| Popis: |
Research ethics committees (RECs) are committees that review proposals to conduct research involving human subjects to assure that it will be performed in compliance with relevant legal and ethical standards. In the United States, where these committees are called institutional review boards (IRBs), their review and approval is required by law for all research that is either supported with federal funds or subject to regulation by the Food and Drug Administration. Most institutions voluntarily extend the requirement for IRB review to all research involving human subjects. IRB membership must include no fewer than 5 persons, both men and women, at least one nonscientist and at least one individual who has no connection with the institution apart from such membership. Historically, IRBs were located in the institution in which the research was carried out. In recent years there has been an increasing number of ‘noninstitutional’ review boards (also called ‘central’ review boards); whether review by such boards is sufficient to accomplish the purposes of IRB review is controversial. Resolution of this and other controversies about the quality of IRB performance is very difficult owing to a lack of widely accepted standards for the evaluation of IRB performance. |
