The pharmacist's role as a member of the institutional review board

Since World War II, concern about the protection of human subjects in biomedical research has increased considerably. The Nuremberg Code and the Helsinki Declaration have been published. The United States Department of Health, Education, and Welfare (DHEW) has developed and published regulations that specify a review process which research institutions must follow in order to receive DHEW funds for research involving human subjects. Part of this process includes a review of research projects by an Institutional Review Board (IRB). Membership on the IRB must be varied and should include allied scientists. Because many of the projects include investigational drugs, the inclusion of a pharmacist as a member is logical. The pharmacist, if properly selected and prepared, can play a vital role in the review of research projects by assisting in the evaluation of the scientific merit of the plan, the appropriateness of the volunteer agreement, and the regulatory compliance of the project. The selected pharmacist should view the duty as another opportunity to practice clinical pharmacy.