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Policy & Guidance Index

Policy and Guidance documents are listed alphabetically below. The columns to the right of the document titles indicate the topic categories in which the documents are grouped.

Please note that all documents in the Policy and Guidance section of the OHRP website reflect current regulatory guidance and findings, including older materials published by OHRP's predecessor organization, the Office for Protection from Research Risks (OPRR).

Superseded policy and guidance documents, and other historical materials, are located in the OHRP Archive. .

Document Topic	Category
	Informed Consent
		Institutional Issues
			For Investigators
				Vulnerable Populations
					Protocol Review
						Biological Materials and Data
							Frequently Asked Questions (FAQs)
								Checklists& Decision Trees
45 CFR 46 (the HHS Human Research Regulations) FAQs (PDF - 38 KB)
AIDS Research, Guidance for IRBs (1984)
Approval of Research with Conditions: OHRP Guidance (2010) (PDF - 63KB)
Assurance Process FAQs (PDF - 68 KB)
Belmont Report
Certificates of Confidentiality - Privacy Protection for Research Subjects: OHRP Guidance (2003) (PDF - 18.9 KB)
Children: Information on Special Protections for Children as Research Subjects
Children Involved as Subjects in Research: Guidance on the HHS 45 CFR 46.407 ("407") Review Process (2005) (PDF - 113 KB)
Children: Research with Children FAQs (PDF - 69 KB)
Clinical Trial Websites: When is IRB Review Required and What Should IRBs Consider with Reviewing? (OHRP Guidance, 2005) (PDF - 33.5 KB)
Coded Private Information or Biological Specimens: Issues to Consider in the Research Use of Stored Data or Tissues, Operation of Biological Repositories: OPRR Memoranda (1996, 1997)
Coded Private Information or Biological Specimens: OHRP Guidance on Research (2008) (PDF - 37.5 KB)
Coded Private Information or Biological Specimens, Research Use (Video)
Compliance Oversight Procedures Used by OHRP (2009) (PDF - 47 KB)
Continuing Review: OHRP Guidance (2010) (PDF - 52 KB)
Correspondence
Emergency Medical Care and Research: OPRR Letter (1991)
Emergency Research Informed Consent Requirements (OPRR Letter, 1996)
Engagement of Institutions in Human Subjects Research: OHRP Guidance (2008) (PDF - 66 KB)
Engagement of Institutions in Human Subjects Research: Correspondence Regarding "Non-engagement" Scenarios (2011) (PDF - 28 KB)
Engagement: When are Survey Firms Engaged in Research?; Clarification Regarding the Relationship between Institutional Engagement and the Federalwide Assurance (FWA) (January 13, 2009, OHRP Letter)
Exculpatory Language in Informed Consent Documents: Examples of Acceptable and Unacceptable Language (OPRR Letter, 1996)
Exempt Research and Research That May Undergo Expedited Review
Exempt Research Determination FAQs (PDF 26 -KB)
Exempt Research: Exemptions for Public Benefit and Service Programs (OPRR Guidance)
Expedited Review: Categories of Research that may be Reviewed Through an Expedited Review Procedure (1998)
Expedited Review Procedures: OHRP Guidance (2003) (PDF - 207 KB)
Expedited Review: Clarification of "Noninvasive" in Expedited Review Category 3
Extension of an Institutional FWA via an Individual Investigator Agreement: OHRP Guidance (2005) (PDF - 43.9 KB)
Fetal Tissue Transplantation: OHRP Guidance (2003) (PDF - 14.7 KB)
Fetal Tissue Transplantation Research, Public Law 103-43, Section 498A (1993)
Financial Conflict of Interest: HHS Guidance (2004) (PDF - 85 KB)
Genetic Information Nondiscrimination Act (GINA): OHRP Guidance (2009) (PDF - 38 KB)
HIV Serostatus, Informing Those Tested, PHS Policy (1988)
HIV Serostatus, Sex-Partner Notification, PHS Policy (1990)
Human Embryonic Stem Cells, Germ Cells, and Cell-Derived Test Articles: OHRP Guidance (2002)
Human Subject Regulations Decision Charts (2004)
Informed Consent Checklist (1998)
Informed Consent FAQs (PDF - 135 KB)
Informed Consent, Legally Effective and Prospectively Obtained (OPRR Letter, 1993)
Informed Consent: Obtaining and Documenting Informed Consent of Non-English Speakers (OPRR Memo, 1995)
Informed Consent Requirements (Video)
Informed Consent Requirements for In Vitro Medical Device Clinical Investigations Conducted Under FDA’s Interim Final Rule at 21 CFR 50.23(e) (OHRP Guidance, 2006) (PDF - 46 KB)
Informed Consent Tips (1993)
Investigator Responsibility FAQs (PDF 44 KB)
IRB Meetings Convened via Telephone Conference Call: OPRR Memorandum (2000) (PDF - 54 KB)
IRB Membership (Video)
IRB Records, Part One (Video)
IRB Records, Part Two (Video)
IRB Registration Process FAQs (PDF - 34 KB)
IRB Review of Applications for HHS Support: OPRR Memorandum (2000)
IRB Review of Protocol and Informed Consent Changes in Cooperative Group Protocols (OHRP Memo to the National Cancer Institute, 2008)
Prisoner Research Certification
Prisoner Research: OHRP Guidance (2003) (PDF - 22 KB)
Prisoner Research FAQs (PDF - 64 KB)
Quality Improvement Activities FAQs (PDF - 37 KB)
Quality Improvement Activities: OHRP Correspondence Regarding Indwelling Catheter Procedures (2008)
Reporting Incidents to OHRP: Guidance on When and How to File Incident Reports (2011) (PDF - 51.6 KB)
Research Involving Vulnerable Populations (Video)
Reviewing and Reporting Unanticipated Problems Involving Risks to Subjects or Others and Adverse Events: OHRP Guidance (2007) (PDF - 180 KB)
Reviewing and Reporting Unanticipated Problems Involving Risks to Subjects or Others and Adverse Events (Video)
Use of a Central Institutional Review Board (OHRP Letter, 2010)
Use of Penalties for Students Who Fail to Show up for Scheduled Research Appointments (OHRP Letter, 2010)
Viewpoint on Conflicting Interests of Pediatric Central IRB (PedCIRB) Members (2005)
Withdrawal of Subjects from Research: Data Retention and Other Related Issues: OHRP Guidance (2010) (PDF - 45 KB)
Written Institutional Review Board (IRB) Procedures: OHRP Guidance (2011) (PDF - 58 KB)