Protecting Research Participants While Reducing Regulatory Burdens

The Department of Health and Human Services has proposed sweeping revisions to the federal regulations for the protection of human research participants. The goal is to "enhance protection while simultaneously eliminating unreasonable burdens." Although the goal is admirable, some changes...

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Bibliographic Details
Published inJAMA : the journal of the American Medical Association Vol. 306; no. 20; pp. 2260 - 2261
Main Authors Lo, Bernard, Barnes, Mark
Format Journal Article
LanguageEnglish
Published United States American Medical Association 23.11.2011
Subjects
Ethics Committees, Research - standards
Federal regulation
Government agencies
Human Experimentation - legislation & jurisprudence
Human subjects
Humans
Informed Consent
Medical research
Multicenter Studies as Topic
Review boards
Risk
United States
United States Dept. of Health and Human Services
Vulnerable Populations
United States
United States > US
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Summary:The Department of Health and Human Services has proposed sweeping revisions to the federal regulations for the protection of human research participants. The goal is to "enhance protection while simultaneously eliminating unreasonable burdens." Although the goal is admirable, some changes intended to remove unnecessary regulatory burdens may allow serious risks particularly to highly vulnerable participants. Lo and Barnes discuss major issues in the Advance Notice of Proposed Rule-Making--ensuring risk-based protections, institutional review board reviews of multisite studies, and informed consent.
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ISSN:0098-7484
1538-3598
1538-3598
DOI:10.1001/jama.2011.1727