NINDS Advisory Council Meeting Minutes, May 25-26, 2006
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- Call to Order and Opening Remarks
- Report of the Director, Division of Extramural Research
- Report of the Director, NINDS
- Report of the NIH Director
- Continuation of the Report of the Director, NINDS
- Concept Approval for FY07 Initiatives
- Opportunities for Collaboration Between NINDS and the Department of Veterans Affairs
- Council Subcommittee Reports
- Evaluation Process for the Morris K. Udall Centers of Excellence in Parkinson's Disease Research- Dr. Bruce Bean
- Discussion of Council Meeting Format - Dr. Robert Finkelstein
- Council Review of Pending Applications
- Adjournment
DEPARTMENT OF HEALTH AND HUMAN SERVICES
PUBLIC HEALTH SERVICE
NATIONAL INSTITUTES OF HEALTH
NATIONAL ADVISORY NEUROLOGICAL DISORDERS AND STROKE COUNCIL
Summary of Meeting 1
May 25-26, 2006
The National Advisory Neurological Disorders and Stroke (NANDS) Council was convened for its 166th meeting on May 25-26, 2006, at Building 31, Conference Room 10, Bethesda, Maryland. Dr. Story Landis, Director of the National Institute of Neurological Disorders and Stroke (NINDS), served as Chairperson.
In accordance with Public Law 92-463, the meeting was:
Open: May 25, 2006 - 10:00 a.m. to 4:40 p.m.
for the review and discussion of program development, needs, and policy; and
Closed: May 26 - 8:10 a.m. to 9:30 a.m.
for the consideration of individual grant applications.
Council members present were:
Mr. Ronald Bartek
Dr. Bruce Bean
Dr. Mr. Robi Blumenstein
Dr. Alicia Conill
Dr. J. Donald Easton
Dr. Francisco Gonzalez-Scarano
Mr. Jeffrey Martin
Ms. Prisca Chen Marvin
Dr. Helen Mayberg
Dr. Laura Ment
Dr. David Van Essen
Mr. Robert Waterman
Council members absent were:
Dr. Raymond Dingledine
Dr. John Loeser
Dr. William Mobley
Dr. Huda Zoghbi
Council Roster (Attachment 1)
Ex Officio Member present:
Dr. Robert Ruff, Department of Veterans Affairs
Dr. Geoffrey Ling, Department of Defense (2/9 only)
Members of the public present for portions of the open meeting included:
Dr. Suzanne Beckner, Westat, Inc.
Mark Bowman, Society for Neuroscience
Donna Meltzer, Epilepsy Foundation
Representative, Palladian Partners
Representative, Scientific Social Sciences
Sarah Hanson, Institute of Medicine
Ellie Edson, Institute of Medicine
Bruce Altevogt, Institute of Medicine
Christin Engelhardt, Reflex Sympathy Dystrophy Syndrome Association
Michelle Rodrigues, SRI International
NINDS employees present for portions of the meeting included:
|
Dr. Alan Willard |
Ms. Margaret Jacobs Dr. Andrea Sawczuk Dr. JoAnn McConnell Dr. David Jett Dr. Michael Nunn Dr. Thomas Miller Dr. Naomi Kleitman Dr. Audrey Penn Dr. Yejun He Dr. Daofen Chen Dr. Paul Scott Dr. Gabrielle LeBlanc Mr. Paul Myers Dr. Richard Crosland Dr. Randall Stewart Ms. Cikena Reid Ms. Lynn Morin Dr. Robert Zalutsky Dr. Katie Woodbury-Harris Dr. Debra Hirtz Dr. Shanta Rajaram Ms. Stacey Chambers Mr. Paul Girolami Ms. Shannon Garnett Dr. Audrey Kalehua Dr. Ray Chaudhuri Dr. Shai Silberberg Dr. Ned Talley Dr. James Coulombe Dr. Joe Pancrazio Dr. Laurie Gutmann Ms. Joanne Odenkirchen Mr. Phil Wiethorn Ms. Holly Campbell Dr. John Lynch Dr. Michelle Jones-London Dr. Mark Scheideler Dr. Robert Riddle Ms. Daphne Robinson Dr. Ramona Hicks Ms. Donna James Dr. Debra Babcock Ms. Christina Vert Ms. Maxine Davis-Vanlue Dr. Janice Cordell Mr. Peter Gilbert Mr. Philip Cotecelli Ms. Debbie Jarman Dr. Lorenzo Refolo Ms. Sabrina Ferguson Ms. Sylvia Parsons |
Other Federal employees present for portions of the meeting included:
Dr. Stefano Bertuzzi, OD
Ms.Sandy Williams, OD
Dr. Bruce Goldstein, OD
Dr. Peter Lyster, NIGMS
Dr. Kevin Quinn, NIMH
Dr. Christine Colvis, NIDA
Dr. Sherry Miller, CSR
Dr. Boris Sokolov, CSR
Dr. William Benzing, CSR
Dr. Christine Melchior, CSR
Dr. Michael Selmanoff, CSR
Dr. Rene Etcheberrigaray, CSR
Dr. Sherry Stuesse, CSR
Dr. Biao Tian, CSR
Dr. Seetha Bhagavan, CSR
Dr. Mary Custer, CSR
I. Call to Order and Opening Remarks
Dr. Story Landis, Director, NINDS, welcomed Council members, guests, and staff to the 166th Council meeting. She announced that Drs. Dingledine, Loeser, Mobley, and Zoghbi were unable to attend this meeting due to other commitments. The new Department of Veterans Affairs ex officio member, Dr. Robert Ruff, is attending his first Council meeting. This is the last Council meeting for Ron Bartek, Jeff Martin, Bruce Bean, and Don Easton. Dr. Landis thanked each one of them for their special contributions to the Council and expressed her appreciation for their participation. The proposed Council slate to replace the outgoing members has been approved by NIH-OD and is currently under review by DHHS. We expect the new members to be in place by September Council. In keeping with the Institute's policy of inviting chairpersons of CSR review committees, Dr. Timothy Collier, Chair of the Clinical Neuroplasticity and Neurotransmitters (CNNT) Study Section in CSR, is attending the open session of the Council meeting. A special guest, NIH Director, Dr. Elias Zerhouni, will be speaking to Council at 10:15 a.m. today.
II. Report of the Director, Division of Extramural Research
Dr. Finkelstein, Director, Division of Extramural Research, reminded Council that they are in open session and will go into closed session to discuss individual grant applications tomorrow.
Conflict of Interest
The regulations concerning conflict of interest were reviewed. Council members were reminded that materials furnished for
review purposes and discussion during the closed portions of the meeting are considered privileged information. All Council
members present signed a statement certifying that they had not been involved in any conflict of interest situations during
the review of grant applications. Council members were also reminded that they need to remove themselves from discussions
of applications from any institution from which they have received an honorarium for one year from the time the honorarium
was received. If the Council member's participation is deemed critical to the discussion, however, an authorization may be
granted by the Institute.
Confidentiality
During the closed session, any information that is discussed and the outcome of any recommendation are considered privileged
information. They may not be discussed outside of the closed session. If an applicant requests support for his or her application
from a Council member, the Council member must respond that he/she is not permitted to discuss the application. Any inquiry
should be referred to Dr. Robert Finkelstein as the Council Executive Secretary, who will then refer the questions to the
appropriate staff member for response.
Consideration of Minutes of Previous Council Meeting
The minutes of the Council meeting of February 9-10, 2006, were considered and accepted as written.
Consideration of Dates for Future Council Meetings
The following dates for future Council meetings were reconfirmed:
| September 14-15, 2006 | (Thursday and Friday) |
| February 15-16, 2007 | (Thursday and Friday) |
| May 24-25, 2007 | (Thursday and Friday) |
| September 20-21, 2007 | (Thursday and Friday) |
| February 7-8, 2008 | (Thursday and Friday) |
| May 29-30, 2008 | (Thursday and Friday) |
| September 18-19, 2008 | (Thursday and Friday) |
Dr. Finkelstein reminded Council that their terms end on July 31 of the year printed next to their names on the Council roster.
Other Items
Expedited Review Process-- The Grants Management Branch has succeeded in expediting approximately half of the 161 eligible applications for award. Those included 11 K awards. Dr. Finkelstein thanked the Council members who served on the Council subcommittee responsible for expediting approval for the applications: Drs. Ray Dingledine, Alicia Conill, and John Loeser. Another three will be asked to serve in this capacity for the next year.
Reports Book-- The Reports Book, which has now been converted to CDs and mailed to Council before the meeting, is comprised of applications that have been expedited, applications approved for funding since the last Council meeting, and applications that were identified for payment through the High Program Priority after the February 2006 Council.
Staff Actions-- Lydia Munger is a new program analyst in the Technology Development group. Departing staff are: Michael Loewe, Chief of the Grants Management Branch, who has already left for a position with the National Institute of Environmental Health Sciences in North Carolina; and James Stoneman, Chief of the Administrative Services Branch. Maxine Davis-Vanlue, formerly at NIMH, has been appointed Acting Chief of Grants Management. Dr. Landis introduced Dr. Robert Ruff, the new VA ex officio member of Council. He is the Acting Director of Rehabilitation, Research and Development and the National Director of Neurology at the VA. He is also medical director of the Functional Electrical Stimulation Center. Dr. Ruff has a diverse background, with an M.D. and Ph.D. from the University of Washington in biophysics and has conducted a number of studies on neuromuscular transmission. His principal research interest now is rehabilitation, particularly in stroke patients. There are potentially many opportunities for NINDS and the VA to collaborate. NINDS and the VA have one pilot collaboration, which is the deep brain stimulation study. It is hoped that many more bridges will be built between the two agencies to advance neuroscience.
Council Input-- At this time of Council member rotation, it is a good time to solicit suggestions for how Council meetings can be improved, whether in their length, subcommittee structure, or in the topics for discussion. Secondly, Council is trying an experiment this time by having the Council subcommittee chairs talk in more depth about the topics discussed at the subcommittee meetings. Subcommittee recommendations must be approved by the full Council, so a full discussion of those items is appropriate. Council is at its most effective if it follows three steps: 1) It identifies the topics to be addressed by the Institute, 2) The topics are then discussed in detail by the relevant subcommittee, and 3) The Chairs of each subcommittee summarize the discussion and open it up to the full Council.
III. Report of the Director, NINDS
Dr. Landis reported on the following topics:
Support for Young Investigators-- This is an area of particular interest to Council. At the last Council meeting, Council members discussed the possibility of a different payline for first-time R01 applicants. Since that time, the Institute has adopted this strategy and has made it retroactive to the beginning of the fiscal year.
K99/R00 NIH Pathway to Independence (PI) Award Program-- This is a new, experimental program which provides two years of mentored K funding and three years of R grant funds for independent research. The intention of the program is to help researchers make the transition to independent research easily and to enable young investigators to move to their first faculty position earlier in their careers to universities. The goal is to fund 170 applications across NIH in FY07. NIH received 430 applications. NINDS received 40 applications; 38 are Ph.D.s and 2 are MDs. They will be reviewed by a Special Emphasis Panel. The next deadline for applications is June 1. The applications cluster in four major areas: stroke, ischemic injury, epilepsy imaging, and development.
Report of the NIH Director
Dr. Elias Zerhouni, Director, NIH, expressed his appreciation to the members of the Council, members of the NINDS review committees, and to the Board of Scientific Counselors who give their time to serve NINDS. He announced that Dr. Landis has recently been appointed to the NIH Steering Committee, which advises him on NIH policies.
In a presentation entitled, "NIH at the Crossroads: Myths, Realities and Strategies for the Future [PDF 1.7 MB]," Dr. Zerhouni explained that the current success-rate difficulty is not new. Much as the business world experiences boom-bust cycles, NIH has faced difficult times in the past. Periods of high competition for limited funds and multiple disincentives to the research enterprise have happened before: in 1982, in the early 1990's, and again now. "History repeats itself. But NIH is strong, and our response to the current situation suggests we'll prevail again." No budget forecaster could have foreseen the "perfect storm" facing NIH in 2006: deep federal and trade deficits, rising expenditures for homeland security, the economic and physical devastation of Hurricane Katrina, preparations for potential pandemic flu, a 3-5 percent inflation rate in research costs that is outpacing the general inflation rate and an increased federal focus on the physical sciences. In addition to these factors, there are current misconceptions about NIH's research priorities that Dr. Zerhouni addressed: NIH is not emphasizing applied over basic research, though in 2002 and 2003 - owing mainly to biodefense needs and infrastructure build-up - there were significant one-time expenses; NIH is not shifting toward solicited research (in 1994 about 91 percent of research project grants were unsolicited vs. 9 percent solicited, and today about 93 percent are unsolicited vs. 7 percent solicited); and the Roadmap initiative is not eating up 30 to 40 percent of the budget, as some have maintained - the real numbers are about 0.8 percent of the budget in 2005, maxing out at around 1.5 to 1.7 percent next year. Furthermore, Roadmap expenditures are not monolithic. In FY 05, there were more than 345 individual awards (at 133 research institutions). "Every great institution needs a little intellectual venture space," he said, where we can try new things that will benefit the entire research enterprise and allow us to take risk for high impact. Far from having been designed to supplant R01 investigator-initiated grants, the Roadmap is largely an implementation of recommendations from the Institute of Medicine and more than 300 representative scientists who contributed their opinions. And even within the 1 percent of the budget it claims, Roadmap grants are 40 percent basic research, 40 percent translational and 20 percent high-risk (e.g., the Director's Pioneer Awards), the latter of which addresses long-standing concerns that NIH invests too timidly in research.
Dr. Zerhouni said there are "three drivers behind the current sense of pain, and by far the largest ones are capacity-building and the increase in tenure-track faculty." The doubling of NIH's budget prompted a building boom on extramural campuses. The increase in capacity was an appropriate response to the growing needs of medical research and public health problems. The difficulty now, however, is that the timing of this boom is no longer concurrent with the availability of funds. The issue of congressional appropriations is the second area of concern for NIH and its constituency. The third main driver of the current crunch, and the biggest reason for declining success rates, is the dramatic upsurge in grant applications: almost the same number arrived in the two years following the doubling that occurred during the entire five-year doubling process itself. The demand for NIH grants took off just as the budget was coming in for a landing. Right now, we are in a period of readjustment. Although getting grants is more competitive now, many more scientists are receiving funds due to the large increase in faculty at institutions. More than 10,500 new applications arrived in 2005. He offered a four-part prescription: know the facts; develop adaptive strategies, including protecting knowledge and discovery, increasing the number of competing grants via management of supply-demand issues, and supporting new investigators through new programs such as the Pathway to Independence Program; convey a unified message to the public about the benefits of medical research; and emphasize NIH's exciting vision for the future. In the next 15-20 years, the paradigm in medicine will shift from a curative approach to a pre-emptive one. He outlined the "four P's" that will characterize medicine's future: predictive, personalized, pre-emptive and participatory. The nation invests $95 per year, per person, on NIH science, while the cost for health care per person each year is $7,000. Dr. Zerhouni concluded, "There is no better investment than biomedical research."
In response to a question from Council, Dr. Zerhouni reported that the total investment by NIH over the past thirty years has been $1300 per person. One result has been a six-year increase in life expectancy. There has also been a 30 percent decrease in disability rates for seniors. 60 percent of the NIH budget goes toward basic research. In terms of total research investment in the U.S., NIH invests $28 billion, industry invests $56 billion, and foundations invest $5-$10 billion. Other questions centered on the public's skepticism of public-private partnerships, the effectiveness of solicited grant programs, the need to support new investigators, the impact of research on health care costs, and strategies for overcoming misperceptions of reduced research funding opportunities.
V. Continuation of the Report of the Director, NINDS
Cost/Benefit Analysis of NINDS Clinical Trials -- At a Clinical Trials subcommittee meeting several rounds ago, subcommittee members raised concerns about the cost of clinical trials and their efficacy. As a result, NINDS contracted with a well-known researcher to analyze the costs and benefits of NINDS-funded clinical trials. The results, published in The Lancet ([1] Johnston SC , Rootenberg JD, Katrak S, Smith WS, Elkins JS. "The impact of an NIH program of clinical trials on public health and costs." The Lancet, April 22, 2006, Vol. 367, pp. 1319-1327), estimated conservatively the economic benefit to the U.S. from just eight of these trials exceeded $15 billion over the course of 10 years. The study also found that new discoveries from the trials were responsible for an estimated additional 470,000 healthy years of life. The analysis showed that the 10-year return on the investment in clinical trials research funding was 4600 percent. The researchers found that the projected benefits of the clinical trial program during the period covered by this study were more than $50 billion - far greater than the total budget of the NINDS ($29.5 billion) during that period. The investment in most of the trials was returned through health benefits within 1.2 years after the trial funding ended; however, it takes an average of seven years for clinical trials' findings to be put into clinical practice. The important findings of this study lead to a consideration of whether mechanisms should be put in place to make this kind of analysis possible for future clinical trials.
NIH Neuroscience Blueprint -- The Blueprint was an initiative created to form a coalition of institutes with a significant investment in neuroscience research. Sixteen I/Cs participate. Progress has been made in the last three years. Eighteen project teams were assembled, involving over 100 program directors. Among the FY06 initiatives were: 1) The creation of Interdisciplinary Center Core grants for neuroscience investigators, 2) The creation of a neuroscience mouse model repository and the development of new models, 3) New ways to image neural activity, and 4) Filling training gaps in areas of neuroscience research.
NIH Accomplishments -- One of the goals for the NIH I/Cs in the coming months is to submit examples, such as the comparison in investment and advancements in coronary heart disease done by NHLBI, for what the I/Cs have accomplished with I/C or NIH funding. The examples should show how advances in research have been translated into better care for patients. NINDS will present several examples, such as how our funding ultimately resulted in the development of Medtronics' DBS device and show how NINDS-supported research continues to guide the industry's products. One such case is the DBS research currently funded with the VA on optimal placement of electrodes for maximum benefit. Another example of practical results of NINDS funding is in the area of stroke.
Council members reinforced the need to inform patients and the public that many treatments were developed as a result of NIH research funding and to avoid double-counting NIH funding. There was support for public service announcements that education the public about the clinical benefits of NIH funding. The case studies Dr. Finkelstein presented at the last Council meeting are good examples of beneficial results of NINDS funding.
NINDS Deputy Director Position -- Job opening announcements have been posted. Several applications have been received, and interviews will begin next month. Dr. Penn has done a spectacular job in supporting the Institute for over a decade and will next focus her attention on health disparities and on auto-immune diseases.
VI. Concept Approval for Fiscal Year 2007 Proposed Initiatives
Dr. Finkelstein asked for Council feedback and concurrence for the following FY07 initiative concepts:
1. Collaborative Activities to Promote Translational Research (CAPTR). This is a supplement program to encourage collaboration between two or more PIs who would derive mutual benefit from collaboration. The goal is to stimulate science and move it along faster. The program provides up to $50,000 for an R01.
2. FY 2007 Neuroscience Blueprint Proposals for Future Areas of Research: 1. New methods for delivering biologically active molecules into the brain or sensory organs with emphasis on blood brain barrier transport 2. Biomarkers/biosignatures for early detection of neurodegeneration (including imaging). 3. A postdoctoral fellowship program (e.g. F32) that would require post-doctoral fellows to have mentors from traditionally distinct disciplines to encourage cross disciplinary research. 4. Six- to twelve-month awards (e.g. K18) awards to established scientists for research training in a laboratory from a different discipline that would foster new approaches. 5. Encourage/facilitate the use of existing biological materials. 6. Better coordination and publicizing of existing NIH programs in translational research that would be applicable to neurodegeneration. 7. Continue to work toward developing and distributing tools to collect, analyze, and integrate large, diverse data sets and prioritize data from the neurodegeneration research community.
Council members expressed support for both concepts. It was noted that the supplement program provides a means to attract experts beyond neuroscientists, such as engineers, mathematicians, and physicists to neurological problems. The two concepts focus on multidisciplinary and cross-cutting efforts that have significant potential benefit.
Both concepts received Council concurrence.
VII. Opportunities for Collaboration Between NINDS and the Department of Veterans Affairs
Dr. Robert Ruff, NANDS Council Member, reported that the VA is the largest healthcare system in the U.S. It provides medical treatment, rehabilitation services and conducts health-related research. With a current budget of $66 billion, it is divided into three divisions: the Veterans Health Administration, the Veterans Benefits Administration, and the National Veterans Cemeteries. The VA organizes its delivery of health care to veterans through 23 Veterans Integrated Service Networks. The VA supports 163 medical centers, over 800 clinics, 135 nursing homes, and 206 counseling centers. It is affiliated with 107 medical schools and employs over 100,000 doctors and 500,000 nurses. Approximately 25 percent of residency positions are paid for by the VA. 96 percent of VA care is devoted to the treatment of chronic diseases; mostly diabetes and obesity. Relevant areas for potential interaction are in Parkinson's Disease, multiple sclerosis, and Alzheimer's Disease research, where the VA's large patient populations and research centers can be utilized. Currently, the VA faces many challenges. The most critical are the wars in Iraq and Afghanistan, which have increased the VA's patient care services. The VA also has a mandate to conduct research. 40.3 percent of its funding goes toward biomedical research, with lesser amounts going toward R&D, rehabilitation, cooperative studies, and clinical research. The VA cannot fund non-VA entities. Dr. Ruff suggested initiating meetings between the leadership of NINDS and VA research labs to explore common interests and areas of collaboration. Dr. Ruff will follow up on this suggestion. Dr. Landis will follow up on identifying NIH's VA representative.
VIII. Council Subcommittee Reports
Clinical Trials Subcommittee, Dr. Don Easton, Chair
1. Dr. John Marler, Associate Director for Clinical Trials, announced that eight new definitive phase III clinical trials were approved during the last year: 1) Thymectomy in Non-Thymomatous Myasthenia Gravis Patients on Prednisone, 2) Interventional Management of Stroke Study (IMS III), 3) Albumin Therapy in Acute Stroke (ALIAS), 4) Locomotor Experience Applied Post-Stroke: A Rehabilitation Trial (LEAPS), 5) Progesterone Therapy for Women with Epilepsy, 6) CoQ10 Therapy for Huntington's Disease, 7) CoQ10 Therapy for Parkinson's Disease and 8) A Randomized Trial on Management of Unruptured Arterial Venous Malformations in the Brain (ARUBA).
2. Dr. Marler updated the subcommittee on the Clinical Research Collaboration (CRC) contract, which is currently underway. The purpose of the contract is to facilitate recruitment of NINDS funded clinical studies by involving community based neurology clinics through a centralized web-based system. The CRC was presented at the April 2006 Annual Neurology meeting in San Diego, California, with great success. The CRC website is now live at www.nindscrc.com.
3. The NINDS Neurological Emergencies Treatment Trials Network initiative is a network that will create a large, multi-center program focused on the delivery of neurological treatment in the emergency room. Applications for the statistical coordinating center and clinical recruitment hubs are currently being submitted, with review planned for late summer.
4. The Request for Proposals for the "Clinical Trial Methods in Neurology" initiative. The intent is to solicit applications to conduct a short training course on clinical trial training. The prospective attendees are clinical fellows and junior faculty.
5. Dr. Brandy Fureman reported on the Conflict of Interest guidelines being drafted by NINDS. As previously reported to the Subcommittee, the NINDS is working to develop explicit guidelines for handling principal investigator financial conflict of interest in NINDS funded phase III clinical trials. The NINDS continues to work with the NIH in addressing conflicts that also involve the primary institution(s) involved in the trial. A copy of the draft guidelines was shared and discussed with the Subcommittee. The Subcommittee was supportive of the proposed guidelines.
6. Dr. Robin Conwit updated the subcommittee on the increasing involvement of international sites in NINDS clinical trials. International sites improve the ability of U.S. funded clinical trials to enroll study patients in a timely manner and may better generalize the results of the trial. Dr. Marler noted that the State Department has been involved in ensuring that clinical trials in Eastern Europe are conducted properly.
7. Dr. Scott Janis discussed: 1. The current NINDS policies and procedures for accepting large clinical projects greater than $1 million per year. The Clinical Trials Subcommittee currently evaluates all clinical proposals with budgets exceeding $1 million per year and makes a recommendation to the NINDS Director whether or not the proposal should be accepted for review. 2. The Clinical Trial Planning Grant program. The grant program is a one-year, $100,000 award, to plan the start of a large, multi-center phase III clinical trial. These applications do not require pre-approval for submission but do require Council approval for funding. If the planning grant is funded, the applicant is given permission to submit the full application for review. Dr. Landis asked Council to take note of this process, since the full application does not need pre-approval for submission.
Training, Career Development, and Special Programs Subcommittee, Dr. Bruce Bean, Chair
1. The subcommittee reviewed and approved a new statement of requirement for institutional commitments for the K02 award. It requires institutions to produce a firm commitment to providing the infrastructure necessary for their investigators.
2. Dr. Steve Korn reviewed the success rates of the training mechanisms, which are very close to the goals for each mechanism.
3. The salary limit for K02 awards is currently $85,000, and the investigator is required to devote 75 percent effort. The subcommittee supported a recommended salary cap increase to $95,000.
4. Presently, there is a limit to the number of pre-doctoral fellows on T32 grants, but institutions are finding that they have more qualified pre-doctoral candidates than there are slots for. The subcommittee supported the recommendation to allow the institution to decide on the most appropriate mix of pre-docs to post-docs on their T32 grants.
5. There are significant amounts of unobligated balances on T32 grants at the end of the year, which amounted to approximately $5 million in the last round. The subcommittee supported the proposal to evaluate unspent funds at the end of every grant year and adjust the following year's award, as appropriate.
6. The subcommittee had a general discussion of several questions: what are the goals of the training programs, should they be changed in light of more limited budgets, are careers available after the training is complete? After a lot of discussion, it was agreed that good data that supports any position on these questions is lacking. Council agreed that more data need to be collected in order to answer these questions.
Basic and Preclinical Programs Subcommittee, Chaired by Dr. Van Essen
Opportunities and Challenges in Neuroscience Data Sharing
The data sharing discussion was prompted by the large amount of experimental data now available as well as the diversity of data in neuroscience research. A small fraction of funded research gets published; therefore, other means of data access are needed for researchers.. Data sharing accelerates research discoveries, improves research efficiency and communication, and promotes collaborations. However, some researchers are reluctant to share their data for proprietary, cost, or other reasons. NIH provides guidelines on the types of data that should be shared and how best to make them available to the research community. In the future, many more databases that are diverse in the data they provide and customized to the needs of the community need to be developed, and better data management software is needed, as well. The Society for Neuroscience lists eighty-three neuroscience databases that are available for the community, many of them funded by NINDS. One of the most widely-used databases in neuroscience, which is a collection of databases, is called, "SenseLab." SenseLab is an example of "database federation," i.e., linking several databases together. Another example is the NCRR-funded, "BIRN: Biomedical Informatics Research Network." Some of the challenges to data sharing that will need to be overcome are the heterogeneity of data, the lack of data standards, the diversity of existing databases, and the expense of maintaining a database. NIH has recently become very interested in the data sharing issue. The NIH Genome Association Information Network requires information related to genome-wide studies to be released immediately and for the phenotypic data to be released nine months after publication. Policy changes, funding support, grant requirements, and building incentives are some ways to increase data sharing. Currently, NIH requires a data sharing plan for all grants with budgets over $500,000. Specific requirements for applicants for their data are difficult due to the restrictions on "pre-application" requirements and due to the diversity of data already being collected by labs. In post-presentation discussion, Council members noted that in the autism field, efforts to encourage data sharing met with problems with intellectual property, publication concerns, and the different forms the data were found to be in. Council agreed that prospective standardization would lead to better results than requiring standardization after a study is completed, as long as it didn't impact creativity. It was agreed that NIH guidance and consensus-building would be useful. The suggestion to require data sharing by all applicants, where feasible, was made.
An update on the Roadmap RFA, "Assay Development for High Throughput Molecular Screening," was given by Dr. Scheideler. NINDS is the lead institute for this ongoing initiative, which is a component of the trans-NIH Roadmap Molecular Libraries Screening Center Network. The NINDS Scientific Review Branch carries out the peer review and NANDS Council acts as the second level of review for NIH as a whole. The goals of the program are to add a pharmacological dimension to investigators' basic science efforts. Investigators are asked to submit assays from their on-going, basic research for targets of interest and configure them into a screening plan that can be used to interrogate a small molecule chemical library. Probe leads coming out of a high-throughput screening exercise using these assays and mating them to a large library of small molecules can then come back into their research programs and allow them to investigate mechanisms and pathways in which their target of interest is involved. The end goal is to develop a portfolio of disease-specific projects that can drive translational efforts at NIH. Website: http://www.ninds.nih.gov/funding/areas/technology_development/HTS_Facility.htm
IX. Evaluation Process for the Morris K. Udall Centers of Excellence in Parkinson's Disease Research- Dr. Bruce Bean
Dr. Bruce Bean, Dr Paul Scott, Dr. Melinda Kelley, and Prisca Chen Marvin formed a committee to evaluate the Udall Centers and compare their progress with the research done with that of comparable research performed outside of the centers. The evaluation is in its early stages and is being done through a contract with Booz Allen Hamilton, Inc. The evaluation will be done on the first 11 centers, based on the results of responses to 10 study questions. Data will be collected through surveys and interviews with staff at the Udall Centers, as well as with Parkinson's disease investigators outside of the centers. Additional data will be collected from publications, progress reports, and citation indices. An External Advisory Panel of experts unrelated to the centers has been assembled. Two issues the committee has dealt with are: 1. The importance of identifying the control group, and 2. Whether the Advisory Panel would have access to the raw data. The second issue has been resolved by the NIH General Counsel, which ruled that the panel could see the raw data.
X. Discussion of Council Meeting Format - Dr. Robert Finkelstein
Dr. Finkelstein invited comments and recommendations from the Council regarding the format, content, subcommittee structure, and length of Council meetings. Council expressed satisfaction with the general format. Most Council members wanted to keep the subcommittee meetings divided between two days, to allow members to attend two subcommittee meetings per round. There was less interest in scientific talks and more interest in policy discussions. Staff could e-mail Council members before a meeting for discussion topics and could preview the agenda to a subgroup of Council members. One suggestion was to add the closed session to the end of the public session day. Council felt it was important to allow time for brain-storming by Council, especially on broad topics such as public-private partnerships, Congressional mandates, etc.
XI. Council Review of Pending Applications
This portion of the meeting, involving specific grant review, was closed to the public. The Council gave special attention to applications from foreign institutions and other applications, which needed specific discussion.
Research Training and Career Development Programs
The Council reviewed a total of 108 research career development and institutional training grant applications; of this total, 76 applications had primary assignment to NINDS, and 53 of them (69.7 percent) were recommended for support in the amount of $7.8 million first-year direct costs. It is anticipated that, of the research career development and institutional training grant applications competing at this Council, NINDS will be able to pay first-year direct costs of approximately $3.1 million.
Research Grant Awards
The Council reviewed a total of 2,749 research grant applications; of this total, 1,592 applications had primary assignment to NINDS, and 903 of them (56.7 percent) were recommended for support in the amount of $270.1 million first-year direct costs. It is anticipated that, of the research grants competing at this Council, NINDS will be able to pay first-year direct costs of approximately $58.2 million.
Senator Jacob Javits Neuroscience Investigator Awards
The Senator Jacob Javits Neuroscience Investigator Awards are made to distinguished investigators who have a record of scientific excellence and productivity, who are actively pursuing an area of research of strategic importance, and who can be expected to continue to be highly productive for a seven-year period. Candidates are nominated and selected at each Council meeting. At this meeting, the Council recommended four investigators as Javits awardees.
Small Business Innovation Research and Small Technology Transfer Award Programs
The Council reviewed a total of 178 Small Business Innovation Research (SBIR) and Small Technology Transfer Award (STTR) grant applications; of this total, 97 applications had primary assignment to NINDS and 50 of them (51.6 percent) were recommended for support in the amount of $9.6 million first-year direct costs. It is anticipated that, of the SBIR and STTR applications competing at this Council, NINDS will be able to pay first-year direct costs of approximately $3.6 million.
XI. Adjournment
The meeting was adjourned at 9:30 a.m. on Friday, May 26.
We certify that, to the best of our knowledge, the foregoing minutes and attachments are accurate and complete.
Robert Finkelstein, Ph.D.
Executive Secretary
National Advisory Neurological Disorders
and Stroke Council
Director, Division of Extramural Research
National Institute of Neurological Disorders and Stroke
Story C. Landis, Ph.D.
Chairperson
National Advisory Neurological Disorders
and Stroke Council
Director National Institute of Neurological Disorders and Stroke
These minutes will be formally considered by the Council at its next meeting. Corrections or notations will be incorporated in the minutes of that meeting.
1 For the record, it is noted that members absent themselves from the meeting when the Council is discussing applications (a) from their respective institutions or (b) in which a real or apparent conflict of interest might occur.
TopLast updated August 27, 2007
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