Pharmacist involvement in institutional review of clinical trials

Abstract

The establishment of an institutional review committee (IRC) for investigational clinical trials in a large community hospital is reported. After the need for an IRC was identified, the pharmacy and therapeutics committee charged the director of pharmacy with drafting a protocol for establishing an IRC. Following a literature review, guidelines were written for the IRC in the form of a committee manual. These guidelines were approved, and composition of the nine-member committee was set as follows: three members of the trustee medical education and research committee, three members of the medical staff, one member each of the clergy staff and the pharmacy staff, and one nonaffiliated community representative. The IRC reviews, approves or denies, and supervises all proposed clinical investigations. Risk/benefit ratios, purpose, recruitment and selection procedures, financial support, and informed consent documents of the proposed study are among the factors considered in the approval process. Guidelines for written policies and procedures governing IRC structure and activities are presented. The involvement of the pharmacist in the establishment and subsequent functions of the committee is described. IRC membership is an opportunity for the pharmacist to work with other professionals in protecting the rights and welfare of human research subjects.