Research ethics committees: main tasks and challenges

What are the “ethics” in Research Ethics, and how should they be handled by RECs?

Should Ethics Committees be ‘ethical’?

This is, of course, a very peculiar question to start with, because on one level the answer is, ‘yes, of course!’, at another level, however, this is a non-obvious question, because the meaning of ‘ethics’[1] is not clear. At one level, it is about ‘professional’ behavior - RECs should behave professionally (i.e. with a bureaucratic and procedural integrity and consistency). At another it is about ‘doing the right thing’; it is about ensuring that proposed research will (and to a lesser extent does) conform to agreed standards (although what those standards are and by whom they are agreed is also not obvious). But there is a more fundamental question underpinning the meaning of ‘ethics’ of the ethics committees: ‘what is the authority for the committee’s pre- and proscription of researchers’ behavior?’ - or put simply, what is ‘ethics’? This section aims to open this discussion.

The Helsinki Declaration exactly captures the problem: Article 1 of the Declaration states,

“The World Medical Association (WMA) has developed the Declaration of Helsinki as a statement of ethical principles for medical research involving human subjects, including research on identifiable human material and data.”[2]

The Declaration then contains a number of principles - principles that accord to those, for example, of Beauchamp and Childress, of autonomy, non-maleficence, beneficence, and justice. So, informed consent is the gold standard, precaution should be operated in relation to risk, and human welfare is paramount. 

Article 23 of the Declaration introduces the REC/IRB:

“The research protocol must be submitted for consideration, comment, guidance and approval to the concerned research ethics committee before the study begins. This  committee must be transparent in its functioning, must be independent of the researcher,  the sponsor and any other undue influence and must be duly qualified. It must take into consideration the laws and regulations of the country or countries in which the research is to be performed as well as applicable international norms and standards. But these must not be allowed to reduce or eliminate any of the protections for research subjects set  forth in this Declaration.

“The committee must have the right to monitor ongoing studies. The researcher must provide monitoring information to the committee, especially information about any serious adverse events. No amendment to the protocol may be made without consideration and approval by the committee. After the end of the study, the researchers must submit a final report to the committee containing a summary of the study’s findings and conclusions.”

Two elements are interesting at this point: “must be duly qualified” and “must not be allowed to reduce or eliminate any of the protections for research subjects set forth in this Declaration”. How does the Declaration, and the requirements for ethics committees, fit into the broader framework of ethics?

What are ‘Ethics’?

The Declaration is very practical. It produces a number of key areas and presumptions about what is acceptable behavior. These approach prescription in a number of key areas, but still require a degree of negotiation or interpretation. And yet, ‘ethics’ are contested.

The contest appears first at an almost functional social level. There is a distinction to be drawn between colloquial and formal ethics. Colloquial uses of the term are an appeal in popular use to mean  that something is ‘right’ or ‘acceptable’, very much in line with the predominant cultural standards in  a particular community. It is more a linguistic way of labelling behavior as acceptable or unacceptable without any appeal to a formal, systematic basis for the claim. Another version of  ‘colloquial ethics’ might be termed ‘practical ethics’ - i.e. a more systematic focus on what is right  and wrong but based in the beliefs of the individual decision-makers, without a formal analysis of the basis of those beliefs. Formal uses of the term are an appeal to ethics as formulated in the branch of philosophy that is moral philosophy or ‘applied ethics’. What is the significance of the distinction?  Perhaps only the degree of systematic formulation of the idea of what is appropriate: formal ethics is concerned with the derivation of the claim to an action being ‘right’ much more than colloquial ethics; colloquial ethics has a more overtly subjective operation. In terms of authority to prescribe or proscribe the behavior of a researcher (in the application or interpretation of broad rules), it would seem that formal ethics’ systematic approach and appeal to a philosophical red-tread may have a greater authority than colloquial ethics’ appeal to a perception of the popular culture. But, in the absence of a framework to adjudicate between competing understandings and interpretations of ethics, it is difficult to resolve the dispute. This places a great emphasis on the constitutional authority of the REC/IRB, which in turn goes to the transparency of its operation.

Formal ethics has a greater systematization of its basis - it is grounded in principles of philosophy - but does this help a REC/IRB? Again, the issue is about the competition between different types of ethics. The obvious distinction is between ‘teleological or consequentialist’ theories, and ‘deontological or duty-based’ theories. These form the basis of every basic ethics course, and most ethics review committee members will be able to articulate the distinction.

Teleological, or consequentialist, theories of ethics look only to the consequences of an action as the determinant of the correctness of an action. Perhaps the best known of these theories is the Utilitarianism of Jeremy Bentham and John Stuart Mill. Their work is captured in the idea that an action is correct if it produces the greatest utility for the greatest number (although there are different ways of expressing that central idea). There are many bioethicists who operate with this consequentialist perspective today, notably John Harris and Peter Singer. In a rights-based world, it is very difficult to accept the theory completely - that there are no ‘trump’ positions.[3]  One cannot say, for example, that to kill someone is wrong if that action brings the greatest utility; the ‘greater good’ really does allow for this most radical expression. This rather exposes the problem of Utilitarianism, one that is found in Mill: 'Utility is not obvious; happiness is somewhat subjective, or at least dependent on perspective'. So, reading Mill, it is clear that there are certain values in play that are brought to the balancing and that it is not a de novo calculus on every occasion. And that is perhaps in part because Bentham and Mill were seeking to answer a different question from ‘what is right?’ They asked, ‘how should governments govern?’ Their question is a question of political ethics, political  theory, at its heart, that perhaps already acknowledges that government, and to a large extent ‘ethics’, is conducted in the environment of a competition for limited resources. ‘How should a government make decisions over limited resources?’ ‘By seeking to maximize utility/ happiness.’ This places the decision-making within its culture, but that does not detract, as Mill recognizes, from the danger of the ‘tyranny of the majority’ - that the answer does not necessarily produce a completely right decision. ‘Utility’ and ‘happiness’ are not self-evident.

Deontological, or duty-based, theories seek to address this problem of subjectivity in ethics by making an appeal to external validity for the theory. Immanuel Kant is probably at the forefront of this, with other theorists such as Alan Gewirth. They ground ethics in reason. They seek to show that as humans are rational, that rationality, that reason, requires particular understanding of the relationship between rational actors upon which the rational being must act. Kant expresses this through the “Categorical Imperative”, and Gewirth through the “Principle of Generic Consistency”. Kant’s Categorical Imperative has a number of expressions in his work, but its central core is that a right action is one  that can be universalized (i.e., there can be no special pleading, every rational being must be able to make the same claim), and that individuals must be “treated as ends in themselves, not merely as means to an end”. Thus, the rational being, on pain of self-contradiction, cannot instrumentalize others. Internally, this is again a matter of interpretation; it is not self-evident from the theory what a ‘right’ action or duty might be in any given situation. And there is considerable debate (and rejection) of the duty-imposing rationality of Kant’s philosophical underpinnings.

Within deontological approaches, John Rawls and Norman Daniels have developed justice approaches. Rawls’ Justice Theory addresses some of the concerns´ levels at Kant, and gives the practical method of reaching ethical decision, the Veil of Ignorance. Rawls suggests that the ethical decision is the one that the reasonable person would have to concede, even against his or her own interests and desires, and that this would be achieved by placing the reasonable person outside society, behind a veil, not knowing the place that s/he will have in the society on returning after making the decision (the ‘veil of ignorance’). In that situation, the reasonable person, stripped of interests but having to entertain the possibility of being the least protected person in society, will act to protect the interest of that least protected person, and thereby produce the ‘just’ decision. How far, however, this produces an objective justice is questionable: the neoliberal reasonable person produces a very different ‘just’ decision from the socialist, and yet each will claim reasonableness, fairness and justice. And this is the heart of the problem: humans are not purely rational or reasonable, they are formed in society and that is a melting pot of culture, politics, religion, emotion and interest. Humans are not purely rational, but rather tend towards self-protection, and ethics seeks to require a curbing of that self-interest without either knock-down arguments (they hang on belief in the type of ethics that resonate with the individual’s interests) or sanction (the stick to ensure compliance).

The problem for RECs (and others trying to consider what constitutes a ‘correct’ action is that the  theories above can produce diametrically opposed answers to the question, ‘what is the right thing to do?’. A consequentialist could well conclude that the right answer is the opposite of the conclusion a deontologist would make, and yet both within their own terms claim that their outcome is ‘moral’ or ‘ethical’. And this is the problem, when a claim is made that some behavior is ‘unethical’ or ‘immoral’, one must ask, according to what criteria - because there is a good chance that the behavior tcan be seen as 'correct' to some. To avoid this seeming contradictions this causes in the heart of the ‘ethics’ of the Research Ethics Committee is difficult - it is almost as if the inclusion of ‘ethics’ in the review it is a political rather than a philosophical appeal (that the research will be validated within the acceptable norms of a particular community - a question of power).

Virtue ethics, and Discourse ethics may bring some assistance to this difficulty. Virtue ethics, with its origins in, for example, Socrates, Plato, and Aristotle, was popular in pre-enlightenment thinking, up to its adoption by Aquinas. It sought to answer the question of how one should live the ‘good life’ (εὐδαιμονία - eudaemonia). This is attractive as it is a more holistic approach to ethics - that whilst the individual must make episodic decisions, it acknowledges that the decision-making is not isolated, and one will make mistakes from which one must learn; critical self-reflection will gradually ensure one becomes virtuous, ‘flourishes’. However, the virtues themselves are contested. Over time, the values that constitute formal virtues have changed; the virtues are culturally specific. Virtue ethics lost its dominance with the enlightenment but found a resurgence in the second half of the 20th century, notably through the work of Elisabeth Anscombe. Again, however, the virtues are contested.

It is then, perhaps, in the discourse ethics of Habermas that a (partial) solution might be found. Habermas addresses the imperfection of human reason by indicating that a constructively critical dialogue between stakeholders is essential to establish ethics, and that is discussed and changeable over time. This is not, perhaps, new. The ‘Politeness’ of Ashley Cooper, Third Earl of Shaftesbury in 1711 has a similar pre-enlightenment grounding in conversation as a social duty, whereby individuals can be ‘polished’ and polite society negotiated. Another iteration of this approach is ‘experimental ethics’ where participants are invited to develop their understanding of particular issues to develop their critical ethics response to an issue.[4] However, how this is undertaken is a matter of practice.

How then should RECs relate to ethics?

This is a more interesting question than it appears at first, because the question ‘why should I follow ethics?’ is a difficult one itself. The compulsion to conform to ethics is not necessarily because of a knock-down appeal from a particular theory, or, indeed, from a fear of sanction (although there may be a contractual obligation to follow particular codes of conduct, but even they are open to interpretation). Ethics might simply be an invitation to a systematic discourse about what could be considered as right or wrong, that finds its authority from the investment of the stakeholders in the process. At least, it would seem incumbent on RECs to consider the range of ethics questions, and to articulate the ‘ethics’ perspectives of the individuals and the committee itself; RECs, in order to claim authority in the community, might need to show critical self-reflection on the range of questions that attend ‘what is ethics?’.

Questions for Discussions

How far should RECs and IRBs be concerned with formal rather than colloquial ethics?

How do I make ‘ethics’ decisions?

What is the basis of my ‘ethics’?

How do I adjudicate between ‘ethics’ positions?

How should this be drawn into the work of the REC/IRB?

How far should REC/IRB ethics be about observing practical protocols more than debating defensible  ethics positions? (Is a REC in place to have debates about ethics, or to apply practical standards  understood by different communities?)

How far should I expect researchers to conform to my idea of what is right?

What opportunities should I give to the researchers to explain their ethics perspective? 

How do I approach interpretations of codes of conduct?

Further Reading

Mill, J. S. Utilitarianism (1861; ed. R. Crisp, 1998) Oxford Philosophical Texts, Oxford University  Press, Oxford.

Kant, I Groundwork of the Metaphysics of Morals (1785; eds. M. Gregor and J. Timmermann, 2012)  Cambridge University Press, Cambridge.

Kant, I. Critique of Pure Reason (1781 and 1787; eds. P Guyer and A. Wood, 1998) Cambridge  University Press, Cambridge.

Gewirth, A. Reason and Morality (1978) University of Chicago Press, Chicago.

Rawls, J. A Theory of Justice (1971, Revised Edition 1999) Belknap Press of Harvard University  Press, Cambridge, Mass.

Daniels, N. “Justice, Health, and Healthcare” American Journal of Bioethics (2001) Spring;1(2):2-16.  Habermas, J. “Morality and Ethical Life: Does Hegel's Critique of Kant Apply to Discourse Ethics?”  Nw. U. L. Rev. 83:38 (1988-1989).


[1] ‘Ethical’, being an adjective, is difficult - an ‘ethical review’ is more a review that would be conducted in an ethical manner, rather than a review relating to ethics (although it tends to be used to mean the latter). So, here ‘ethical’ is avoided.

[2] WMA Declaration of Helsinki – Ethical Principles for Medical Research Involving Human Subjects (1964, and subsequently amended, most recently in 2013) helsinki-ethical-principles-for-medical-research-involving-human-subjects/

[3] to use the term that Ronald Dworkin brings to his modification of Utilitarianism in his book Taking Rights Seriously.  

[4] This differs from ‘empirical bioethics’, as merely taking public opinion unchallenged, does not recognise the social duty to interaction and reflection. Indeed, this could be one of the characteristics of ethics: ethics are positions that have to be devised, teased out, challenged - it is a work that the individual citizen has to undertake as  part of the social contract, part of the contract to live in a community. It is not enough to believe that ‘what I reck- on’ is a sufficient basis upon which to claim an authoritative position to pre- or proscribe the actions of others.  

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1. International Ethical Guidelines for Health-related Research Involving Humans, Fourth Edition. Geneva. Council for International Organizations of Medical Sciences (CIOMS); 2016, Guideline 23.

2. Council of Europe Additional Protocol to the Convention on Human Rights and Biomedicine on Biomedical Research.

3. Explanatory Report to Additional Protocol to the Convention on Human Rights and Biomedicine on Biomedical research:

4. Declaration of Helsinki (2013).

5. Council of Europe. Steering Committee on Bioethics. Guide for Research Ethics Committee Members. Council of Europe, 2012.

6. World Health Organization. Standards and Operational Guidance for Ethics Review of Health-Related Research with Human Participants. Geneva: World Health Organization; 2011.

7. World Health Organization. Research ethics committees. Basic concepts for capacity building. World Health Organization 2009.

8. UNESCO Establishing Bioethics Committees. Guide No.1. Paris, 2005.

Learning objectives

  • to understand the roles of REC members and the scope of RECs activities based on the international and national guidelines and regulations
  • to discuss potential challenges that REC members may face and share good practices to resolve them


Research ethics committees (RECs) are defined as multidisciplinary, independent groups of individuals appointed to review biomedical research protocols involving human beings (Additional Protocol to the Convention on Human Rights and Biomedicine, concerning Biomedical Research[1]). The RECs have to ensure that the dignity, fundamental rights, safety, and well-being of research participants are duly respected and protected[2]. RECs may be established at the institutional, local, regional or national level and are increasingly provided for by law. Although there are differences with respect to the appointment and work of RECs among different European countries, common issues in terms of roles and challenges for REC members may be identified.

Roles and responsibilities of REC members

There is a common agreement that RECs have a dual goal: to protect the rights and welfare of human research subjects and to support and facilitate the conduct of valuable research[3].

In respect to the main objective – to ensure that biomedical research is conducted ethically with respect to the dignity, rights, safety, and well-being of the research participants – REC members may have specific roles before, during, and after a research study is authorized and conducted.

The primary task of a REC is the ethical review of research proposals and supporting documents. As defined in the Additional Protocol to the Convention on Human Rights and Biomedicine, concerning Biomedical Research, approval or disapproval of the research is based on the ethical acceptability of the research, including its social value and scientific validity, an acceptable ratio of potential benefits to risks of harm, the minimization of risks, adequate informed consent procedures (including cultural appropriateness and mechanisms to ensure voluntariness), measures to ensure protection of vulnerable populations, fair procedures for selection of participants, and attention to the impact of research on the communities from which participants will be drawn, both during the research and after it is complete[4].

The RECs should follow up the ongoing research projects that they have approved. This may involve monitoring research in a variety of ways such as requiring reports at regular intervals or at the end of a project and notification of adverse reactions or even in some cases by carrying out ad hoc inspections or audits of research[5]. REC members may have the responsibility of deciding whether a trial ought to be terminated or continued in the light of any new developments during its conduct. However, these roles are remit-dependent and vary from country to country[6].

The roles of REC members after the research is completed are currently limited to ensuring that the obligations of researchers to the research participants, and/or to the groups or society from which they were recruited, are fulfilled. RECs may also demand to make the conclusions of the research publicly available[7].

In addition to their role in the protection of participants, they specifically help to ensure that research is soundly based and trustworthy, and consequently that medical interventions and treatments prescribed to patients have been assessed adequately. In this way, RECs help ultimately to improve the quality of health care[8].

Functions that aim to improve the overall culture of biomedical research, enhance communication between researchers and society, and raise awareness of ethical issues in biomedical research might include such activities as protecting and advocating the research participants during or after the research process or providing ethical or scientific advice to researchers. REC members may also be involved in the public education about research ethics policy and decision making[9].


There are several measures to ensure that REC members can effectively – carry on the tasks they are assigned, but at the same time REC members may face particular challenges in fulfilling their duties.

Defining the scope of ethical review: REC members may have to review a wide range of biomedical research studies: from those involving interventions to those using stored biological samples and personal data. RECs are not responsible for reviewing the ethical aspects of clinical practice, although the so-called ‘grey’ area of clinical audit, monitoring activities, experimental treatment is problematic in terms of their distinction from biomedical research. Recent discussion on the distinction between the use of innovative treatment (experimental treatment) in clinical practice and biomedical research is one of the examples[10],[11].

Ensuring both the ethical and scientific expertise: RECs are expected to ensure a plurality of different approaches and perspectives. REC membership consists of scientific, ethical, legal expertise to ensure the scientific quality of the research proposal, its conformity with national law and it must also represent the lay perspective to reflect the views of the public as well as those of patients (for example patient organizations, NGOs, or local communities). When evaluating a biomedical research proposal, REC members need to consider the ethical issues involved in respect to applicable ethical principles, to take into account legal provisions and any prior scientific reviews. It may be challenging to decide how to deal with a positive scientific evaluation of research proposals (that have been done either by the REC or by other competent bodies) if there are some ethical concerns and at the same time not to make ethical reviews overburdensome and too interventionist and not to prevent or delay worthwhile research.[12]

Collective decision making: As a rule, REC decisions are made during official periodic meetings where REC members discuss their concerns and opinions related to the protocols and the associated documents. Decisions are made either by consensus or voting in case the consensus cannot be reached. Given the pluralistic approach to moral decision making required from REC members the challenge might be to take into account the view of one member who objects to the research on the grounds of his or her personal moral commitments.

Independence basically means that RECs as such need to be autonomous from any political, institutional, professional, and market influences in their formation, procedures, and decision-making and REC members should be free from any professional or personal relation with the researchers and their sponsors. Ensuring this can be a significant challenge, for example, when institutional REC members may be asked to vote on proposals submitted by their colleagues or senior members of their department[13].

Managing conflicts of interest: Measures of independence can help to avoid serious conflicts of interest. In addition to that, when people are appointed to be REC members, they should declare any actual or potential conflicts of interest with respect to the work of the REC and agree to declare any conflicts that may arise subsequently. (Please, find more on conflict of interest in here)

Ensuring confidentiality: All REC members and staff should treat any information provided to RECs as confidential. Another aspect of confidentiality concerns the need to keep the content of discussions among REC members confidential in order to promote free and open discussion when proposals are reviewed. On the other hand, a REC as an institution is expected to be transparent and accountable to the public and to the appointing authorities (such as the Ministry of Health or the administration of the institution, for example universities). RECs should also make appropriate contacts and exchange information with other relevant bodies that are taking part in the review, authorization, and follow-up of research projects at regional, national, or international level. Reports of their activities should also be made available publicly[14].

Continuous training: The appropriate initial and continuing training adapted to the REC members’ needs are regarded as key elements to ensure the quality of RECs activities[15]. Training should lead to an understanding of ethical principles and their application in biomedical research; research design and methods and practicalities of conducting research. Regular meetings or conferences of RECs to share experience, to meet with representatives of regulatory authorities and experts in specific fields related to biomedicine are also very important. It should be noted that at least in some countries training of REC members is likely to be limited and resource dependent.


[1] Council of Europe. Additional Protocol to the Convention on Human Rights and Biomedicine, concerning Biomedical Research, 2005.

[2] The term Research Ethics Committees (REC) will be used in this module as it is a common term adopted in the European international documents and is used as a synonym of Institutional Review Board (in the USA) or research ethics review board used in other international guidelines or literature.

[3] Morris, M. C., & Morris, J. Z. (2016). The importance of virtue ethics in the IRB. Research Ethics, 12(4), 201–216.

[4] World Health Organization. Standards and Operational Guidance for Ethics Review of Health-Related Research with Human Participants. Geneva: World Health Organization; 2011.

[5] European Commission. European Textbook on Ethics in Research. European Luxembourg: Publications Office of the European Union, 2010.

[6] Council of Europe. Steering Committee on Bioethics. Guide for Research Ethics Committee Members. Council of Europe, 2012.

[7] Ibid.

[8] Ibid.

[9] Morris, M. C., & Morris, J. Z. (2016). The importance of virtue ethics in the IRB. Research Ethics, 12(4), 201–216.

[10] Asplund K., Hermerén G. The need to revise the Helsinki Declaration. The Lancet, Volume 389, No. 10075, p1190–1191. DOI:

[11] The Swedish National Council on Medical Ethics. Summary of the report Ethical assessments at the border between health and medical care and research, 2016:1.

[12] For further information please see the e-Manual.

[14] Council of Europe. Steering Committee on Bioethics. Guide for Research Ethics Committee Members. Council of Europe, 2012.

[15] Angela J. Bowen. Models of institutional review board function. Ezekiel J. Emanuel, Christine C. Grady, Robert A. Crouch, Reidar K. Lie, Franklin G. Miller, David D. Wendler. The Oxford Textbook of Clinical Research Ethics. Oxford University Press, 2008. p. 552-559

Cases and Questions - REC

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Case 1 Scope of the ethical review

One of the questions in the P. Macchiarini case was whether a novel treatment (transplantations using a synthetic trachea seeded with the patient's own stem cells) should be considered as a medical care or a research. According to the report Ethics Ethical assessments at the border between health and medical care and research, 2016:1, issued by the Swedish National Council on Medical Ethics: „Professor P. Macchiarini’s transplants have been the subject of intense debate among researchers and the general public. One of the questions in this case was whether the surgical procedures carried out should have been considered medical care or research. According to the Karolinska University Hospital, the procedures should have been regarded as medical care carried out on vital indications, whereas many others (including the Swedish Research Council, the Karolinska Institutet’s external investigator, the Karolinska University Hospital’s external investigator and the Health and Social Care Inspectorate) have suggested that they should have been evaluated as research experiments. “

- What makes an activity a biomedical research to be reviewed by the research ethics committee?