Federal Regulations and Guidelines
- Department of Health and Human Services (DHHS) Regulations (Common Rule) (45 CFR 46)
- OHRP Common Findings and Guidance
- Food & Drug Administration (FDA) Human Research Regulations
- Food & Drug Administration (FDA) Information Sheet
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 has developed the background information below on the proposed changes.
The ANPRM comment period ended on October 26, 2011, and there has been no new information from the federal government on the proposed changes.
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.