一项关于机构审查委员会（IRB）决策的12年审计。

A 12-year audit of IRB decisions.

作者信息

Grodin M A, Zaharoff B E, Kaminow P V

出版信息

QRB Qual Rev Bull. 1986 Mar;12(3):82-6. doi: 10.1016/s0097-5990(16)30018-5.

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.

摘要

机构审查委员会（IRB）是由联邦政府授权的跨学科委员会，负责审查所有涉及在接受联邦资金的机构中开展的人体受试者的研究方案。IRB的目的是保护这些受试者免受不必要的风险或超过潜在益处的风险。在波士顿市医院，对该医院IRB在12年期间（从1973年至1984年）的决策过程进行了一项研究，以实证确定所审查的研究方案类型、经常解决的问题、采取的行动以及决策过程的一致性。