Donehew G R, Schaumberg J P
Hosp Pharm. 1979 Sep;14(9):508-9, 512, 515 passim.
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.
自第二次世界大战以来，人们对生物医学研究中保护人类受试者的关注显著增加。《纽伦堡法典》和《赫尔辛基宣言》已发布。美国卫生、教育与福利部（DHEW）制定并发布了相关规定，明确了研究机构为获得DHEW用于涉及人类受试者研究的资金而必须遵循的审查程序。该程序的一部分包括由机构审查委员会（IRB）对研究项目进行审查。IRB的成员必须多样化，且应包括相关科学家。由于许多项目都包含研究性药物，因此吸纳一名药剂师作为成员是合理的。如果选择得当并做好准备，药剂师在审查研究项目时可以发挥至关重要的作用，协助评估计划的科学价值、志愿者协议的适当性以及项目的法规合规性。选定的药剂师应将这项职责视为临床药学实践的又一次机会。
