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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.

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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
• Peer review
• Ethnography

Research bias

• Implicit bias
• Cognitive bias
• Conformity bias
• Hawthorne effect
• Availability heuristic
• Attrition bias
• Social desirability bias

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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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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Addressing ethical issues in your research proposal

This article explores the ethical issues that may arise in your proposed study during your doctoral research degree.

What ethical principles apply when planning and conducting research?

Research ethics are the moral principles that govern how researchers conduct their studies (Wellcome Trust, 2014). As there are elements of uncertainty and risk involved in any study, every researcher has to consider how they can uphold these ethical principles and conduct the research in a way that protects the interests and welfare of participants and other stakeholders (such as organisations).  

You will need to consider the ethical issues that might arise in your proposed study. Consideration of the fundamental ethical principles that underpin all research will help you to identify the key issues and how these could be addressed. As you are probably a practitioner who wants to undertake research within your workplace, consider how your role as an ‘insider’ influences how you will conduct your study. Think about the ethical issues that might arise when you become an insider researcher (for example, relating to trust, confidentiality and anonymity).  

What key ethical principles do you think will be important when planning or conducting your research, particularly as an insider? Principles that come to mind might include autonomy, respect, dignity, privacy, informed consent and confidentiality. You may also have identified principles such as competence, integrity, wellbeing, justice and non-discrimination.  

Key ethical issues that you will address as an insider researcher include:

• Gaining trust
• Avoiding coercion when recruiting colleagues or other participants (such as students or service users)
• Practical challenges relating to ensuring the confidentiality and anonymity of organisations and staff or other participants.

(Heslop et al, 2018)

A fuller discussion of ethical principles is available from the British Psychological Society’s Code of Human Research Ethics (BPS, 2021).

You can also refer to guidance from the British Educational Research Association and the British Association for Applied Linguistics .

Ethical principles are essential for protecting the interests of research participants, including maximising the benefits and minimising any risks associated with taking part in a study. These principles describe ethical conduct which reflects the integrity of the researcher, promotes the wellbeing of participants and ensures high-quality research is conducted (Health Research Authority, 2022).  

Research ethics is therefore not simply about gaining ethical approval for your study to be conducted. Research ethics relates to your moral conduct as a doctoral researcher and will apply throughout your study from design to dissemination (British Psychological Society, 2021). When you apply to undertake a doctorate, you will need to clearly indicate in your proposal that you understand these ethical principles and are committed to upholding them.  

Where can I find ethical guidance and resources? 

Professional bodies, learned societies, health and social care authorities, academic publications, Research Ethics Committees and research organisations provide a range of ethical guidance and resources. International codes such as the Universal Declaration of Human Rights underpin ethical frameworks (United Nations, 1948).  

You may be aware of key legislation in your own country or the country where you plan to undertake the research, including laws relating to consent, data protection and decision-making capacity, for example, the Data Protection Act, 2018 (UK).  If you want to find out more about becoming an ethical researcher, check out this Open University short course: Becoming an ethical researcher: Introduction and guidance: What is a badged course? - OpenLearn - Open University  

You should be able to justify the research decisions you make. Utilising these resources will guide your ethical judgements when writing your proposal and ultimately when designing and conducting your research study. The Ethical Guidelines for Educational Research (British Educational Research Association, 2018) identifies the key responsibilities you will have when you conduct your research, including the range of stakeholders that you will have responsibilities to, as follows:   

• to your participants (e.g. to appropriately inform them, facilitate their participation and support them)
• clients, stakeholders and sponsors
• the community of educational or health and social care researchers
• for publication and dissemination
• your wellbeing and development

The National Institute for Health and Care Research (no date) has emphasised the need to promote equality, diversity and inclusion when undertaking research, particularly to address long-standing social and health inequalities. Research should be informed by the diversity of people’s experiences and insights, so that it will lead to the development of practice that addresses genuine need. A commitment to equality, diversity and inclusion aims to eradicate prejudice and discrimination on the basis of an individual or group of individuals' protected characteristics such as sex (gender), disability, race, sexual orientation, in line with the Equality Act 2010.  

The NIHR has produced guidance for enhancing the inclusion of ‘under-served groups’ when designing a research study (2020). Although the guidance refers to clinical research it is relevant to research more broadly.  

You should consider how you will promote equality and diversity in your planned study, including through aspects such as your research topic or question, the methodology you will use, the participants you plan to recruit and how you will analyse and interpret your data.    

What ethical issues do I need to consider when writing my research proposal?

You might be planning to undertake research in a health, social care, educational or other setting, including observations and interviews. The following prompts should help you to identify key ethical issues that you need to bear in mind when undertaking research in such settings.  

1.     Imagine you are a potential participant. Think about the questions and concerns that you might have:

• How would you feel if a researcher sat in your space and took notes, completed a checklist, or made an audio or film recording?
• What harm might a researcher cause by observing or interviewing you and others?
• What would you want to know about the researcher and ask them about the study before giving consent?
• When imagining you are the participant, how could the researcher make you feel more comfortable to be observed or interviewed? 

2.     Having considered the perspective of your potential participant, how would you take account of concerns such as privacy, consent, wellbeing and power in your research proposal?  

[Adapted from OpenLearn course: Becoming an ethical researcher, Week 2 Activity 3: Becoming an ethical researcher - OpenLearn - Open University ]  

The ethical issues to be considered will vary depending on your organisational context/role, the types of participants you plan to recruit (for example, children, adults with mental health problems), the research methods you will use, and the types of data you will collect. You will need to decide how to recruit your participants so you do not inappropriately exclude anyone.  Consider what methods may be necessary to facilitate their voice and how you can obtain their consent to taking part or ensure that consent is obtained from someone else as necessary, for example, a parent in the case of a child. 

You should also think about how to avoid imposing an unnecessary burden or costs on your participants. For example, by minimising the length of time they will have to commit to the study and by providing travel or other expenses. Identify the measures that you will take to store your participants’ data safely and maintain their confidentiality and anonymity when you report your findings. You could do this by storing interview and video recordings in a secure server and anonymising their names and those of their organisations using pseudonyms.  

Professional codes such as the Code of Human Research Ethics (BPS, 2021) provide guidance on undertaking research with children. Being an ‘insider’ researching within your own organisation has advantages. However, you should also consider how this might impact on your research, such as power dynamics, consent, potential bias and any conflict of interest between your professional and researcher roles (Sapiro and Matthews, 2020).  

How have other researchers addressed any ethical challenges?

The literature provides researchers’ accounts explaining how they addressed ethical challenges when undertaking studies. For example, Turcotte-Tremblay and McSween-Cadieux (2018) discuss strategies for protecting participants’ confidentiality when disseminating findings locally, such as undertaking fieldwork in multiple sites and providing findings in a generalised form. In addition, professional guidance includes case studies illustrating how ethical issues can be addressed, including when researching online forums (British Sociological Association, no date).

Watch the videos below and consider what insights the postgraduate researcher and supervisor provide  regarding issues such as being an ‘insider researcher’, power relations, avoiding intrusion, maintaining participant anonymity and complying with research ethics and professional standards. How might their experiences inform the design and conduct of your own study?

Postgraduate researcher and supervisor talk about ethical considerations

Your thoughtful consideration of the ethical issues that might arise and how you would address these should enable you to propose an ethically informed study and conduct it in a responsible, fair and sensitive manner. 

British Educational Research Association (2018)  Ethical Guidelines for Educational Research.  Available at:  https://www.bera.ac.uk/publication/ethical-guidelines-for-educational-research-2018  (Accessed: 9 June 2023).

British Psychological Society (2021)  Code of Human Research Ethics . Available at:  https://cms.bps.org.uk/sites/default/files/2022-06/BPS%20Code%20of%20Human%20Research%20Ethics%20%281%29.pdf  (Accessed: 9 June 2023).

British Sociological Association (2016)  Researching online forums . Available at:  https://www.britsoc.co.uk/media/24834/j000208_researching_online_forums_-cs1-_v3.pdf  (Accessed: 9 June 2023).

Health Research Authority (2022)  UK Policy Framework for Health and Social Care Research . Available at:  https://www.hra.nhs.uk/planning-and-improving-research/policies-standards-legislation/uk-policy-framework-health-social-care-research/uk-policy-framework-health-and-social-care-research/#chiefinvestigators  (Accessed: 9 June 2023).

Heslop, C., Burns, S., Lobo, R. (2018) ‘Managing qualitative research as insider-research in small rural communities’,  Rural and Remote Health , 18: pp. 4576.

Equality Act 2010, c. 15.  Available at:   https://www.legislation.gov.uk/ukpga/2010/15/introduction   (Accessed: 9 June 2023).

National Institute for Health and Care Research (no date)  Equality, Diversity and Inclusion (EDI) . Available at:  https://arc-kss.nihr.ac.uk/public-and-community-involvement/pcie-guide/how-to-do-pcie/equality-diversity-and-inclusion-edi  (Accessed: 9 June 2023).

National Institute for Health and Care Research (2020)  Improving inclusion of under-served groups in clinical research: Guidance from INCLUDE project.  Available at:   https://www.nihr.ac.uk/documents/improving-inclusion-of-under-served-groups-in-clinical-research-guidance-from-include-project/25435  (Accessed: 9 June 2023).

Sapiro, B. and Matthews, E. (2020) ‘Both Insider and Outsider. On Conducting Social Work Research in Mental Health Settings’,  Advances in Social Work , 20(3). Available at:  https://doi.org/10.18060/23926

Turcotte-Tremblay, A. and McSween-Cadieux, E. (2018) ‘A reflection on the challenge of protecting confidentiality of participants when disseminating research results locally’,  BMC Medical Ethics,  19(supplement 1), no. 45. Available at:   https://bmcmedethics.biomedcentral.com/articles/10.1186/s12910-018-0279-0

United Nations General Assembly (1948)  The Universal Declaration of Human Rights . Resolution A/RES/217/A. Available at:  https://www.un.org/en/about-us/universal-declaration-of-human-rights#:~:text=Drafted%20by%20representatives%20with%20different,all%20peoples%20and%20all%20nations . (Accessed: 9 June 2023).

Wellcome Trust (2014)  Ensuring your research is ethical: A guide for Extended Project Qualification students . Available at:  https://wellcome.org/sites/default/files/wtp057673_0.pdf  (Accessed: 9 June 2023).

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Ethical Issues in Research: Perceptions of Researchers, Research Ethics Board Members and Research Ethics Experts

• Published: 12 August 2022
• Volume 21 , pages 269–292, ( 2023 )

Cite this article

• Marie-Josée Drolet   ORCID: orcid.org/0000-0001-8384-4193 1 ,
• Eugénie Rose-Derouin 2 ,
• Julie-Claude Leblanc 2 ,
• Mélanie Ruest 2 &
• Bryn Williams-Jones 3  

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In the context of academic research, a diversity of ethical issues, conditioned by the different roles of members within these institutions, arise. Previous studies on this topic addressed mainly the perceptions of researchers. However, to our knowledge, no studies have explored the transversal ethical issues from a wider spectrum, including other members of academic institutions as the research ethics board (REB) members, and the research ethics experts. The present study used a descriptive phenomenological approach to document the ethical issues experienced by a heterogeneous group of Canadian researchers, REB members, and research ethics experts. Data collection involved socio-demographic questionnaires and individual semi-structured interviews. Following the triangulation of different perspectives (researchers, REB members and ethics experts), emerging ethical issues were synthesized in ten units of meaning: (1) research integrity, (2) conflicts of interest, (3) respect for research participants, (4) lack of supervision and power imbalances, (5) individualism and performance, (6) inadequate ethical guidance, (7) social injustices, (8) distributive injustices, (9) epistemic injustices, and (10) ethical distress. This study highlighted several problematic elements that can support the identification of future solutions to resolve transversal ethical issues in research that affect the heterogeneous members of the academic community.

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Introduction

Research includes a set of activities in which researchers use various structured methods to contribute to the development of knowledge, whether this knowledge is theoretical, fundamental, or applied (Drolet & Ruest, accepted ). University research is carried out in a highly competitive environment that is characterized by ever-increasing demands (i.e., on time, productivity), insufficient access to research funds, and within a market economy that values productivity and speed often to the detriment of quality or rigour – this research context creates a perfect recipe for breaches in research ethics, like research misbehaviour or misconduct (i.e., conduct that is ethically questionable or unacceptable because it contravenes the accepted norms of responsible conduct of research or compromises the respect of core ethical values that are widely held by the research community) (Drolet & Girard, 2020 ; Sieber, 2004 ). Problematic ethics and integrity issues – e.g., conflicts of interest, falsification of data, non-respect of participants’ rights, and plagiarism, to name but a few – have the potential to both undermine the credibility of research and lead to negative consequences for many stakeholders, including researchers, research assistants and personnel, research participants, academic institutions, and society as a whole (Drolet & Girard, 2020 ). It is thus evident that the academic community should be able to identify these different ethical issues in order to evaluate the nature of the risks that they pose (and for whom), and then work towards their prevention or management (i.e., education, enhanced policies and procedures, risk mitigation strategies).

In this article, we define an “ethical issue” as any situation that may compromise, in whole or in part, the respect of at least one moral value (Swisher et al., 2005 ) that is considered socially legitimate and should thus be respected. In general, ethical issues occur at three key moments or stages of the research process: (1) research design (i.e., conception, project planning), (2) research conduct (i.e., data collection, data analysis) and (3) knowledge translation or communication (e.g., publications of results, conferences, press releases) (Drolet & Ruest, accepted ). According to Sieber ( 2004 ), ethical issues in research can be classified into five categories, related to: (a) communication with participants and the community, (b) acquisition and use of research data, (c) external influence on research, (d) risks and benefits of the research, and (e) selection and use of research theories and methods. Many of these issues are related to breaches of research ethics norms, misbehaviour or research misconduct. Bruhn et al., ( 2002 ) developed a typology of misbehaviour and misconduct in academia that can be used to judge the seriousness of different cases. This typology takes into consideration two axes of reflection: (a) the origin of the situation (i.e., is it the researcher’s own fault or due to the organizational context?), and (b) the scope and severity (i.e., is this the first instance or a recurrent behaviour? What is the nature of the situation? What are the consequences, for whom, for how many people, and for which organizations?).

A previous detailed review of the international literature on ethical issues in research revealed several interesting findings (Beauchemin et al., 2021 ). Indeed, the current literature is dominated by descriptive ethics, i.e., the sharing by researchers from various disciplines of the ethical issues they have personally experienced. While such anecdotal documentation is relevant, it is insufficient because it does not provide a global view of the situation. Among the reviewed literature, empirical studies were in the minority (Table  1 ) – only about one fifth of the sample (n = 19) presented empirical research findings on ethical issues in research. The first of these studies was conducted almost 50 years ago (Hunt et al., 1984 ), with the remainder conducted in the 1990s. Eight studies were conducted in the United States (n = 8), five in Canada (n = 5), three in England (n = 3), two in Sweden (n = 2) and one in Ghana (n = 1).

Further, the majority of studies in our sample (n = 12) collected the perceptions of a homogeneous group of participants, usually researchers (n = 14) and sometimes health professionals (n = 6). A minority of studies (n = 7) triangulated the perceptions of diverse research stakeholders (i.e., researchers and research participants, or students). To our knowledge, only one study has examined perceptions of ethical issues in research by research ethics board members (REB; Institutional Review Boards [IRB] in the USA), and none to date have documented the perceptions of research ethics experts. Finally, nine studies (n = 9) adopted a qualitative design, seven studies (n = 7) a quantitative design, and three (n = 3) a mixed-methods design.

More studies using empirical research methods are needed to better identify broader trends, to enrich discussions on the values that should govern responsible conduct of research in the academic community, and to evaluate the means by which these values can be supported in practice (Bahn, 2012 ; Beauchemin et al., 2021 ; Bruhn et al., 2002 ; Henderson et al., 2013 ; Resnik & Elliot, 2016; Sieber 2004 ). To this end, we conducted an empirical qualitative study to document the perceptions and experiences of a heterogeneous group of Canadian researchers, REB members, and research ethics experts, to answer the following broad question: What are the ethical issues in research?

Research Methods

Research design.

A qualitative research approach involving individual semi-structured interviews was used to systematically document ethical issues (De Poy & Gitlin, 2010 ; Hammell et al., 2000 ). Specifically, a descriptive phenomenological approach inspired by the philosophy of Husserl was used (Husserl, 1970 , 1999 ), as it is recommended for documenting the perceptions of ethical issues raised by various practices (Hunt & Carnavale, 2011 ).

Ethical considerations

The principal investigator obtained ethics approval for this project from the Research Ethics Board of the Université du Québec à Trois-Rivières (UQTR). All members of the research team signed a confidentiality agreement, and research participants signed the consent form after reading an information letter explaining the nature of the research project.

Sampling and recruitment

As indicated above, three types of participants were sought: (1) researchers from different academic disciplines conducting research (i.e., theoretical, fundamental or empirical) in Canadian universities; (2) REB members working in Canadian organizations responsible for the ethical review, oversight or regulation of research; and (3) research ethics experts, i.e., academics or ethicists who teach research ethics, conduct research in research ethics, or are scholars who have acquired a specialization in research ethics. To be included in the study, participants had to work in Canada, speak and understand English or French, and be willing to participate in the study. Following Thomas and Polio’s (2002) recommendation to recruit between six and twelve participants (for a homogeneous sample) to ensure data saturation, for our heterogeneous sample, we aimed to recruit approximately twelve participants in order to obtain data saturation. Having used this method several times in related projects in professional ethics, data saturation is usually achieved with 10 to 15 participants (Drolet & Goulet, 2018 ; Drolet & Girard, 2020 ; Drolet et al., 2020 ). From experience, larger samples only serve to increase the degree of data saturation, especially in heterogeneous samples (Drolet et al., 2017 , 2019 ; Drolet & Maclure, 2016 ).

Purposive sampling facilitated the identification of participants relevant to documenting the phenomenon in question (Fortin, 2010 ). To ensure a rich and most complete representation of perceptions, we sought participants with varied and complementary characteristics with regards to the social roles they occupy in research practice (Drolet & Girard, 2020 ). A triangulation of sources was used for the recruitment (Bogdan & Biklen, 2006 ). The websites of Canadian universities and Canadian health institution REBs, as well as those of major Canadian granting agencies (i.e., the Canadian Institutes of Health Research, the Natural Sciences and Engineering Research Council of Canada, and the Social Sciences and Humanities Research Council of Canada, Fonds de recherche du Quebec), were searched to identify individuals who might be interested in participating in the study. Further, people known by the research team for their knowledge and sensitivity to ethical issues in research were asked to participate. Research participants were also asked to suggest other individuals who met the study criteria.

Data Collection

Two tools were used for data collecton: (a) a socio-demographic questionnaire, and (b) a semi-structured individual interview guide. English and French versions of these two documents were used and made available, depending on participant preferences. In addition, although the interview guide contained the same questions, they were adapted to participants’ specific roles (i.e., researcher, REB member, research ethics expert). When contacted by email by the research assistant, participants were asked to confirm under which role they wished to participate (because some participants might have multiple, overlapping responsibilities) and they were sent the appropriate interview guide.

The interview guides each had two parts: an introduction and a section on ethical issues. The introduction consisted of general questions to put the participant at ease (i.e., “Tell me what a typical day at work is like for you”). The section on ethical issues was designed to capture the participant’s perceptions through questions such as: “Tell me three stories you have experienced at work that involve an ethical issue?” and “Do you feel that your organization is doing enough to address, manage, and resolve ethical issues in your work?”. Although some interviews were conducted in person, the majority were conducted by videoconference to promote accessibility and because of the COVID-19 pandemic. Interviews were digitally recorded so that the verbatim could be transcribed in full, and varied between 40 and 120 min in duration, with an average of 90 min. Research assistants conducted the interviews and transcribed the verbatim.

Data Analysis

The socio-demographic questionnaires were subjected to simple descriptive statistical analyses (i.e., means and totals), and the semi-structured interviews were subjected to qualitative analysis. The steps proposed by Giorgi ( 1997 ) for a Husserlian phenomenological reduction of the data were used. After collecting, recording, and transcribing the interviews, all verbatim were analyzed by at least two analysts: a research assistant (2nd author of this article) and the principal investigator (1st author) or a postdoctoral fellow (3rd author). The repeated reading of the verbatim allowed the first analyst to write a synopsis, i.e., an initial extraction of units of meaning. The second analyst then read the synopses, which were commented and improved if necessary. Agreement between analysts allowed the final drafting of the interview synopses, which were then analyzed by three analysts to generate and organize the units of meaning that emerged from the qualitative data.

Participants

Sixteen individuals (n = 16) participated in the study, of whom nine (9) identified as female and seven (7) as male (Table  2 ). Participants ranged in age from 22 to 72 years, with a mean age of 47.5 years. Participants had between one (1) and 26 years of experience in the research setting, with an average of 14.3 years of experience. Participants held a variety of roles, including: REB members (n = 11), researchers (n = 10), research ethics experts (n = 4), and research assistant (n = 1). As mentioned previously, seven (7) participants held more than one role, i.e., REB member, research ethics expert, and researcher. The majority (87.5%) of participants were working in Quebec, with the remaining working in other Canadian provinces. Although all participants considered themselves to be francophone, one quarter (n = 4) identified themselves as belonging to a cultural minority group.

With respect to their academic background, most participants (n = 9) had a PhD, three (3) had a post-doctorate, two (2) had a master’s degree, and two (2) had a bachelor’s degree. Participants came from a variety of disciplines: nine (9) had a specialty in the humanities or social sciences, four (4) in the health sciences and three (3) in the natural sciences. In terms of their knowledge of ethics, five (5) participants reported having taken one university course entirely dedicated to ethics, four (4) reported having taken several university courses entirely dedicated to ethics, three (3) had a university degree dedicated to ethics, while two (2) only had a few hours or days of training in ethics and two (2) reported having no knowledge of ethics.

• Ethical issues

As Fig.  1 illustrates, ten units of meaning emerge from the data analysis, namely: (1) research integrity, (2) conflicts of interest, (3) respect for research participants, (4) lack of supervision and power imbalances, (5) individualism and performance, (6) inadequate ethical guidance, (7) social injustices, (8) distributive injustices, (9) epistemic injustices, and (10) ethical distress. To illustrate the results, excerpts from verbatim interviews are presented in the following sub-sections. Most of the excerpts have been translated into English as the majority of interviews were conducted with French-speaking participants.

Ethical issues in research according to the participants

Research Integrity

The research environment is highly competitive and performance-based. Several participants, in particular researchers and research ethics experts, felt that this environment can lead both researchers and research teams to engage in unethical behaviour that reflects a lack of research integrity. For example, as some participants indicated, competition for grants and scientific publications is sometimes so intense that researchers falsify research results or plagiarize from colleagues to achieve their goals.

Some people will lie or exaggerate their research findings in order to get funding. Then, you see it afterwards, you realize: “ah well, it didn’t work, but they exaggerated what they found and what they did” (participant 14). Another problem in research is the identification of authors when there is a publication. Very often, there are authors who don’t even know what the publication is about and that their name is on it. (…) The time that it surprised me the most was just a few months ago when I saw someone I knew who applied for a teaching position. He got it I was super happy for him. Then I looked at his publications and … there was one that caught my attention much more than the others, because I was in it and I didn’t know what that publication was. I was the second author of a publication that I had never read (participant 14). I saw a colleague who had plagiarized another colleague. [When the colleague] found out about it, he complained. So, plagiarism is a serious [ethical breach]. I would also say that there is a certain amount of competition in the university faculties, especially for grants (…). There are people who want to win at all costs or get as much as possible. They are not necessarily going to consider their colleagues. They don’t have much of a collegial spirit (participant 10).

These examples of research misbehaviour or misconduct are sometimes due to or associated with situations of conflicts of interest, which may be poorly managed by certain researchers or research teams, as noted by many participants.

Conflict of interest

The actors and institutions involved in research have diverse interests, like all humans and institutions. As noted in Chap. 7 of the Canadian Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans (TCPS2, 2018),

“researchers and research students hold trust relationships, either directly or indirectly, with participants, research sponsors, institutions, their professional bodies and society. These trust relationships can be put at risk by conflicts of interest that may compromise independence, objectivity or ethical duties of loyalty. Although the potential for such conflicts has always existed, pressures on researchers (i.e., to delay or withhold dissemination of research outcomes or to use inappropriate recruitment strategies) heighten concerns that conflicts of interest may affect ethical behaviour” (p. 92).

The sources of these conflicts are varied and can include interpersonal conflicts, financial partnerships, third-party pressures, academic or economic interests, a researcher holding multiple roles within an institution, or any other incentive that may compromise a researcher’s independence, integrity, and neutrality (TCPS2, 2018). While it is not possible to eliminate all conflicts of interest, it is important to manage them properly and to avoid temptations to behave unethically.

Ethical temptations correspond to situations in which people are tempted to prioritize their own interests to the detriment of the ethical goods that should, in their own context, govern their actions (Swisher et al., 2005 ). In the case of researchers, this refers to situations that undermine independence, integrity, neutrality, or even the set of principles that govern research ethics (TCPS2, 2018) or the responsible conduct of research. According to study participants, these types of ethical issues frequently occur in research. Many participants, especially researchers and REB members, reported that conflicts of interest can arise when members of an organization make decisions to obtain large financial rewards or to increase their academic profile, often at the expense of the interests of members of their research team, research participants, or even the populations affected by their research.

A company that puts money into making its drug work wants its drug to work. So, homeopathy is a good example, because there are not really any consequences of homeopathy, there are not very many side effects, because there are no effects at all. So, it’s not dangerous, but it’s not a good treatment either. But some people will want to make it work. And that’s a big issue when you’re sitting at a table and there are eight researchers, and there are two or three who are like that, and then there are four others who are neutral, and I say to myself, this is not science. I think that this is a very big ethical issue (participant 14). There are also times in some research where there will be more links with pharmaceutical companies. Obviously, there are then large amounts of money that will be very interesting for the health-care institutions because they still receive money for clinical trials. They’re still getting some compensation because its time consuming for the people involved and all that. The pharmaceutical companies have money, so they will compensate, and that is sometimes interesting for the institutions, and since we are a bit caught up in this, in the sense that we have no choice but to accept it. (…) It may not be the best research in the world, there may be a lot of side effects due to the drugs, but it’s good to accept it, we’re going to be part of the clinical trial (participant 3). It is integrity, what we believe should be done or said. Often by the pressure of the environment, integrity is in tension with the pressures of the environment, so it takes resistance, it takes courage in research. (…) There were all the debates there about the problems of research that was funded and then the companies kept control over what was written. That was really troubling for a lot of researchers (participant 5).

Further, these situations sometimes have negative consequences for research participants as reported by some participants.

Respect for research participants

Many research projects, whether they are psychosocial or biomedical in nature, involve human participants. Relationships between the members of research teams and their research participants raise ethical issues that can be complex. Research projects must always be designed to respect the rights and interests of research participants, and not just those of researchers. However, participants in our study – i.e., REB members, researchers, and research ethics experts – noted that some research teams seem to put their own interests ahead of those of research participants. They also emphasized the importance of ensuring the respect, well-being, and safety of research participants. The ethical issues related to this unit of meaning are: respect for free, informed and ongoing consent of research participants; respect for and the well-being of participants; data protection and confidentiality; over-solicitation of participants; ownership of the data collected on participants; the sometimes high cost of scientific innovations and their accessibility; balance between the social benefits of research and the risks to participants (particularly in terms of safety); balance between collective well-being (development of knowledge) and the individual rights of participants; exploitation of participants; paternalism when working with populations in vulnerable situations; and the social acceptability of certain types of research. The following excerpts present some of these issues.

Where it disturbs me ethically is in the medical field – because it’s more in the medical field that we’re going to see this – when consent forms are presented to patients to solicit them as participants, and then [these forms] have an average of 40 pages. That annoys me. When they say that it has to be easy to understand and all that, adapted to the language, and then the hyper-technical language plus there are 40 pages to read, I don’t understand how you’re going to get informed consent after reading 40 pages. (…) For me, it doesn’t work. I read them to evaluate them and I have a certain level of education and experience in ethics, and there are times when I don’t understand anything (participant 2). There is a lot of pressure from researchers who want to recruit research participants (…). The idea that when you enter a health care institution, you become a potential research participant, when you say “yes to a research, you check yes to all research”, then everyone can ask you. I think that researchers really have this fantasy of saying to themselves: “as soon as people walk through the door of our institution, they become potential participants with whom we can communicate and get them involved in all projects”. There’s a kind of idea that, yes, it can be done, but it has to be somewhat supervised to avoid over-solicitation (…). Researchers are very interested in facilitating recruitment and making it more fluid, but perhaps to the detriment of confidentiality, privacy, and respect; sometimes that’s what it is, to think about what type of data you’re going to have in your bank of potential participants? Is it just name and phone number or are you getting into more sensitive information? (participant 9).

In addition, one participant reported that their university does not provide the resources required to respect the confidentiality of research participants.

The issue is as follows: researchers, of course, commit to protecting data with passwords and all that, but we realize that in practice, it is more difficult. It is not always as protected as one might think, because professor-researchers will run out of space. Will the universities make rooms available to researchers, places where they can store these things, especially when they have paper documentation, and is there indeed a guarantee of confidentiality? Some researchers have told me: “Listen; there are even filing cabinets in the corridors”. So, that certainly poses a concrete challenge. How do we go about challenging the administrative authorities? Tell them it’s all very well to have an ethics committee, but you have to help us, you also have to make sure that the necessary infrastructures are in place so that what we are proposing is really put into practice (participant 4).

If the relationships with research participants are likely to raise ethical issues, so too are the relationships with students, notably research assistants. On this topic, several participants discussed the lack of supervision or recognition offered to research assistants by researchers as well as the power imbalances between members of the research team.

Lack of Supervision and Power Imbalances

Many research teams are composed not only of researchers, but also of students who work as research assistants. The relationship between research assistants and other members of research teams can sometimes be problematic and raise ethical issues, particularly because of the inevitable power asymmetries. In the context of this study, several participants – including a research assistant, REB members, and researchers – discussed the lack of supervision or recognition of the work carried out by students, psychological pressure, and the more or less well-founded promises that are sometimes made to students. Participants also mentioned the exploitation of students by certain research teams, which manifest when students are inadequately paid, i.e., not reflective of the number of hours actually worked, not a fair wage, or even a wage at all.

[As a research assistant], it was more of a feeling of distress that I felt then because I didn’t know what to do. (…) I was supposed to get coaching or be supported, but I didn’t get anything in the end. It was like, “fix it by yourself”. (…) All research assistants were supposed to be supervised, but in practice they were not (participant 1). Very often, we have a master’s or doctoral student that we put on a subject and we consider that the project will be well done, while the student is learning. So, it happens that the student will do a lot of work and then we realize that the work is poorly done, and it is not necessarily the student’s fault. He wasn’t necessarily well supervised. There are directors who have 25 students, and they just don’t supervise them (participant 14). I think it’s really the power relationship. I thought to myself, how I saw my doctorate, the beginning of my research career, I really wanted to be in that laboratory, but they are the ones who are going to accept me or not, so what do I do to be accepted? I finally accept their conditions [which was to work for free]. If these are the conditions that are required to enter this lab, I want to go there. So, what do I do, well I accepted. It doesn’t make sense, but I tell myself that I’m still privileged, because I don’t have so many financial worries, one more reason to work for free, even though it doesn’t make sense (participant 1). In research, we have research assistants. (…). The fact of using people… so that’s it, you have to take into account where they are, respect them, but at the same time they have to show that they are there for the research. In English, we say “carry” or take care of people. With research assistants, this is often a problem that I have observed: for grant machines, the person is the last to be found there. Researchers, who will take, use student data, without giving them the recognition for it (participant 5). The problem at our university is that they reserve funding for Canadian students. The doctoral clientele in my field is mostly foreign students. So, our students are poorly funded. I saw one student end up in the shelter, in a situation of poverty. It ended very badly for him because he lacked financial resources. Once you get into that dynamic, it’s very hard to get out. I was made aware of it because the director at the time had taken him under her wing and wanted to try to find a way to get him out of it. So, most of my students didn’t get funded (participant 16). There I wrote “manipulation”, but it’s kind of all promises all the time. I, for example, was promised a lot of advancement, like when I got into the lab as a graduate student, it was said that I had an interest in [this particular area of research]. I think there are a lot of graduate students who must have gone through that, but it is like, “Well, your CV has to be really good, if you want to do a lot of things and big things. If you do this, if you do this research contract, the next year you could be the coordinator of this part of the lab and supervise this person, get more contracts, be paid more. Let’s say: you’ll be invited to go to this conference, this big event”. They were always dangling something, but you have to do that first to get there. But now, when you’ve done that, you have to do this business. It’s like a bit of manipulation, I think. That was very hard to know who is telling the truth and who is not (participant 1).

These ethical issues have significant negative consequences for students. Indeed, they sometimes find themselves at the mercy of researchers, for whom they work, struggling to be recognized and included as authors of an article, for example, or to receive the salary that they are due. For their part, researchers also sometimes find themselves trapped in research structures that can negatively affect their well-being. As many participants reported, researchers work in organizations that set very high productivity standards and in highly competitive contexts, all within a general culture characterized by individualism.

Individualism and performance

Participants, especially researchers, discussed the culture of individualism and performance that characterizes the academic environment. In glorifying excellence, some universities value performance and productivity, often at the expense of psychological well-being and work-life balance (i.e., work overload and burnout). Participants noted that there are ethical silences in their organizations on this issue, and that the culture of individualism and performance is not challenged for fear of retribution or simply to survive, i.e., to perform as expected. Participants felt that this culture can have a significant negative impact on the quality of the research conducted, as research teams try to maximize the quantity of their work (instead of quality) in a highly competitive context, which is then exacerbated by a lack of resources and support, and where everything must be done too quickly.

The work-life balance with the professional ethics related to work in a context where you have too much and you have to do a lot, it is difficult to balance all that and there is a lot of pressure to perform. If you don’t produce enough, that’s it; after that, you can’t get any more funds, so that puts pressure on you to do more and more and more (participant 3). There is a culture, I don’t know where it comes from, and that is extremely bureaucratic. If you dare to raise something, you’re going to have many, many problems. They’re going to make you understand it. So, I don’t talk. It is better: your life will be easier. I think there are times when you have to talk (…) because there are going to be irreparable consequences. (…) I’m not talking about a climate of terror, because that’s exaggerated, it’s not true, people are not afraid. But people close their office door and say nothing because it’s going to make their work impossible and they’re not going to lose their job, they’re not going to lose money, but researchers need time to be focused, so they close their office door and say nothing (participant 16).

Researchers must produce more and more, and they feel little support in terms of how to do such production, ethically, and how much exactly they are expected to produce. As this participant reports, the expectation is an unspoken rule: more is always better.

It’s sometimes the lack of a clear line on what the expectations are as a researcher, like, “ah, we don’t have any specific expectations, but produce, produce, produce, produce.” So, in that context, it’s hard to be able to put the line precisely: “have I done enough for my work?” (participant 3).

Inadequate ethical Guidance

While the productivity expectation is not clear, some participants – including researchers, research ethics experts, and REB members – also felt that the ethical expectations of some REBs were unclear. The issue of the inadequate ethical guidance of research includes the administrative mechanisms to ensure that research projects respect the principles of research ethics. According to those participants, the forms required for both researchers and REB members are increasingly long and numerous, and one participant noted that the standards to be met are sometimes outdated and disconnected from the reality of the field. Multicentre ethics review (by several REBs) was also critiqued by a participant as an inefficient method that encumbers the processes for reviewing research projects. Bureaucratization imposes an ever-increasing number of forms and ethics guidelines that actually hinder researchers’ ethical reflection on the issues at stake, leading the ethics review process to be perceived as purely bureaucratic in nature.

The ethical dimension and the ethical review of projects have become increasingly bureaucratized. (…) When I first started working (…) it was less bureaucratic, less strict then. I would say [there are now] tons of forms to fill out. Of course, we can’t do without it, it’s one of the ways of marking out ethics and ensuring that there are ethical considerations in research, but I wonder if it hasn’t become too bureaucratized, so that it’s become a kind of technical reflex to fill out these forms, and I don’t know if people really do ethical reflection as such anymore (participant 10). The fundamental structural issue, I would say, is the mismatch between the normative requirements and the real risks posed by the research, i.e., we have many, many requirements to meet; we have very long forms to fill out but the research projects we evaluate often pose few risks (participant 8). People [in vulnerable situations] were previously unable to participate because of overly strict research ethics rules that were to protect them, but in the end [these rules] did not protect them. There was a perverse effect, because in the end there was very little research done with these people and that’s why we have very few results, very little evidence [to support practices with these populations] so it didn’t improve the quality of services. (…) We all understand that we have to be careful with that, but when the research is not too risky, we say to ourselves that it would be good because for once a researcher who is interested in that population, because it is not a very popular population, it would be interesting to have results, but often we are blocked by the norms, and then we can’t accept [the project] (participant 2).

Moreover, as one participant noted, accessing ethics training can be a challenge.

There is no course on research ethics. […] Then, I find that it’s boring because you go through university and you come to do your research and you know how to do quantitative and qualitative research, but all the research ethics, where do you get this? I don’t really know (participant 13).

Yet, such training could provide relevant tools to resolve, to some extent, the ethical issues that commonly arise in research. That said, and as noted by many participants, many ethical issues in research are related to social injustices over which research actors have little influence.

Social Injustices

For many participants, notably researchers, the issues that concern social injustices are those related to power asymmetries, stigma, or issues of equity, diversity, and inclusion, i.e., social injustices related to people’s identities (Blais & Drolet, 2022 ). Participants reported experiencing or witnessing discrimination from peers, administration, or lab managers. Such oppression is sometimes cross-sectional and related to a person’s age, cultural background, gender or social status.

I have my African colleague who was quite successful when he arrived but had a backlash from colleagues in the department. I think it’s unconscious, nobody is overtly racist. But I have a young person right now who is the same, who has the same success, who got exactly the same early career award and I don’t see the same backlash. He’s just as happy with what he’s doing. It’s normal, they’re young and they have a lot of success starting out. So, I think there is discrimination. Is it because he is African? Is it because he is black? I think it’s on a subconscious level (participant 16).

Social injustices were experienced or reported by many participants, and included issues related to difficulties in obtaining grants or disseminating research results in one’s native language (i.e., even when there is official bilingualism) or being considered credible and fundable in research when one researcher is a woman.

If you do international research, there are things you can’t talk about (…). It is really a barrier to research to not be able to (…) address this question [i.e. the question of inequalities between men and women]. Women’s inequality is going to be addressed [but not within the country where the research takes place as if this inequality exists elsewhere but not here]. There are a lot of women working on inequality issues, doing work and it’s funny because I was talking to a young woman who works at Cairo University and she said to me: “Listen, I saw what you had written, you’re right. I’m willing to work on this but guarantee me a position at your university with a ticket to go”. So yes, there are still many barriers [for women in research] (participant 16).

Because of the varied contextual characteristics that intervene in their occurrence, these social injustices are also related to distributive injustices, as discussed by many participants.

Distributive Injustices

Although there are several views of distributive justice, a classical definition such as that of Aristotle ( 2012 ), describes distributive justice as consisting in distributing honours, wealth, and other social resources or benefits among the members of a community in proportion to their alleged merit. Justice, then, is about determining an equitable distribution of common goods. Contemporary theories of distributive justice are numerous and varied. Indeed, many authors (e.g., Fraser 2011 ; Mills, 2017 ; Sen, 2011 ; Young, 2011 ) have, since Rawls ( 1971 ), proposed different visions of how social burdens and benefits should be shared within a community to ensure equal respect, fairness, and distribution. In our study, what emerges from participants’ narratives is a definite concern for this type of justice. Women researchers, francophone researchers, early career researchers or researchers belonging to racialized groups all discussed inequities in the distribution of research grants and awards, and the extra work they need to do to somehow prove their worth. These inequities are related to how granting agencies determine which projects will be funded.

These situations make me work 2–3 times harder to prove myself and to show people in power that I have a place as a woman in research (participant 12). Number one: it’s conservative thinking. The older ones control what comes in. So, the younger people have to adapt or they don’t get funded (participant 14).

Whether it is discrimination against stigmatized or marginalized populations or interest in certain hot topics, granting agencies judge research projects according to criteria that are sometimes questionable, according to those participants. Faced with difficulties in obtaining funding for their projects, several strategies – some of which are unethical – are used by researchers in order to cope with these situations.

Sometimes there are subjects that everyone goes to, such as nanotechnology (…), artificial intelligence or (…) the therapeutic use of cannabis, which are very fashionable, and this is sometimes to the detriment of other research that is just as relevant, but which is (…), less sexy, less in the spirit of the time. (…) Sometimes this can lead to inequities in the funding of certain research sectors (participant 9). When we use our funds, we get them given to us, we pretty much say what we think we’re going to do with them, but things change… So, when these things change, sometimes it’s an ethical decision, but by force of circumstances I’m obliged to change the project a little bit (…). Is it ethical to make these changes or should I just let the money go because I couldn’t use it the way I said I would? (participant 3).

Moreover, these distributional injustices are not only linked to social injustices, but also epistemic injustices. Indeed, the way in which research honours and grants are distributed within the academic community depends on the epistemic authority of the researchers, which seems to vary notably according to their language of use, their age or their gender, but also to the research design used (inductive versus deductive), their decision to use (or not use) animals in research, or to conduct activist research.

Epistemic injustices

The philosopher Fricker ( 2007 ) conceptualized the notions of epistemic justice and injustice. Epistemic injustice refers to a form of social inequality that manifests itself in the access, recognition, and production of knowledge as well as the various forms of ignorance that arise (Godrie & Dos Santos, 2017 ). Addressing epistemic injustice necessitates acknowledging the iniquitous wrongs suffered by certain groups of socially stigmatized individuals who have been excluded from knowledge, thus limiting their abilities to interpret, understand, or be heard and account for their experiences. In this study, epistemic injustices were experienced or reported by some participants, notably those related to difficulties in obtaining grants or disseminating research results in one’s native language (i.e., even when there is official bilingualism) or being considered credible and fundable in research when a researcher is a woman or an early career researcher.

I have never sent a grant application to the federal government in English. I have always done it in French, even though I know that when you receive the review, you can see that reviewers didn’t understand anything because they are English-speaking. I didn’t want to get in the boat. It’s not my job to translate, because let’s be honest, I’m not as good in English as I am in French. So, I do them in my first language, which is the language I’m most used to. Then, technically at the administrative level, they are supposed to be able to do it, but they are not good in French. (…) Then, it’s a very big Canadian ethical issue, because basically there are technically two official languages, but Canada is not a bilingual country, it’s a country with two languages, either one or the other. (…) So I was not funded (participant 14).

Researchers who use inductive (or qualitative) methods observed that their projects are sometimes less well reviewed or understood, while research that adopts a hypothetical-deductive (or quantitative) or mixed methods design is better perceived, considered more credible and therefore more easily funded. Of course, regardless of whether a research project adopts an inductive, deductive or mixed-methods scientific design, or whether it deals with qualitative or quantitative data, it must respect a set of scientific criteria. A research project should achieve its objectives by using proven methods that, in the case of inductive research, are credible, reliable, and transferable or, in the case of deductive research, generalizable, objective, representative, and valid (Drolet & Ruest, accepted ). Participants discussing these issues noted that researchers who adopt a qualitative design or those who question the relevance of animal experimentation or are not militant have sometimes been unfairly devalued in their epistemic authority.

There is a mini war between quantitative versus qualitative methods, which I think is silly because science is a method. If you apply the method well, it doesn’t matter what the field is, it’s done well and it’s perfect ” (participant 14). There is also the issue of the place of animals in our lives, because for me, ethics is human ethics, but also animal ethics. Then, there is a great evolution in society on the role of the animal… with the new law that came out in Quebec on the fact that animals are sensitive beings. Then, with the rise of the vegan movement, [we must ask ourselves]: “Do animals still have a place in research?” That’s a big question and it also means that there are practices that need to evolve, but sometimes there’s a disconnection between what’s expected by research ethics boards versus what’s expected in the field (participant 15). In research today, we have more and more research that is militant from an ideological point of view. And so, we have researchers, because they defend values that seem important to them, we’ll talk for example about the fight for equality and social justice. They have pressure to defend a form of moral truth and have the impression that everyone thinks like them or should do so, because they are defending a moral truth. This is something that we see more and more, namely the lack of distance between ideology and science (participant 8).

The combination or intersectionality of these inequities, which seems to be characterized by a lack of ethical support and guidance, is experienced in the highly competitive and individualistic context of research; it provides therefore the perfect recipe for researchers to experience ethical distress.

Ethical distress

The concept of “ethical distress” refers to situations in which people know what they should do to act ethically, but encounter barriers, generally of an organizational or systemic nature, limiting their power to act according to their moral or ethical values (Drolet & Ruest, 2021 ; Jameton, 1984 ; Swisher et al., 2005 ). People then run the risk of finding themselves in a situation where they do not act as their ethical conscience dictates, which in the long term has the potential for exhaustion and distress. The examples reported by participants in this study point to the fact that researchers in particular may be experiencing significant ethical distress. This distress takes place in a context of extreme competition, constant injunctions to perform, and where administrative demands are increasingly numerous and complex to complete, while paradoxically, they lack the time to accomplish all their tasks and responsibilities. Added to these demands are a lack of resources (human, ethical, and financial), a lack of support and recognition, and interpersonal conflicts.

We are in an environment, an elite one, you are part of it, you know what it is: “publish or perish” is the motto. Grants, there is a high level of performance required, to do a lot, to publish, to supervise students, to supervise them well, so yes, it is clear that we are in an environment that is conducive to distress. (…). Overwork, definitely, can lead to distress and eventually to exhaustion. When you know that you should take the time to read the projects before sharing them, but you don’t have the time to do that because you have eight that came in the same day, and then you have others waiting… Then someone rings a bell and says: “ah but there, the protocol is a bit incomplete”. Oh yes, look at that, you’re right. You make up for it, but at the same time it’s a bit because we’re in a hurry, we don’t necessarily have the resources or are able to take the time to do things well from the start, we have to make up for it later. So yes, it can cause distress (participant 9). My organization wanted me to apply in English, and I said no, and everyone in the administration wanted me to apply in English, and I always said no. Some people said: “Listen, I give you the choice”, then some people said: “Listen, I agree with you, but if you’re not [submitting] in English, you won’t be funded”. Then the fact that I am young too, because very often they will look at the CV, they will not look at the project: “ah, his CV is not impressive, we will not finance him”. This is complete nonsense. The person is capable of doing the project, the project is fabulous: we fund the project. So, that happened, organizational barriers: that happened a lot. I was not eligible for Quebec research funds (…). I had big organizational barriers unfortunately (participant 14). At the time of my promotion, some colleagues were not happy with the type of research I was conducting. I learned – you learn this over time when you become friends with people after you enter the university – that someone was against me. He had another candidate in mind, and he was angry about the selection. I was under pressure for the first three years until my contract was renewed. I almost quit at one point, but another colleague told me, “No, stay, nothing will happen”. Nothing happened, but these issues kept me awake at night (participant 16).

This difficult context for many researchers affects not only the conduct of their own research, but also their participation in research. We faced this problem in our study, despite the use of multiple recruitment methods, including more than 200 emails – of which 191 were individual solicitations – sent to potential participants by the two research assistants. REB members and organizations overseeing or supporting research (n = 17) were also approached to see if some of their employees would consider participating. While it was relatively easy to recruit REB members and research ethics experts, our team received a high number of non-responses to emails (n = 175) and some refusals (n = 5), especially by researchers. The reasons given by those who replied were threefold: (a) fear of being easily identified should they take part in the research, (b) being overloaded and lacking time, and (c) the intrusive aspect of certain questions (i.e., “Have you experienced a burnout episode? If so, have you been followed up medically or psychologically?”). In light of these difficulties and concerns, some questions in the socio-demographic questionnaire were removed or modified. Talking about burnout in research remains a taboo for many researchers, which paradoxically can only contribute to the unresolved problem of unhealthy research environments.

Returning to the research question and objective

The question that prompted this research was: What are the ethical issues in research? The purpose of the study was to describe these issues from the perspective of researchers (from different disciplines), research ethics board (REB) members, and research ethics experts. The previous section provided a detailed portrait of the ethical issues experienced by different research stakeholders: these issues are numerous, diverse and were recounted by a range of stakeholders.

The results of the study are generally consistent with the literature. For example, as in our study, the literature discusses the lack of research integrity on the part of some researchers (Al-Hidabi et al., 2018 ; Swazey et al., 1993 ), the numerous conflicts of interest experienced in research (Williams-Jones et al., 2013 ), the issues of recruiting and obtaining the free and informed consent of research participants (Provencher et al., 2014 ; Keogh & Daly, 2009 ), the sometimes difficult relations between researchers and REBs (Drolet & Girard, 2020 ), the epistemological issues experienced in research (Drolet & Ruest, accepted; Sieber 2004 ), as well as the harmful academic context in which researchers evolve, insofar as this is linked to a culture of performance, an overload of work in a context of accountability (Berg & Seeber, 2016 ; FQPPU; 2019 ) that is conducive to ethical distress and even burnout.

If the results of the study are generally in line with those of previous publications on the subject, our findings also bring new elements to the discussion while complementing those already documented. In particular, our results highlight the role of systemic injustices – be they social, distributive or epistemic – within the environments in which research is carried out, at least in Canada. To summarize, the results of our study point to the fact that the relationships between researchers and research participants are likely still to raise worrying ethical issues, despite widely accepted research ethics norms and institutionalized review processes. Further, the context in which research is carried out is not only conducive to breaches of ethical norms and instances of misbehaviour or misconduct, but also likely to be significantly detrimental to the health and well-being of researchers, as well as research assistants. Another element that our research also highlighted is the instrumentalization and even exploitation of students and research assistants, which is another important and worrying social injustice given the inevitable power imbalances between students and researchers.

Moreover, in a context in which ethical issues are often discussed from a micro perspective, our study helps shed light on both the micro- and macro-level ethical dimensions of research (Bronfenbrenner, 1979 ; Glaser 1994 ). However, given that ethical issues in research are not only diverse, but also and above all complex, a broader perspective that encompasses the interplay between the micro and macro dimensions can enable a better understanding of these issues and thereby support the identification of the multiple factors that may be at their origin. Triangulating the perspectives of researchers with those of REB members and research ethics experts enabled us to bring these elements to light, and thus to step back from and critique the way that research is currently conducted. To this end, attention to socio-political elements such as the performance culture in academia or how research funds are distributed, and according to what explicit and implicit criteria, can contribute to identifying the sources of the ethical issues described above.

Contemporary culture characterized by the social acceleration

The German sociologist and philosopher Rosa (2010) argues that late modernity – that is, the period between the 1980s and today – is characterized by a phenomenon of social acceleration that causes various forms of alienation in our relationship to time, space, actions, things, others and ourselves. Rosa distinguishes three types of acceleration: technical acceleration , the acceleration of social changes and the acceleration of the rhythm of life . According to Rosa, social acceleration is the main problem of late modernity, in that the invisible social norm of doing more and faster to supposedly save time operates unchallenged at all levels of individual and collective life, as well as organizational and social life. Although we all, researchers and non-researchers alike, perceive this unspoken pressure to be ever more productive, the process of social acceleration as a new invisible social norm is our blind spot, a kind of tyrant over which we have little control. This conceptualization of the contemporary culture can help us to understand the context in which research is conducted (like other professional practices). To this end, Berg & Seeber ( 2016 ) invite faculty researchers to slow down in order to better reflect and, in the process, take care of their health and their relationships with their colleagues and students. Many women professors encourage their fellow researchers, especially young women researchers, to learn to “say No” in order to protect their mental and physical health and to remain in their academic careers (Allaire & Descheneux, 2022 ). These authors also remind us of the relevance of Kahneman’s ( 2012 ) work which demonstrates that it takes time to think analytically, thoroughly, and logically. Conversely, thinking quickly exposes humans to cognitive and implicit biases that then lead to errors in thinking (e.g., in the analysis of one’s own research data or in the evaluation of grant applications or student curriculum vitae). The phenomenon of social acceleration, which pushes the researcher to think faster and faster, is likely to lead to unethical bad science that can potentially harm humankind. In sum, Rosa’s invitation to contemporary critical theorists to seriously consider the problem of social acceleration is particularly insightful to better understand the ethical issues of research. It provides a lens through which to view the toxic context in which research is conducted today, and one that was shared by the participants in our study.

Clark & Sousa ( 2022 ) note, it is important that other criteria than the volume of researchers’ contributions be valued in research, notably quality. Ultimately, it is the value of the knowledge produced and its influence on the concrete lives of humans and other living beings that matters, not the quantity of publications. An interesting articulation of this view in research governance is seen in a change in practice by Australia’s national health research funder: they now restrict researchers to listing on their curriculum vitae only the top ten publications from the past ten years (rather than all of their publications), in order to evaluate the quality of contributions rather than their quantity. To create environments conducive to the development of quality research, it is important to challenge the phenomenon of social acceleration, which insidiously imposes a quantitative normativity that is both alienating and detrimental to the quality and ethical conduct of research. Based on our experience, we observe that the social norm of acceleration actively disfavours the conduct of empirical research on ethics in research. The fact is that researchers are so busy that it is almost impossible for them to find time to participate in such studies. Further, operating in highly competitive environments, while trying to respect the values and ethical principles of research, creates ethical paradoxes for members of the research community. According to Malherbe ( 1999 ), an ethical paradox is a situation where an individual is confronted by contradictory injunctions (i.e., do more, faster, and better). And eventually, ethical paradoxes lead individuals to situations of distress and burnout, or even to ethical failures (i.e., misbehaviour or misconduct) in the face of the impossibility of responding to contradictory injunctions.

Strengths and Limitations of the study

The triangulation of perceptions and experiences of different actors involved in research is a strength of our study. While there are many studies on the experiences of researchers, rarely are members of REBs and experts in research ethics given the space to discuss their views of what are ethical issues. Giving each of these stakeholders a voice and comparing their different points of view helped shed a different and complementary light on the ethical issues that occur in research. That said, it would have been helpful to also give more space to issues experienced by students or research assistants, as the relationships between researchers and research assistants are at times very worrying, as noted by a participant, and much work still needs to be done to eliminate the exploitative situations that seem to prevail in certain research settings. In addition, no Indigenous or gender diverse researchers participated in the study. Given the ethical issues and systemic injustices that many people from these groups face in Canada (Drolet & Goulet, 2018 ; Nicole & Drolet, in press ), research that gives voice to these researchers would be relevant and contribute to knowledge development, and hopefully also to change in research culture.

Further, although most of the ethical issues discussed in this article may be transferable to the realities experienced by researchers in other countries, the epistemic injustice reported by Francophone researchers who persist in doing research in French in Canada – which is an officially bilingual country but in practice is predominantly English – is likely specific to the Canadian reality. In addition, and as mentioned above, recruitment proved exceedingly difficult, particularly amongst researchers. Despite this difficulty, we obtained data saturation for all but two themes – i.e., exploitation of students and ethical issues of research that uses animals. It follows that further empirical research is needed to improve our understanding of these specific issues, as they may diverge to some extent from those documented here and will likely vary across countries and academic research contexts.

Conclusions

This study, which gave voice to researchers, REB members, and ethics experts, reveals that the ethical issues in research are related to several problematic elements as power imbalances and authority relations. Researchers and research assistants are subject to external pressures that give rise to integrity issues, among others ethical issues. Moreover, the current context of social acceleration influences the definition of the performance indicators valued in academic institutions and has led their members to face several ethical issues, including social, distributive, and epistemic injustices, at different steps of the research process. In this study, ten categories of ethical issues were identified, described and illustrated: (1) research integrity, (2) conflicts of interest, (3) respect for research participants, (4) lack of supervision and power imbalances, (5) individualism and performance, (6) inadequate ethical guidance, (7) social injustices, (8) distributive injustices, (9) epistemic injustices, and (10) ethical distress. The triangulation of the perspectives of different members (i.e., researchers from different disciplines, REB members, research ethics experts, and one research assistant) involved in the research process made it possible to lift the veil on some of these ethical issues. Further, it enabled the identification of additional ethical issues, especially systemic injustices experienced in research. To our knowledge, this is the first time that these injustices (social, distributive, and epistemic injustices) have been clearly identified.

Finally, this study brought to the fore several problematic elements that are important to address if the research community is to develop and implement the solutions needed to resolve the diverse and transversal ethical issues that arise in research institutions. A good starting point is the rejection of the corollary norms of “publish or perish” and “do more, faster, and better” and their replacement with “publish quality instead of quantity”, which necessarily entails “do less, slower, and better”. It is also important to pay more attention to the systemic injustices within which researchers work, because these have the potential to significantly harm the academic careers of many researchers, including women researchers, early career researchers, and those belonging to racialized groups as well as the health, well-being, and respect of students and research participants.

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Acknowledgements

The team warmly thanks the participants who took part in the research and who made this study possible. Marie-Josée Drolet thanks the five research assistants who participated in the data collection and analysis: Julie-Claude Leblanc, Élie Beauchemin, Pénéloppe Bernier, Louis-Pierre Côté, and Eugénie Rose-Derouin, all students at the Université du Québec à Trois-Rivières (UQTR), two of whom were active in the writing of this article. MJ Drolet and Bryn Williams-Jones also acknowledge the financial contribution of the Social Sciences and Humanities Research Council of Canada (SSHRC), which supported this research through a grant. We would also like to thank the reviewers of this article who helped us improve it, especially by clarifying and refining our ideas.

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Drolet, MJ., Rose-Derouin, E., Leblanc, JC. et al. Ethical Issues in Research: Perceptions of Researchers, Research Ethics Board Members and Research Ethics Experts. J Acad Ethics 21 , 269–292 (2023). https://doi.org/10.1007/s10805-022-09455-3

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• Open access
• Published: 16 August 2024

Towards an understanding of the ethics of electronic consent in clinical trials

• Katherine Sahan 2 ,
• Rohan Wijesurendra 1 ,
• David Preiss 1 ,
• Marion Mafham 1 &
• Mark Sheehan   ORCID: orcid.org/0000-0002-7191-901X 2  

Trials volume  25 , Article number:  545 ( 2024 ) Cite this article

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There are good practical reasons to use electronic consent (e-consent) in randomised trials, especially when conducting large-scale clinical trials to answer population-level health research questions. However, determining ethical reasons for e-consent is not so clear and depends on a proper understanding of what e-consent means when used in clinical trials and its ethical significance. Here we focus on four features of ethical significance which give rise to a range of ethical considerations relating to e-consent and merit further focused ethics research.

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Practical reasons for development of e-consent

Informed consent is a fundamental legal and ethical requirement in research involving human participants, including clinical trials for investigational medical products (CTIMPs). It is the instantiation of the ethical requirement that participants actively choose and so, provide autonomous authorisation to take part in the study [ 1 ]. It ensures that participants are able to exercise their autonomy free from coercion and with sufficient information and comprehension of what participation means [ 2 ]. Conventionally, obtaining informed consent would involve provision of written paper information and an in-person, face-to-face discussion between participant and researcher before providing a wet ink signature on a consent form. Importantly, various aspects of these conventions have been challenged on practical grounds across a range of contexts.

First, the need for paper has been questioned. Paper forms can be long, legalistic, and hard to comprehend. Using paper-based processes may not suit some research contexts [ 3 ] and may give rise to logistical and security challenges (e.g. where, how to store paper records) [ 4 ]. Second, the need for in-person interaction or discussion during the consent process has been queried for certain types of research, such as research where participating involves only some or no clinic visits and therefore meeting in-person may be burdensome or extraneous for both participants and researchers. These research studies are referred to as remote, home-based [ 5 , 6 ], Footnote 1 direct-to-consumer or direct-to-participant studies. More recently such studies have included formal CTIMPs [ 8 , 9 ].

Large-scale CTIMPs to answer population health research questions present challenges that are paradigmatic of the practical challenges of conventional consent. When recruiting thousands of participants, it may simply be unfeasible (for example, costly or inefficient) to consent each patient in-person and obtain their consent documented on paper. Nor may any clinic visits be necessary, as study drugs can be mailed to the home (ASCEND PLUS, Footnote 2 LENS, Footnote 3 [ 9 ]) or even administered within the home where this involves professionals having to infuse drugs [ 10 ]. This has led to the development of alternatives to conventional consent processes. These can include remote consent where paper forms (invitation, screening, information, and consent) are mailed out to participant’s homes [ 9 , 11 ] without the need for an in-person interaction. The remote consent process can also be run electronically. Footnote 4 Paper forms can be sent in electronic copy by email, or the information can be presented using web-based platforms which create a ‘user profile’ for the participant (or provide an individualised link) and take her through a set of web pages and forms, sometimes using visual information such as animated videos instead of written text. The consent form itself can be an electronic form, signed using a secure system and logged in the trial’s electronic storage. Again, an in-person interaction is not needed though can be requested.

Alternatively, electronic consent may have benefits when used in a non-remote fashion. For example, the trial or study may still be run in a clinic or hospital setting, but eligible patients may present out of hours when researchers are not working. In this case, having an electronic consent on hand to recruit them in the first instance can be valuable [ 4 ] by potentially cutting down on the amount of time required of research personnel. This use of electronic methods to conduct all or part of the trial recruitment process (from invitation through screening, informing, to obtaining informed consent) is known as electronic consent or e-consent ([ 12 ], Introduction p40).

Uses of e-consent in CTIMPs to date

The use of e-consent in CTIMPs to date is uncommon. Although there are published studies with RCT designs which use e-consent, the majority of these are not the consent of real participants to real CTIMPs. Instead, they test e-consent processes in ‘mock’ or ‘simulated patient’ situations where a hypothetical trial is proposed but the e-consent testers are not in an active study or trial [ 4 , 13 ] Other studies which used e-consent were neither RCTs nor interventional, following observational or health data sharing designs [ 14 ]. In these studies, some e-consent processes were tested for user satisfaction without a comparator, and at other times were compared with paper formats [ 15 , 16 ].

A few CTIMPs have used an e-consent process on real trial participants [ 8 , 10 , 17 , 18 , 19 ]. Of these, many were low risk as they used licensed drugs [ 8 ,  10 ,  19 ]. Haussen et al. [ 17 , 18 ] used e-consent in interventional stroke trials, one of a drug, and the others of devices for thrombectomy. Here the context of using e-consent was more ethically complex as risks were more than minimal, and they used legally authorised representatives (LARs) to provide consent on the patients’ behalf. Their evaluations of the e-consent process found efficiency savings from e-consent and a statistically significant user preference for e-consent over paper [ 18 ]. Haussen [ 17 ] found that the time from door-to-randomisation improved using e-consent. Evidence to date, therefore, is fairly limited, but indicates modest support for using e-consent in CTIMPs on practical grounds, and clearly requires further study. In all of this, however, the ethical grounds for using e-consent in CTIMPs are far less clear.

Understanding ethical reasons for e-consent as specifically applied to use in CTIMPs

The literature on the ethics of e-consent in CTIMPs is underdeveloped. This is largely because certain features of using e-consent in CTIMPs which are ethically significant have been overlooked or over-emphasised at the expense of other key considerations. Here, we describe four of these features and show that there are a broader range of ethical considerations to be understood in the ethics of e-consent.

E-consent in ‘mock’ trials can, at best, provide only a limited picture of the ethics landscape

A number of issues arise regarding the empirical data surrounding e-consent. First, this data, which is taken to inform e-consent’s acceptability, largely comes from mock tests of e-consent on simulated participants. This risks providing only a limited picture of the ethical considerations relevant to e-consent. This is not to say that mock e-consent studies have not generated some useful starting considerations. These studies report benefits from using e-consent including logistical efficiencies [ 17 ] (also for efficiency given pandemic conditions, see e.g. [ 20 ] NeuroSAFE and [ 19 ] PRINCIPLE), increased comprehension of information [ 21 ], ability to test comprehension [ 14 ], ability to present information in more meaningful ways e.g. tiering [ 22 ] and better user experience [ 18 ]. One frequently stated risk is that e-consent might increase the social inequality of access to trials [ 5 , 20 ], also referred to as increasing the ‘digital divide’ between technologically savvy and less savvy groups, for which there is modest empirical support [ 23 , 24 ]. Other studies noted a further risk that ‘cultural conditioning’ which causes us to agree to other types of e-consent without scrutiny (e.g. in click through agreements) might lead to poorly informed or otherwise illegitimate e-consent in medical research [ 22 , 25 ]. To mitigate the mindless click through effect, Wilbanks suggests that ‘cognitive friction’ — a phenomenon which refers to glitches in design communication processes causing users to stumble over content — should be deliberately built into e-consent processes to encourage users to ask questions, express doubt and self-reflect on trial participation. Footnote 5

These starting considerations are interesting but provide a limited picture of the ethics landscape for the following reasons. First, mock e-consent users have a lack of ‘skin in the game’: they are not genuinely presented with terms of participation and are not faced with the prospect of undergoing risk in any real sense. This means we have few empirical insights into how real trial participants understand risk in an e-consent process, nor how they deal with other common CTIMP comprehension pitfalls such as understanding of placebo controls and randomisation. Because the consent is broadly hypothetical, how participants actually understand these processes matters less (or perhaps differently) both for them and for the ethical acceptability of the consent. Second, we lack insight into the experiences of researchers and trial staff who are administering electronic consent processes in reality, including how these processes might combine with real phone and video interactions with patients who have questions. This misses interesting considerations about whether e-consent depends on human interaction for its administration, as well as questions about how reactive and flexible a consent process should be in response to particular participants’ needs.

The second set of issues arising from this, albeit limited, empirical data on e-consent is its actual relationship to an account of ethical acceptability. The broadest form of this set of issues points to the distinction between what is ethically acceptable and what is taken to be ethically acceptable. Famously, it is often supposed that if we asked people generally whether they thought capital punishment was an acceptable form of punishment, the comfortable majority would say that it is. However, we would rightly be hesitant to take it to follow that capital punishment is ethically acceptable. This kind of thought experiment shows that ‘what is ethically acceptable’ and ‘what is taken to be ethically acceptable’ can come apart in important ways. In the context here, this means that we should be careful of how we extrapolate from empirical findings which show approval in one form or another to ethical acceptability: we cannot simply read ethical acceptability off from participant approval.

In concrete methodological terms, this gap can be bridged by combining or integrating empirical approaches with conceptual, normative methods. So rather than simply asking participants for their opinions of the process, the researcher should ask for the reasons or justifications of those opinions and could potentially engage the participant in reflection on the adequacy of them. These methods are well described in the literature on empirical ethics methodologies [ 27 , 28 ]. They have the advantage of getting at the reasoning processes behind an avowed approval and allowing it to be scrutinised in terms of argumentative content and force. As researchers we are then in a position to know, not just what stakeholders think, but why they do so.

Overall, then, to fully understand the nature and ethical ramifications of e-consent, it should be used in real CTIMPs by real participants and other stakeholders, then analysed using a mix of empirical and conceptual, normative approaches.

E-consent is not (just) documenting consent

A second feature of current discussions of e-consent that is important here is an over-emphasis on the documentation of e-consent rather than on the e-consent processes themselves. This is found in some of the e-consent literature and regulations which seem overly focused on documentation-related questions, such as what standards are appropriate in order to verify a person’s identity when they sign an electronic consent form, and how to ensure personal information is transferred and stored securely [ 12 ]. For example, the UK joint statement seems very much dominated by the verification question (see Summary p1). These concerns are ethically relevant to an extent — we should certainly protect participants’ safety and confidentiality by having robust systems in place to verify their identity, and trial datasets should not be corrupted by rogue data. However, these concerns are also fairly uncontroversial, ethically speaking, and clearly can be managed by legal and regulatory safeguards.

The distinction between consent and its documentation is worthy of comment. In the normal course of events, we want to ensure that the potential participant actually makes a decision to participate. This is distinct from ensuring that it is actually the participant who makes the decision. It is the decision which matters. But when we focus on guarantees about the identity of the participant, the focus shifts from the decision to the decision-maker. The identity of the decision-maker matters ethically when having someone else decide has direct consequences for the person being ‘decided for.’ In the case of remote consent or e-consent, it is hard to see what the direct, pressing consequences could be. If the wrong person takes the medication this is of concern, but this is not resolved by ensuring identity — and we can reasonably assume that people generally do not take unknown medication. There may be concerns about access to data without proper permission, but the risk of harm here seems quite remote and certainly not blameworthy. In general, these concerns seem to be mostly borne out of a misplaced worry about the lack of control outside of the clinical setting. But of course, the same autonomy and the same ability to make independent responsible choices, both of which are to be respected in the clinical setting, is present in the home.

What needs more recognition is that e-consent in CTIMPs may encapsulate the whole recruitment process from invitation through to documenting consent. This might involve using electronic invitation, screening stages, information provision and interactive discussion (video/phone calls with real researchers or potentially a live chat system) during the participants’ digest of the information and comprehension stages. This is then followed by electronic documention of consent.

Documenting consent is not consent. Although the final signing of a document can represent the act of making a (final) decision, the signing is the contingent marking of that decision and could just as easily be captured in multiple alternative ways [ 3 ]. The earlier parts of the process, those that crucially contribute to the decision-making process, raise many more ethical questions to do with comprehension and voluntariness, as well as the role of relational factors e.g. the role of participant trust in an electronic consent process versus one delivered by humans.

E-consent should be distinguished from dynamic consent

Third, it is important to emphasise that e-consent is not dynamic consent and specifically could not mean dynamic consent in the CTIMP case. This is because dynamic consent is consent iterated over time (albeit often electronically) to multiple research opportunities, allowing participants to opt in and out of multiple studies [ 29 ]. E-consent to a CTIMP, however, is (and must be) a specific consent to a particular interventional protocol. This view conflicts with some of the literature on e-consent which either implicitly or explicitly characterises it and its benefits/risks as those of dynamic consent. For example, Petrini et al. warn that a risk of decentralised trials using e-consent is that consent could go ‘beyond the study scope’, so indicating a conflation between dynamic consent and e-consent. Also, de Sutter et al. define electronic IC as ‘an interactive online-based IC application which could facilitate interactions over time and could enable a personalized approach, adapted to research participants’ needs’ [ 30 ]. They also note a benefit of e-consent as being the ability to give feedback and return results to participants, even tailoring them to be relevant to participants’ particular interests or clinical features. In both of these cases, e-consent is confused with the use of an ‘electronic’ platform or system: clearly e-consent requires some form of electronic platform, but it does not entail all uses of such platforms.

While a personalised approach to feedback and results might be useful functions of a trial data management system, they do not relate to e-consent in particular, nor are they relevant arguments for (or against) using it in a CTIMP. This is because if we equate the benefits of e-consent too closely with tailoring of information, we may over-associate e-consent with the ability to frame or withhold information. This involves distinguishing the presentation of information from personalising information. The trial consent literature has advocated improvements to how information during IC is presented, such as using ‘choice architecture’ or tiered consent models such that information is more digestible to different educational and cultural backgrounds [ 22 , 30 , 31 ]. E-consent platforms lend themselves to this tiering approach, alongside other approaches such as the use of visuals and animation to replace dry written information.

This is different from tailoring or personalising information, which relies on the designer of the IC process anticipating or deciding how much information to give to a particular participant or cohort, potentially withholding some information. This makes assumptions about what people want to know and how much information is sufficient to make an informed decision, with substantial ethical and legal risks [ 32 ]. Therefore, one important consideration is being clear that we should not choose for participants the information we think they would want to know during e-consent (though we might more defensibly do this at later ‘feedback’ stages of trial participation). Nor should we imply — as the conflation of consent with dynamic consent discourse invites — that certain participants should be excluded from being offered at least essential trial information during a CTIMP e-consent process, even though they may choose not to receive the offer. This is granting that issues of information overload and comprehension still need managing in any appropriate e-consent process. So, in order to be clear about what e-consent to CTIMPs entails, we should distinguish it from the dynamic consent model.

The ethical importance of ‘in-person’ meetings and ‘two-way communication’ in consent

The final under-considered set of issues involves the ethical significance of ‘in-person’ or ‘two-way communication’ interactions during consent processes generally. Clearly, if these features matter, then work is needed on appropriately preserving or replicating them in the e-consent context. Importantly, some literature and some regulatory guidance on e-consent have stressed the importance of maintaining the option for in-person interaction and ‘two-way communication’ during the consent process [ 5 , 12 , 33 ], perhaps on the basis that this would be part of conventional consent, but these examples lack sustained critical attention.

Notably, the UK regulator’s guidance prefers an in-person interview to form part of the e-consent process, unless this is not possible [ 12 ]. When it is not possible, preferably there should still be a ‘two-way communication in real-time’ by telephone, video conferencing or similar. This is both in order to verify identity and because such a communication delivers the interactivity of an in-person interview, which ‘allows the participants to ask questions and receive answers from the investigator or member of the investigating team’ (2018 p6).

However, it may be that the need to preserve in-person interaction is overstated. In particular, if we are less concerned about the verification of identity issue, then it may be that the in-person connection is of less significance for understanding than it may first appear. It is unclear what extra ethical value meeting in-person gives us. On the face of it, there are clear methods for answering questions which do not require another person, either on a call or in-person.

The answer to this question partly turns on demonstrating the ethical value of in-person interaction in the conventional consent setting, perhaps that it welcomes the asking of questions or engaging with the trial material in a way that enhances consent. Then a further claim would need to be made about whether e-consent discourages questions and engagement. However, this makes assumptions about both the conventional and electronic consent context. In a conventional context, there may be no meaningful meeting or communication. Instead, being handed a paper Patient Information Sheet (PIS) and consent form may be all that time and resources allow for. Equally, the electronic context may provide better engagement with material, more time and allow for questions to be asked and answered at times convenient to participant and researcher. Additionally, interacting in-person may have disadvantages associated with biases and assumed relationships, such as heightening the ‘therapeutic misconception’ [ 34 ] or leading to an over-reliance on assumptions about roles and relational trust between the clinician and the patient at the expense of comprehension and clearly focussed choice [ 35 ]. For similar reasons, we should query the preference for ‘two-way’ or ‘thorough and interactive’ communication that goes over and above what is technologically available. In some cases, thorough, interactive interpersonal communication may be useful in order to engage patients and answer their queries, but in others, it may introduce unnecessary resource costs. In the context of modern technology, with automated chat facilities and the ability to clarify and answer questions electronically, the question remains as to what extra role and extra value is provided by live, person-to-person interaction.

The issue of in-person and two-way interaction is therefore important to subject to further ethical analysis but not perhaps for the reasons given by the literature and guidance so far. In fact, the issue points to ways in which conventional consent may not be all as it seems — in theory, conventional consent facilitates an informed, voluntary agreement but in practice may be more reliant on trust with the investigator and subtle power dynamics, which work against what is ethically important about the process. One interesting question arising from this is whether such reliance poses a kind of ethical ‘problem’ for the legitimacy of consent, and therefore whether adopting e-consent would or should correct the problem (for example, of therapeutic misconception, or overly trusting relationships).

Towards a better understanding of the ethics of e-consent in CTIMPs

In the above, we have described some challenges to using conventional consent processes in large-scale clinical trials in population health. Alternatives are being developed which might better suit the designs of these trials and other remote or decentralised trial designs. These alternatives include electronic consent (e-consent) processes spanning from invitation through screening, information-giving, and consent stages. To date, the use of e-consent processes in real CTIMPs remains uncommon but indicates (alongside mock studies of e-consent) good practical reasons for its use. However, the ethical grounds for using e-consent in CTIMPs need further attention and research.

We have sketched four features of the broader ethical landscape connected to the use of e-consent in CTIMPs which further focused on ethical analysis. Importantly, developing ethical grounds for using e-consent should avoid reproducing existing ethical problems associated with conventional consent processes. This involves giving a proper account of what consent should accomplish in contemporary clinical trials when designing future e-consent processes.

We have argued this work should begin by addressing some features of e-consent which have been overlooked or contrastingly over-emphasised in terms of their ethical significance. Firstly, we should use e-consent in real CTIMPs and evaluate its effectiveness and ethical acceptability. Secondly, we should consider ethical questions arising throughout the e-consent process overall, not just at the digital consent or identity verification stage. Thirdly, we should separate the analysis of e-consent from the discourse on dynamic consent, in order to be clear about the risks of over-framing or personalising information during consent. Finally, we should question the extent to which preserving features of conventional consent such as in-person interaction and two-way communication in e-consent processes is required, for fear of reproducing the problems of consent in the digital age.

Availability of data and materials

Not applicable.

Where some clinic visits are still needed, this is termed decentralised or hybrid clinical trials [ 5 , 7 ].

https://www.ascend-plus-trial.org/.

https://www.ctsu.ox.ac.uk/lens.

Note though e-consent is most logically suited for remote designs, we have found at least one RCT (TOPAZ) where e-consent is used even though research nurses physically interact with the participants (in order to infuse the study drug) and so could conduct some parts of the consent process with participants in-person.

Interestingly, this makes important presumptions about the ethical inadequacy of ‘click through’ consent in the context of CTIMPS: namely, that competent individuals are incapable of deciding whether this example of ‘click through’ consent involving a CTIMP is distinct from the ‘click through’ consent on another kind of webpage [ 26 ].

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Acknowledgements

MS is grateful for the support of the Oxford NIHR Biomedical Research Centre.

This work was conducted using departmental funding within the Nuffield Department of Population Health (NDPH), University of Oxford. NDPH receives support from the UK Medical Research Council, the British Heart Foundation, Cancer Research UK and Health Data Research (HDR) UK. MS is funded by the Oxford NIHR Biomedical Research Centre. RW acknowledges funding from the National Institute for Health Research (NIHR) Biomedical Research Centre (BRC) based at Oxford University Hospitals NHS Foundation Trust at the University of Oxford, UK.

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KS drafted an initial document based on a background document prepared by RW. DP, MM and MS commented and edited various versions. MS made some final edits.

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Sahan, K., Wijesurendra, R., Preiss, D. et al. Towards an understanding of the ethics of electronic consent in clinical trials. Trials 25 , 545 (2024). https://doi.org/10.1186/s13063-024-08330-3

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Chapter 3. Psychological Science

Conducting Ethical Research

Amelia Liangzi Shi

Approximate reading time : 11 minutes

Learning Objectives

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

• Discuss how research involving human subjects is regulated
• Summarise the processes of informed consent and debriefing
• Explain how research involving animal subjects is regulated

Research Involving Humans

Any experiment involving the participation of human subjects is governed by extensive, strict guidelines designed to ensure that the experiment does not result in harm. In Canada, there are two bodies that provide guidelines for ethical human research that must be adhered to. The Canadian Psychological Association has a code of ethics that members must follow (Canadian Psychological Association, 2017). The Tri-Council Policy Statement 2 (TCPS 2) is the most recent set of guidelines for ethical standards in research adhered to by those doing research with human subjects (Canadian Institutes of Health Research, Natural Sciences and Engineering Research Council of Canada, & Social Sciences and Humanities Research Council of Canada, 2022). The TCPS 2 is based on three core principles: respect for persons, concern for welfare, and justice. Details on these core principles are found in TCP2 Article 1.1.

Any research institution that receives federal support for research involving human participants must have access to an institutional review board (IRB) . The IRB is a committee of individuals often made up of members of the institution’s administration, scientists, and community members. The purpose of the IRB is to review proposals for research that involves human participants. The IRB reviews these proposals with the principles mentioned above in mind, and generally, approval from the IRB is required in order for the experiment to proceed.

An institution’s IRB requires several components in any experiment it approves. For one, each participant must provide an informed consent before they can participate in the experiment. In cases where research participants are under the age of 18, the parents or legal guardians are required to sign the informed consent form. An informed consent form contains a written description of what participants can expect during the experiment, like potential risks and implications of the research. It also lets participants know that their involvement is completely voluntary and can be discontinued without penalty at any time. Students in psychology classes may be allowed, or even required, to participate in research, but they are also always given an option to perform other activities instead. Additionally, once an experiment begins, the research participant is always free to leave the experiment if they wish. Concerns with free choice also occur in institutional settings such as schools, hospitals, corporations and prisons, when individuals are required by the institutions to take certain tests or when employees are told to participate in research.

Furthermore, the informed consent guarantees that any data collected in the experiment will remain completely confidential . In some cases, data can be kept anonymous by not having the respondents put any identifying information on their questionnaires. In other cases, the data cannot be anonymous because the researcher needs to keep track of which respondent contributed the data. In this case, one technique is to have each participant use a unique code number to identify their data, such as the last four digits of the student ID number. In this way, the researcher can keep track of which person completed which questionnaire, but no one will be able to connect the data with the individual who contributed them.

While the informed consent form should be as honest as possible in describing exactly what participants will be doing, sometimes deception is necessary to prevent participants’ knowledge of the exact research question from influencing the results of the study. Deception involves purposely misleading experiment participants in order to maintain the integrity of the experiment, but not to the point where the deception could be considered harmful. For example, if we are interested in how our opinion of someone is affected by their attire, we might use deception in describing the experiment to prevent that knowledge from affecting participants’ responses. Researchers must balance the use of deception, like not disclosing the true purpose of the study, with potential harm to the participants. The use of deception must be justified. In cases where deception is involved, participants must receive a full debriefing upon conclusion of the study: complete, honest information about the purpose of the experiment, the ways in which the data collected will be used, the reasons why deception was necessary, and the process to obtain additional information about the study.

Today, scientists agree that good research is ethical in nature and guided by a basic respect for human dignity and safety. Unfortunately, the ethical guidelines that exist for research today were not always applied in the past. In 1932 poor, rural, Black, male sharecroppers from Tuskegee, Alabama, were recruited to participate in an experiment conducted by the US Public Health Service, with the aim of studying syphilis in Black men. In exchange for free medical care, meals, and burial insurance, 600 men agreed to participate in the study – 399 who tested positive for syphilis and 201 who did not have the disease. However, those individuals that tested positive were never informed that they had the disease. While there was no treatment for syphilis when the study began, by 1947 penicillin was recognised as an effective treatment for the disease. Despite this, no penicillin was administered to the participants in this study, and the participants were not allowed to seek treatment at any other facilities if they continued in the study. Over the course of 40 years, many of the participants unknowingly spread syphilis to their wives (and subsequently their children born from their wives) and eventually died because they never received treatment for the disease. This study was discontinued in 1972 when the experiment was discovered by the National Press (Tuskegee University, n.d.). The resulting outrage over the experiment led directly to the National Research Act of 1974 and the strict ethical guidelines for research on humans. Visit the CDC’s Tuskegee Timeline to learn more.

Research Involving Animals

Many psychologists conduct research involving animal subjects. Because many basic processes in animals are sufficiently similar to those in humans, these animals are acceptable substitutes for research that would be considered unethical in human participants. However, this does not mean that animal researchers are exempt from ethical concerns. The following are the Canadian Psychological Association’s (2017) guidelines on research with animals.

Research involving animals must:

• Treat animals humanely and not expose them to unnecessary discomfort, pain, or disruption.
• Not use animals in their research unless there is a reasonable expectation that the research will increase understanding of the structures and processes underlying behaviour, or increase understanding of the particular animal species used in the study, or result in benefits to the health and welfare of humans or other animals.
• Keep themselves up to date with animal care legislation, guidelines, and best practices, if using animals in direct service, research, teaching, or supervision.
• Use a procedure subjecting animals to pain, stress, or privation only if an alternative procedure is unavailable and the goal is justified by its prospective scientific, educational, or applied value.
• Submit any research that includes procedures that subject animals to pain, stress, or privation to an appropriate review panel or committee for review.
• Make every effort to minimise the discomfort, illness, and pain of animals. This would include using appropriate anaesthesia, analgesia, tranquilization and/or adjunctive relief measures sufficient to prevent or alleviate animal discomfort, pain, or distress, when using a procedure or condition likely to cause more than short-term, low-intensity suffering. It also would include, if killing animals at the termination of a research study, doing so as compassionately and painlessly as possible.
• Use animals in classroom demonstrations only if the instructional objectives cannot be achieved through the use of electronic recordings, films, computer simulations or other methods, and if the type of demonstration is warranted by the anticipated instructional gain.” (p. 24)

Animal experimental proposals are reviewed by an Institutional Animal Care and Use Committee (IACUC). An IACUC consists of institutional administrators, scientists, veterinarians, and community members. No animal research project can proceed without the committee’s approval. This committee also conducts semi-annual inspections of all animal facilities to ensure that the research protocols are being followed.

Opinions about using animals in research vary from wanting to completely stop using animals for research to strongly supporting it (Ormandy & Schuppli, 2014). Some people argue that it is morally unacceptable to experiment on animals, while others recognise the importance of animal research. For instance, drugs that can reduce the incidence of cancer or AIDS may be tested on animals first, and surgical procedures that can save human lives may be practiced on animals first. Furthermore, research on animals has contributed to a better understanding of the physiological reasons behind depression, phobias, stress, and various other illnesses. Considering the benefits that animal research brings, many scientists believe that this kind of research can and should continue, as long as we ensure the humane treatment of the animals involved.

Image Attributions

Figure PS.11. “ IHA Board Meeting 56 ” by International Hydropower Association is licensed under a CC BY 2.0 license .

Figure PS.12. “ Photograph of Participants in the Tuskegee Syphilis Study ” by the Department of Health, Education, and Welfare , n.d., in the National Archives Catalogue is in the public domain .

Figure PS.13. “ Wistar rat ” by Janet Stephens is in the public domain .

To calculate this time, we used a reading speed of 150 words per minute and then added extra time to account for images and videos. This is just to give you a rough idea of the length of the chapter section. How long it will take you to engage with this chapter will vary greatly depending on all sorts of things (the complexity of the content, your ability to focus, etc).

Conducting Ethical Research Copyright © 2024 by Amelia Liangzi Shi is licensed under a Creative Commons Attribution-NonCommercial-ShareAlike 4.0 International License , except where otherwise noted.

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Ethical challenges of researchers in qualitative studies: the necessity to develop a specific guideline

Mahnaz sanjari.

1 Nursing PhD Candidate, School of Nursing and Midwifery, Tehran University of Medical Sciences, Tehran, Iran

Fatemeh Bahramnezhad

Fatemeh khoshnava fomani, mahnaz shoghi.

2 Assistant Professor, School of Nursing and Midwifery, Iran University of Medical Sciences, Tehran, Iran

Mohammad Ali Cheraghi

3 Associate Professor, School of Nursing and Midwifery, Tehran University of Medical Sciences, Tehran, Iran.

Considering the nature of qualitative studies, the interaction between researchers and participants can be ethically challenging for the former, as they are personally involved in different stages of the study. Therefore, formulation of specific ethical guidelines in this respect seems to be essential. The present paper aimed to discuss the necessity to develop explicit guidelines for conducting qualitative studies with regard to the researchers’ role. For this purpose, a literature review was carried out in domestic and international databases by related keywords.

Health care providers who carry out qualitative research have an immense responsibility. As there is no statistical analysis in qualitative studies, the researcher has to both evaluate what he or she observes and to interpret it. Providing researchers with the necessary skills and applying stringent supervision can lead to better extraction of reliable information from qualitative studies. This article presents a debate in order to illustrate how researchers could cover the ethical challenges of qualitative studies and provide applicable and trustworthy outcomes.

Researchers face ethical challenges in all stages of the study, from designing to reporting. These include anonymity, confidentiality, informed consent, researchers’ potential impact on the participants and vice versa. It seems of paramount importance that health care providers, educators and clinicians be well informed of all the different aspects of their roles when acting as qualitative researchers. Hence, these adroit roles need to be well defined, and the use of practical guidelines and protocols in all stages of qualitative studies should be encouraged.

Introduction

In the recent millennium, the constant trend of change in the demands of the community as well as transforming the trend of knowledge production has highlighted the necessity for researchers to adopt a more comprehensive approach. Increasingly, many academic disciplines are utilizing qualitative research (QR) as the qualitative method investigating the why and how of the process of a developed concept ( 1 , 2 ). Qualitative research is sometimes defined as interpretive research, and as interpretations can be incorrect or biased, the findings may be controversial ( 3 ). However, qualitative research is not only useful as the first stage of quantitative research, but can also play a key role in ‘validating’ it or in providing a different viewpoint on the same social phenomena ( 4 ).

Qualitative studies tend to use methods that result in text production rather than numerical outputs. Given that the researcher is considered to be the research instrument, and the plan of inquiry needs to be developed and altered as the study progresses, a qualitative researcher cannot depend upon traditional approaches to address certain concerns such as bias and credibility. Therefore, learning from a series of mistakes is often considered an integral part of qualitative research ( 5 , 6 ).

In this study, a literature review was carried out in international electronic databases including PubMed, Web of Sciences, Cumulative Index to Nursing and Allied Health Literature (CINAHL), Scopus, Ebsco, EMBASE and Science Direct without any time limitation, using the search terms “qualitative research”, “researchers’ role”, “ethical challenges” and “ethical guidelines”. These keywords were also searched on national electronic databases including Scientific Information Database (SID), Iran Medex and Medical Articles Library (Medlib) using the same strategy.

Authors of the present article endeavor to shine a light on the ethical issues affecting researchers and propose strategies to face the ethical challenges of qualitative studies, so as to provide applicable and trustworthy outcomes. This could be the basis for the formulation of specific ethical guidelines in this regard.

An overview on qualitative research in health care

Up to the 1970s, qualitative research was solely employed by anthropologists and sociologists. During the 1970s and 1980s, however, it was favored by various disciplines and experts of different branches of science and humanity such as health care, psychology , nursing, management, political science , education, and communication studies ( 2 , 7 ).

Qualitative research has been conducted in the field of nursing in order to identify, describe and explain related concepts, experiences and phenomena and to develop the nursing knowledge. Nursing professionals simultaneously introduced qualitative research to their peers. Since 1970, qualitative research has been performed to achieve the concepts of patient care and other main perceptions in the nursing profession. Qualitative studies provide nurses with sensitivity to the lived experiences of individuals from different nursing care aspects ( 4 , 8 ).

Role of researchers in qualitative studies

In the case of nurses who perform qualitative research, ethical issues are raised when the nurse-patient relationship in the research area leads to some degree of therapeutic communication for the participants ( 9 ). Thus, nurse researchers must be aware of the impact of the questioning on the participants, and in order to decrease such harmful effects on human subjects, the “reflexive approach” is recommended ( 10 ).

In qualitative studies researchers are often required to clarify their role in the research process ( 11 ). In the QR procedure the researcher is involved in all stages of the study from defining a concept to design, interview, transcription, analysis, verification and reporting the concepts and themes. Therefore, whenever instruments are involved in qualitative research, a human being will be an integral part of the process ( 12 ).

It is argued that humans have increasingly become the “instrument of choice” for naturalistic research due to certain characteristics: they are highly responsive to environmental stimuli, have the ability to interact with the situation, pull together different pieces of information at multiple levels simultaneously, and perceive situations holistically; moreover, they are able to process findings the instant they become available, can present immediate feedback, and feel unusual responses. Nevertheless, researchers need to improve the abilities that make them appropriate human instruments and consequently, their interpersonal skills are of major importance in natural settings and study processes ( Table 1 ) ( 13 , 14 ).

Researcher’s role in qualitative methods at a glance

Ethical challenges in qualitative studies:

The researcher-participant relationship.

The relationship and intimacy that is established between the researchers and participants in qualitative studies can raise a range of different ethical concerns, and qualitative researchers face dilemmas such as respect for privacy, establishment of honest and open interactions, and avoiding misrepresentations ( 19 ). Ethically challenging situations may emerge if researchers have to deal with contradicting issues and choose between different methodological strategies in conflict arises. In such cases, disagreements among different components such as participants, researchers, researchers’ discipline, the funding body and the society may be inevitable ( 20 , 21 ). Some important ethical concerns that should be taken into account while carrying out qualitative research are: anonymity, confidentiality and informed consent ( 22 ).

According to Richards and Schwartz’ findings ( 22 ), the term ‘confidentiality’ conveys different meanings for health care practitioners and researchers. For health care practitioners, confidentiality means that no personal information is to be revealed except in certain situations. For researchers, however, the duty of confidentiality is less clear and involves elaboration of the form of outcome that might be expected from the study ( 22 , 23 ).

The researcher must endeavor to minimize the possibility of intrusion into the autonomy of study participants by all means. When highly sensitive issues are concerned, children and other vulnerable individuals should have access to an advocate who is present during initial phases of the study, and ideally, during data gathering sessions. It is sometimes even necessary that the researcher clarify in writing which persons can have access to the initial data and how the data might be used ( 24 , 25 ).

Informed consent has been recognized as an integral part of ethics in research carried out in different fields. For qualitative researchers, it is of the utmost importance to specify in advance which data will be collected and how they are to be used ( 26 ). The principle of informed consent stresses the researcher’s responsibility to completely inform participants of different aspects of the research in comprehensible language. Clarifications need to include the following issues: the nature of the study, the participants’ potential role, the identity of the researcher and the financing body, the objective of the research, and how the results will be published and used ( 27 ).

Informed consent naturally requires ongoing negotiation of the terms of agreement as the study progresses ( 26 ). Many people consider it necessary to participate in research that their peers, community and/or society may benefit from. Therefore, qualitative health researchers need to clarify that the research they carry out will benefit science and can contribute to the improvement of health policy ( 5 ).

Research design

The qualitative method is utilized to explain, clarify and elaborate the meanings of different aspects of the human life experience. Therefore, researchers can interpret people’s experiences because they are involved in human activities. The principle of ‘no harm’ to participants ought to be considered by researchers, who should be aware of the potential harms that might be inflicted upon study subjects. Obviously, sometimes a conflict between the right to know (defended on the basis of benefits to the society) and the right of privacy (advocated based on the rights of the individual) may happen ( 27 , 28 ).

There are several effective strategies to protect personal information, for instance secure data storage methods, removal of identifier components, biographical details amendments and pseudonyms (applicable to names of individuals, places and organizations) ( 27 ). Researchers have the responsibility of protecting all participants in a study from potentially harmful consequences that might affect them as a result of their participation. It is getting increasingly common for research ethics committees to seek documented proof of consent in a written, signed, and ideally, witnessed form. Researchers can only do their best to protect their respondent’s identity and hold the information strictly confidential as there would be no guarantee for it otherwise ( 29 ). Furthermore, in investigations of sensitive topics where written consent puts the informants at risk, audio recorded oral consent would be more appropriate ( 30 ).

Development of personal relationships with participants may be inevitable while collecting certain data. Therefore, researchers should seriously consider the potential impact they may have on the participants and vice versa, and details of such interactions should be clearly mentioned in research proposals ( 23 ). Overall, the role of the researcher as (a) stranger, (b) visitor, (c) initiator, (d) insider-expert or other should be well defined and explained ( 3 ). As Brenner quoted Kvale state that, preparing an ethical protocol can cover issues in a qualitative research project from planning through reporting ( 30 ).

Data gathering and data analysis

In qualitative research, data are collected with a focus on multifaceted interviews and narratives to produce a description of the experiences. The researchers, therefore, play the role of a mediator between the experiences of the respondents and the community of concerned people ( 28 , 31 ). The post-interview comment sheet could assist the researcher to note the feelings of informants, as well as interpretations and comments that occurred during the interview ( 32 ).

Data collection needs to be as overt as possible, and findings should be recorded. Although there is no guarantee of absolute confidentiality, openly recording field notes assists participants to decide what they wish to have on the record. In health care research, the problem may be even more exaggerated as the researcher is sometimes the health provider as well ( 33 ).

In comparison with other research methods, ethnography has singular characteristics. When a researcher aims to study the culture of certain people, living amongst them is inevitable. This method of collecting data is a subject of debate from an ethical point of view. Long presence of the researcher amongst people of a particular culture necessitates informed consent. Participants should always be aware of the information that has been obtained and is being recorded, and consent to it. Sometimes this cannot be achieved easily and conflicts may happen, as in studies of cultural and ethnic characteristics ( 18 ).

The physical presence of the researchers within the culture requires them to be responsible for their role and potential consequences on the field. For instance, when criminals or a group of war veterans suffering from a disease are the subject of a study, the risks involved in living amongst them should be considered. Ethnographers must be vigilant about any distractions stemming from close interactions that can be potentially harmful to participants in the long run ( 33 , 34 ). Researchers can benefit from supervision sessions directed at learning, mentoring and skill development, all of which can foster their ability to carry out research without risking their health. Adequate professional supervision (which may be outside of the university) can be of service to researchers in dealing with the potential stress associated with the study ( 35 – 37 ).

In order to gain explicit data, ethnographers need to know the role of instrument details. There are eleven steps defined in ethnography which are meant to assist researchers. These steps include participant observation, ethnographic record, descriptive observation, taxonomic analysis, selected observation, componential analysis, discovering the cultural theme, cultural inventory, and finally writing ethnography ( 38 , 39 ).

Researchers should always be aware of the precise reason for involvement in a study in order to prevent undesirable personal issues. The probability of exposure to vicarious trauma as a result of the interviews needs to be evaluated. Interviewers should be properly scheduled to provide the researcher with sufficient recovery time and reduce the risk of emotional exhaustion, while allowing ample time for analysis of the objective and emotional aspects of the research. It is also necessary for the researcher to be familiar with signs of extreme fatigue and be prepared to take necessary measures before too much harm is done ( 40 – 42 ).

In qualitative studies, researchers have a great responsibility and play many different roles. It is argued that qualitative research that deals with sensitive topics in depth can pose emotional and other risks to both participants and researchers. Clear protocols for dealing with distress should be in place so that both parties involved in research can use them if necessary. It is not usually easy to predict what topics are likely to lead to distress, and researchers should therefore receive sufficient training in predicting traumatic situations.

Preventive measures for researchers who carry out sensitive qualitative studies should include official arrangements for a peer support program consisting of a list of researchers who are involved, or a constellation of researcher support activities aiming at improving psychological fitness in the form of a professional confidence building module. Other such measures include offering adequate supervision to provide opportunities for self-development and self-care, and facilitating the process of self-reflection and self-monitoring.

Strategies for emotional distancing need to be considered and adopted if the research topic or participants have the potential to be emotionally challenging. An appropriate planning should be in place before the commencement of the fieldwork, and it must be perfectly clear how the study should be conducted and what level of relationship development is necessary. Measures must also be taken so that levels of self-disclosure, objective displays of emotion during the interviews, and strategies to end the relationships are well defined and communicated.

One of the most prominent tasks of qualitative researchers is to minimize the flaws in observation and endeavor to gain truthful knowledge. Therefore, it is necessary for researchers to continuously update their investigation skills in terms of methodology and find novel techniques to better carry out studies in the field of health and sociology.

As explained before, qualitative research is carried out in natural settings, which requires researchers to work in close collaboration with other members of the team and under direct supervision to discuss and resolve issues as they arise. Therefore, development of practical strategies and communicating them to researchers can be of great benefit and assist them in conducting more perceptive qualitative studies. It is noteworthy that such research should be directed towards making a difference in people’s lives, improving care delivery in different settings and at all levels, and providing a framework for health sciences without any ethical disturbances.

As a result of the extensive body of research in the field of medical sciences, patients comprise a large proportion of the public who are frequently subjects of studies. Research Ethics Committees are formed to provide independent advice to participants, researchers, funders/sponsors and healthcare organizations on the extent to which research proposals comply with universally endorsed ethical standards.

In the history of social and medical science, there have been a few research studies that seriously injured people, and many more in which their welfare was not sufficiently protected. Nations and research associations have taken steps to prevent hurtful and intrusive research. To return to the matter of privacy, the researcher should not rely solely on the informant to identify possible intrusion, but needs to work at anticipating it in advance. Confidentiality does not necessarily preclude intrusion, as anonymity by itself is not enough to protect a person’s privacy or prevent disclosure of personal issues. Investigators should refrain from soliciting private information that is not closely related to the research question.

Considering the aforementioned challenges, it is recommended to conduct further research in order to provide meticulous and explicit ethical protocols, guidelines and codes with respect to qualitative studies.

Acknowledgments

The authors would like to offer special thanks to Dr. Ali Tootee for his assistance in the language editing of this article.