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IRB Directors' Perceptions of Proposed Revisions to the Regulations for Protecting Human Subjects
McDowell, Ryan
McDowell, Ryan
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Abstract
In July, the U.S. Department of Health and Human Services (HHS), in association with the Office of Human Research Protections (OHRP) and the Food and Drug Administration (FDA), issued an Advance Notice of Proposed Rulemaking focused on modernizing the federal regulations for the protection of human subjects. Three areas targeted for revisions would have a substantial effect on how IRBs review human subjects research: ensuring risk-based protections, streamlining IRB review of multi-site studies and improving informed consent. The current study aimed to assess IRB Directors' perceptions of these proposed revisions and identify any barriers to implementation. The results of the study showed that IRB Directors agree that the federal regulations need to be updated and generally agree with the proposed revisions regarding mandating singe IRB review of multi-site studies and efforts to improve the length and complexity of informed consent forms. However, subjects did not agree with the proposed changes in regards to the new "excused" category, specifically the concept of allowing investigators to register studies with the IRB opposed to submitting for IRB review and approval prior to commencing research activities.
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Date
2011-12-31
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Publisher
University of Kansas
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Research Projects
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Keywords
Ethics, Medical ethics, Public health, Common rule, Informed consent, Irb, Multi-site studies, Regulation, Risk