|
 |
OPRR Reports "Dear Colleague Letters"
Documents marked Archived have been replaced by more current information or withdrawn because they no longer apply.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.
- Jan 6, 1999: Archived Expedited IRB Review--1998 Revised Categories (OPRR Reports 99-01)
- Jul 1, 1998: Archived NIH Policy on the Inclusion of Children in Research (98-03)
- Jun 30, 1998: Archived Proposed Revision of 45 CFR 46 Subpart B (98-02)
- Nov 26, 1997: Archived Expedited Review of Certain Research by Institutional Review Boards, Proposed Revision (98-01)
- Feb 20, 1997: Archived Expedited Review, Protocols Closed to New Enrollments (97-02)
- Oct 31, 1996: Informed Consent Requirements in Emergency Research (97-01)
- May 5, 1995: Exempt Research and Research That May Undergo Expedited Review (95-02)
- Jan 10, 1995: Archived Continuing Review--Institutional and Institutional Review Board Responsibilities (95-01)
- Jul 22, 1994: Archived In Vitro Fertilization of Human Ova--Prior Review by the Ethical Advisory Board No Longer Required for HHS Funding (94-03)
- Jun 15, 1994: Archived Summary Statement Codes for Human Subjects (OPRR Bulletin)
- Jun 1, 1994: Archived Awardee Compliance with 45 CFR 46 Requirements (OPRR Bulletin)
- Apr 29 1994: Archived Fetal Tissue Transplantation--Ban on Research Replaced by New Statutory Requirements (94-02)
- Apr 25, 1994: Archived Inclusion of Women and Minorities in Research (94-01)
- Sep 1993: Local Institutional Review Board (IRB) Review of Multicenter Clinical Trials Sponsored by the Division of Aids (DAIDS) National Institute of Allergy and Infectious Diseases (NIAID)
- Aug 13, 1993: Archived Food and Drug Administration Guideline for the Study and Evaluation of Gender Differences in the Clinical Evaluation of Drugs(93-4)
- Aug 1993: Informed Consent--Legally Effective and Prospectively Obtained (93-3)
- Feb 26, 1993: Archived Waiver of Applicability of Title 45 CFR Part 46, Requirement for Local IRB Review for the Investigational New Drug d4T in the Parallel Track (93-02)
- Nov 1992: Local IRB Review of Multicenter Clinical Trials (93-01)
- Jun 1991:Final Common Rule for the Protection of Human Subjects
 [Pg 1-11 Background(1.85MB)]
[Pg 12-18 Common Rule Text(1.35MB)] [Pg 18-23 Amendments(.86MB)] [Pg 24-32 FDA Final Rule/Dept of Ed Interim Final Rule(1.35MB)] [Pg 1-32 Entire Document(5.0MB)]
- May 1991: Emergency Medical Care (91-01)
- May 1990: PHS Policy on Sex-Partner Notification
- Jun 1988: PHS Policy on Informing Those Tested About HIV Serostatus
- Dec 1984: Guidance for Institutional Review Boards for AIDS Studies
Documents above, marked [PDF document] are in Portable Document Format
(PDF) to retain the original format. To view or print these documents, you must use the
Adobe Acrobat viewer. Acrobat is free and available directly from Adobe's website with
full installation instructions.
|
Download Reader 
