OHRP: Assurances & IRB Registration and Guidance Topics

• OHRP Home

• Assurances
• FAQs on Assurances
• OHRP Searchable Database – Approved Assurances and IRB Registry
• FAQs on IRB Registration
• Electronic Submission System for Federalwide Assurances and IRB/IEC Registrations
• Guidance on Extension of an FWA to Cover Collaborating Individual Investigators and Introduction of the Individual Investigator Agreement

• Applicability of 45 CFR part 46 to Clinical Investigations Conducted Under FDA's Interim Final Rule at 21 CFR 50.23(e) . See new FAQ
• Children Involved as Subjects in Research: Guidance on the HHS 45 CFR 46.407 (407) Review Process
• Engagement of Institutions in Research
• Engagement of Pharmaceutical Companies in HHS-Supported Research (PDF - 215 KB)
• Financial Relationships and Interests in Research Involving Human Subjects: Guidance for Human Subject Protection (PDF - 36 KB)
• Guidance for Investigators and Institutional Review Boards Regarding Research Involving Human Embryonic Stem Cells, Germ Cells and Stem Cell-Derived Test Articles (PDF - 29 KB)
• Guidance on Reporting Incidents to OHRP
• Guidance on Research Involving Coded Private Information or Biological Specimens (PDF - 24 KB)
• Human Subject Regulations Decision Charts
• The International Compilation of Human Subject Research Protections (PDF - 1.15 MB)
• IRB Guidebook
• Issues to Consider in the Research Use of Stored Data or Tissues
• OHRP Guidance on the Involvement of Prisoners in Research
• Oral History Letter and Policy Statement (in PDF - 264 KB) or letter text in (MS Word - 24 KB)
• Research that may be Reviewed through an Expedited Procedure
• Special Protections for Children as Research Participants

FDA Policies and Guidance

• Guidance for Institutional Review Boards and Clinical Investigators, 1998 Update

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