

Three main areas of molecular mimicry research were identified by a thematic analysis of the literature (Fig.  2 A):

Mapping of terms used in research on molecular mimicry. A : Research topics clustered by mapping the cooccurrences of terms for publications on molecular mimicry. Of the 59,752 terms, 305 terms occurred at least 50 times. B : Overlay visualization map of the time sequence of frequently used terms in molecular mimicry (1965–2023). The yellow terms represent the most recent research

This group investigates how the immune system can become confused by pathogen molecules that have structures similar to those of our own cells. Rheumatoid arthritis and Guillain–Barré syndrome are examples of autoimmune diseases that can arise when the immune system targets these ‘mimicked’ self-cells. The purpose of this research was to discover possible targets for treatment and elucidate the role that molecular mimicry plays in autoimmunity.

This group looks into the possibility of creating vaccines through molecular mimicry. Vaccines have the potential to induce a potent immune response by mimicking particular pathogen molecules without actually triggering the disease. These studies were aimed to develop safe and efficient mimicry-based vaccines as well as optimal mimicry targets.

This group addresses the difficulty of attaining accurate targeting in molecular mimicry research. Important aspects include creating computational tools to detect highly specific mimics and ensuring that these mimics do not cause unwanted immune responses. Here, research has attempted to improve targeting tactics and make use of computing power to speed up the detection of mimics. Researchers are looking for ways to improve the specificity and design therapies that target specific mimics involved in the disease.

To illustrate the distribution of keyword frequencies across publications, I classified keywords by publication year and assigned them the corresponding colors, as shown in Fig.  2 B. The blue keywords represent research areas emphasized in earlier studies (before 2012), while the yellow keywords highlight topics addressed in more recent publications (post 2012). Notably, keywords related to “targeting, mimicry discovery through specificity, and computational tools” emerged as a prominent theme after 2012, suggesting their growing importance for future research. On the contrary, research prior to 2012 appears to have focused more on “molecular mimicry and vaccine development” and “molecular mimicry’s function in autoimmune diseases”.

In conclusion, molecular mimicry has enormous potential for improving our understanding and ability to treat a wide range of human diseases. There has been a significant increase in publications on molecular mimicry since 1991, indicating a growing interest and activity in this area of research. After 2012, keyword analysis revealed a shift in research focus toward specificity and computational tools, indicating a growing emphasis on improving therapeutic and targeting approaches. In addition to their academic value, the findings of this study emphasize the importance of molecular mimicry in understanding disease mechanisms and developing therapeutic interventions, with implications for future research directions and practical applications.

Data availability

All the data generated or analyzed during this study are included in this published article. In addition, other datasets used during the current study are available from the author upon reasonable request ([email protected]).

Damian RT. Molecular mimicry: antigen sharing by parasite and host and its consequences. Am Nat. 1964;98(900):129–49.

Article   Google Scholar  

Rojas M, Restrepo-Jimenez P, Monsalve DM, Pacheco Y, Acosta-Ampudia Y, Ramirez-Santana C, Leung PSC, Ansari AA, Gershwin ME, Anaya JM. Molecular mimicry and autoimmunity. J Autoimmun. 2018;95:100–23.

Article   CAS   PubMed   Google Scholar  

Suliman BA. Potential clinical implications of molecular mimicry-induced autoimmunity. Immun Inflamm Dis. 2024;12(2):e1178.

Article   CAS   PubMed   PubMed Central   Google Scholar  

Ellegaard O, Wallin JA. The bibliometric analysis of scholarly production: how great is the impact? Scientometrics 2015, 105(3):1809–31.

Ninkov A, Frank JR, Maggio LA. Bibliometrics: methods for studying academic publishing. Perspect Med Educ. 2022;11(3):173–6.

Article   PubMed   Google Scholar  

Hou A, Yang L, Lü J, Yang L, Kuang H, Jiang H. A bibliometrics visualization analysis and hotspots prediction for natural product on osteoporosis research from 2000 to 2021. J Future Foods. 2022;2(4):326–37.

Baas J, Schotten M, Plume A, Côté G, Karimi R. Scopus as a curated, high-quality bibliometric data source for academic research in quantitative science studies. Quant Sci Stud. 2020;1(1):377–86.

AlRyalat SAS, Malkawi LW, Momani SM. Comparing Bibliometric Analysis using PubMed, Scopus, and web of Science Databases. J Vis Exp 2019(152).

Garg A, Kumari B, Singhal N, Kumar M. Using molecular-mimicry-inducing pathways of pathogens as novel drug targets. Drug Discov Today. 2019;24(9):1943–52.

Miraglia F, Colla E. Microbiome, Parkinson’s Disease and Molecular Mimicry. Cells 2019, 8(3).

Xiao S, Wang Y, Shan S, Zhou Z. The interplay between viral molecular mimicry and host chromatin dynamics. Nucleus. 2023;14(1):2216560.

Article   PubMed   PubMed Central   Google Scholar  

van Eck NJ, Waltman L. Software survey: VOSviewer, a computer program for bibliometric mapping. Scientometrics. 2010;84(2):523–38.

Wucherpfennig KW, Strominger JL. Molecular mimicry in T cell-mediated autoimmunity: viral peptides activate human T cell clones specific for myelin basic protein. Cell. 1995;80(5):695–705.

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Zyoud, S.H. Mapping the global research landscape on molecular mimicry: a visualization and bibliometric study. J Transl Med 22 , 531 (2024). https://doi.org/10.1186/s12967-024-05357-7

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Cardiac renewal

Cardiac ACTN2 enhancer regulates cardiometabolism and maturation

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• Cardiovascular genetics
• Heart stem cells
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A study describes the role of the ACTN2 enhancer in myocardial maturation, highlighting its relevance in regulating structural, functional and metabolic dynamics in the heart. These findings offer insights that may advance our understanding of cardiovascular disease.

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Vincent, S. D. & Buckingham, M. E. Curr. Top. Dev. Biol. 90 , 1–41 (2010).

Article   PubMed   Google Scholar  

Guo, Y. & Pu, W. Circ. Res. 126 , 1086–1106 (2020).

Article   CAS   PubMed   PubMed Central   Google Scholar  

Tu, C., Chao, B. S. & Wu, J. C. Circ. Res. 123 , 512–514 (2018).

Arvanitis, M. et al. Nat. Commun. 11 , 1122 (2020).

Article   PubMed   PubMed Central   Google Scholar  

Wamstad, J. A., Wang, X., Demuren, O. O. & Boyer, L. A. Trends Cell Biol. 24 , 294–302 (2014).

Article   CAS   PubMed   Google Scholar  

Sjöblom, B., Salmazo, A. & Djinović-Carugo, K. Cell. Mol. Life Sci. 65 , 2688–2701 (2008).

Htet, M. et al. Nat. Cardiovasc. Res. https://doi.org/10.1038/s44161-024-00484-2 (2024).

Article   Google Scholar  

Akazawa, H. & Komuro, I. Circ. Res. 92 , 1079–1088 (2003).

Saxton, R. A. & Sabatini, D. M. Cell 168 , 960–976 (2017).

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Galdos, F.X., Lee, C. & Wu, S.M. Cardiac ACTN2 enhancer regulates cardiometabolism and maturation. Nat Cardiovasc Res (2024). https://doi.org/10.1038/s44161-024-00483-3

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Purdue HHS students recognized with highly competitive awards for research/study abroad

Written by: Denise Buhrmester, [email protected]

Nine Purdue University College of Health and Human Sciences students were recently recognized by the National and International Scholarship Office in the John Martinson Honors College for receiving highly selective external awards requiring a campus nomination from Purdue.

• Samuel Gray (psychological sciences major) — Fulbright U.S. Student Program Alternate*
• Victoria Patellos (psychological sciences major) — Fulbright U.S. Student Program Grant Offered
• Deirdre Sullivan (psychological sciences major) — Fulbright U.S. Student Program Alternate*
• Lydia Farmer (psychological sciences and developmental and family science majors) — Gilman Scholarship Recipient
• Marina Haworth-Snow (medical laboratory sciences major) — Gilman Scholarship Recipient
• Madison Koenig (family and consumer sciences education major) — Gilman Scholarship Recipient
• Autumn Reynolds (public health major) — Gilman Scholarship Recipient
• Nicholas Walters (kinesiology major) — Gilman Scholarship Recipient
• Alanna Patterson (early childhood education and exceptional needs major) — Gilman-McCain Scholarship Recipient

Fullbright U.S. Student Program

The Fulbright U.S. Student Program provides postbaccalaureate funding for eight to 12 months for individuals to study, research or teach abroad while promoting cultural exchange and mutual understanding. Eligible applicants include undergraduates entering their senior year, alumni who earned a bachelor’s or master’s degree from Purdue as their most recent degree, and current graduate students who will not have completed a PhD prior to the beginning of their grant year.

There are two major types of Fulbright awards for U.S. students: study/research grants and English teaching assistantship grants .

Gilman Scholarship

The Gilman Scholarship Program broadens the student population that studies and interns abroad by supporting undergraduates who might not otherwise participate due to financial constraints.  The program also aims to encourage students to study and intern in a diverse array of countries and world regions.

Award amounts vary depending on the length of study and student need. Applicants who are studying  a critical-need language  while abroad in a country in which the language is predominately spoken may be considered for the Critical Need Language Award for a total maximum award of $8,000.

New:  In 2023, Gilman now offers a STEM Supplemental Award of up to $1,000 to conduct STEM research associated with the student’s study abroad program.

Gilman-McCain Scholarship

The  Gilman-McCain Scholarship is a congressionally funded initiative of the Bureau of Educational and Cultural Affairs at the U.S. Department of State and named after the late senator John S. McCain from Arizona. The Gilman-McCain Scholarship provides awards of $5,000 for child dependents of active duty service members to study or intern abroad on credit-bearing programs.

*Fulbright Alternate: A candidate who can be promoted to finalist status if additional funding becomes available.

Cancer patients often do better with less intensive treatment, research shows

Scaling back treatment for three kinds of cancer can make life easier for patients without compromising outcomes, doctors reported at the world’s largest cancer conference .

It’s part of a long-term trend toward studying whether doing less — less surgery, less chemotherapy or less radiation — can help patients live longer and feel better. The latest studies involved ovarian and esophageal cancer and Hodgkin lymphoma.

Thirty years ago, cancer research was about doing more, not less. In one sobering example, women with advanced breast cancer were pushed to the brink of death with massive doses of chemotherapy and bone marrow transplants. The  approach didn’t work  any better than chemotherapy and patients suffered.

Now, in a quest to optimize cancer care, researchers are asking: “Do we need all that treatment that we have used in the past?”

It’s a question, “that should be asked over and over again,” said Dr. Tatjana Kolevska, medical director for the Kaiser Permanente National Cancer Excellence Program, who was not involved in the new research.

Often, doing less works because of improved drugs.

“The good news is that cancer treatment is not only becoming more effective, it’s becoming easier to tolerate and associated with less short-term and long-term complications,” said Dr. William G. Nelson of Johns Hopkins School of Medicine, who was also not involved in the new research.

Latest news on cancer treatment

• Cancer-fighting antibodies inject chemo directly into tumor cells, upping effectiveness.
• Long-term study shows 'remarkable' treatment helps patients with deadly nonsmoking-related lung cancer.
• FDA approves groundbreaking treatment for advanced melanoma.

Studies demonstrating the trend were discussed over the weekend at an American Society of Clinical Oncology conference in Chicago. Here are the highlights:

Ovarian cancer

French researchers found that it’s safe to avoid removing lymph nodes that appear healthy during surgery for advanced ovarian cancer. The study compared the results for 379 patients — half had their lymph nodes removed and half did not. After nine years, there was no difference in how long the patients lived and those with less-extreme surgery had fewer complications, such as the need for blood transfusions. The research was funded by the National Institute of Cancer in France.

Esophageal cancer

This German study looked at 438 people with a type of cancer of the esophagus that can be treated with surgery. Half received a common treatment plan that included chemotherapy and surgery on the esophagus, the tube that carries food from the throat to the stomach. Half got another approach that includes radiation too. Both techniques are considered standard. Which one patients get can depend on where they get treatment.

After three years, 57% of those who got chemo and surgery were alive, compared to 51% of those who got chemo, surgery and radiation. The German Research Foundation funded the study.

Hodgkin lymphoma

A comparison of two chemotherapy regimens for advanced Hodgkin lymphoma found the less intensive treatment was more effective for the blood cancer and caused fewer side effects.

After four years, the less harsh chemo kept the disease in check in 94% of people, compared to 91% of those who had the more intense treatment. The trial included 1,482 people in nine countries — Germany, Austria, Switzerland, the Netherlands, Denmark, Sweden, Norway, Australia and New Zealand — and was funded by Takeda Oncology, the maker of one of the drugs used in the gentler chemo that was studied.

The Associated Press

OpenSAFELY: Effectiveness of COVID-19 vaccination in children and adolescents

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Background Children and adolescents in England were offered BNT162b2 as part of the national COVID-19 vaccine roll out from September 2021. We assessed the safety and effectiveness of first and second dose BNT162b2 COVID-19 vaccination in children and adolescents in England.

Methods With the approval of NHS England, we conducted an observational study in the OpenSAFELY-TPP database, including a) adolescents aged 12-15 years, and b) children aged 5-11 years and comparing individuals receiving i) first vaccination with unvaccinated controls and ii) second vaccination to single-vaccinated controls. We matched vaccinated individuals with controls on age, sex, region, and other important characteristics. Outcomes were positive SARS-CoV-2 test (adolescents only); COVID-19 A&E attendance; COVID-19 hospitalisation; COVID-19 critical care admission; COVID-19 death, with non-COVID-19 death and fractures as negative control outcomes and A&E attendance, unplanned hospitalisation, pericarditis, and myocarditis as safety outcomes.

Results Amongst 820,926 previously unvaccinated adolescents, the incidence rate ratio (IRR) for positive SARS-CoV-2 test comparing vaccination with no vaccination was 0.74 (95% CI 0.72-0.75), although the 20-week risks were similar. The IRRs were 0.60 (0.37-0.97) for COVID-19 A&E attendance, 0.58 (0.38-0.89) for COVID-19 hospitalisation, 0.99 (0.93-1.06) for fractures, 0.89 (0.87-0.91) for A&E attendances and 0.88 (0.81-0.95) for unplanned hospitalisation. Amongst 441,858 adolescents who had received first vaccination IRRs comparing second dose with first dose only were 0.67 (0.65-0.69) for positive SARS-CoV-2 test, 1.00 (0.20-4.96) for COVID-19 A&E attendance, 0.60 (0.26-1.37) for COVID-19 hospitalisation, 0.94 (0.84-1.05) for fractures, 0.93 (0.89-0.98) for A&E attendance and 0.99 (0.86-1.13) for unplanned hospitalisation. Amongst 283,422 previously unvaccinated children and 132,462 children who had received a first vaccine dose, COVID-19-related outcomes were too rare to allow IRRs to be estimated precisely. A&E attendance and unplanned hospitalisation were slightly higher after first vaccination (IRRs versus no vaccination 1.05 (1.01-1.10) and 1.10 (0.95-1.26) respectively) but slightly lower after second vaccination (IRRs versus first dose 0.95 (0.86-1.05) and 0.78 (0.56-1.08) respectively). There were no COVID-19-related deaths in any group. Fewer than seven (exact number redacted) COVID-19-related critical care admissions occurred in the adolescent first dose vs unvaccinated cohort. Among both adolescents and children, myocarditis and pericarditis were documented only in the vaccinated groups, with rates of 27 and 10 cases/million after first and second doses respectively.

Conclusion BNT162b2 vaccination in adolescents reduced COVID-19 A&E attendance and hospitalisation, although these outcomes were rare. Protection against positive SARS-CoV-2 tests was transient.

Competing Interest Statement

BG has received research funding from the Laura and John Arnold Foundation, the NHS National Institute for Health Research (NIHR), the NIHR School of Primary Care Research, NHS England, the NIHR Oxford Biomedical Research Centre, the Mohn-Westlake Foundation, NIHR Applied Research Collaboration Oxford and Thames Valley, the Wellcome Trust, the Good Thinking Foundation, Health Data Research UK, the Health Foundation, the World Health Organisation, UKRI MRC, Asthma UK, the British Lung Foundation, and the Longitudinal Health and Wellbeing strand of the National Core Studies programme; he is a Non-Executive Director at NHS Digital; he also receives personal income from speaking and writing for lay audiences on the misuse of science. BMK is also employed by NHS England working on medicines policy and clinical lead for primary care medicines data. IJD has received unrestricted research grants and holds shares in GlaxoSmithKline (GSK).

Funding Statement

The OpenSAFELY Platform is supported by grants from the Wellcome Trust (222097/Z/20/Z); MRC (MR/V015757/1, MC_PC-20059, MR/W016729/1); NIHR (NIHR135559, COV-LT2-0073), and Health Data Research UK (HDRUK2021.000, 2021.0157). In addition, this research used data assets made available as part of the Data and Connectivity National Core Study, led by Health Data Research UK in partnership with the Office for National Statistics and funded by UK Research and Innovation (grant ref MC_PC_20058). BG has also received funding from: the Bennett Foundation, the Wellcome Trust, NIHR Oxford Biomedical Research Centre, NIHR Applied Research Collaboration Oxford and Thames Valley, the Mohn-Westlake Foundation; all Bennett Institute staff are supported by BG's grants on this work. The views expressed are those of the authors and not necessarily those of the NIHR, NHS England, UK Health Security Agency (UKHSA) or the Department of Health and Social Care.

Funders had no role in the study design, collection, analysis, and interpretation of data; in the writing of the report; and in the decision to submit the article for publication.

Author Declarations

I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained.

The details of the IRB/oversight body that provided approval or exemption for the research described are given below:

This study was approved by the Health Research Authority (REC reference 20/LO/0651) and by the London School of Hygeine and Tropical Medicine Ethics Board (reference 21863).

I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals.

I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance).

I have followed all appropriate research reporting guidelines, such as any relevant EQUATOR Network research reporting checklist(s) and other pertinent material, if applicable.

Data Availability

All data were linked, stored and analysed securely using the OpenSAFELY platform, https://www.opensafely.org/ , as part of the NHS England OpenSAFELY COVID-19 service. Data include pseudonymised data such as coded diagnoses, medications and physiological parameters. No free text data was included. All code is shared openly for review and re-use under MIT open license [ https://github.com/opensafely/vaccine-effectiveness-in-kids ]. Detailed pseudonymised patient data is potentially re-identifiable and therefore not shared. Primary care records managed by the GP software provider, TPP were linked to ONS death data and the Index of Multiple Deprivation through OpenSAFELY.

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