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OHRP Guidance – Obsolete Guidances

Office for Human Research Protections (OHRP)

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Archived Documents

The materials in this Archive are for reference only. All documents have been replaced by more current information or withdrawn because they no longer apply. They remain here solely as a reference for historical purposes and are not to be considered as appropriate for providing current guidance on implementation of 45 CFR Part 46.

For current guidance, please see Guidance Topics by Subject.
OPRR Decision Charts (February 1998)
Archived OPRR Reports "Dear Colleague" Letters
Jan 6, 1999: Expedited IRB Review--1998 Revised Categories (OPRR REPORTS 99-01)

Jul 1, 1998: Proposed Revision of 45 CFR 46 Subpart B (OPRR REPORTS 98-02)

Jun 30, 1998: NIH Policy on the Inclusion of Children in Research (OPRR REPORTS 98-03)

Nov 26, 1997: Expedited IRB Review, Proposed Revision of List (OPRR REPORTS 98-01)

Feb 20, 1997: Expedited IRB Review, Protocols Closed to New Enrollments (OPRR REPORTS 97-02)

Jan 10, 1995: Continuing Review--Institutional and Institutional Review Board Responsibilities (OPRR REPORTS 95-01)

Jul 22, 1994: In Vitro Fertilization, Prior EAB Review No Longer Required (OPRR REPORTS 94-03)

Jun 15, 1994: Summary Statement (NIH) Human Subject Coding (OPRR BULLETIN 6/15/1994)

Jun 1, 1994: HHS Awardee Compliance with 45 CFR 46 (OPRR BULLETIN 6/1/1994)

Apr 29, 1994 Fetal Tissue Transplantation--Ban on Research Replaced by New Statutory Requirements (OPRR REPORTS 94-02)

Apr 25, 1994: Women and Minorities, NIH Guidelines for Inclusion (OPRR REPORTS 94-01)

Aug 13, 1993: Gender Differences, Cllinical Evaluation of Drugs, FDA Guideline (OPRR REPORTS 93-04)

Feb 26, 1993: Parallel Track, Waiver of Local IRB Review for IND d4T (OPRR REPORTS 93-02)
Other Archived Documents
Certificate of Confidentiality: Privacy Protection for Research Subjects 9/1998

Compliance Oversight Procedures [PDF - 278K]

Continuing Review of DSMB-Monitored Clinical Trials 5/22/2000

Guidance on Continuing Review 7/11/2002 [PDF - 52KB]

Human Embryonic Stem Cells, Germ Cells and Cell-Derived Test Articles Guidance 11/16/2001

Institutional Review Board (IRB), Written Procedures 4/2/2002

International Research - An Introduction

IRB Approval Periods and Continuing Review of Research 1/20/2000 [PDF document]

IRB Written Procedures 7/11/2002 [PDF - 34KB]

Prisoner Research: OPRR Guidance 5/19/2000

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