DHHS-OHRP Proposed New Rulemaking


HHS Announces Proposal to Improve Rules Protecting Human Research Subjects

Changes under consideration would ensure the highest standards of protections for human subjects involved in research, while enhancing effectiveness of oversight

The comment period for the proposed changes to the HHS regulations has been extended to October 26, 2011. The U.S. Department of Health and Human Services (HHS)  announced on July 22, 2011 that the federal government is contemplating various ways of enhancing the regulations overseeing human subjects research.  See OHRP Portal at:  http://www.hhs.gov/ohrp/

Our local discussion board is now up and running. Login to mybb.gvsu.edu with a gvsu network faculty or student ID and start giving some wiki-style feedback! "Research Protections Program" will be a new item in your organizations panel. If you have problems or questions or you would like to be added to this new organization please email rpp@gvsu.edu.

This new organization in blackboard will allow researchers in the community to collaborate their ideas and improve the proposed new rules. 

Research Protections Program Chairman Dr. Reitemeier has prepared condensed resources for your viewing pleasure:

Highlights (46 pages)

PNRM Summary Highlights (1 Page)

PNRM Summary with 74 Questions (11 Pages)


Comparison of Rules Chart.pdf

Learn more on the web:

Emanuel & Menikoff A Process for Revising the Common Rule (6 pages)

ANPRM Frequently Asked Questions

PNRM Powerpoint

Proposed Data Security Standards

Explore presentations of the Advanced Notice of Proposed New Rule Making:

DHHS/OHRP Proposed New Rule Making (14:19min)

ANPRM Sections II-VIII (6:34min)

ANPRM Section II (6:02min)

ANPRM Section II.B.3 (3:45min)

ANPRM Section II.B.3(a) (6:22min)

ANPRM Section II.B.3(a)(3) (8:34min)

ANPRM Section II.B.3(c) (2:57min)

ANPRM Summary (5:50min)

Page last modified October 31, 2011