title: A 12-year audit of IRB decisions.
abstract: Institutional review boards (IRBs) are inter-disciplinary committees mandated by the federal government to review all research protocols that involve human subjects developed in institutions receiving federal funds. The purpose of the IRB is to protect those subjects from unnecessary risk or from risks that outweigh potential benefits. At Boston City Hospital, a study was conducted of the decision-making process of the hospital's IRB over a 12-year period (from 1973-1984) to determine empirically the types of research protocols reviewed, problems frequently addressed, actions taken, and the consistency of the decision-making process.
mesh_terms: D001900:Boston; D003219:Confidentiality; D026724:Ethical Review; D004989:Ethics; D028741:Ethics Committees, Clinical; D028744:Ethics Committees, Research; D004991:Ethics, Institutional; D035082:Federal Government; D033161:Government Regulation; D006746:Hospital Bed Capacity, 500 and over; D006773:Hospitals, Municipal / Q000592:standards*; D006779:Hospitals, Public / Q000592:standards*; D006805:Human Experimentation; D006801:Humans; D007258:Informed Consent; D008485:Medical Audit / Q000379:methods*; D011367:Professional Staff Committees