Alphabetical List

AIDS Research, Guidance for IRBs (1984)

Approval of Research with Conditions: OHRP Guidance (2010)

Certificates of Confidentiality - Privacy Protection for Research Subjects: OHRP Guidance (2003)

Children as Research Subjects and the HHS "407" Process

Children: Information on Special Protections for Children as Research Subjects

Clinical Data Registries - OHRP Correspondence (2015)

Clinical Trial Websites: When is IRB Review Required and What Should IRBs Consider with Reviewing? (OHRP Guidance, 2005)

Coded Private Information or Biospecimens Used in Research, Guidance (2018)

Coded Private Information or Specimens Use in Research, Guidance (2008)

Continuing Review Guidance (2010)

Correspondence on "Non-engaged" Scenarios

Determining When Institutions are Engaged in Research (January 13, 2009)

Effects of Disasters on Human Research Protections Programs Guidance

Emergency Medical Care and Research: OPRR Letter (1991)

Engagement of Institutions in Human Subjects Research (2008)

Engagement: When are Survey Firms Engaged in Research?; Clarification Regarding the Relationship between Institutional Engagement and the Federal Wide 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

Exemptions for Public Benefit and Service Programs

Expedited Review Procedures Guidance (2003)

Expedited Review: Categories of Research that may be Reviewed Through an Expedited Review Procedure (1998)

Extending an FWA to Cover Collaborating Investigators (2005)

Fetal Tissue Transplantation Research Guidance (2003)

Financial Conflict of Interest: HHS Guidance (2004)

Genetic Information Nondiscrimination Act (GINA): OHRP Guidance (2009)

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

Human Subject Regulations Decision Charts: 2018 Requirements

Human Subject Regulations Decision Charts: Pre-2018 Requirements

Indwelling Catheter QI Procedures: (July 30, 2008)

Indwelling Catheter QI Procedures: Letter, July 30, 2008

Informed Consent Checklist (1998)

Informed Consent of Subjects Who Do Not Speak English (1995)

Informed Consent Posting Instructions (2022)

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)

Informed Consent Requirements in Emergency Research (OPRR Letter, 1996)

Informed Consent Tips (1993)

Informed Consent, Legally Effective and Prospectively Obtained (OPRR Letter, 1993)

Institutional Review Board Written Procedures: Guidance for Institutions and IRBs (2018)

IRB Meetings Convened via Telephone Conference Call: OPRR Memorandum (2000)

IRB Review of Applications for HHS Support (2000)

IRB Review of Protocol and Informed Consent Changes for NCI/CTEP-Sponsored Clinical Trials

IRB Review of Protocol and Informed Consent Changes in Cooperative Group Protocols (OHRP Memo to the National Cancer Institute, 2008)

Issues to Consider in the Research Use of Stored Data or Tissues (1996, 1997)

Minutes of Institutional Review Board (IRB) Meetings Guidance for Institutions and IRBs

National Health Registry Activities and 45 CFR part 46 (2011)

National Health Registry Activities, OHRP August 11, 2011

National Health Registry Activities, OHRP December 29, 2011

OHRP Guidance on Coronavirus (2020)

OHRP Guidance on Elimination of IRB Review of Research Applications and Proposals (2020)

OHRP Guidance on Maintaining Consistency Regarding the Applicability of the 2018 or Pre-2018 Requirements (2020)

OHRP’s Compliance Oversight Assessments (2024)

OHRP’s Viewpoint on Conflicting Interests of PedCIRB Members

Posting Requirement for the Exemption at 45 CFR 46.104(d)(5) of the 2018 Requirements (2022)

Prisoner Involvement in Research (2003)

Quality Improvement Activities: OHRP Correspondence Regarding Indwelling Catheter Procedures (2008)

Reporting Incidents to OHRP (2022)

Reviewing and Reporting Unanticipated Problems Involving Risks to Subjects or Others and Adverse Events: OHRP Guidance (2007)

Secretarial Waivers

Statute on Fetal Tissue Transplantation Research (1993)

Student Subject Pools and Use of Penalties for Students Who Fail to Show up for Scheduled Research Appointments (January 8, 2010)

Text Version of OHRP Decision Charts: Pre-2018 (2016)

Use of a Central Institutional Review Board (OHRP Letter, 2010)

Use of a Central IRB: Announcement (2010)

Use of a Central IRB: McDeavitt to Menikoff, April 13, 2010

Use of a Central IRB: Menikoff to McDeavitt, April 30, 2010

Use of Electronic Informed Consent: Questions and Answers

Use of Penalties for Students Who Fail to Show up for Scheduled Research Appointments (January 8, 2010)

Use of Penalties for Students Who Fail to Show up: Letter to SONA SYSTEMS, (January 8, 2010)

Withdrawal of Subjects from Research Guidance (2010)