June 28, 2010

National Academies Launches Study of Research Universities

The National Academies has created an ad hoc committee to conduct a study and issue a report with findings and recommendations on the question: “What are the top ten actions that Congress, the federal government, state governments, research universities, and others could take to assure the ability of the American research university to maintain the excellence in research and doctoral education needed to help the United States compete, prosper, and achieve national goals for health, energy, the environment, and security in the global community of the 21st century?”

The Consensus Report is scheduled to be released in approximately May 2011. The 21-member committee includes UC Berkeley faculty member Laura D’Andrea Tyson.

June 01, 2010

NIH Seeks Comments on Proposed Changes to Financial Conflict of Interest Regulations

The Department of Health and Human Services issued a Notice of Proposed Rulemaking in the May 21 Federal Register requesting public comment on the proposed changes to the Public Health Service (PHS) regulations on the Responsibility of Applicants for Promoting Objectivity in Research for which PHS Funding is Sought and Responsible Prospective Contractors. The National Institutes of Health is accepting comments on behalf of the PHS; comments must be received by July 20, 2010.

NIH Director Francis Collins stated in a May 20 press briefing that this “will be a substantial change in the way in which NIH seeks to oversee potential financial conflicts of interest.”

Briefly, the proposed rules would change the threshold for a “significant financial interest” to $5,000 from the current $10,000, and would require institutions to determine if a conflict of interest is significant, report to the NIH or other PHS agency details on how conflicts of interest are being managed, and publish information concerning identified financial conflicts of interests on publicly accessible web sites. See the 26-page Federal Register Notice and other resources for complete information.

July 21 Update

The Department of Health and Human Services has extended the comment period for 30 days to August 19, 2010, to clarify certain elements of the proposed rule for which HHS is seeking additional comment.

New NIH Policy on Post-Submission Application Materials

The National Institutes of Health is changing agency policy to only allow grant application materials to be accepted after submission of the application but before the initial peer review if they result from unforeseen administrative issues. The change will be effective for applications submitted for the September 25, 2010 receipt date and thereafter.

The May 21 NIH Guide Notice includes lists of acceptable post-submission materials under the new policy, unacceptable post-submission materials, exceptions, and page limits for post-submission materials.

Exceptions include:
  • Applications submitted in response to Requests for Applications that have only one due date.
  • Applications for training grants. NIH posted additional guidance for training grant applications in a June 11 NIH Guide Notice.
  • Certain NIH Funding Opportunity Announcements may allow certain other types of post-submission materials to facilitate the goals of the program.

June 11, 2010: Enhancing Peer Review Advance Notice: New NIH Policy on Post-Submission Application Materials (NOT-OD-10-091)
July 23, 2010: Enhancing Peer Review: New NIH Policy on Post-Submission Application Materials (NOT-OD-10-115)