research on ethical issues

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National Institute of Environmental Health Sciences

Your environment. your health., what is ethics in research & why is it important, by david b. resnik, j.d., ph.d..

December 23, 2020

The ideas and opinions expressed in this essay are the author’s own and do not necessarily represent those of the NIH, NIEHS, or US government.

When most people think of ethics (or morals), they think of rules for distinguishing between right and wrong, such as the Golden Rule ("Do unto others as you would have them do unto you"), a code of professional conduct like the Hippocratic Oath ("First of all, do no harm"), a religious creed like the Ten Commandments ("Thou Shalt not kill..."), or a wise aphorisms like the sayings of Confucius. This is the most common way of defining "ethics": norms for conduct that distinguish between acceptable and unacceptable behavior.

Most people learn ethical norms at home, at school, in church, or in other social settings. Although most people acquire their sense of right and wrong during childhood, moral development occurs throughout life and human beings pass through different stages of growth as they mature. Ethical norms are so ubiquitous that one might be tempted to regard them as simple commonsense. On the other hand, if morality were nothing more than commonsense, then why are there so many ethical disputes and issues in our society?

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One plausible explanation of these disagreements is that all people recognize some common ethical norms but interpret, apply, and balance them in different ways in light of their own values and life experiences. For example, two people could agree that murder is wrong but disagree about the morality of abortion because they have different understandings of what it means to be a human being.

Most societies also have legal rules that govern behavior, but ethical norms tend to be broader and more informal than laws. Although most societies use laws to enforce widely accepted moral standards and ethical and legal rules use similar concepts, ethics and law are not the same. An action may be legal but unethical or illegal but ethical. We can also use ethical concepts and principles to criticize, evaluate, propose, or interpret laws. Indeed, in the last century, many social reformers have urged citizens to disobey laws they regarded as immoral or unjust laws. Peaceful civil disobedience is an ethical way of protesting laws or expressing political viewpoints.

Another way of defining 'ethics' focuses on the disciplines that study standards of conduct, such as philosophy, theology, law, psychology, or sociology. For example, a "medical ethicist" is someone who studies ethical standards in medicine. One may also define ethics as a method, procedure, or perspective for deciding how to act and for analyzing complex problems and issues. For instance, in considering a complex issue like global warming , one may take an economic, ecological, political, or ethical perspective on the problem. While an economist might examine the cost and benefits of various policies related to global warming, an environmental ethicist could examine the ethical values and principles at stake.

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Many different disciplines, institutions , and professions have standards for behavior that suit their particular aims and goals. These standards also help members of the discipline to coordinate their actions or activities and to establish the public's trust of the discipline. For instance, ethical standards govern conduct in medicine, law, engineering, and business. Ethical norms also serve the aims or goals of research and apply to people who conduct scientific research or other scholarly or creative activities. There is even a specialized discipline, research ethics, which studies these norms. See Glossary of Commonly Used Terms in Research Ethics and Research Ethics Timeline .

There are several reasons why it is important to adhere to ethical norms in research. First, norms promote the aims of research , such as knowledge, truth, and avoidance of error. For example, prohibitions against fabricating , falsifying, or misrepresenting research data promote the truth and minimize error.

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Second, since research often involves a great deal of cooperation and coordination among many different people in different disciplines and institutions, ethical standards promote the values that are essential to collaborative work , such as trust, accountability, mutual respect, and fairness. For example, many ethical norms in research, such as guidelines for authorship , copyright and patenting policies , data sharing policies, and confidentiality rules in peer review, are designed to protect intellectual property interests while encouraging collaboration. Most researchers want to receive credit for their contributions and do not want to have their ideas stolen or disclosed prematurely.

Third, many of the ethical norms help to ensure that researchers can be held accountable to the public . For instance, federal policies on research misconduct, conflicts of interest, the human subjects protections, and animal care and use are necessary in order to make sure that researchers who are funded by public money can be held accountable to the public.

Fourth, ethical norms in research also help to build public support for research. People are more likely to fund a research project if they can trust the quality and integrity of research.

Finally, many of the norms of research promote a variety of other important moral and social values , such as social responsibility, human rights, animal welfare, compliance with the law, and public health and safety. Ethical lapses in research can significantly harm human and animal subjects, students, and the public. For example, a researcher who fabricates data in a clinical trial may harm or even kill patients, and a researcher who fails to abide by regulations and guidelines relating to radiation or biological safety may jeopardize his health and safety or the health and safety of staff and students.

Codes and Policies for Research Ethics

Given the importance of ethics for the conduct of research, it should come as no surprise that many different professional associations, government agencies, and universities have adopted specific codes, rules, and policies relating to research ethics. Many government agencies have ethics rules for funded researchers.

• National Institutes of Health (NIH)
• National Science Foundation (NSF)
• Food and Drug Administration (FDA)
• Environmental Protection Agency (EPA)
• US Department of Agriculture (USDA)
• Singapore Statement on Research Integrity
• American Chemical Society, The Chemist Professional’s Code of Conduct
• Code of Ethics (American Society for Clinical Laboratory Science)
• American Psychological Association, Ethical Principles of Psychologists and Code of Conduct
• Statement on Professional Ethics (American Association of University Professors)
• Nuremberg Code
• World Medical Association's Declaration of Helsinki

Ethical Principles

The following is a rough and general summary of some ethical principles that various codes address*:

Strive for honesty in all scientific communications. Honestly report data, results, methods and procedures, and publication status. Do not fabricate, falsify, or misrepresent data. Do not deceive colleagues, research sponsors, or the public.

Objectivity

Strive to avoid bias in experimental design, data analysis, data interpretation, peer review, personnel decisions, grant writing, expert testimony, and other aspects of research where objectivity is expected or required. Avoid or minimize bias or self-deception. Disclose personal or financial interests that may affect research.

Keep your promises and agreements; act with sincerity; strive for consistency of thought and action.

Carefulness

Avoid careless errors and negligence; carefully and critically examine your own work and the work of your peers. Keep good records of research activities, such as data collection, research design, and correspondence with agencies or journals.

Share data, results, ideas, tools, resources. Be open to criticism and new ideas.

Transparency

Disclose methods, materials, assumptions, analyses, and other information needed to evaluate your research.

Accountability

Take responsibility for your part in research and be prepared to give an account (i.e. an explanation or justification) of what you did on a research project and why.

Intellectual Property

Honor patents, copyrights, and other forms of intellectual property. Do not use unpublished data, methods, or results without permission. Give proper acknowledgement or credit for all contributions to research. Never plagiarize.

Confidentiality

Protect confidential communications, such as papers or grants submitted for publication, personnel records, trade or military secrets, and patient records.

Responsible Publication

Publish in order to advance research and scholarship, not to advance just your own career. Avoid wasteful and duplicative publication.

Responsible Mentoring

Help to educate, mentor, and advise students. Promote their welfare and allow them to make their own decisions.

Respect for Colleagues

Respect your colleagues and treat them fairly.

Social Responsibility

Strive to promote social good and prevent or mitigate social harms through research, public education, and advocacy.

Non-Discrimination

Avoid discrimination against colleagues or students on the basis of sex, race, ethnicity, or other factors not related to scientific competence and integrity.

Maintain and improve your own professional competence and expertise through lifelong education and learning; take steps to promote competence in science as a whole.

Know and obey relevant laws and institutional and governmental policies.

Animal Care

Show proper respect and care for animals when using them in research. Do not conduct unnecessary or poorly designed animal experiments.

Human Subjects protection

When conducting research on human subjects, minimize harms and risks and maximize benefits; respect human dignity, privacy, and autonomy; take special precautions with vulnerable populations; and strive to distribute the benefits and burdens of research fairly.

* Adapted from Shamoo A and Resnik D. 2015. Responsible Conduct of Research, 3rd ed. (New York: Oxford University Press).

Ethical Decision Making in Research

Although codes, policies, and principles are very important and useful, like any set of rules, they do not cover every situation, they often conflict, and they require interpretation. It is therefore important for researchers to learn how to interpret, assess, and apply various research rules and how to make decisions and act ethically in various situations. The vast majority of decisions involve the straightforward application of ethical rules. For example, consider the following case:

The research protocol for a study of a drug on hypertension requires the administration of the drug at different doses to 50 laboratory mice, with chemical and behavioral tests to determine toxic effects. Tom has almost finished the experiment for Dr. Q. He has only 5 mice left to test. However, he really wants to finish his work in time to go to Florida on spring break with his friends, who are leaving tonight. He has injected the drug in all 50 mice but has not completed all of the tests. He therefore decides to extrapolate from the 45 completed results to produce the 5 additional results.

Many different research ethics policies would hold that Tom has acted unethically by fabricating data. If this study were sponsored by a federal agency, such as the NIH, his actions would constitute a form of research misconduct , which the government defines as "fabrication, falsification, or plagiarism" (or FFP). Actions that nearly all researchers classify as unethical are viewed as misconduct. It is important to remember, however, that misconduct occurs only when researchers intend to deceive : honest errors related to sloppiness, poor record keeping, miscalculations, bias, self-deception, and even negligence do not constitute misconduct. Also, reasonable disagreements about research methods, procedures, and interpretations do not constitute research misconduct. Consider the following case:

Dr. T has just discovered a mathematical error in his paper that has been accepted for publication in a journal. The error does not affect the overall results of his research, but it is potentially misleading. The journal has just gone to press, so it is too late to catch the error before it appears in print. In order to avoid embarrassment, Dr. T decides to ignore the error.

Dr. T's error is not misconduct nor is his decision to take no action to correct the error. Most researchers, as well as many different policies and codes would say that Dr. T should tell the journal (and any coauthors) about the error and consider publishing a correction or errata. Failing to publish a correction would be unethical because it would violate norms relating to honesty and objectivity in research.

There are many other activities that the government does not define as "misconduct" but which are still regarded by most researchers as unethical. These are sometimes referred to as " other deviations " from acceptable research practices and include:

• Publishing the same paper in two different journals without telling the editors
• Submitting the same paper to different journals without telling the editors
• Not informing a collaborator of your intent to file a patent in order to make sure that you are the sole inventor
• Including a colleague as an author on a paper in return for a favor even though the colleague did not make a serious contribution to the paper
• Discussing with your colleagues confidential data from a paper that you are reviewing for a journal
• Using data, ideas, or methods you learn about while reviewing a grant or a papers without permission
• Trimming outliers from a data set without discussing your reasons in paper
• Using an inappropriate statistical technique in order to enhance the significance of your research
• Bypassing the peer review process and announcing your results through a press conference without giving peers adequate information to review your work
• Conducting a review of the literature that fails to acknowledge the contributions of other people in the field or relevant prior work
• Stretching the truth on a grant application in order to convince reviewers that your project will make a significant contribution to the field
• Stretching the truth on a job application or curriculum vita
• Giving the same research project to two graduate students in order to see who can do it the fastest
• Overworking, neglecting, or exploiting graduate or post-doctoral students
• Failing to keep good research records
• Failing to maintain research data for a reasonable period of time
• Making derogatory comments and personal attacks in your review of author's submission
• Promising a student a better grade for sexual favors
• Using a racist epithet in the laboratory
• Making significant deviations from the research protocol approved by your institution's Animal Care and Use Committee or Institutional Review Board for Human Subjects Research without telling the committee or the board
• Not reporting an adverse event in a human research experiment
• Wasting animals in research
• Exposing students and staff to biological risks in violation of your institution's biosafety rules
• Sabotaging someone's work
• Stealing supplies, books, or data
• Rigging an experiment so you know how it will turn out
• Making unauthorized copies of data, papers, or computer programs
• Owning over $10,000 in stock in a company that sponsors your research and not disclosing this financial interest
• Deliberately overestimating the clinical significance of a new drug in order to obtain economic benefits

These actions would be regarded as unethical by most scientists and some might even be illegal in some cases. Most of these would also violate different professional ethics codes or institutional policies. However, they do not fall into the narrow category of actions that the government classifies as research misconduct. Indeed, there has been considerable debate about the definition of "research misconduct" and many researchers and policy makers are not satisfied with the government's narrow definition that focuses on FFP. However, given the huge list of potential offenses that might fall into the category "other serious deviations," and the practical problems with defining and policing these other deviations, it is understandable why government officials have chosen to limit their focus.

Finally, situations frequently arise in research in which different people disagree about the proper course of action and there is no broad consensus about what should be done. In these situations, there may be good arguments on both sides of the issue and different ethical principles may conflict. These situations create difficult decisions for research known as ethical or moral dilemmas . Consider the following case:

Dr. Wexford is the principal investigator of a large, epidemiological study on the health of 10,000 agricultural workers. She has an impressive dataset that includes information on demographics, environmental exposures, diet, genetics, and various disease outcomes such as cancer, Parkinson’s disease (PD), and ALS. She has just published a paper on the relationship between pesticide exposure and PD in a prestigious journal. She is planning to publish many other papers from her dataset. She receives a request from another research team that wants access to her complete dataset. They are interested in examining the relationship between pesticide exposures and skin cancer. Dr. Wexford was planning to conduct a study on this topic.

Dr. Wexford faces a difficult choice. On the one hand, the ethical norm of openness obliges her to share data with the other research team. Her funding agency may also have rules that obligate her to share data. On the other hand, if she shares data with the other team, they may publish results that she was planning to publish, thus depriving her (and her team) of recognition and priority. It seems that there are good arguments on both sides of this issue and Dr. Wexford needs to take some time to think about what she should do. One possible option is to share data, provided that the investigators sign a data use agreement. The agreement could define allowable uses of the data, publication plans, authorship, etc. Another option would be to offer to collaborate with the researchers.

The following are some step that researchers, such as Dr. Wexford, can take to deal with ethical dilemmas in research:

What is the problem or issue?

It is always important to get a clear statement of the problem. In this case, the issue is whether to share information with the other research team.

What is the relevant information?

Many bad decisions are made as a result of poor information. To know what to do, Dr. Wexford needs to have more information concerning such matters as university or funding agency or journal policies that may apply to this situation, the team's intellectual property interests, the possibility of negotiating some kind of agreement with the other team, whether the other team also has some information it is willing to share, the impact of the potential publications, etc.

What are the different options?

People may fail to see different options due to a limited imagination, bias, ignorance, or fear. In this case, there may be other choices besides 'share' or 'don't share,' such as 'negotiate an agreement' or 'offer to collaborate with the researchers.'

How do ethical codes or policies as well as legal rules apply to these different options?

The university or funding agency may have policies on data management that apply to this case. Broader ethical rules, such as openness and respect for credit and intellectual property, may also apply to this case. Laws relating to intellectual property may be relevant.

Are there any people who can offer ethical advice?

It may be useful to seek advice from a colleague, a senior researcher, your department chair, an ethics or compliance officer, or anyone else you can trust. In the case, Dr. Wexford might want to talk to her supervisor and research team before making a decision.

After considering these questions, a person facing an ethical dilemma may decide to ask more questions, gather more information, explore different options, or consider other ethical rules. However, at some point he or she will have to make a decision and then take action. Ideally, a person who makes a decision in an ethical dilemma should be able to justify his or her decision to himself or herself, as well as colleagues, administrators, and other people who might be affected by the decision. He or she should be able to articulate reasons for his or her conduct and should consider the following questions in order to explain how he or she arrived at his or her decision:

• Which choice will probably have the best overall consequences for science and society?
• Which choice could stand up to further publicity and scrutiny?
• Which choice could you not live with?
• Think of the wisest person you know. What would he or she do in this situation?
• Which choice would be the most just, fair, or responsible?

After considering all of these questions, one still might find it difficult to decide what to do. If this is the case, then it may be appropriate to consider others ways of making the decision, such as going with a gut feeling or intuition, seeking guidance through prayer or meditation, or even flipping a coin. Endorsing these methods in this context need not imply that ethical decisions are irrational, however. The main point is that human reasoning plays a pivotal role in ethical decision-making but there are limits to its ability to solve all ethical dilemmas in a finite amount of time.

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Most academic institutions in the US require undergraduate, graduate, or postgraduate students to have some education in the responsible conduct of research (RCR) . The NIH and NSF have both mandated training in research ethics for students and trainees. Many academic institutions outside of the US have also developed educational curricula in research ethics

Those of you who are taking or have taken courses in research ethics may be wondering why you are required to have education in research ethics. You may believe that you are highly ethical and know the difference between right and wrong. You would never fabricate or falsify data or plagiarize. Indeed, you also may believe that most of your colleagues are highly ethical and that there is no ethics problem in research..

If you feel this way, relax. No one is accusing you of acting unethically. Indeed, the evidence produced so far shows that misconduct is a very rare occurrence in research, although there is considerable variation among various estimates. The rate of misconduct has been estimated to be as low as 0.01% of researchers per year (based on confirmed cases of misconduct in federally funded research) to as high as 1% of researchers per year (based on self-reports of misconduct on anonymous surveys). See Shamoo and Resnik (2015), cited above.

Clearly, it would be useful to have more data on this topic, but so far there is no evidence that science has become ethically corrupt, despite some highly publicized scandals. Even if misconduct is only a rare occurrence, it can still have a tremendous impact on science and society because it can compromise the integrity of research, erode the public’s trust in science, and waste time and resources. Will education in research ethics help reduce the rate of misconduct in science? It is too early to tell. The answer to this question depends, in part, on how one understands the causes of misconduct. There are two main theories about why researchers commit misconduct. According to the "bad apple" theory, most scientists are highly ethical. Only researchers who are morally corrupt, economically desperate, or psychologically disturbed commit misconduct. Moreover, only a fool would commit misconduct because science's peer review system and self-correcting mechanisms will eventually catch those who try to cheat the system. In any case, a course in research ethics will have little impact on "bad apples," one might argue.

According to the "stressful" or "imperfect" environment theory, misconduct occurs because various institutional pressures, incentives, and constraints encourage people to commit misconduct, such as pressures to publish or obtain grants or contracts, career ambitions, the pursuit of profit or fame, poor supervision of students and trainees, and poor oversight of researchers (see Shamoo and Resnik 2015). Moreover, defenders of the stressful environment theory point out that science's peer review system is far from perfect and that it is relatively easy to cheat the system. Erroneous or fraudulent research often enters the public record without being detected for years. Misconduct probably results from environmental and individual causes, i.e. when people who are morally weak, ignorant, or insensitive are placed in stressful or imperfect environments. In any case, a course in research ethics can be useful in helping to prevent deviations from norms even if it does not prevent misconduct. Education in research ethics is can help people get a better understanding of ethical standards, policies, and issues and improve ethical judgment and decision making. Many of the deviations that occur in research may occur because researchers simply do not know or have never thought seriously about some of the ethical norms of research. For example, some unethical authorship practices probably reflect traditions and practices that have not been questioned seriously until recently. If the director of a lab is named as an author on every paper that comes from his lab, even if he does not make a significant contribution, what could be wrong with that? That's just the way it's done, one might argue. Another example where there may be some ignorance or mistaken traditions is conflicts of interest in research. A researcher may think that a "normal" or "traditional" financial relationship, such as accepting stock or a consulting fee from a drug company that sponsors her research, raises no serious ethical issues. Or perhaps a university administrator sees no ethical problem in taking a large gift with strings attached from a pharmaceutical company. Maybe a physician thinks that it is perfectly appropriate to receive a $300 finder’s fee for referring patients into a clinical trial.

If "deviations" from ethical conduct occur in research as a result of ignorance or a failure to reflect critically on problematic traditions, then a course in research ethics may help reduce the rate of serious deviations by improving the researcher's understanding of ethics and by sensitizing him or her to the issues.

Finally, education in research ethics should be able to help researchers grapple with the ethical dilemmas they are likely to encounter by introducing them to important concepts, tools, principles, and methods that can be useful in resolving these dilemmas. Scientists must deal with a number of different controversial topics, such as human embryonic stem cell research, cloning, genetic engineering, and research involving animal or human subjects, which require ethical reflection and deliberation.

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• Ethical Considerations in Research | Types & Examples

Ethical Considerations in Research | Types & Examples

Published on October 18, 2021 by Pritha Bhandari . Revised on May 9, 2024.

Ethical considerations in research are a set of principles that guide your research designs and practices. Scientists and researchers must always adhere to a certain code of conduct when collecting data from people.

The goals of human research often include understanding real-life phenomena, studying effective treatments, investigating behaviors, and improving lives in other ways. What you decide to research and how you conduct that research involve key ethical considerations.

These considerations work to

• protect the rights of research participants
• enhance research validity
• maintain scientific or academic integrity

Table of contents

Why do research ethics matter, getting ethical approval for your study, types of ethical issues, voluntary participation, informed consent, confidentiality, potential for harm, results communication, examples of ethical failures, other interesting articles, frequently asked questions about research ethics.

Research ethics matter for scientific integrity, human rights and dignity, and collaboration between science and society. These principles make sure that participation in studies is voluntary, informed, and safe for research subjects.

You’ll balance pursuing important research objectives with using ethical research methods and procedures. It’s always necessary to prevent permanent or excessive harm to participants, whether inadvertent or not.

Defying research ethics will also lower the credibility of your research because it’s hard for others to trust your data if your methods are morally questionable.

Even if a research idea is valuable to society, it doesn’t justify violating the human rights or dignity of your study participants.

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Before you start any study involving data collection with people, you’ll submit your research proposal to an institutional review board (IRB) .

An IRB is a committee that checks whether your research aims and research design are ethically acceptable and follow your institution’s code of conduct. They check that your research materials and procedures are up to code.

If successful, you’ll receive IRB approval, and you can begin collecting data according to the approved procedures. If you want to make any changes to your procedures or materials, you’ll need to submit a modification application to the IRB for approval.

If unsuccessful, you may be asked to re-submit with modifications or your research proposal may receive a rejection. To get IRB approval, it’s important to explicitly note how you’ll tackle each of the ethical issues that may arise in your study.

There are several ethical issues you should always pay attention to in your research design, and these issues can overlap with each other.

You’ll usually outline ways you’ll deal with each issue in your research proposal if you plan to collect data from participants.

Voluntary participation means that all research subjects are free to choose to participate without any pressure or coercion.

All participants are able to withdraw from, or leave, the study at any point without feeling an obligation to continue. Your participants don’t need to provide a reason for leaving the study.

It’s important to make it clear to participants that there are no negative consequences or repercussions to their refusal to participate. After all, they’re taking the time to help you in the research process , so you should respect their decisions without trying to change their minds.

Voluntary participation is an ethical principle protected by international law and many scientific codes of conduct.

Take special care to ensure there’s no pressure on participants when you’re working with vulnerable groups of people who may find it hard to stop the study even when they want to.

Informed consent refers to a situation in which all potential participants receive and understand all the information they need to decide whether they want to participate. This includes information about the study’s benefits, risks, funding, and institutional approval.

You make sure to provide all potential participants with all the relevant information about

• what the study is about
• the risks and benefits of taking part
• how long the study will take
• your supervisor’s contact information and the institution’s approval number

Usually, you’ll provide participants with a text for them to read and ask them if they have any questions. If they agree to participate, they can sign or initial the consent form. Note that this may not be sufficient for informed consent when you work with particularly vulnerable groups of people.

If you’re collecting data from people with low literacy, make sure to verbally explain the consent form to them before they agree to participate.

For participants with very limited English proficiency, you should always translate the study materials or work with an interpreter so they have all the information in their first language.

In research with children, you’ll often need informed permission for their participation from their parents or guardians. Although children cannot give informed consent, it’s best to also ask for their assent (agreement) to participate, depending on their age and maturity level.

Anonymity means that you don’t know who the participants are and you can’t link any individual participant to their data.

You can only guarantee anonymity by not collecting any personally identifying information—for example, names, phone numbers, email addresses, IP addresses, physical characteristics, photos, and videos.

In many cases, it may be impossible to truly anonymize data collection . For example, data collected in person or by phone cannot be considered fully anonymous because some personal identifiers (demographic information or phone numbers) are impossible to hide.

You’ll also need to collect some identifying information if you give your participants the option to withdraw their data at a later stage.

Data pseudonymization is an alternative method where you replace identifying information about participants with pseudonymous, or fake, identifiers. The data can still be linked to participants but it’s harder to do so because you separate personal information from the study data.

Confidentiality means that you know who the participants are, but you remove all identifying information from your report.

All participants have a right to privacy, so you should protect their personal data for as long as you store or use it. Even when you can’t collect data anonymously, you should secure confidentiality whenever you can.

Some research designs aren’t conducive to confidentiality, but it’s important to make all attempts and inform participants of the risks involved.

As a researcher, you have to consider all possible sources of harm to participants. Harm can come in many different forms.

• Psychological harm: Sensitive questions or tasks may trigger negative emotions such as shame or anxiety.
• Social harm: Participation can involve social risks, public embarrassment, or stigma.
• Physical harm: Pain or injury can result from the study procedures.
• Legal harm: Reporting sensitive data could lead to legal risks or a breach of privacy.

It’s best to consider every possible source of harm in your study as well as concrete ways to mitigate them. Involve your supervisor to discuss steps for harm reduction.

Make sure to disclose all possible risks of harm to participants before the study to get informed consent. If there is a risk of harm, prepare to provide participants with resources or counseling or medical services if needed.

Some of these questions may bring up negative emotions, so you inform participants about the sensitive nature of the survey and assure them that their responses will be confidential.

The way you communicate your research results can sometimes involve ethical issues. Good science communication is honest, reliable, and credible. It’s best to make your results as transparent as possible.

Take steps to actively avoid plagiarism and research misconduct wherever possible.

Plagiarism means submitting others’ works as your own. Although it can be unintentional, copying someone else’s work without proper credit amounts to stealing. It’s an ethical problem in research communication because you may benefit by harming other researchers.

Self-plagiarism is when you republish or re-submit parts of your own papers or reports without properly citing your original work.

This is problematic because you may benefit from presenting your ideas as new and original even though they’ve already been published elsewhere in the past. You may also be infringing on your previous publisher’s copyright, violating an ethical code, or wasting time and resources by doing so.

In extreme cases of self-plagiarism, entire datasets or papers are sometimes duplicated. These are major ethical violations because they can skew research findings if taken as original data.

You notice that two published studies have similar characteristics even though they are from different years. Their sample sizes, locations, treatments, and results are highly similar, and the studies share one author in common.

Research misconduct

Research misconduct means making up or falsifying data, manipulating data analyses, or misrepresenting results in research reports. It’s a form of academic fraud.

These actions are committed intentionally and can have serious consequences; research misconduct is not a simple mistake or a point of disagreement about data analyses.

Research misconduct is a serious ethical issue because it can undermine academic integrity and institutional credibility. It leads to a waste of funding and resources that could have been used for alternative research.

Later investigations revealed that they fabricated and manipulated their data to show a nonexistent link between vaccines and autism. Wakefield also neglected to disclose important conflicts of interest, and his medical license was taken away.

This fraudulent work sparked vaccine hesitancy among parents and caregivers. The rate of MMR vaccinations in children fell sharply, and measles outbreaks became more common due to a lack of herd immunity.

Research scandals with ethical failures are littered throughout history, but some took place not that long ago.

Some scientists in positions of power have historically mistreated or even abused research participants to investigate research problems at any cost. These participants were prisoners, under their care, or otherwise trusted them to treat them with dignity.

To demonstrate the importance of research ethics, we’ll briefly review two research studies that violated human rights in modern history.

These experiments were inhumane and resulted in trauma, permanent disabilities, or death in many cases.

After some Nazi doctors were put on trial for their crimes, the Nuremberg Code of research ethics for human experimentation was developed in 1947 to establish a new standard for human experimentation in medical research.

In reality, the actual goal was to study the effects of the disease when left untreated, and the researchers never informed participants about their diagnoses or the research aims.

Although participants experienced severe health problems, including blindness and other complications, the researchers only pretended to provide medical care.

When treatment became possible in 1943, 11 years after the study began, none of the participants were offered it, despite their health conditions and high risk of death.

Ethical failures like these resulted in severe harm to participants, wasted resources, and lower trust in science and scientists. This is why all research institutions have strict ethical guidelines for performing research.

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

• Normal distribution
• Measures of central tendency
• Chi square tests
• Confidence interval
• Quartiles & Quantiles
• Cluster sampling
• Stratified sampling
• Thematic analysis
• Cohort study
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Research bias

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Ethical considerations in research are a set of principles that guide your research designs and practices. These principles include voluntary participation, informed consent, anonymity, confidentiality, potential for harm, and results communication.

Scientists and researchers must always adhere to a certain code of conduct when collecting data from others .

These considerations protect the rights of research participants, enhance research validity , and maintain scientific integrity.

Research ethics matter for scientific integrity, human rights and dignity, and collaboration between science and society. These principles make sure that participation in studies is voluntary, informed, and safe.

Anonymity means you don’t know who the participants are, while confidentiality means you know who they are but remove identifying information from your research report. Both are important ethical considerations .

You can only guarantee anonymity by not collecting any personally identifying information—for example, names, phone numbers, email addresses, IP addresses, physical characteristics, photos, or videos.

You can keep data confidential by using aggregate information in your research report, so that you only refer to groups of participants rather than individuals.

These actions are committed intentionally and can have serious consequences; research misconduct is not a simple mistake or a point of disagreement but a serious ethical failure.

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Ensuring ethical standards and procedures for research with human beings

Research ethics govern the standards of conduct for scientific researchers. It is important to adhere to ethical principles in order to protect the dignity, rights and welfare of research participants. As such, all research involving human beings should be reviewed by an ethics committee to ensure that the appropriate ethical standards are being upheld. Discussion of the ethical principles of beneficence, justice and autonomy are central to ethical review.

WHO works with Member States and partners to promote ethical standards and appropriate systems of review for any course of research involving human subjects. Within WHO, the Research Ethics Review Committee (ERC) ensures that WHO only supports research of the highest ethical standards. The ERC reviews all research projects involving human participants supported either financially or technically by WHO. The ERC is guided in its work by the World Medical Association Declaration of Helsinki (1964), last updated in 2013, as well as the International Ethical Guidelines for Biomedical Research Involving Human Subjects (CIOMS 2016).

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Nih clinical research trials and you, guiding principles for ethical research.

Pursuing Potential Research Participants Protections

“When people are invited to participate in research, there is a strong belief that it should be their choice based on their understanding of what the study is about, and what the risks and benefits of the study are,” said Dr. Christine Grady, chief of the NIH Clinical Center Department of Bioethics, to Clinical Center Radio in a podcast.

Clinical research advances the understanding of science and promotes human health. However, it is important to remember the individuals who volunteer to participate in research. There are precautions researchers can take – in the planning, implementation and follow-up of studies – to protect these participants in research. Ethical guidelines are established for clinical research to protect patient volunteers and to preserve the integrity of the science.

NIH Clinical Center researchers published seven main principles to guide the conduct of ethical research:

Social and clinical value

Scientific validity, fair subject selection, favorable risk-benefit ratio, independent review, informed consent.

• Respect for potential and enrolled subjects

Every research study is designed to answer a specific question. The answer should be important enough to justify asking people to accept some risk or inconvenience for others. In other words, answers to the research question should contribute to scientific understanding of health or improve our ways of preventing, treating, or caring for people with a given disease to justify exposing participants to the risk and burden of research.

A study should be designed in a way that will get an understandable answer to the important research question. This includes considering whether the question asked is answerable, whether the research methods are valid and feasible, and whether the study is designed with accepted principles, clear methods, and reliable practices. Invalid research is unethical because it is a waste of resources and exposes people to risk for no purpose

The primary basis for recruiting participants should be the scientific goals of the study — not vulnerability, privilege, or other unrelated factors. Participants who accept the risks of research should be in a position to enjoy its benefits. Specific groups of participants  (for example, women or children) should not be excluded from the research opportunities without a good scientific reason or a particular susceptibility to risk.

Uncertainty about the degree of risks and benefits associated with a clinical research study is inherent. Research risks may be trivial or serious, transient or long-term. Risks can be physical, psychological, economic, or social. Everything should be done to minimize the risks and inconvenience to research participants to maximize the potential benefits, and to determine that the potential benefits are proportionate to, or outweigh, the risks.

To minimize potential conflicts of interest and make sure a study is ethically acceptable before it starts, an independent review panel should review the proposal and ask important questions, including: Are those conducting the trial sufficiently free of bias? Is the study doing all it can to protect research participants? Has the trial been ethically designed and is the risk–benefit ratio favorable? The panel also monitors a study while it is ongoing.

Potential participants should make their own decision about whether they want to participate or continue participating in research. This is done through a process of informed consent in which individuals (1) are accurately informed of the purpose, methods, risks, benefits, and alternatives to the research, (2) understand this information and how it relates to their own clinical situation or interests, and (3) make a voluntary decision about whether to participate.

Respect for potential and enrolled participants

Individuals should be treated with respect from the time they are approached for possible participation — even if they refuse enrollment in a study — throughout their participation and after their participation ends. This includes:

• respecting their privacy and keeping their private information confidential
• respecting their right to change their mind, to decide that the research does not match their interests, and to withdraw without a penalty
• informing them of new information that might emerge in the course of research, which might change their assessment of the risks and benefits of participating
• monitoring their welfare and, if they experience adverse reactions, unexpected effects, or changes in clinical status, ensuring appropriate treatment and, when necessary, removal from the study
• informing them about what was learned from the research

More information on these seven guiding principles and on bioethics in general

This page last reviewed on March 16, 2016

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Cover Story

Five principles for research ethics

Cover your bases with these ethical strategies

By DEBORAH SMITH

Monitor Staff

January 2003, Vol 34, No. 1

Print version: page 56

13 min read

• Conducting Research

Not that long ago, academicians were often cautious about airing the ethical dilemmas they faced in their research and academic work, but that environment is changing today. Psychologists in academe are more likely to seek out the advice of their colleagues on issues ranging from supervising graduate students to how to handle sensitive research data , says George Mason University psychologist June Tangney, PhD.

"There has been a real change in the last 10 years in people talking more frequently and more openly about ethical dilemmas of all sorts," she explains.

Indeed, researchers face an array of ethical requirements: They must meet professional, institutional and federal standards for conducting research with human participants, often supervise students they also teach and have to sort out authorship issues, just to name a few.

Here are five recommendations APA's Science Directorate gives to help researchers steer clear of ethical quandaries:

1. Discuss intellectual property frankly

Academe's competitive "publish-or-perish" mindset can be a recipe for trouble when it comes to who gets credit for authorship . The best way to avoid disagreements about who should get credit and in what order is to talk about these issues at the beginning of a working relationship, even though many people often feel uncomfortable about such topics.

"It's almost like talking about money," explains Tangney. "People don't want to appear to be greedy or presumptuous."

APA's Ethics Code offers some guidance: It specifies that "faculty advisors discuss publication credit with students as early as feasible and throughout the research and publication process as appropriate." When researchers and students put such understandings in writing, they have a helpful tool to continually discuss and evaluate contributions as the research progresses.

However, even the best plans can result in disputes, which often occur because people look at the same situation differently. "While authorship should reflect the contribution," says APA Ethics Office Director Stephen Behnke, JD, PhD, "we know from social science research that people often overvalue their contributions to a project. We frequently see that in authorship-type situations. In many instances, both parties genuinely believe they're right." APA's Ethics Code stipulates that psychologists take credit only for work they have actually performed or to which they have substantially contributed and that publication credit should accurately reflect the relative contributions: "Mere possession of an institutional position, such as department chair, does not justify authorship credit," says the code. "Minor contributions to the research or to the writing for publications are acknowledged appropriately, such as in footnotes or in an introductory statement."

The same rules apply to students. If they contribute substantively to the conceptualization, design, execution, analysis or interpretation of the research reported, they should be listed as authors. Contributions that are primarily technical don't warrant authorship. In the same vein, advisers should not expect ex-officio authorship on their students' work.

Matthew McGue, PhD, of the University of Minnesota, says his psychology department has instituted a procedure to avoid murky authorship issues. "We actually have a formal process here where students make proposals for anything they do on the project," he explains. The process allows students and faculty to more easily talk about research responsibility, distribution and authorship.

Psychologists should also be cognizant of situations where they have access to confidential ideas or research, such as reviewing journal manuscripts or research grants, or hearing new ideas during a presentation or informal conversation. While it's unlikely reviewers can purge all of the information in an interesting manuscript from their thinking, it's still unethical to take those ideas without giving credit to the originator.

"If you are a grant reviewer or a journal manuscript reviewer [who] sees someone's research [that] hasn't been published yet, you owe that person a duty of confidentiality and anonymity," says Gerald P. Koocher, PhD, editor of the journal Ethics and Behavior and co-author of "Ethics in Psychology: Professional Standards and Cases" (Oxford University Press, 1998).

Researchers also need to meet their ethical obligations once their research is published: If authors learn of errors that change the interpretation of research findings, they are ethically obligated to promptly correct the errors in a correction, retraction, erratum or by other means.

To be able to answer questions about study authenticity and allow others to reanalyze the results, authors should archive primary data and accompanying records for at least five years, advises University of Minnesota psychologist and researcher Matthew McGue, PhD. "Store all your data. Don't destroy it," he says. "Because if someone charges that you did something wrong, you can go back."

"It seems simple, but this can be a tricky area," says Susan Knapp, APA's deputy publisher. "The APA Publication Manual Section 8.05 has some general advice on what to retain and suggestions about things to consider in sharing data."

The APA Ethics Code requires psychologists to release their data to others who want to verify their conclusions, provided that participants' confidentiality can be protected and as long as legal rights concerning proprietary data don't preclude their release. However, the code also notes that psychologists who request data in these circumstances can only use the shared data for reanalysis; for any other use, they must obtain a prior written agreement.

2. Be conscious of multiple roles

APA's Ethics Code says psychologists should avoid relationships that could reasonably impair their professional performance or could exploit or harm others. But it also notes that many kinds of multiple relationships aren't unethical--as long as they're not reasonably expected to have adverse effects.

That notwithstanding, psychologists should think carefully before entering into multiple relationships with any person or group, such as recruiting students or clients as participants in research studies or investigating the effectiveness of a product of a company whose stock they own.

For example, when recruiting students from your Psychology 101 course to participate in an experiment, be sure to make clear that participation is voluntary. If participation is a course requirement, be sure to note that in the class syllabus, and ensure that participation has educative value by, for instance, providing a thorough debriefing to enhance students' understanding of the study. The 2002 Ethics Code also mandates in Standard 8.04b that students be given equitable alternatives to participating in research.

Perhaps one of the most common multiple roles for researchers is being both a mentor and lab supervisor to students they also teach in class. Psychologists need to be especially cautious that they don't abuse the power differential between themselves and students, say experts. They shouldn't, for example, use their clout as professors to coerce students into taking on additional research duties.

By outlining the nature and structure of the supervisory relationship before supervision or mentoring begins, both parties can avoid misunderstandings, says George Mason University's Tangney. It's helpful to create a written agreement that includes both parties' responsibilities as well as authorship considerations, intensity of the supervision and other key aspects of the job.

"While that's the ideal situation, in practice we do a lot less of that than we ought to," she notes. "Part of it is not having foresight up front of how a project or research study is going to unfold."

That's why experts also recommend that supervisors set up timely and specific methods to give students feedback and keep a record of the supervision, including meeting times, issues discussed and duties assigned.

If psychologists do find that they are in potentially harmful multiple relationships, they are ethically mandated to take steps to resolve them in the best interest of the person or group while complying with the Ethics Code.

3. Follow informed-consent rules

When done properly, the consent process ensures that individuals are voluntarily participating in the research with full knowledge of relevant risks and benefits.

"The federal standard is that the person must have all of the information that might reasonably influence their willingness to participate in a form that they can understand and comprehend," says Koocher, dean of Simmons College's School for Health Studies.

APA's Ethics Code mandates that psychologists who conduct research should inform participants about:

The purpose of the research, expected duration and procedures.

Participants' rights to decline to participate and to withdraw from the research once it has started, as well as the anticipated consequences of doing so.

Reasonably foreseeable factors that may influence their willingness to participate, such as potential risks, discomfort or adverse effects.

Any prospective research benefits.

Limits of confidentiality, such as data coding, disposal, sharing and archiving, and when confidentiality must be broken.

Incentives for participation.

Who participants can contact with questions.

Experts also suggest covering the likelihood, magnitude and duration of harm or benefit of participation, emphasizing that their involvement is voluntary and discussing treatment alternatives, if relevant to the research.

Keep in mind that the Ethics Code includes specific mandates for researchers who conduct experimental treatment research. Specifically, they must inform individuals about the experimental nature of the treatment, services that will or will not be available to the control groups, how participants will be assigned to treatments and control groups, available treatment alternatives and compensation or monetary costs of participation.

If research participants or clients are not competent to evaluate the risks and benefits of participation themselves--for example, minors or people with cognitive disabilities--then the person who's giving permission must have access to that same information, says Koocher.

Remember that a signed consent form doesn't mean the informing process can be glossed over, say ethics experts. In fact, the APA Ethics Code says psychologists can skip informed consent in two instances only: When permitted by law or federal or institutional regulations, or when the research would not reasonably be expected to distress or harm participants and involves one of the following:

The study of normal educational practices, curricula or classroom management methods conducted in educational settings.

Anonymous questionnaires, naturalistic observations or archival research for which disclosure of responses would not place participants at risk of criminal or civil liability or damage their financial standing, employability or reputation, and for which confidentiality is protected.

The study of factors related to job or organization effectiveness conducted in organizational settings for which there is no risk to participants' employability, and confidentiality is protected.

If psychologists are precluded from obtaining full consent at the beginning--for example, if the protocol includes deception, recording spontaneous behavior or the use of a confederate--they should be sure to offer a full debriefing after data collection and provide people with an opportunity to reiterate their consent, advise experts.

The code also says psychologists should make reasonable efforts to avoid offering "excessive or inappropriate financial or other inducements for research participation when such inducements are likely to coerce participation."

4. Respect confidentiality and privacy

Upholding individuals' rights to confidentiality and privacy is a central tenet of every psychologist's work. However, many privacy issues are idiosyncratic to the research population, writes Susan Folkman, PhD, in " Ethics in Research with Human Participants " (APA, 2000). For instance, researchers need to devise ways to ask whether participants are willing to talk about sensitive topics without putting them in awkward situations, say experts. That could mean they provide a set of increasingly detailed interview questions so that participants can stop if they feel uncomfortable.

And because research participants have the freedom to choose how much information about themselves they will reveal and under what circumstances, psychologists should be careful when recruiting participants for a study, says Sangeeta Panicker, PhD, director of the APA Science Directorate's Research Ethics Office. For example, it's inappropriate to obtain contact information of members of a support group to solicit their participation in research. However, you could give your colleague who facilitates the group a letter to distribute that explains your research study and provides a way for individuals to contact you, if they're interested.

Other steps researchers should take include:

Discuss the limits of confidentiality. Give participants information about how their data will be used, what will be done with case materials, photos and audio and video recordings, and secure their consent.

Know federal and state law. Know the ins and outs of state and federal law that might apply to your research. For instance, the Goals 2000: Education Act of 1994 prohibits asking children about religion, sex or family life without parental permission.

Another example is that, while most states only require licensed psychologists to comply with mandatory reporting laws, some laws also require researchers to report abuse and neglect. That's why it's important for researchers to plan for situations in which they may learn of such reportable offenses. Generally, research psychologists can consult with a clinician or their institution's legal department to decide the best course of action.

Take practical security measures. Be sure confidential records are stored in a secure area with limited access, and consider stripping them of identifying information, if feasible. Also, be aware of situations where confidentiality could inadvertently be breached, such as having confidential conversations in a room that's not soundproof or putting participants' names on bills paid by accounting departments.

Think about data sharing before research begins. If researchers plan to share their data with others, they should note that in the consent process, specifying how they will be shared and whether data will be anonymous. For example, researchers could have difficulty sharing sensitive data they've collected in a study of adults with serious mental illnesses because they failed to ask participants for permission to share the data. Or developmental data collected on videotape may be a valuable resource for sharing, but unless a researcher asked permission back then to share videotapes, it would be unethical to do so. When sharing, psychologists should use established techniques when possible to protect confidentiality, such as coding data to hide identities. "But be aware that it may be almost impossible to entirely cloak identity, especially if your data include video or audio recordings or can be linked to larger databases," says Merry Bullock, PhD, associate executive director in APA's Science Directorate.

Understand the limits of the Internet. Since Web technology is constantly evolving, psychologists need to be technologically savvy to conduct research online and cautious when exchanging confidential information electronically. If you're not a Internet whiz, get the help of someone who is. Otherwise, it may be possible for others to tap into data that you thought was properly protected.

5. Tap into ethics resources

One of the best ways researchers can avoid and resolve ethical dilemmas is to know both what their ethical obligations are and what resources are available to them.

"Researchers can help themselves make ethical issues salient by reminding themselves of the basic underpinnings of research and professional ethics," says Bullock. Those basics include:

The Belmont Report. Released by the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research in 1979, the report provided the ethical framework for ensuing human participant research regulations and still serves as the basis for human participant protection legislation (see Further Reading).

APA's Ethics Code , which offers general principles and specific guidance for research activities.

Moreover, despite the sometimes tense relationship researchers can have with their institutional review boards (IRBs), these groups can often help researchers think about how to address potential dilemmas before projects begin, says Panicker. But psychologists must first give their IRBs the information they need to properly understand a research proposal.

"Be sure to provide the IRB with detailed and comprehensive information about the study, such as the consent process, how participants will be recruited and how confidential information will be protected," says Bullock. "The more information you give your IRB, the better educated its members will become about behavioral research, and the easier it will be for them to facilitate your research."

As cliché as it may be, says Panicker, thinking positively about your interactions with an IRB can help smooth the process for both researchers and the IRBs reviewing their work.

Further reading

American Psychological Association. (2002). Ethical principles of psychologists and code of conduct. American Psychologist, 57 (12).

Sales, B.D., & Folkman, S. (Eds.). (2000). Ethics in research with human participants . Washington, DC: American Psychological Association.

APA's Research Ethics Office in the Science Directorate; e-mail ; Web site: APA Science .

The National Institutes of Health (NIH) offers educational materials on human subjects .

NIH Bioethics Resources Web site .

The Department of Health and Human Services' (DHHS) Office of Research Integrity Web site .

DHHS Office of Human Research Protections Web site .

The 1979 Belmont Report on protecting human subjects .

Association for the Accreditation of Human Research Protection Programs Web site: www.aahrpp.org .

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Understanding Ethical Challenges in Medical Education Research

Klitzman, Robert

Rapidly advancing biomedical and electronic technologies, ongoing health disparities, and new online educational modalities are all changing medicine and medical education. As medical training continues to evolve, research is increasingly critical to help improve it, but medical education research can pose unique ethical challenges. As research participants, medical trainees may face several risks and in many ways constitute a vulnerable group. In this commentary, the author examines several of the ethical challenges involved in medical education research, including confidentiality and the risk of stigma; the need for equity, diversity, and inclusion; genetic testing of students; clustered randomized trials of training programs; and questions about quality improvement activities. The author offers guidance for navigating these ethical challenges, including the importance of engaging with institutional review boards. Academic medical institutions should educate and work closely with faculty to ensure that all research adheres to appropriate ethical guidelines and regulations and should provide instruction about the ethics of medical education research to establish a strong foundation for the future of the field. Research on medical education will become increasingly important. Given the potential sensitivity of the data collected in such research, investigators must understand and address potential ethical challenges as carefully as possible.

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• Tiny Matters

Pig hearts in people: Xenotransplantation's long history, current promise, and the ethical use of brain-dead people in research

In the early hours of January 7, 2022, David Bennett was out of options. At just 57 years old, he was bedridden, on life support, and in desperate need of a heart transplant for which he was ineligible. Yet Bennett would go on to live for two more months — not with a human heart, but with a heart from a pig. David Bennett was the first case of a pig heart being transplanted into a human, an example of xenotransplantation — when the cells, tissues or organs from one species are transplanted into another. In the United States, over 100,000 kids and adults are currently on the national transplant waiting list, and every day around 17 people on that list die while waiting. 

In today's episode, we cover the science that made Bennett’s transplant possible, and what doctors learned from him that helped the next heart xenotransplant recipient, Lawrence Faucette, live even longer. We also get into some of the ethics conversations surrounding xenotransplantation work — not just questions about the use of animals like pigs and baboons, but experiments with recently deceased, i.e. brain dead, people.

Transcript of this Episode

Sam Jones: In the early hours of January 7, 2022, David Bennett was out of options. At just 57 years old, he was bedridden, on life support, and in desperate need of a heart transplant for which he was ineligible. Yet Bennett would go on to live for two more months — not with a human heart, but with a heart from a pig. 

Welcome to Tiny Matters, I’m Sam Jones and today I’m joined by my co-host, science communicator and producer, George Zaidan. George, welcome to Tiny Matters!

George Zaidan: Thanks so much for having me! I’m especially glad to be here because this is such a fascinating story. David Bennett was the first case of a pig heart being transplanted into a human, an example of xenotransplantation — when the cells, tissues or organs from one species are transplanted into another. In the United States, over 100,000 kids and adults are currently on the national transplant waiting list, and every day around 17 people on that list die while waiting. 

Sam: So today on the show we’re going to talk about the science and history that made Bennett’s transplant possible, and what doctors learned from him that helped the next heart xenotransplant recipient, Lawrence Faucette, live even longer. We’ll also get into some of the ethics conversations surrounding xenotransplantation work — not just questions about the use of animals like pigs and baboons, but experiments with recently deceased people.

Throughout history, you’ll find stories of human-beast hybrids, for instance the ancient Egyptian god Anubis — body of a man with the head of a dog — or the sphinx in Ancient Greece, who was part woman, part bird, part lion. Starting centuries ago, there are records of taking the blood and skin from other animals and using them in humans.

Muhammad Mohiuddin: Even in the early 1600s, they tried to put a dog skull in a nobleman just to repair a defect there. However, the church disallowed it and they took it out and the nobleman died.

George: That’s Muhammad Mohiuddin, a professor of surgery and the Director of the Cardiac Xenotransplantation Program at the University of Maryland School of Medicine. He co-led the team that performed both David Bennett and Lawrence Faucette’s surgeries. 

He told us that in the early 1900s, there was a rise in xenotransplantation attempts using organs from a number of species, but the survival rate was low — like hours, not even days. That’s not surprising given what we now know about the immune system, and the role it plays in an organ being rejected by a transplant recipient’s body after what may have looked like a successful surgery. 

Muhammad has dedicated his life to understanding the immune response to xenotransplantation and how to temper it. And we’re going to get into that a bit later in this episode. But first let’s talk about a few milestones in the xenotransplantation world. Because immunosuppressant drugs weren’t available in the early 1900s, doctors were at a loss, and by the mid 1920s many had moved away from xenotransplantation. And it stayed that way for decades. 

Sam: A big turning point came in 1963, when surgeon Keith Reemtsma at Tulane University transplanted the kidneys of chimpanzees and, in one case, a rhesus monkey, into people. One of the chimpanzee kidney recipients survived an astonishing 9 months. That huge jump in survival time was attributed to new immunosuppressive drugs that kept the immune system from immediately flaring up and rejecting the organ. Unfortunately, the other xenotransplant recipients died within a couple of months, either due to immune rejection or because their immune system was so depleted that they developed an infection they would have typically be able to fight off. 

George: A year later, in 1964, a doctor tried the first cardiac xenotransplantation in humans, using a chimpanzee heart. Unfortunately, the patient died within a couple of hours. But twenty years later, Baby Fae really put cardiac xenotransplantation on the map. In 1984, a surgeon named Leonard Bailey at Loma Linda University Medical Center in California transplanted a baboon heart into 12-day-old Stephanie Fae Beauclair, better known as Baby Fae.

Baby Fae was born with hypoplastic left heart syndrome. This is a condition where the left side of the heart is so underdeveloped that it has trouble pumping blood. In Baby Fae’s case it was so severe that she wouldn’t have survived. As her heart failed, Bailey performed the surgery. Just hours later, her new baboon heart began beating. Sadly, just a few weeks after that, Baby Fae’s immune system rejected the heart and she passed away. But in the years since then, researchers have made huge strides in immunosuppression medications, and treatment approaches and have also moved away from using organs from non-human primates. 

Muhammad Mohiuddin: We found out that chimpanzees or baboons, though very similar to humans, there are several disadvantages of transplanting their organs. 

Sam: One disadvantage is that they carry diseases that can easily transmit to us, including simian immunodeficiency viruses or SIV, notorious for crossing into humans and causing HIV. Muhammad told us the focus soon began to shift to pigs.

Muhammad Mohiuddin: They are domestic animals raised well in captivity, they grow very fast. So for a human of about 80 kilograms, you need a pig of only one year of age, and that heart or other organs will be compatible with human organ size. 

Sam: Researchers also know a lot about the pig genome, which means we can tinker with their genetics. 

Muhammad Mohiuddin: So with the technology now we have to modify genes, we can alter their genes and take out the genes that are immunogenic to humans and then put in some human genes to make them more compatible to human.

Sam: This is a huge deal, because it means pig heart xenotransplant recipients are no longer fully reliant on immunosuppressants. Researchers are able to remove the genes in pigs that code for the production of molecules that trigger the human immune system. At the same time, researchers can now insert genes that make a pig’s heart appear to be more human to our immune system. 

George: This is possible thanks to cloning. The company Muhammad and his colleagues work with is called Revivicor, which is a spinoff of PPL Therapeutics, which is the company that cloned Dolly the sheep. 

Revivicor retrieves eggs from the ovaries of female pigs, removes the DNA and replaces it with new DNA. And in that new DNA, the researchers removed three genes that are responsible for rejection of pig organs by human immune systems. The gene for a growth hormone receptor was also removed to prevent the pig heart from growing too much once transplanted. 

Sam: Six human genes were also inserted into the new DNA, which would help with immune acceptance. They then placed the eggs, now fertilized, back in the pig’s uterus where they developed into embryos. There can still be some variation in genes even with these genetic modifications, but the team is ultimately working to create a stable breeding line where pigs who show stable genetics would then be bred with each other so you’d always get these 10 desired genetic mutations in their offspring. You’d no longer need cloning.

So by 2021, Muhammad and his colleagues had not only genetically modified pigs but were using better immunosuppressants, including a new anti-CD40 antibody, which targets an incredibly important immune pathway in humans.  

Muhammad Mohiuddin: So at that time, we thought that this is the right time to take this to humans and save millions of people throughout the world who cannot get a human heart either because of the shortage or because of certain conditions these patients have, which make them ineligible for a human heart.

George: So they approached the FDA. And although xenotransplantation surgery is not yet approved, it falls under “compassionate use” rules for emergency situations, similar to how new cancer drugs that are not FDA approved can be used in a terminal patient, with their consent of course. And that brings us back to David Bennett. Muhammad told us that, after going back and forth several times with the FDA, they were granted compassionate use approval.

Muhammad Mohiuddin: And then we presented this idea to Mr. Bennett and he graciously accepted it saying that even if it doesn't help me, it may help other people. So he volunteered his life for this purpose.

George: On January 7th, 2022, cardiothoracic surgeon Bartley Griffith, alongside Muhammad and the rest of the team at the University of Maryland Medical Center, performed the first successful xenotransplantation surgery placing a genetically modified pig heart into a person.

Muhammad Mohiuddin: When we were doing this transplant, nobody knew what to expect because there was no precedence. So we even told the patient, and the patient understood that there is not even a guarantee that he will recover from this transplant. Even wake up. So every day from that point on, we took it as success. And finally he lived for 60 days. 

George: Now for context, the first person to receive a heart transplant from another human only lived for 18 days. Over the course of David Bennett’s 60 days before his immune system ultimately rejected the pig heart he not only got more time with his family — Muhammad and the team were also learning from him.

Muhammad Mohiuddin: At one point we had to stop one of the major immunosuppressive drugs for a little bit. We did not know what levels of the CD40 that we used very successfully in baboons is enough for this particular patient, because of course he’s not a baboon. And also there were so many other issues going on simultaneously that we had difficulty maintaining the levels of that drug.

Sam: At one point David Bennett’s immune system took such a dip that they actually needed to give him intravenous immunoglobulins or IVIG, which is an antibody serum from healthy volunteers. 

Muhammad Mohiuddin: But what we didn't realize at that time, that pool serum also had antibodies against pigs. So we believe that those antibodies kind of attack the pig heart and caused the graft to fail.

Sam: In addition, the pig heart David Bennett received was unknowingly infected with a latent virus called CMV.

Muhammad Mohiuddin: We do look for the viruses in these donors. However, we were not able to detect this virus because it was very deep seated. Since this patient, we have developed a lot of new techniques to detect even these deep-seated viruses. And in the second case, we were able to screen that virus out, so we didn’t see any issue with any virus in the second case. 

So if you say, what were the reasons the first patient lived for only 60 days, not a hundred days? I would say the number one was his own condition, a very vulnerable condition where we could not maintain the immunosuppression that we wanted to give to protect the heart from rejection. Number two was the IVIG that we gave acted against the heart. And number three, the virus may have caused some kind of initial damage or immune reaction that may have caused the destruction of the heart cells, causing rejection or graft failure.

Sam: Right now, the team at the University of Maryland is continuing to evaluate patients for future pig heart transplants while also optimizing their approach. 

Muhammad Mohiuddin: Every transplant, we will learn something, but we want to improve and not repeat. Everything that we learned in the first transplant that we thought that had gone wrong, we never repeated it.

Sam: The second patient, 58 year old Lawrence Faucette, received a genetically modified pig heart on September 20, 2023 and lived for nearly 6 weeks before his body rejected it. Faucette, a retired U.S. Navy veteran and histology technician at the NIH, was able to spend that time with family members and even begin physical therapy. 

George: There has been so much work to get to this point, and people like David Bennett and Lawrence Faucette have been invaluable in that progress. But there are also many other species, including pigs but also many non-human primates, that have played an essential role in understanding immune rejection. One of the main reasons the FDA granted compassionate use approval for David Bennett’s surgery was a landmark study done by Muhammad and his team, in which a pig heart was transplanted into a baboon who went on to survive for nearly for 3 more years. 

Sam with Muhammad Mohiuddin: Xenotransplantation is, in my opinion, really important, but it's not like you can just go from pig to human and not do a lot of things in between. And a pig heart, it's still a pig. And some people might get upset that it's a pig. And so, how do you navigate those conversations surrounding, ‘is it ethical to have all of these pigs that are being raised for this purpose or working with baboons?’ I’m just kind of curious how you manage that or how you view that in your work. 

Muhammad Mohiuddin: Every single drug that we use these days, or every single procedure, has been tested in an animal before we used it. So it is unfortunate, we all love animals and we don't want to use them for this purpose, but we don't have any computational models or anything else to replace a live human biology. And I've been doing it for the past 33 years. We do receive a lot of, you'll say hate mails or we've been questioned a lot. But I was very surprised when we did these two humans — 99% of the mail or the communication I received was very positive. A lot of people said, “where were you 10 years ago when we lost our dear one?” It is unfortunate that to keep one human alive, we have to kill one pig. But again, 90,000 pigs are killed per day in the United States for our dietary needs. That's one of the reasons that pigs were chosen because they are already being sacrificed every day for other purposes. There are about 105 products that we use — even maybe the makeup you're using — was derived from pig products. To me, saving one life takes precedence over everything. And just imagine if this becomes a routine. Every 80 minutes a patient dies waiting for an organ. So you can save millions of lives throughout the world, just within a year.

George: But baboons and other non-human primates are not the only option for studying xenotransplant rejection. Another approach is experimenting in people who are recently deceased. In 2022, surgeons at NYU made headlines when they transplanted pig hearts with the same 10 genetic changes as David Bennett’s donor pig heart into two recently deceased people who were then monitored for three days. 

Sam: I came across this side of xenotransplantation research in a story titled, “The Allure and Dangers of Experimenting With Brain-Dead Bodies,” written by Jyoti Madhusoodanan, who is a freelance science journalist based in Portland, Oregon. A couple years before writing the story, Jyoti was working on an article about xenotransplantation for the Journal of the American Medical Association. David Bennett had just received his pig heart transplant.

Jyoti Madhusoodanan: There was a lot of news and excitement about it, and I was speaking with researchers about not just the transplant itself, but this massive body of work they had done leading up to that moment. And in the course of that conversation, it came about that some of that research had been done in people who were recently deceased.

George: Recently deceased people are sometimes referred to as brain dead people or decedents. And although they’re legally dead, machines keep their blood pumping and air flowing into and out of their lungs. What Jyoti soon learned was that using recently deceased people opens up a massive can of worms when it comes to regulation. In the U.S., since 1991 we’ve had the Federal Policy for the Protection of Human Subjects which is also known as the “Common Rule.”

Jyoti Madhusoodanan: And the Common Rule is basically a set of federal policies that are meant to protect people who participate in scientific research. So the common rule covers things like making sure that protected classes of people like children or communities that are especially vulnerable, like people who are in prison or pregnant people, are protected from experiments that could be harmful to them or that might in some way violate their freedoms, for instance.

George: And over time the Common Rule has expanded and shifted to be more encompassing of different kinds of research. 

Jyoti Madhusoodanan: It also covers biospecimens, which are things like blood or tissue or organs. And essentially for all of these things that are done with people who are living, whether they're minors or not, or whether they're tissue samples or not, you have things like informed consent, meaning no one can use your tissue, a blood sample from you for a genetic test or whatever, without your consent. There's also institutional review boards which offer oversight within institutions. 

Sam: Researchers proposing to do work with living people have to get approval from an institutional review board or IRB before moving ahead with a project. 

Jyoti Madhusoodanan: And there's also another set of rules about research involving tissues or bodies of people who are deceased. But what I discovered while reporting this is that recently deceased people, people who've been declared brain dead are in this gray area. So there's not a lot of regulation about how to do research with recently deceased subjects. There are groups of researchers and ethicists who've developed guidance to help the community, but none of that is formal regulation per se.

Sam: And what that does is open things up to a range of treatment, both good and bad.  

Jyoti Madhusoodanan: There were some truly wonderful stories from the U.S. actually, where it was moving to see how much researchers cared about doing things the right way. They sort of adhered to the highest standards they could find because there weren't any other standards for them, which was really heartwarming and wonderful to see. At the same time, there was this one instance from India that really stood out. It started out as a U.S.-based company that wanted to conduct experiments with trying to revive brain dead subjects, and they didn't get the consent they needed in the U.S. So then they moved out of the U.S. to, they say, a few different countries, and didn't really get off the ground because of the pandemic. But there is one institute in India where the researcher says they have been continuing that sort of work on their own without the US company being involved, and they are using a combination of stem cells and other treatments to literally revive brain activity in people who've suffered brain injuries during traffic accidents.

Sam: Although they’re not working in the xenotransplantation space, at least to our knowledge, it gives you a sense of how so much gray area surrounding this regulation means things can get dicey real fast. 

Jyoti Madhusoodanan: All the researchers that I spoke with about that work described it as premature. Ethicists have published review articles, opinion pieces, describing how that work is essentially exploitative of grieving families by giving them false hope that their loved ones might come back to life. And if you contrast that with the xenotransplantation work, where there has been decades of work in animal models to see what needs to be done to make that process feasible for humans. And then they carried out the work in recently deceased subjects and then went into a living human, which is a very methodical, systematic way of bringing the research to a point where it's acceptable to experiment on a human being.

George: The 2022 NYU study where pig hearts were transplanted into two recently deceased people was a great example of decedent work being done ethically. One of the people in that study was a woman named Alva Capuano.

Jyoti Madhusoodanan: Alva Capuano had dealt with so many health issues over the course of her life that really epitomized the need for xenotransplant research. 

George: In her reporting, Jyoti had the opportunity to speak with Alva’s son Tim. 

Jyoti Madhusoodanan: The conversation I had with Tim really framed for me how when research is done well, how it can really build trust with people who participate. His mom had signed up to donate her own organs because of her complicated life experience and knowing the value of a donated organ. And unfortunately, it turned out that because of her complicated medical history, when they were trying to arrange this gift at the end of her life, the family kept running into rejection of people telling them they can't use this organ or that organ or the other. And it was this really traumatizing, grueling process for them. And they were really reaching the end of it, end of that process when they heard about the possibility of her participating in this study, in this experiment.

George: The medical team at NYU explained the process to the Capuano family and they decided it was the right move. Alva wanted to contribute to research that could ultimately save the lives of people like her who were in need of a transplant. 

Jyoti Madhusoodanan: And apparently, Tim said during our interview, that at the time, during those few days that they were conducting the experiment, the researchers would call them. So they had frequent updates about how things were going, what the researchers were learning from what they were doing, and things like that, which is just a really sweet example of how science that engages the people that it hopes to help can do so much more when it's done well.

Sam: In this country, every 8 minutes someone is added to the transplant waiting list. As of March of this year over 3,000 children and adults were waiting for a new heart. And now, cardiac xenotransplantation is no longer some sci-fi pipe dream. There are a lot of patients and doctors out there with a lot of hope. 

Let's tiny show-and-tell.

George: All right, let's do it.

Sam: What do you think, George? First tiny show-and-tell.

George: Yeah, I know. Does that mean I should go first or second?

Sam: You decide.

George: Normally I do rock, paper, scissors, but I'll just go first.

Sam: Okay, go for it.

George: My tiny show-and-tell has to do with a disease called progeria. Have you ever heard of it?

Sam: I've heard of it, but I can't quite remember, so remind me.

George: So it's basically... It's kids with super accelerated aging. So it's like a 10-year-old who looks like a 50-year-old, a 27-year-old who looks like an 85-year-old, that kind of thing. And interestingly, I didn't know this, but it's caused by a single-point mutation in one gene. It's a really, really rare disease. It only affects... I think there's only 18 living patients in the US.

And the thing that was highlighted by this article that I was reading about this is that there are about 7,000 genetic disorders for which we know the mutation. 85% of those disorders are super, super rare, and only a few hundred of the 7,000 currently have any sort of treatment, and progeria is one of those. There was no treatment. So researchers created a protein that actually fixes this point mutation. They tested it in mice. It showed a lot of promise. And this is where you get to guess. Can you guess how they created this protein that fixed the problem in mice?

Sam: How they created it? It's like an enzyme? Did they do something in pigs?

George: I actually don't know what animal they did it in. So this is actually... Maybe you're the wrong person to ask because you know about these things, but I feel like most people would just be like, "CRISPR. They used CRISPR, right?" And the shocker is they did not. They used directed evolution. So not all work being done in genetics and proteins is CRISPR, which I thought was cool.

So the next step is to do a clinical trial in humans, which they want to do in the next two years. And the NIH director, he's one of the labs that did this work. So I thought that was also very, very cool. And that's the limit of my... I'm a chemist by training, so that's... Everything I just told you is the limit of my biology knowledge.

Sam: That's really fascinating. In the episode description, we always link to the article or the paper so that if someone is listening and they want to really deep dive, then they know where to go for it.

George: Great. It's a nature paper, so it'll be fun.

Sam: Today I have something very different for you. I have a cool cicada fact for you that was actually brought to my attention by a colleague's five-year-old daughter named Ellie. So thank you, Ellie. Before I get to Ellie's fact, I'm going to talk a little bit about cicadas. So just bear with me, George. I know you're not a big fan.

George: Yeah, I'm not. Insects are not my jam. But...

George: Go ahead.

Sam: Well, you're going to have to suck it up for a sec. All right. There's of course been a lot of cicada talk in recent years with people particularly excited about the magic cicada genus. Those are the ones that hang out underground in their nymphal stage for up to 17 years and then have this big emergence. They're what are called periodical cicadas, and groups of them called broods will emerge all at once in a specific area and year based on a very predictable cycle of development, which is kind of cool that you can say, "Okay, they're back underground, but they're actually going to come out now in 13 years or 15 years or whatever it may be."

So after female cicadas mate, they go to lay their eggs. And when they do that, they use something called an ovipositor to cut through wood, typically trees, where they then lay those eggs. So this ovipositor kind of looks like a serrated sword and it sticks out the female cicadas abdomen.

George: Love it.

Sam: Yeah. It's a great visual. And you would think to cut through wood, it must be pretty strong, right? So a few years back, researchers hypothesized that it might contain different inorganic elements to make it strong, including different metals. So they used a couple different techniques. They used energy dispersive, X-ray spectroscopy and electron microscopy to identify and quantify the elements that were actually present in the ovipositor and then be able to map their locations as well. And so they found 14 inorganic elements including silicon, iron, and zinc. So cicadas are part metal, and that was Ellie's fact.

George: That's amazing.

Sam: And then I went a little bit deeper, but don't worry, I'm almost done with these insects. So something else that I really found fascinating was that a lot of these, what are called cuticles on insects, so this is technically what it’s called. The ovipositor is a cuticle. A lot of them are reinforced with metal, including spider fangs,

George: Oh no.

Sam: Insect mandibles, which are the appendages that are near the mouth that help them crush or bite or cut things, and also, the jaws of marine polychaetes, which are these very creepy-looking worms that you find in the water. So just a fun little fact. I hope you sleep well tonight, George.

George: I guarantee you I will not. Thanks, Sam.

Thanks for tuning in to this week’s episode of Tiny Matters, a production of the American Chemical Society. This week’s script was written by Sam, who is also our executive producer, and was edited by me, George Zaidan, and by Michael David. It was fact-checked by Michelle Boucher. The Tiny Matters theme and episode sound design is by Michael Simonelli and the Charts & Leisure team. 

Sam: Thanks so much to Muhammad Mohiuddin and Jyoti Madhusoodanan for joining us. To be featured in our bonus series, “Tiny Show and Tell Us,” write in to tinymatters@acs.org with science news you’re itching to share, a science factoid you love telling friends about, or maybe even a personal science story. We want to hear about it! And while you’re at it, subscribe to our newsletter! I’ve put links in the episode description. See ya next time!

George: Please don’t share insect stories anymore.

Sam: Only insect tiny show and tells from now on.

George: No insect stories…

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• Volume 50, Issue 9
• Ethical issues in Nipah virus control and research: addressing a neglected disease
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• http://orcid.org/0000-0003-2071-4302 Tess Johnson 1 , 2 ,
• Euzebiusz Jamrozik 1 , 2 , 3 ,
• Tara Hurst 2 ,
• Phaik Yeong Cheah 1 , 4 , 5 ,
• Michael J Parker 1
• 1 Ethox Centre, Nuffield Department of Population Health , University of Oxford , Oxford , UK
• 2 Pandemic Sciences Institute, Nuffield Department of Medicine , University of Oxford , Oxford , UK
• 3 Royal Melbourne Hospital Department of Medicine , University of Melbourne , Melbourne , Victoria , Australia
• 4 Centre for Tropical Medicine and Global Health, Nuffield Department of Medicine , University of Oxford , Oxford , UK
• 5 Mahidol-Oxford Tropical Medicine Research , Mahidol University , Bangkok , Thailand
• Correspondence to Dr Tess Johnson, Ethox Centre, Nuffield Department of Population Health, University of Oxford, Oxford, Oxfordshire, UK; tess.johnson{at}philosophy.ox.ac.uk

Nipah virus is a priority pathogen that is receiving increasing attention among scientists and in work on epidemic preparedness. Despite this trend, there has been almost no bioethical work examining ethical considerations surrounding the epidemiology, prevention, and treatment of Nipah virus or research that has already begun into animal and human vaccines. In this paper, we advance the case for further work on Nipah virus disease in public health ethics due to the distinct issues it raises concerning communication about the modes of transmission, the burdens of public health surveillance, the recent use of stringent public health measures during epidemics, and social or religious norms intersecting with preventive measures. We also advance the case for further work on Nipah virus disease in research ethics, given ethical issues surrounding potential vaccine trials for a high-fatality disease with sporadic spillover events, the different local contexts where trials may occur, and the potential use of unproven therapeutics during outbreaks. Further bioethics work may help to ensure that research and public health interventions for Nipah virus disease are ethically acceptable and more likely to be effective.

• Communicable Diseases
• Ethics- Research
• Ethics- Medical
• Clinical Trial

Data availability statement

Data sharing not applicable as no datasets generated and/or analysed for this study.

This is an open access article distributed in accordance with the Creative Commons Attribution 4.0 Unported (CC BY 4.0) license, which permits others to copy, redistribute, remix, transform and build upon this work for any purpose, provided the original work is properly cited, a link to the licence is given, and indication of whether changes were made. See:  https://creativecommons.org/licenses/by/4.0/ .

https://doi.org/10.1136/jme-2023-109469

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Introduction

Nipah virus is a paramyxovirus of the genus Henipavirus. Henipaviruses are primarily carried by fruit bats, causing infections in humans but no signs of illness in bats. 1 Nipah virus disease was first recognised in humans 25 years ago during outbreaks in Malaysia and Singapore in 1998–1999 1 (see figure 1 ). The virus was spread to humans via interaction with pigs, an intermediate host for the virus. 2 More recently, seasonal outbreaks have occurred in Bangladesh and India due to consumption of fruit and raw date palm sap into which bats have shed virus, although infected bat excreta do not always cause disease. 3 It remains possible that Nipah could spillover into humans in other countries where fruit bats are found. Much is still unknown about the virus, including the accuracy of reported case rates. Since the original outbreaks, cases in Bangladesh were the first to demonstrate the possibility of human-to-human spread, 1 primarily via saliva in circumstances of close contact and crowded conditions. 1 4 The illness may be mild, but can cause encephalitis, coma and death. 5 Overall, the case fatality rate was around 40% in the original outbreaks in 1998 but has been steady at 70%–75% in Bangladesh. 1 5

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. Timeline of Nipah virus outbreaks.

Human-to-human transmission, along with the lack of medical countermeasures and the high fatality rate, has secured Nipah virus a place on the World Health Organization’s priority pathogens list. 6 It has garnered more attention since the COVID-19 pandemic as global leaders focus on preparing for Disease X. Nipah is considered a possible candidate for another global public health emergency and there are multiple initiatives to develop medical countermeasures to prevent or treat infection. For instance, the Coalition for Epidemic Preparedness has shown increasing interest in tackling the gaps in knowledge and developing medical countermeasures for Nipah, including a greater understanding of the biology and sequence diversity of the virus, 7 through funding vaccines and treatments. 8 9

In what follows, we argue that further ethical work ought to be done on Nipah virus disease. We consider why Nipah might be neglected and why it should not be, before outlining areas of inquiry in public health ethics and research ethics.

Why Nipah is neglected and why it should not be

Both public health policies for controlling outbreaks and research regarding Nipah raise numerous ethical issues, for example regarding: (1) the development of ethically acceptable interventions to respond to or prevent outbreaks; (2) delineation of the moral responsibilities of researchers, policy-makers and practitioners in relation to Nipah; (3) incorporation of the values and perspectives of community members who may participate in research and public health interventions; and (4) optimal approaches to Nipah virus research. Yet, despite a wealth of ethical questions surrounding Nipah, to date, there is little published research outside of epidemiology, 1 and even less specifically featuring ethical analysis of policies, responses, research or outbreak conditions relating to Nipah virus. 2 There are a number of reasons why this literature may be underdeveloped in comparison to the risk Nipah virus may pose as a priority pathogen. 6

First, the clearest potential reason might be that Nipah virus is—wrongly, in our view—judged not to raise any unique ethical concerns over and above other priority pathogens such as SARS-CoV-2, Ebola, Lassa fever and Zika. In that case, it may not be seen to require separate ethical analysis. There has been significant research effort directed at issues such as ethical allocation of vaccines in the COVID-19 context, 10 11 the ethical conduct of clinical research trials during Ebola outbreaks, 9 injustices such as stigmatisation associated with Lassa fever, 12 public engagement and involvement in policy responses to Zika virus, 13 14 and cross-cutting issues such as ethical considerations related to public health surveillance, treatment access, and intersections with existing health disparities. 13 15 Nipah virus disease has received less attention, despite its importance as a priority pathogen, and despite having several features that are distinct from those of other priority pathogens. These distinct features raise ethical issues especially salient to Nipah. For instance, Nipah virus typically spreads from bats in specific contexts and, to date, human-to-human transmission has been relatively limited, meaning more questions are raised about preventing animal-human spillover events. In addition, with a particularly high case fatality rate and low transmission, we cannot assume that measures used in response to other pathogens with lower case fatality rate and higher transmission will be effective and/or ethically appropriate in the Nipah virus case. Further, methods of Nipah virus transmission from bats to humans and potential mitigation measures may raise concerns regarding respect for traditional practices. In Bangladesh, transmission has been associated with the collection of date palm sap as a traditional delicacy. 1 3 Mitigation measures that do not consider the importance of these practices for communities and the potential to implement existing, local prevention methods 16 may be unacceptable or infeasible, as we discuss in detail below.

A second reason why Nipah is neglected in academic literature may be that, even if it does raise new concerns, the attention it has received may be proportionate to the harm it has caused to date. Nipah virus has thus far caused very few deaths compared with mortality from other priority pathogens, with the number of cases ranging from 0 to 67 reported in Bangladesh in 2001–2023. 17 However, Nipah should arguably receive greater attention and resources insofar as health justice considerations favour the prioritisation of diseases that primarily affect disadvantaged communities. 18 Moreover, disease burdens associated with Nipah virus may increase in future, for example, because of increased transmissibility, changed climate conditions, increasing natural destruction and intensive land-use in endemic regions, 19 or acts of bioterrorism. 20 21

Finally, Nipah may be neglected because there are simply too many higher priorities. More specifically, there may be more pressing health concerns for communities at risk of Nipah exposure, and/or for bioethics researchers. Consider communities first. Issues such as access to stable employment, better health infrastructure, or food security may be more pressing than the risks of Nipah virus for rural populations in the South East Asian countries where Nipah virus outbreaks have occurred to date, especially given that previous Nipah epidemics have been curtailed without extreme public health measures 22 . However, this highlights why there is a particular need for justice considerations to be included in analyses of actions against Nipah virus. There are intersecting vulnerabilities to Nipah virus disease, including those related to employment insecurity 23 and the effects of climate change. 24 What is more, communities may have difficulty accessing local healthcare, 25 and the effects of land exploitation and destruction may play a role in multiple disadvantages. 26 Recognising the links between risks of Nipah virus exposure and structural conditions can both help in better addressing disease vulnerabilities, and bringing communities’ other needs and priorities surrounding these structural conditions into the spotlight for national and international governance. Next, consider bioethics researchers who may have competing global health research priorities. The COVID-19 pandemic demonstrated how public health emergencies can affect research prioritisation according to salience of the threat. 27 28 Between outbreaks, there may be little motivation to conduct or fund research on Nipah virus disease. However, we ought to avoid past mistakes: insofar as Nipah is a pathogen with major epidemic or perhaps even pandemic potential 6 20 , this raises justice concerns, 29 in that Nipah may deserve a higher-priority ranking. Failure to address the threat may result in lack of preparation and much worse outcomes in future outbreaks. Another reason why Nipah virus should be a research priority for bioethicists is its usefulness as a case study for future zoonotic spillover events in general. Since Nipah virus has to date resulted in limited human-to-human transmission, a significant proportion of the (limited) scientific literature on Nipah virus has primarily examined interventions in animals and the environment, to prevent spillover events. 16 24 30 Nipah virus may be a good candidate for developing research regarding interventions for zoonotic spillover more generally. 31 32 Ethical analysis may contribute to research regarding causes of zoonotic spillover, and the development of effective and ethically acceptable interventions to change land-use, reduce high-risk contact with wildlife reservoirs and alter human behaviours that act as drivers of spillover.

In the ‘Public health ethics topics’ and ‘Research ethics topics’ sections below, we outline key areas or topics requiring further bioethical work.

Public health ethics topics

Transmission and public health communication.

One key area for further development within public health ethics is ethically acceptable communication and education on measures to control or prevent Nipah virus transmission. For example, social norms in Bangladesh dictate that family members provide care and are in close contact with infected relatives, 33 including those infected with Nipah virus. This can exacerbate transmission, and has done so in previous outbreaks. An obvious solution might be the discouragement of close care practices, or isolation, which has been suggested. 34 However, the biomedical explanation of Nipah virus transmission does not always align with community understanding and advising family members not to care for their relatives may conflict with key values. In an anthropological case study on Nipah, 33 members of one village associated Nipah virus disease with people spending too long in the sun, with punishment from Allah, and with a supernatural force. The latter explanation was reinforced by the lack of effective treatment for those suffering from Nipah virus symptoms. Furthermore, interviewees were resistant to the idea of human-to-human spread through close contact, noting the rarity of such transmission and numerous examples where family members had had close contact with an infected individual without themselves becoming infected. This study shows how much more work is needed examining the design of ethical infection control and public health communication measures and how this may be influenced by social norms and religious requirements relating to Nipah. It may be that such measures can be designed to work around social norms and religious requirements. 16 If this is not the case, more work will be needed to ensure that public health communication is presented with adequate evidence, relevance and involvement of communities. This is emphasised by previous cases of community mistrust in doctors advising preventive measures against Nipah virus, where doctors explained the cause of Nipah as consuming raw date palm sap without explaining that this was because the sap was often contaminated by bats. 35 Research aiming to improve the local ethical acceptability of prevention measures can also lead to co-creation of measures, as with the development of bamboo skirts for date palm sap pipes and jugs developed with sap harvesters in Bangladesh. 16

Stigmatisation and politicisation

A second area for work in public health ethics on Nipah virus is exploring the potential for stigmatisation and politicisation of control and prevention measures. An example from Malaysia can be used to highlight this possible ethical issue. In Malaysian outbreaks, Nipah transmission to humans has occurred via contact with pigs. This means that the populations most likely to be infected are farmers who raise pigs, those administering injections to pigs, those assisting in the birth of piglets, and their local communities. Since the consumption of pork is forbidden among the majority Muslim population of Malaysia, pig farmers are more likely to be among the non-Muslim minority. While the raising and selling of pigs is one contention, the potential for the pigs to carry and spread diseases to the Malaysian population has been a further locus of social tensions and can result in further stigma for the minority non-Muslim pig-farming population. The proliferation of pig farms in Malaysia was noted by the United Nations Development Programme as causing ‘religious and social problems’ as far back as 1975. 36 Various regulatory changes led to the semilegal ‘occupation’ of pig farms in one state of Malaysia in the early 1990s 37 , and when Nipah virus outbreaks occurred in farms in other states of Malaysia, it was suggested that all pig farms in the state should be shut down. Pig farmers responded with protests and tensions between the Muslim and non-Muslim population arose. The industry as a whole remains destabilised and politicised. This situation might be exacerbated further by an association between farmers and Nipah virus in the event of future significant outbreaks. Preventive measures such as pig culls and animal vaccination ought to be considered as situated in the context of a politically and socially tense, destabilised industry.

Surveillance burdening disadvantaged populations

A key public health measure to monitor and control Nipah virus outbreaks is the ongoing development of public health surveillance systems. By detecting cases early in humans (and/or animal reservoirs), surveillance may help to focus measures that prevent the spread of infection where risk is highest—and may, in the long term, increase scientific knowledge regarding the epidemiology of Nipah. Surveillance for Nipah raises a range of ethical issues, in particular because—as for several other pathogens—the populations most likely to be subject to surveillance and resultant public health interventions are often poor and rural communities with multiple intersecting vulnerabilities, who are then further burdened with prevention measures. 15 While local communities may, in principle, benefit from surveillance and the early detection of outbreaks, data sharing with distant government agencies and public health interventions may not always be welcomed (especially if designed without adequate community consultation). 34 Further, one reason for surveillance is the prevention of spread of disease to other populations (e.g., capital cities or international centres) who stand to benefit from such public health activities while the burdens of these activities are concentrated in high-risk communities. 15 Such asymmetries in the distribution of risk as well as the benefits and burdens of public health activities arguably give rise to ethical obligations for public health agencies. First, the principle of reciprocity requires that those who are burdened by public health activities should receive adequate assistance (e.g., access to Nipah virus testing and care) and compensation (e.g., for costs arising from public health interventions). 38 It is reasonable to expect national and international funding for such reciprocal support, given the wider benefits of preventing the spread of Nipah virus. Second, there is arguably an ethical obligation of community engagement to inform the design and conduct of public health activities. These should be sensitive to local priorities and values as a matter of respect for affected populations, but also because context-sensitive public health programmes may produce more benefits and fewer harms.

Use of excessively stringent public health measures

In mid-September 2023, two deaths were registered from Nipah virus disease in a hospital in Kerala, India. The regional government subsequently created seven containment zones where business activity was limited, schools were closed, and social distancing and mask mandates were put in place. 39 In addition, neighbouring Indian states have been put on alert, 39 and arrivals from India to locations such as Bali, Indonesia, face screening intended to detect potential Nipah cases. 40 These policies seem to mirror those often implemented during the COVID-19 pandemic.

It is important to avoid unreflectively applying control measures from the pandemic context to the case of Nipah virus disease. For example, Nipah virus has different transmission dynamics to those observed in respiratory virus pandemics such as COVID-19. On the one hand, Nipah is less transmissible than pandemic respiratory viruses, with the majority of human-to-human spread occuring among household members and patients or staff exposed in healthcare settings 22 . This renders community interventions commonly used against respiratory diseases less effective (e.g., because general community measures do not reduce household and healthcare spread of infection) and therefore less ethically justifiable. On the other hand, Nipah is also more fatal than average pandemic respiratory viruses, meaning that each case of transmission prevented may avoid a large potential harm to individuals, however this does not necessarily mean that extreme measures to prevent Nipah virus spread are ethically justifiable (e.g., cordons sanitaires, lockdowns, etc.). Border screening also lacks a strong ethical basis given that it is unlikely to be be sensitive or specific enough to be efficient for the detection of rare infected individuals. Moreover, a high fatality and significant transmission risk to close contacts means that stay-at-home orders and household quarantine (if not carefully implemented) might plausibly increase risks of transmission within households during outbreaks.

Social distancing, lockdown, travel restrictions, and border screening are therefore unlikely to reduce transmission of Nipah to a significant degree, while being likely to cause harms including lost livelihoods, increased risk of domestic abuse, adverse effects on mental health, potential increased spread of infection in some contexts, and the undermining of public trust. Further, it is now well recognised that the harms of stringent public health measures are often concentrated among disadvantaged groups. 41 If the transmission dynamics of Nipah virus were to significantly change toward higher risk of human-to-human spread among casual contacts, wider public health measures may, under certain conditions, become more ethically acceptable. However, such measures are not currently justifable given that most spread of Nipah virus occurs among close contacts, and the previous Kerala outbreak in 2018 was controlled without extreme measures such as lockdown - with the response instead focusing on healthcare settings in particular 22 .

Public health agencies should therefore avoid assumptions that measures used for COVID19 (or other epidemics with different features) would be effective or ethically justifiable for Nipah outbreaks. In general, less restrictive measures should be preferred to more restrictive alternatives. For example, standard measures such as contact tracing may be very effective against Nipah virus transmission, under the current transmission dynamics, provided that affected communities trust public health agencies enough to participate - and excessively restrictive measures may undermine trust. While common public health ethics principles and frameworks 38 42 may be applicable, Nipah outbreak epidemic responses may yet face new challenges and raise new ethical questions, given different biomedical and contextual factors as compared with other epidemics.

Research ethics topics

Currently there are vaccines in development for Nipah virus. However, conducting vaccine trials is challenging due to the low incidence and sporadic nature of disease outbreaks. After initial first-in-human trials in a small group of people in highly controlled settings, phase 2 clinical trials would most likely be conducted in non-outbreak settings with healthy volunteers, in whom T cell activation or the production of neutralising antibodies can be used as evidence of protective immune response. 43 This is necessary to ensure that the vaccines are ready for roll-out during an outbreak, where it would be ethically questionable to use a control arm, whether placebo or another vaccine.

Phases 1 and 2 vaccine trials

Early phase vaccine trials in healthy volunteers are essential to provide data on safety (phase 1) and immunogenicity (phase 2) prior to an outbreak. Ideally, these trials should take place in locations with populations where a roll-out is likely, such as populations that harvest date palm sap in Bangladesh and India, and pig farmers in Malaysia. Among other things, conducting phase 1 and 2 trials in individuals at high risk of future exposure provides the opportunity to enrol the same individuals in any subsequent phase 3 efficacy trials. However, trials in these settings pose numerous challenges. There is a low level of scientific and health literacy, and communities hold different beliefs about the origins of disease, 35 which may make the informed consent process challenging. Moreover, understanding the reasons for vaccine trials in the absence of an outbreak can be difficult. Vaccine trials could potentially create anxieties among the population, as they might wonder whether there is an actual outbreak that is not being revealed to them. There is also a potential for stigmatising trial populations. In Malaysia, pig farmers were thought to have spread the Nipah virus after catching it from infected pigs. 2 37 If they were to take part in these trials, they might face further stigmatisation.

Phase 3 vaccine trials

The design of vaccine efficacy (phase 3) trials for Nipah virus disease may also raise several practical and ethical challenges. 44 Demonstrating efficacy in humans in a phase 3 vaccine trial can be difficult because of the sporadic nature of spillover events and the fact that suppression of transmission via public health measures, while beneficial, may reduce the probability that vaccine trial participants are infected (which is required for the trial to prove that vaccines are efficacious). Vaccine trials may, therefore, be likely to recruit healthcare workers in high-risk areas (either before or during epidemics) and/or community members who are likely to have contact with bats, pigs or infectious human cases (e.g., household contacts of cases). One option, used for Ebola vaccine trials, would be a ring vaccination design, where the (‘ring’ of) contacts of infectious cases are randomised to receive an experimental vaccine or placebo. 45 However, such study designs may be highly infeasible in the current Nipah context. 44 In any case, the high mortality of Nipah virus and the perception or presumption that an experimental vaccine is more likely to provide benefit than a placebo (although this presumption is not always reliable) may influence on trial design, including where local communities would not accept a placebo arm. There should ideally be prospective community engagement to determine whether trials using a control arm with placebo (or a licensed vaccine for a disease other than Nipah) are acceptable, given that this would be the most reliable method of determining vaccine efficacy. If local populations do not accept standard placebo designs due to concerns regarding risks of disease in the placebo arm, other designs might be tried. These might include stepped wedge randomisation or immediate vs delayed vaccination which may result in all trial participants being vaccinated without unduly undermining analyses of vaccine efficacy. 44 45

Therapeutics and non-pharmaceutical interventions

Trials of therapeutics and non-pharmaceutical interventions may also raise ethical issues. Public health emergencies are often associated with use of unproven interventions, 46 47 sometimes out of a perception that potential benefits outweigh potential harms. As far as possible, there is arguably an ethical imperative that unproven interventions should be tested in rigorous trial designs rather than in ad hoc clinical or public health use, as this is the most expedient way to produce evidence to guide practice—as illustrated by trials of COVID-19 therapeutics. 47 Where rigorous trials are not acceptable to local populations, other approaches such as the monitored emergency use of unregistered interventions framework 48 may help to maximise the production of reliable data (even if these data may not be as reliable as those from formal clinical trials). Similarly, there is an ethical imperative to collect data regarding the benefits and harms of non-pharmaceutical interventions, as this may help to refine public health control strategies over time by improving the balance of benefits and harms as well as determining which measures are most acceptable to local communities. More broadly, there is increasing awareness of the ethical case for trials of policy, 49 and the rationale for such research may be particularly compelling for high-consequence pathogens such as Nipah virus. In addition to the kinds of research described above, social and behavioural research is increasingly recognised as vital to effective epidemic prevention, preparedness and response. For example, social and behavioural research may help to improve the design and conduct of intervention trials as well as public health programmes. Yet social and behavioural research itself may also raise specific ethical issues which should be identified, analysed and addressed.

In this paper, we have argued that Nipah virus disease should receive more attention in the bioethics literature. There are several distinctive characteristics of Nipah virus that raise important ethical questions, many of which are not present for other priority pathogens. Furthermore, the disease burden may increase significantly in future, and the health injustice concerns raised already indicate it already deserves further ethical attention.

In public health ethics, further bioethics research ought to focus on stigmatisation and politicisation of preventive measures, especially surrounding pig culls, effective and respectful public health communication, the burden associated with public health surveillance of already-disadvantaged populations, and avoiding inappropriate transplantation of control measures designed for other disease contexts. In research ethics, research ought to focus on effective vaccine trial design in the context of a disease with distinctively sporadic zoonotic spillover. It ought to also focus on the adaptation of vaccine trials to specific local contexts where possible and necessary, on health policy trials, and on reducing the use of unproven therapeutics.

A key feature of work going forward must be collaboration with local bioethicists, biomedical scientists, and communities (likely to be) experiencing Nipah virus outbreaks, to ensure that the development of interventions considers all ethically relevant factors. Nipah virus is now a priority pathogen. The threats it poses to global health and health equity, as well as the need to develop ethically appropriate research and public health responses, are significant reasons for more work, including in bioethics, to address this previously neglected disaese.

Ethics statements

Patient consent for publication.

Not applicable.

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X @drtessjohnson, @michaelethox

Contributors MJP and TH primarily conceived of the presented argument and topic, with TJ, EJ and PYC developing the argument further. TJ wrote the first draft of the manuscript. EJ made significant edits to the first draft, with later edits by TH, MJP and PYC. TH compiled data and created the monochrome figure. All authors contributed to the final manuscript. TJ is guarantor.

Funding This work was funded in part by the Wellcome Trust [096527, 203132, 220211, 221719]. The Pandemic Sciences Institute Trust and Confidence Theme is supported by the Moh Family Foundation.

Competing interests None declared.

Provenance and peer review Not commissioned; externally peer reviewed.

↵ Although, for exceptions, see papers examining policy and human causal transmission factors. 31 32 49

↵ Although, for an exception, see one paper on ethical considerations in deploying healthcare workers in Nipah-affected areas. 13

Read the full text or download the PDF:

Other content recommended for you.

• Scoping future outbreaks: a scoping review on the outbreak prediction of the WHO Blueprint list of priority diseases Nils Jonkmans et al., BMJ Global Health, 2021
• Importance of diagnostics in epidemic and pandemic preparedness Cassandra D Kelly-Cirino et al., BMJ Global Health, 2019
• Diagnostics for Nipah virus: a zoonotic pathogen endemic to Southeast Asia Laura T Mazzola et al., BMJ Global Health, 2019
• Historical trends demonstrate a pattern of increasingly frequent and severe spillover events of high-consequence zoonotic viruses Amanda Jean Meadows et al., BMJ Global Health, 2023
• What could the next pandemic be? Mun-Keat Looi, BMJ, 2023
• Towards global health security: response to the May 2018 Nipah virus outbreak linked to Pteropus bats in Kerala, India Rajeev Sadanadan et al., BMJ Global Health, 2018
• Global epidemics: how well can we cope? Jennifer Leigh et al., BMJ, 2018
• Evolving pharmacovigilance requirements with novel vaccines and vaccine components Patrick L F Zuber et al., BMJ Global Health, 2021
• Post-Ebola reforms: ample analysis, inadequate action Suerie Moon et al., BMJ, 2017
• Challenges to biobanking in LMICs during COVID-19: time to reconceptualise research ethics guidance for pandemics and public health emergencies? Shenuka Singh et al., Journal of Medical Ethics, 2021

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• Indian J Anaesth
• v.60(9); 2016 Sep

Legal and ethical issues in research

Camille yip.

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

Nian-Lin Reena Han

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

Ban Leong Sng

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

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

INTRODUCTION

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

ISSUES RELATED TO THE RESEARCH PARTICIPANTS

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

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

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

Consent, possibility of causing harm

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

Essential components of an informed consent

Special populations

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

Special case: Emergency research

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

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

Collecting patient information and sensitive personal information, confidentiality maintenance

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

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

Providing incentives

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

ISSUES RELATED TO THE RESEARCHER

Legal issues pertaining to regulatory bodies.

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

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

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

Fraud in research and publication

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

Plagiarism and its checking

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

Overlapping publications

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

Duplicate publication, redundant publication

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

Salami publication

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

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

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

Authorship and its various associations

The ICMJE recommendation lists four criteria of authorship:

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

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

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

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

Financial support and sponsorship

Conflicts of interest.

There are no conflicts of interest.

Ethics Explored Discussions - 2024

University of utah health.

• Patient Care
• U Health Plans

2024 Discussions

(This series is approved for 1.5 hours of CME credit)

May 13: "UCEER: The Past and Future of Scholarship in Ethical, Legal, and Social Issues in Genetics"

April 11: "More Than Just a Number: Using Our Stories to Navigate Anti-Black Racism and Poor Health"

March 6: "Imagining Socially Just Policy Narratives About Dementia"

February 22: "The Arc of Hope: Existential Questions in Serious Illness"

"UCEER: The Past and Future of Scholarship in Ethical, Legal, and Social Issues in Genetics"

Jeffrey botkin, md, mph .

Dr. Jeffrey Botkin, former Principal Investigator for the Utah Center for Excellence in ELSI Research, will discuss the history of the CEER program at the NIH and the genesis of the UCEER program at the University of Utah. He will provide an overview of the rationale for the focus of the UCEER on genetic screening and will summarize the impressive productivity of the UCEER scholars from a diverse set of disciplines. The presentation will prompt a discussion of what should come next to foster national dialogue and research on the ethical, legal, and social issues in genetics. 

in collaboration with the Utah Center for Excellence in ELSI Research (UCEER)

2023-2024 COWAN MAYDEN LECTURE

"more than just a number: using our stories to navigate anti-black racism and poor health", keisha ray, phd.

McGovern Center for Humanities & Ethics at UT Health Houston & Director of the Medical Humanities Scholarly Concentration co-sponsored with the Spencer S. Eccles Health Sciences Library (EHSL) &  in collaboration with the U of U Spencer Fox Eccles School of Medicine (SFESOM) - Department of Internal Medicine

"Imagining Socially Just Policy Narratives About Dementia"

Nancy berlinger, phd.

Senior Research Scholar, The Hastings Center 

This interactive talk will present work in progress on an NEH-funded Collaborative Research project, "The Meanings of Dementia: Interpreting Cultural Narratives of Aging Societies." It will focus on ways to bring creativity and encouragement to the task of real-world policymaking by imaging socially just policy narratives for America's aging society. Drawing on health humanities approaches, we will explore several prominent cultural narratives about dementia and consider how to intervene in narratives that do not lead to improved lives for people facing dementia and for dementia caregivers.

2023-2024 DAVID GREEN LECTURE

"the arc of hope: existential questions in serious illness", sabrina derrington, md, ma, hec-c, faap.

Senior Research Scholar, The Hastings Center

What is the role of hope in facing a serious illness or injury? What can we do when a patient or their family are holding onto hope that is totally unrealistic? Our conversation will explore the complexities of hope for patients, families, and healthcare providers, and consider moral obligations relevant to communication and decision-making.

BACKGROUND READINGS:

Reder, EAK and Serwint, JR. Until the Last Breath: Exploring the Concept of Hope for Parents and Health Care Professionals During a Child's Serious Illness . Arch Pediatr Adolesc Med. 2009;163(7):653–657. doi:10.1001/archpediatrics.2009.87 Silver, Anya Krugovoy.

  I Watched You Disappear: Poems (Strawberries in Snow). Louisiana State University Press, 2014. Project MUSE, muse.jhu.edu/book/28553.