Ethical Challenges

6. Research Ethics Committees

Research ethics committees review and oversee research involving humans.
Known as Institutional Review Boards (IRBs) in the US and as Ethics Review Boards (ERBs) or Research Ethics Committees (RECs) in other countries, they are the mechanism for enforcing research ethics standards and overseeing ongoing research.  Breaches in accepted ethical practices resulted in the establishment of oversight mechanisms.

Research ethics committees exist is almost every country and operate under legal/regulatory authority.  In the US, they are mandated by federal regulations that have the force of law but are appointed by and report to a research institution, such as a university, hospital, or research institute. There also are free standing for profit and not-for-profit IRBs. The Regulations mandate structure, composition/membership, meeting requirements, standard operating procedures and record keeping requirements.

Composition of IRBs/RECs is diverse. Generally, appointments include men and women from various scientific and nonscientific fields, members who are independent of institution(s) conducting the research or the organization(s) sponsoring it, and people who understand the research subjects and their environments.  Consultants may be called upon as needed, particularly if the research involves an area in which few or no regular members have expertise. Anyone with conflicts of interest must disclose those interest(s) and not participate in decision-making. Although scientists, advocates, institutional officials and ethicists all have views and interests, it is assumed that the group process, transparency and disclosure will result in balanced decisions.

Level of Review

 The US Regulations offer considerable latitude about whether a research proposal requires full review, expedited review or fits one of the exemption categories specified the Regulations.  Nonetheless, some institutions are hesitant to use the full range of review options and insist on full committee review of all proposals. Review of research that the ethics committee considers to be minimal risk may be expedited.  Some categories of research (46.110), as stipulated in the Regulations, may be exempt. The proposed rule changes will most likely update exempt and expedited categories as well as change the initial review requirements for types of research that may fit them.