NINDS, like other institutes and centers at NIH, has an advisory council that provides advice to the Institute. Eighteen members serve on our council -- six basic neuroscientists, six clinical neuroscientists, and six lay members. The council meets three times a year and each meeting includes an open session during which Institute programs and policies are discussed. In addition, there is a closed session in which the council reviews applications for relevance to the Institute’s mission and objectives and provides a secondary level of review for specific funding decisions. The NINDS advisory council last met on September 15th. Below is a brief summary of the issues that I discussed in my opening remarks.
In opening the meeting, I provided an update on the proposed NIH National Center for Advancing Translational Science (NCATS). When the new center is established it will incorporate programs currently housed in the National Center for Research Resources (NCRR), the National Human Genome Research Institute and in the NIH Office of the Director. These include the Clinical and Translational Science Awards, components of the NIH Molecular Libraries program, NIH-RAID, the NIH Therapeutics for Rare and Neglected Diseases program and the Office of Rare Diseases Research. Not surprisingly, Council members asked how the creation of NCATS might impact translational research at NINDS. The short answer is that NCATS will not take away anything from NINDS programs but rather it should significantly enhance our translational and rare disease efforts. I am sure that NINDS will collaborate as effectively with NCATS when the new center is launched as we have in the past with each of its components.
I summarized recent changes in the regulations that govern oversight of financial conflict of interest. The new policies were put in place in mid-August and institutions have a year to comply. Major changes include a revised definition of significant financial interest - lowering the threshold for disclosure from $10,000 to $5,000; an expansion in the scope of information that investigators must disclose to their institutions; and an increase in required training. On the institutional side, organizations receiving grants will need to report potential financial conflicts and how they are managing them to NIH. They will also need to make more information accessible to the public. Additional details about the 2011 Financial Conflict of Interest Regulations can be found at http://grants.nih.gov/grants/policy/coi/.
I also provided an overview of the recent HHS proposal to improve regulations protecting human research subjects. These regulations, referred to as the Common Rule, were last reviewed approximately 20 years ago. The Department is currently seeking public input on an array of issues related to the ethics, safety and oversight of human research. Some of the changes under consideration include proposals for the use of a single Institutional Review Board (IRB) for all domestic sites of multi-site studies, revision of the forms and processes used for informed consent, and expansion of other aspects of Federal oversight. Please refer to www.hhs.gov/ohrp/humansubjects/anprm2011page.html for details. As announced in the Federal Register, the comment period has been extended through October 26, 2011.
I presented Council with our current understanding of the NINDS budget for FY12 and FY13. In FY11, the NIH budget was approximately 1% less than in FY10. The President’s budget for FY2012 included a 2.6% increase for NIH. The FY12 fiscal year begins October 1 and we are operating under a continuing resolution until our appropriation is set by Congress. It is difficult to predict our final budget but NIH may receive a decrease in FY12 as we did in FY2011. Planning is already well underway for the FY13 President’s budget. All indications are that any possible reduction should not be accomplished through across the board cuts. Instead, each organization should engage in strategic assessment and planning regarding which programs to keep, to cut or to initiate.
Several years ago NINDS undertook a planning process to inform how we might best manage our resources to maximize scientific opportunities and accelerate progress. Several principles emerged. NINDS should balance research opportunities across basic, translational and clinical science. We should actively manage our programs and monitor them to make sure that they are meeting their goals. As a result, we have closed a number of programs and reshaped others. These actions allowed us to undertake several important new initiatives while maintaining our payline at the 14th percentile for investigator initiated grants and continuing to fund independent early stage investigators past the payline and to support training of future investigators. These include NeuroNEXT, a Phase II clinical trials-network which we hope will transform the way we design and conduct clinical trials; the Epilepsy Centers without Walls program, which is creating consortia to address critical unanswered questions in epilepsy; the Parkinson’s Disease Biomarkers Project which should facilitate clinical trials aimed at slowing disease progression and the Blueprint Therapeutics Grand Challenge which is aimed at accelerating therapeutic development in brain disorders.
As we manage our budget in challenging fiscal times, it is clear that there are no magic bullets. We must avoid doing irreversible damage to the biomedical research enterprise. Strategies that are being considered across NIH include limiting award sizes, limiting the number of grants or total NIH dollars each principal investigator can receive, and redistributing funds among grant mechanisms. Whatever measures we take, NINDS needs to be sure that they are consistent with our core mission.
Last updated October 24, 2011