Research Ethics Committees

In one line

The one safeguard in this module that operates before anything happens, and the only one that does not depend on the judgment of the person who wants the research to proceed.

In the wording a student can write in an exam: a research ethics committee reviews a research protocol before the research begins and has authority to approve, require changes to, withdraw approval for and suspend it; article 19 of the UNESCO Declaration of 2005 requires that independent, multidisciplinary and pluralist ethics committees be established, promoted and supported at the appropriate level; and the Declaration of Helsinki requires prior submission of the protocol, independence and authority to resist undue influence from the researcher, the sponsor or others, and, in international collaborative research, approval by committees in both the sponsoring and the host countries.

Why prior review is the decisive safeguard

Everything else in this module operates on the participant or on the investigator. Consent operates on the participant, who cannot assess the science. The other Nuremberg points operate on the investigator, who is the person with the strongest interest in proceeding.

A committee is the only mechanism that is prior, external and empowered. It sees the protocol before a participant is approached; it is not the person who wants the answer; and it can refuse.

The history in [Human Experimentation Before Nuremberg] explains why that combination is needed. The investigators there were competent and eminent, so competence is not a safeguard. The participants were unable to refuse, so consent is not a safeguard in the settings where research is easiest to conduct. What was missing was somebody with the power to say no who did not want the research to happen.

Article 19: what a committee must be

Independent, multidisciplinary and pluralist ethics committees should be established, promoted and supported at the appropriate level in order to:

• (a) assess the relevant ethical, legal, scientific and social issues related to research projects involving human beings;
• (b) provide advice on ethical problems in clinical settings;
• (c) assess scientific and technological developments, formulate recommendations and contribute to the preparation of guidelines on issues within the scope of the Declaration; and
• (d) foster debate, education and public awareness of, and engagement in, bioethics.

The three adjectives in the opening line are the examinable part.

Independent means independent of the researcher, the institution and the sponsor. A committee constituted by the body whose funding depends on the trial is not one, and this is the requirement most often defeated in practice.

Multidisciplinary because the issues are simultaneously scientific, legal, ethical and social, as clause (a) states, and no single discipline can assess all four. A committee of clinicians will not see the legal problem; a committee of lawyers will not see the design problem.