Fiscal Year 2009 will not be leaving us with a shortage of topics to discuss. Are you as out of breath as I am? Many Peer Review enhancements have been implemented with the remaining changes on the horizon. Recovery Act implementation is in high gear with Challenge Grant reviews under way and with recipient reporting requirements now outlined by the White House. Human Embryonic Stem Cell (hESC) registry will soon go live, including approved lines that can be federally funded under the new NIH Guidelines. And let’s not forget about Financial Conflict of Interest policy review and recommendations. What a year it has been (and still is)! We’re working continuously to keep you up to date and to keep resources at your fingertips.
After requesting feedback on several proposed changes to Financial Conflict of Interest Regulations through the Advanced Notice of Proposed Rule-Making (ANPRM), which closed on July 7, 2009, we’re reviewing the comments and major recommendations we received. The Federal Register notice published May 8, 2009 sought comments on several proposed changes to the existing regulations [Responsibility of Applicants for Promoting Objectivity in Research for which Public Health Service (PHS) Funding Is Sought (42 C.F.R. Part 50, Subpart F) and Responsible Prospective Contractors (45 C.F.R. Part 94)].
A total of 81 comments came in from a diverse cross-section of individuals, research institutions, and professional societies. These comments have been posted online for viewing at www.regulations.gov.
NIH will be analyzing these comments determining how best to move forward in potentially changing the existing PHS FCOI regulation. It is anticipated that any Notice of Proposed Rule Making would be forthcoming by the end of the year, which will allow public comment on a draft regulation with a goal to have a new regulation in place by end of summer 2010.
For those who submitted comments, we greatly value your insights and appreciate your participation in this effort. Working together is of utmost importance for effective stewardship of the extramural research enterprise. We’re committed to keeping you up to date and to keeping resources at your fingertips.Read on for further discussion of what’s new in hESC Guideline and Recovery Act implementation and more–all happening through the great partnerships that have made FY2009 a year to remember.