Proposed Changes to Federal Regulations Governing Human Subjects Research

On July 26, 2011, an Advance Notice of Proposed Rule Making (ANPRM) was published in the Federal Register. The advance notice – Enhancing Protections for Research Subjects and Reducing Burden, Delay, and Ambiguity for Investigators – outlines proposed changes to the Federal regulations governing protection of human subjects in research.

All stakeholders, including researchers, were encouraged to review the advance notice and submit comments for consideration. In order to encourage members of the University community to get involved in this issue, the office of the Institutional Review Board created this webpage to provide background information on the proposed changes.

The ANPRM comment period ended on October 26, 2011, but this webpage will remain active until the Federal Office for Human Research Protections releases a Notice of Proposed Rule Making sometime in 2013.

Helpful Information about the Proposed Changes

• The text of the Federal Register notice: Federal Register HHS-OPHS 2011-0005
• A table developed by the Office for Human Research Protections comparing existing rules with some of the proposed changes: OHRP ANPRM Change Table
• The ANPRM rule page put together by the Office for Human Research Protections, containing additional information of interest to stakeholders. 
• An article about the proposed changes published by the New England Journal of Medicine on July 25, 2011. 

Presentation by the IRB Coordinator

On Friday, September 2, 2011, the IRB Coordinator, Michelle L. Bowles, gave a presentation about the proposed changes as part of the College of Nursing’s Responsible Conduct of Research seminar series. Dr. Cindy Anderson, Associate Dean of Research for the College of Nursing, has graciously agreed to let us share this presentation with the University community.

• The Powerpoint of this presentation with audio embedded: UND ANPRM Slideshow (PPT with audio)
• An mp3 file of the audio only of this presentation: UND ANPRM Audio File (mp3)
• The Powerpoint slides in PDF format for this presentation: UND ANPRM Handout