Beneficence - Protecting Human Subject Research Participants

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Protecting Human Research ParticipantsCodes and RegulationsMain Menu | Glossary | HelpEngagement in Human Subjects ResearchPrevious Page 17 of 19NextEach institution that is engaged in NIH-funded human subjects research must:●●Obtain or hold a current Federalwide Assurance (FWA), assuring that an institution will complywith HHS regulatory requirements for the protection of human subjects (this is obtained from theHHS Office for Human Subjects Protections (OHRP); andCertify to NIH that grant applications and contract proposals describing research involving humansubjects has been reviewed and approved by an Institutional Review Board (IRB) designated in theFWA, and will be subject to continuing review by an IRB.IRBs are committees that consist of 5 or more members with varying expertise and diversity that areresponsible for reviewing and approving human subjects research activities on behalf of institutions.The Common Rule specifies:● IRB membership (45 CFR 46.107)● IRB functions & operations (45 CFR 46.108)● IRB review of research (45 CFR 46.109 and 45 CFR 46.110)● Criteria for IRB approval of research (45 CFR 46.111)And more!The roles and responsibilities of IRBs are discussed extensively in the module on Beneficence.http://phrp.nihtraining.com/codes/17_codes.php (1 of 2)6/20/2008 10:02:13 AM
Protecting Human Research ParticipantsCodes and RegulationsMain Menu | Glossary | HelpExemptionsPrevious Page 18 of 19NextThe HHS regulations describe categories of human subjects research that may be exempt fromrequirements described in the HHS regulations including IRB oversight.Studies proposing only research that falls under one or more of the exemptcategories of research do not require IRB review and approval, but the HHSOffice for Human Research Protections (OHRP) has stated that:“Institutions should have a clear policy in place on who shalldetermine what research is exempt under 46.101(b)” and thatinvestigators should not be able to determine whether or not their ownresearch is exempt. This authority should rest with the IRB or other entitydesignated by the institution.The exemptions can be found at 45 CFR 46.101(b).Previous Page 18 of 19Nexthttp://phrp.nihtraining.com/codes/18_codes.php6/20/2008 10:04:49 AM
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