This page features documents, mostly public-domain, of the IRB debate that may not be easily found elsewhere.

Documents on the NPRM

• Zachary M. Schrag. Comments on Notice of Proposed Rulemaking: Federal Policy for the Protection of Human Subjects. 1 January 2016

Documents on the ANPRM

Documents related to Department of Health and Human Services, “Human Subjects Research Protections: Enhancing Protections for Research Subjects and Reducing Burden, Delay, and Ambiguity for Investigators,” Federal Register 76, No. 143 (26 July 2011).

• Zachary M. Schrag, “How should human subjects regulations change? A guide to ‘Human Subjects Research Protections: Enhancing Protections for Research Subjects and Reducing Burden, Delay, and Ambiguity for Investigators’ for scholars in the social sciences, humanities, and journalism, and the organizations that serve them.”
• Zachary M. Schrag, Comments on advance notice of proposed rulemaking, “Human Subjects Research Protections: Enhancing Protections for Research Subjects and Reducing Burden, Delay, and Ambiguity for Investigators, 25 October 2011.

Comments to OHRP

Comments sent in reply to Federal Register notices enter the public domain, and they often contain important facts and insights about pressing matters of public policy. The federal Office of Human Research Protection (OHRP) does a good job of making comments available to individuals who request them, but it does not post those comments on the web. I have therefore set up this page to archive copies of the comments I request in the course of my research on IRBs.

Human Subjects Protection Training and Education Programs, 2008

• Federal Register notice, July 1, 2008 (Volume 73, Number 127), pages 37460-37463.
• Comments, October 2008.
  • Education RFI Comments_vol 1_10-2-2008
  • Education RFI Comments_Vol 2_10-2-2008
  • Education RFI Comments_Vol 3_10-2-2008
  • Education RFI Comments_Vol 4_10-2-2008
  • Education RFI Comments_Vol 5_10-2-2008
  • Education RFI Comments_Vol 6_10-29-2008

Categories of Research That May Be Reviewed by the Institutional Review Board Through an Expedited Review Procedure, 2007

• Federal Register notice, October 26, 2007 (Volume 72, Number 207), pages 60848-60851.
• Comments, January 2008. Expedited Review List Comments 25 Jan 08
• Historians’ Comments to OHRP, edited by Zachary M. Schrag

Information on Federalwide Assurances

• Colleges and universities not voluntarily extending FWAs to all research, January 2006. This list was provided by the Department of Health and Human Services in response to a Freedom of Information Act request from Jonathan Knight of the American Association of University Professors. I downloaded it from MedAnthro.net but could not find it again in the summer of 2010. AAUP List
• FWAs Not Optionally Selecting to Apply Federal Regs to All Research, 20 April 2010. This list was provided to me by the Department of Health and Human Services in response to a Freedom of Information Act request in April 2010. FWAs_Not Optionally Selecting to Apply Federal Regs to All Research_20 April 10
• Unchecked Boxes, 2006 and 2010. A comparison of the 2006 and 2010 lists.

Legal Cases

• Li v. Brown University in Providence
  • Complaint, 25 February 2011
  • Answer to Complaint, 6 April 2011
  • Order Referring Case to Mediation, 30 June 2011
  • Motion for Extension of Time, 13 January 2012
  • Dismissal Stipulation, 23 March 2012.
• Halikas v. University of Minnesota. Case number 4-94-CV-448, Federal District Court, Fourth Division, District of Minnesota; filed 18 May 1994; Judgment entered 9 June 1996

Federal Documents

U.S. Public Health Service, PPO #129: Clinical Investigations Using Human Subjects, 8 February 1966, Res 3-1. Human Subjects Policy & Regulations 1965-67, RG 443: Central Files of the Office of the Director, NIH, 1960-1982, National Archives, College Park, Maryland.

Reports and Policies

Smithsonian Institution, “HUMAN SUBJECTS RESEARCH FAQs,” June 2010. Accessed from http://www.si.edu/osp/Compliance/Human%20Subjects%20in%20Research/HUMAN%20SUBJECTS%20RESEARCH%20FAQs.doc, July 2010.

University of Texas System, “IRB Task Force Report: Trust, Integrity, and Responsibility in the Conduct of Human Subjects Research,” April 2009

Investigations of Specific Protocols and Researchers

• University of California, Davis.Attachments to 17 October 2011 letter to the Food and Drug Administration, concerning “Unauthorized Use of Biologic and Notification of Finding of Serious and Continuing Noncompliance.” The letter to the FDA concerning allegations of misconduct by Dr. J. Paul Muizelaar and Dr. Rudolph J. Schrot has been posted by the Sacramento Bee.

Non-Public Domain

“Big Drop in OHRP Letters, Open Cases Raise Questions of Agency Commitment,” Report on Research Compliance, March 2011, 1-3. Posted with permission.