Institutional review boards: Actions needed to improve federal oversight and examine effectiveness : report to congressional requesters

Institutional review boards: Actions needed to improve federal oversight and examine effectiveness : report to congressional requesters

Collection:
Health Policy and Services Research
Alternate Title(s):
Actions needed to improve federal oversight and examine effectiveness: report to congressional requesters
Contributor(s):
United States. Government Accountability Office, issuing body.
Publication:
Washington, DC : United States Government Accountability Office, January 2023
Language(s):
English
Format:
Text
Subject(s):
Ethics Committees, Research -- legislation & jurisprudence
Government Regulation
Legislation, Medical
Research Subjects -- legislation & jurisprudence
Risk Assessment -- legislation & jurisprudence
United States
Genre(s):
Technical Report
Abstract:
Why GAO did this study. IRBs review research studies involving human subjects to ensure that risks to subjects are minimized and participants have sufficient information to consent to participate. In the past, IRBs were based at research institutions, such as academic centers. Over time, independent IRBs have played a more prominent role in reviewing research on human subjects. Some policymakers and others have raised questions about the increased use of independent IRBs and the effects on protecting human subjects. GAO was asked to examine independent IRBs, processes used to protect human subjects, and standards of IRB quality, among other things. This report describes the composition of the IRB market and examines OHRP and FDA oversight of IRBs, among other objectives. GAO reviewed federal laws and regulations and articles published between 2010 and June 2021; analyzed IRB registration, drug application, and inspection data; and interviewed FDA and OHRP officials, experts and stakeholders, and 11 IRBs selected for variation in type, size, and other factors. What GAO Recommends. GAO is making four recommendations, including that HHS and FDA conduct annual risk assessments to determine if the agencies are routinely inspecting an adequate number of IRBs and to optimize the use of inspections in the oversight of IRBs and protection of research participants, and examine and implement approaches for measuring IRB effectiveness. HHS concurred with the recommendations.
Copyright:
The National Library of Medicine believes this item to be in the public domain. (More information)
Extent:
1 online resource (1 PDF file (iii, 91 pages))
Illustrations:
Illustrations
NLM Unique ID:
9918589885906676 (See catalog record)
Permanent Link:
http://resource.nlm.nih.gov/9918589885906676