Beneficence - Protecting Human Subject Research Participants

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Protecting Human Research ParticipantsCodes and RegulationsMain Menu | Glossary | HelpThe HHS Regulations – Protection of Human SubjectsPrevious Page 7 of 19NextThe ethical principles for research involving human subjects describedin the Belmont Report are codified in the Code of Federal Regulations,45 CFR 46. The NIH follows all Subparts of the HHS regulations:Subpart A – Basic HHS Policy for Protection of Human ResearchSubjectsSubpart B – Additional Protections for Pregnant Women, HumanFetuses and Neonates Involved in ResearchSubpart C – Additional Protections Pertaining to Biomedical andBehavioral Research Involving Prisoners as SubjectsSubpart D – Additional Protections for Children Involved as Subjects inResearchPrevious Page 7 of 19Nexthttp://phrp.nihtraining.com/codes/08_codes.php (1 of 2)6/20/2008 9:08:52 AM
Protecting Human Research ParticipantsCodes and RegulationsPrevious Page 8 of 19NextMain Menu | Glossary | HelpSubpart A - Basic HHS Policy for Protection of Human ResearchSubjectsSubpart A, also called “The Common Rule”, describes the required protections for all human subjects.Subpart A defines a human subject as “a livingindividual about whom an investigator...conductingresearch obtains:1. Data through intervention or interaction withthe individual, or2. Identifiable private information.”Subpart A defines research as “a systematicinvestigation...designed to develop or contribute togeneralizable knowledge.”This definition includes:●●●Research developmentTestingEvaluationPrevious Page 8 of 19Nexthttp://phrp.nihtraining.com/codes/08_codes.php (1 of 2)6/20/2008 10:13:14 AM
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