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Latest DAIDS Policies and SOPs |
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National Institutes of Health (NIH)
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- NIH Revitalization Act of 1993
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- NIH Brochure - Research on Human Specimens
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- Guidance on Data and Safety Monitoring for Phase I and II Trials
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- Notice to Grantees/Contractors re: FDA-NIH Interaction
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- Guidelines on Inclusion of Women/Minorities as Clinical Research Subjects
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- Required Education in Protection of Human Research Participants
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Guides to IND and Human Subject Regulations, Policies and Guidance - Applicable to DAIDS-Sponsored Clinical Trials - Food and Drug Administration (FDA)
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- 21 CFR Part 312 - Investigational New Drug Application
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- 21 CFR Part 312.32 - IND Safety Reports
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- 21 CFR Part 50 - Protection of Human Subjects
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- 21 CFR Part 54 - Financial Disclosure by Clinical Investigators
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- FDA Information Sheets - Guidance for Institutional Review Boards and Clinical Investigators
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- International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) - Good Clinical Practice
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Office for Human Research Protections (OHRP)
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- 45 CFR Part 46--Protection of Human Subjects
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- 2003 - Certificates of Confidentiality
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- 2003 - Guidance on Approving Research Involving Prisoners
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- 1997 - Storage of Tissue/Cell Repositories
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- 1993 - IRB Review of DAIDS clinical trials
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- 1988 - PHS Policy on Informing Those Tested About HIV Serostatus
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- 1984 - Guidance for Institutional Review Boards for AIDS Studies
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