- POLICY ISSUES
COGR Meets with OIRA Staff to Discuss Final Common Rule Under Review
COGR's Letter on NIH GCP Training Requirement
Analysis of Common Rule Comments
In January 2016, COGR staff and university and association volunteers began an analysis of the 2,186 comments submitted to regulations.gov in response to the Notice of Proposed Rulemaking (NPRM) on the Federal Policy for the Protection of Human Subjects (Common Rule). Respondents were grouped by category (e.g., patient, public, university, researcher, etc.) and comments on major provisions coded. A summary and table of the findings, as well as summaries for each respondent category, can be found below. For more information on this analysis, please contact Lisa Nichols, Director for Research & Regulatory Reform.
Common Rule NPRM Comment Summaries by Respondent Category:
HHS Office for Human Research Protections Review of Public Comments on the Common Rule NPRM
Common Rule Notices of Proposed Rulemaking
➣COGR's 2011 response to the Department of Health and Human Services (HHS) and White House Office of Science and Technology Policy (OSTP) advanced notice of proposed rulemaking (ANPRM) on Human Subjects Protections also known as the “Common Rule”.
➣COGR’s December 8, 2015 response to the HHS Common Rule notice of proposed rulemaking (NPRM) and response summary
Notification Letter for 45 CFR 46.118 Determinations for NSF Awards
COGR has been working with NSF staff to develop a letter that universities can submit for proposals lacking definite plans for involvement of human subjects. The letter indicates that the grant or protocol meets the requirements of 45 CFR 46.118 and stipulates that “one year from the date identified above, the Authorized Organizational Representative is required to either verify that the project continues to lack immediate plans for the involvement of human subjects, their data, or their specimens; or provide documentation to the cognizant NSF Program Officer to demonstrate that IRB approval has been obtained.” Universities that utilize this notification letter will therefore track the expiration through their financial or IRB systems (or other mechanisms). These changes will be reflected in the next version of the NSF Proposal and Award Policies and Procedures Guide that is scheduled for release in October 2016 and a link provided to the letter which will be available on the NSF website. Please contact Lisa Nichols if you have questions about the use of this letter.