1. Public Law 109-482: National Institutes of Health Reform Act of 2006 (Dr. Elias Zerhouni)
Dr. Zerhouni updated the Advisory Committee to the Director (ACD) on the National Institutes of Health Reform Act of 2006. This legislation provides the NIH with some new authorities while affirming and supporting other ongoing activities. Some key provisions in the Act include the creation of a Division of Program Coordination, Planning and Strategic Initiatives (DPCPSI); the establishment of a Scientific Management Review Board; and new reporting requirements. Dr. Raynard Kington is leading an ad hoc Working Group to address the legislation and implementation. This Working Group has Institute and Center representation as well as leadership from NIH offices of Science Policy, Legislation, Management, Communications, Extramural Activities, Budget, and General Counsel.
Discussion
ACD members inquired about the effect of the Act and establishment of the Common Fund on the size and number of R01 awards. Dr. Zerhouni stated that no Common Fund program is designed to last beyond 5 to 10 years. The NIH posted its current policy goal of maintaining levels of investigator-initiated research (see NIH Fiscal Policy for Grant Awards – FY 2007). The Common Fund is not designed to affect R01 levels but, instead, is expected to enable research to run more efficiently. Furthermore, many Common Fund initiatives will use the R01 funding mechanism.
Inquiry was made as to whether establishment of DPCPSI would have implications for the offices and programs currently within the Office of the Director. Dr. Kington stated that it was not the intent of the legislation to change the authorities of the programmatic offices and that those offices are represented in the ad hoc Working Group — Dr. Vivian Pinn, Office of Research on Women's Health, and Dr. David Abrams, Office of Behavioral and Social Sciences Research.
2. FY 07 NIH Priorities and Fiscal Policy (Dr. Elias Zerhouni and Mr. John Bartrum, Office of Budget)
Dr. Zerhouni provided a summary of the actions leading to the development of the NIH Fiscal Policy for Grant Awards – FY 2007. This policy represented an NIH-wide effort to stabilize the yearly variation in the annual number of research project grant (RPG) awards during a challenging budget environment. Funds for new or competing awards for fiscal year (FY) 2007 would come from not only RPG award recycling but also from inflationary increases originally intended for RPGs that do not have to compete for funds in FY 2007. While NIH Institutes and Centers have the flexibility to manage their portfolios, the NIH will work to fund approximately 9,600 new and competing RPGs and approximately 1,500 new investigators. Guidelines have been issued to buttress vulnerable populations such as investigators applying for their first renewal and investigators with insufficient other support, both of which must receive review scores near the nominal payline of the relevant Institute or Center to be given appropriate consideration.
Mr. Bartrum updated the ACD on the FY 2007 Joint Resolution that was recently passed by Congress and signed by the President on February 15, 2007. Key highlights of the resolution include: 1) direct funding for the Common Fund/Roadmap, thereby allowing NIH Institutes and Centers to receive increased program funding as they retain their 2007 Roadmap contribution, totaling $332 million; and 2) funding to support vulnerable areas of biomedical research and new investigators. It also provides direct funding for the National Children's Study in FY 2007. Total NIH funds for FY 2007 from the Joint Resolution are approximately $28.96 billion (including a pay adjustment estimate which has not yet been finalized). However, the FY 2007 Joint Resolution changes are not incorporated into the FY 2008 President's Budget Overview, which projects NIH FY 2008 funding at approximately $28.62 billion if passed without changes from Congress. Dr. Zerhouni pointed out that in FY 2008 NIH will have recycled RPG award funds from FY 2004, which was NIH's largest budget to date. However, we will not know the impact of the FY 2007 enacted funding on the FY 2008 President's Budget until we finish the development of the FY 2007 operating plans.
3. Peer Review Update (Dr. Elias Zerhouni and Dr. Norka Ruiz Bravo, Office of Extramural Research)
Dr. Zerhouni and Dr. Ruiz Bravo outlined recent efforts by NIH to review and consider changes to the NIH Peer Review process. While the NIH peer review process is highly valued, IC Directors and NIH leadership have voiced concerns regarding the increased load on the peer review system due to the steady rise in applications and to the increased complexity of biomedical science. An ad hoc “Peer Review Brainstorming Group” has convened; and at an IC Directors retreat, the Group reported a list of current and future efforts/ideas to address critical needs for peer review. Next steps include formation of an ACD Working Group to hold a series of meetings with the external scientific community to collect input and synthesize recommendations for a report at an upcoming ACD meeting. A process for policy development will follow, including public input, internal clearances, and reporting of the new policy to the ACD for review and input.
Discussion
Dr. Zerhouni noted that the brainstorming process identified several short, medium, and long-term recommendations for peer review, some of which are already underway (e.g. a pilot study to shorten the review cycle for R01 grant applications and a Request for Information on shorter grant applications). ACD members voiced concerns that scoring and ranking systems within the peer review system should also be under examination as peer reviewers are suffering from burn out and are discouraged by decreasing NIH pay lines. However, current feedback on peer review is primarily anecdotal; and many members agreed that the efforts of this ACD Working Group will be important in forming the peer review process.
4. Update on E-Submissions (Dr. Norka Ruiz Bravo, Office of Extramural Research)
Dr. Ruiz Bravo provided the ACD with an update on the electronic grant submission for R01 applications. In planning for 4,500 to 5,000 electronic applications, NIH, Grants.gov, and applicants were well prepared with a record number of application submissions arriving before the February 5th deadline – 70 percent were error-free on the first submission attempt, and 94 percent were error free within two attempts. eRA Commons and the Commons help desk were busy but not overwhelmed. A minimal number of applicants actually missed the deadline. ACD members congratulated NIH on a very positive outcome. Dr. Zerhouni noted that as NIH now receives approximately 80,000 applications per year, this was a very successful outcome.
In response to members' desire for the ACD to be kept informed and be more active, Dr. Kington outlined planned activities involving the ACD. In addition to the in-person biannual meetings regularly scheduled in June and December, NIH plans to provide one to two open teleconferences (such as this teleconference) for updating and briefing the ACD. Also, the FY 2007 Joint Resolution has created a new NIH Director's Innovator Award, which will be managed by the same project team that administers the NIH Director's Pioneer Award program. The ACD may be asked to provide the final council-level review on both the Pioneer and the Innovator awards, which will probably take place at three closed teleconferences in August.
GAIN ACD Working Group (Dr. Francis Collins, National Human Genome Research Institute, and Dr. Lana Skirboll, Office of Science Policy)
Dr. Collins and Dr. Skirboll provided details on a proposal to form a new ACD Working Group on Participant and Data Protection (PDP) for the Genetic Association Information Network (GAIN). The PDP Working Group will serve to provide independent advice about GAIN participant, data protection, and management policies in order to maintain the highest possible standards for protecting participant privacy and confidentiality. This group will be selected by the NIH Director and will have private, public, and community representation and expertise in protection of human research subjects, bioethics, privacy and confidentiality, genomics, informatics and other relevant areas. At least one ACD member will be on this Working Group, which will report back to the ACD and the NIH Director. Dr. Collins and Dr. Skirboll noted that the Working Group would provide high level oversight for GAIN by reviewing data and information provided by NIH staff. Also, it was noted that the NIH has limited ability of enforcement, so community resolve will be as important as policies are established – all participants must be made fully aware of the consequences of policy breaches.
Open Comment Period
ACD members thanked Dr. Zerhouni for the teleconference, stating that the NIH has been thoughtful in their efforts. Several members noted that the teleconference format was very valuable, and it was mentioned that these activities need to include members of the public. Dr. Zerhouni agreed and stated that this was the intent of these meetings and conferences.
Raynard S. Kington, M.D., Ph.D. Executive Director, Advisory Committee to the Director Deputy Director, NIH
Elias A. Zerhouni, M.D. Chairman, Advisory Committee to the Director Director, NIH
