Chapter 5.Committee Review and the Institutional Review Board System

Abstract

The ethical review of research protocols by an independent committee ensures that the rights and welfare of study participants are protected and that the potential benefits outweigh the risks to participants (where this is appropriate). Before embarking on a study, researchers are obligated by law to submit a protocol describing the study methods and its significance to a review committee which, in the United States, is known as an institutional review board (IRB). In other countries, however, alternative terms have been used to refer to ethics review committees. For example, in Canada, they have been referred to as research ethics boards (Canadian Institutes of Health Research 1998). Committee members, including professionals and lay persons, must be independent from the investigators and the sponsor of the research or funding agency (Levine 2009). In addition to reviewing the research protocol, members of review committees should carefully examine the informed consent statement submitted by the investigators for its completeness and clarity. Provisions for obtaining the informed consent of participants respect their autonomous right to make an informed decision whether to participate in the study (as discussed in Chapter 3). Consent statements must be written in a language that is understandable to a lay person. The members of the review committee should also ensure that there is no manipulation or coercion in recruiting research participants.