The Work of Phase I Ethics Committees: Expert and Lay Membership

Abstract

Previous research has noted that members of research ethics committees are unclear about the extent of their roles. In this study, research amongst members of independent ethics committees (IECs) about how the ‘expert’ and ‘lay’ roles are understood and operationalized offers an explanation for this lack of clarity.

IECs were selected for study because they have only addressed one type of research (Phase 1 ‘healthy volunteer’ studies) and this limited remit suggested that it would be in such committees that the member roles would have become most pronounced.

Drawing on findings from the sociology of professions and employing a phenomenological approach to understanding, 20 semi-structured interviews with both expert and lay members of these committees revealed that a number of members were not only unclear about the roles, but unclear too whether they, or certain of their colleagues, were in which membership category. Notwithstanding this fact, and paradoxically, the ‘expert’ designation was seen as granting its members a privileged position on the committees. The expert member was seen to be either a medically qualified member or one tightly associated with the medical model. Such a repository of expertise being with the medical model privileges this model in ethics review such that other matters formally to be scrutinized by ethics committees become marginalised.

Participant safety was the prime concern of the ethics review for IEC members. This relegated other matters including the adequacy of the insurance arrangements, the readability of the consent forms, the fairness of the inclusion criteria, and so forth, into areas of lesser concern. That this occurs though when the science, the safety and the methodology of the trials are already – separately - subject to an independent analysis by a body of experts, whose statutory role is to concern itself with these issues such that no trial may occur without their sanction, is of significance. IEC members were cognizant of this duplication of role but unable to resolve it. The situation could be accounted for as due to capture by the medical model and a cognitive dissonant process.

Members’ training and education were found to have been neglected because under the medical professions’ gaze no other type of knowledge was considered necessary in ethics review. The study revealed that the medical profession’s dominance of such committees accounts for the members’ role uncertainty and as such allies itself to Freidson’s theory of professional dominance. If such a concept has been thought to be an obsolete one, this study suggests such a notion of the status of the theory is premature. The medical model’s status is implicitly accepted such that nothing else need be considered.

The research calls for further studies to corroborate such findings in other research ethics settings and for a debate about what society wants its ethics committees to focus upon in their review.