DHHS - Advanced Notice of Proposed Rulemaking

Date: September 9, 2011

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/.

The discussion board and documents are now up and running! Login to mybb.gvsu.edu and work with others in the community to improve the proposed new rules. Researchers will have to log into the blackboard site with their faculty/student login and then click the course labeled "Research Protections Program" where you will be able to collaborate comments and concerns with other professionals in the research community. If you are having trouble finding the course or logging in, feel free to contact the HRRC or RPP via email or phone.

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)

Concerns

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

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