DHHS-OHRP Proposed New Rulemaking

July, 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 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/. Because the announcement came in the middle of summer when many academic researchers were off campus, and due to significant negative pressure from the regulated community for the short 60 day comment period for the proposed changes to the HHS regulations was extended an additional 60 days to October 26, 2011. More than 1200 comments were received inn the web portal by the deadline, including one from the HRRC at GVSU..

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.

Human Research Review Committee has condensed resources concerning the proposed changes to the regulations and the GVSU response to them. At the December, 2014 meeting of the national Public Responsibility in Medicine and Research (PRIM&R) it was announced that while some significant progress had been made concerning some of the revisions to the regulations proposed new regulations were unlikely to appear in the near future. When they do appear, there will be several opportunities for public comment before the new rules are finalized and effective.

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

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)