- Home
- Research
- Research & Economic Development
- Institutional Review Board
- Feedback-IRB Federal Regs Changes
Research & Economic Development
Office of Vice PresidentDivision Units
Biomedical Research CenterComputational Research CtrGrants & Contracts- Contact
- Cost Accounting Standards
- Department Training Manual
- Federal Information
- Forms
- Grants Management
- Main Page
- Proposals
- Feedback- IRB Federal Regs Changes
- Policies and Procedures
- IRB Forms
- Human Subject Education
- Schedule of Meetings
- IRB Members
- Research Participants
- Fed. Reg. & Guidelines
- Frequently Asked Questions
- IRB Links
- Main Page
- Contact
- External Funding
- Internal Funding
- Forms
- Main Page
- Proposal Preparation
- Compliance Policies and Procedures
Division Information
Add'l Resources/InformationCommittees- Associate Deans for Research
- Conflict of Interest/Scientific Misconduct
- Institutional Animal Care and Use Committee (IACUC)
- Institutional Biosafety Committee
- Intellectual Property Committee
- Radiation Safety and Hazardous Materials Committee
- Senate of Scholarly Activities
Feedback - IRB Federal Regulations Changes
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 2012.
Helpful Information about the Proposed Changes
The text of the Federal Register notice may be found here: Federal Register HHS-OPHS 2011-0005 (PDF)
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: http://www.hhs.gov/ohrp/humansubjects/anprm2011page.html
An article about the proposed changes published by the New England Journal of Medicine on July 25, 2011: http://www.nejm.org/doi/full/10.1056/NEJMsb1106942
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 (PDF)
Leave this field empty