NINDS Advisory Council Meeting Minutes, February 7-8, 2008
Skip secondary menu
DEPARTMENT OF HEALTH AND HUMAN SERVICES
PUBLIC HEALTH SERVICE
NATIONAL INSTITUTES OF HEALTH
NATIONAL ADVISORY NEUROLOGICAL DISORDERS AND STROKE COUNCIL
Summary of Meeting1
February 7-8, 2008
The National Advisory Neurological Disorders and Stroke (NANDS) Council was convened for its 171st meeting on February 7-8,
2008, 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: February 7, 2008 - 10:30 a.m. to 5:00 p.m.
for the review and discussion of program development, needs, and policy; and
Closed: February 7, 2008 - 5:00 p.m. to 5:20 p.m.
February 8, 2008 - 8:10 a.m. to 9:45 a.m.
for the review of the Board of Scientific Counselors’ Reports and for the consideration of individual grant applications.
Council members present were:
Ms. Susan Axelrod
Mr. Robi Blumenstein
Dr. Lucie Bruijn
Dr. Ralph Dacey
Dr. Francisco Gonzalez-Scarano
Dr. Edgar Kenton
Dr. John Loeser
Dr. Helen Mayberg
Dr. Laura Ment
Ms. Cindy Parseghian
Dr. Timothy Pedley (absent 2/8)
Dr. John Povlishock
Dr. Caroline Tanner (absent 2/8)
Dr. David Van Essen
Dr. Gary Westbrook
Dr. Vicky Holets Whittemore
Council Roster (Attachment 1)
Council Members absent:
Dr. Luis Parada
Ms. Prisca Chen Marvin
Ex Officio Members present:
Dr. Robert Ruff, Department of Veterans Affairs
Dr. Geoffrey Ling, Department of Defense (absent 2/8)
Members of the public present for portions of the open meeting included:
Mr. Ronald Bartek, Friedreich's Ataxia Research Alliance
Dr. Elizabeth Hoffman, American Psychological Association
Ms. Michelle Rodrigues - SRI International
Beth Roy, Social and Scientific Systems, Inc.
NINDS employees present for portions of the meeting include:
|
Dr. Alan Willard |
Ms. Margaret Jacobs |
Other Federal employees present for portions of the meeting included:
Dr. James Stansbury, OBSSR, NIH
Dr. Pat Manos, CSR
Dr. Jay Joshi, CSR
Dr. George McKie, CSR
Dr. Dianne Rausch, NIMH
Dr. Rene Etcheberrigaray, CSR
Dr. Mary Custer, CSR
Dr. Jonathan Ivins, CSR
I. Call to Order and Opening Remarks
Dr. Landis welcomed Council members, visitors, and staff to the 171st meeting of the National Advisory Neurological Disorders and Stroke Council meeting. Dr. Luis Parada and Ms. Prisca Chen Marvin were unable to attend this meeting. Dr. Landis announced the following news items: 1) Dr. John Marler, Associate Director for Clinical Trials, has taken a sabbatical and will return to the Institute in 18 months, 2) Dr. Richard Benson of the Office of Minority Health and Research is leaving at the end of March, and 3) with Dr. Bob Baughman's departure to join the leadership of the Okinawa Institute of Science and Technology, there is a vacancy to lead the Technology Development Group. This position will be advertised within the next month. The Clinical Trials group will be organized into a new Office of Clinical Research, and a new director will be recruited. Dr. Koroshetz is chairing those search committees and co-chairing the search committee for the Clinical Director position in the Intramural Division. Dr. Landis invited Council members' recommendations for these positions.
II. Report of the Associate Director for Extramural Research, NINDS
Dr. Robert Finkelstein, Associate Director for Extramural Research, NINDS, informed the Council that they would be in open session until late afternoon after which they will go into closed session to hear the Board of Scientific Counselors' report from the Division of Intramural Research. The public and extramural staff must leave at that time. Tomorrow's session, where individual grants are discussed, is closed to the public as well.
Approval of Council Minutes - Dr. Finkelstein requested, and the Council voted approval, for the September 20-21, 2007, Council meeting minutes.
The following future Council meeting dates were confirmed and the new dates for 2010 introduced:
May 29-30, 2008 (Thursday and Friday)
September 18-19, 2008 (Thursday and Friday)
February 5-6, 2009 (Thursday and Friday)
May 28-29, 2009 (Thursday and Friday)
September 17-18, 2009 (Thursday and Friday)
February 4-5, 2010 (Thursday and Friday)
May 27-28, 2010 (Thursday and Friday)
September 16-17, 2010 (Thursday and Friday)
Expedited Review Process-A subset of Council members, prior to the meeting, approve applications within the payline for which there are no unresolved issues. For this round, there were 134 applications eligible to be expedited for payment, and 122 have been issued.
DER Staff Updates- Dr. Finkelstein introduced the following new staff: Program Directors Dr. Beth-Anne Sieber in the Neurodegeneration Cluster and Dr. May Wong in the Neural Environment Cluster; Dr. Ti Lin, program analyst in Neurodegeneration; and Dr. Kevin Lee in the Anti-Convulsant Screening program.
Council Operating Procedures-The only significant change is in the new requirement that all funding must be approved by the Council, including co-funding and conference grants. Council voted to approve the new Council Operating Procedures.
III. Report of the Director, NINDS
FY 2008 Budget-The final FY 2008 NINDS budget is $1.544 billion; an increase of 0.54% over 2007. The Institute was able to raise the payline to the 10th percentile, and the administrative reductions remained the same at 12.5% for modular grants and 17.5% for non-modular grants. Congress mandated a 1% inflationary increase over last year for non-competing awards. Support for new investigators in these difficult times is an NIH priority, with each Institute/Center (I/C) given a target number of new investigators to support. NINDS is on track to fund the mandated 128 new investigators and to fund 13 "Pathway to Independence" awards. NIH also made available funds to bridge vulnerable investigators between awarded grants. Looking ahead to 2009, the President's budget provides $1.54 billion for NINDS; however, the Congressional appropriations process has not yet begun for 2009, and that figure may change.
NIH Public Access Policy - The 2008 NIH appropriations law changed NIH policy from "requesting" to "requiring" that NIH-funded investigators make their manuscripts public. All peer-reviewed, published articles must be submitted to the NIH National Library of Medicine's Pub Med Central repository within 12 months of publication. It is also NIH policy to require program staff to ensure compliance.
Conflict of Interest-The HHS Inspector General's (IG) report concluded that there is no accurate accounting for conflicts of interest on the part of NIH grantee institutions. To address this omission, the IG report recommended that NIH increase the oversight of its funded institutions, increase the reporting requirements of its funded institutions, and require greater transparency.
Update on NIH Peer Review Report-The examination of the NIH peer review process is almost complete. The Peer Review Working Group solicited input from NIH staff, peer review participants, and the extramural research community. Some of the issues they addressed were the volume of applications, the number of funding mechanisms, the quality of the reviews, and the level of participation by external investigators. One recommendation is to create a "Select NIH Investigator Award" that would allow institutes to fund applications outside of the payline process, under certain conditions. The committee will submit its recommendations to Dr. Zerhouni at the end of the month.
NIH Roadmap-Included in the Roadmap process is a requirement to assess on-going Roadmap projects and to consider new projects. Concepts must have broad community support. The first round of Roadmap projects are currently being reviewed and some are being discontinued. Two new Roadmap projects will be introduced in the areas of the human microbiome and the epigenome. There is $50 million available for Roadmap initiatives.
NINDS Strategic Planning-There are four working groups of scientists from the extramural community matched with four working groups of NINDS staff engaged in strategic planning. The co-chairs of each group will meet to discuss possible overlap, strategies for dealing with it, and the questions each module will undertake. The internal groups will collect data and report back to their external counterparts. The final plan will address science, process, and opportunities. It should identify opportunities in translational research. Dr. Westbrook suggested that the NINDS portfolio be assessed in other ways besides a key-word search. Dr. Landis responded that the Institute is investing in a new software program that will provide a more refined analysis of the currently-funded research. There was support for including an analysis of neuro-related research across NIH into the planning process. Council members requested an update on the Blue Sky activities. The agenda was full for this Council meeting, but an update will be on the next Council agenda.
IV. The Evolving Context for the Use of Animals in Research
Dr. Norka Ruiz-Bravo, Director, Office of Extramural Research, Office of the Director, NIH, discussed the role of animals in NIH-funded research, the changing environment, and the opportunities for investigators within the current environment. The most significant change has been the increase in activities aimed at disrupting on-going research and in the severity of threats to investigators. The editor of Science wrote an editorial describing the most recent examples of animal activism and challenging the research community to address the growing problem. There are several parties involved in ensuring that research on animals takes place in a safe and humane environment: research institutions, Congress, professional societies, and funding institutions. Dr. Ruiz-Bravo reviewed the steps being taken by NIH. She announced a new website, entitled "Animals in Research" that will provide comprehensive information on policies and guidance for the care and use of animals, recent advances in animal research, and other resources for NIH staff and investigators.
Following Dr. Ruiz-Bravo's presentation, participants affirmed NIH's role in education and outreach and emphasized the need for greater vigilance in protecting investigators and their work. Suggestions were made to better advertise advances in both human and pet health due to animal research.
V. NIH Research, Condition, and Disease Categorization (RCDC) Introduction
Dr. Timothy Hays, Chief, Portfolio Analysis and Scientific Opportunities Branch, Division of Resource Development and Analysis, Office of Portfolio Analysis and Strategic Initiatives, Office of the Director, NIH, talked about Research, Condition, and Disease Categorization (RCDC). This is a new electronic system that reports NIH spending by research and disease area to Congress. It was adopted in response to recent National Academy of Sciences' reports raising questions about NIH's methodology and the precision of its data. RCDC aims to provide consistency, transparency, and the ability to conduct portfolio analyses across NIH. Council members questioned the low priority of accuracy as a goal of the new system. Dr. Hays responded that they are checking RCDC grant coding against last year's system, and they will continue to refine the definitions for greater accuracy.
VI. Discussion of NINDS Initiatives
Dr. Jill Heemskerk, Acting Chief, Office of Technology Development, reported that NINDS uses two models to support translational research. The first is Institute-initiated and is disease specific, and the other is investigator-initiated and is based on translational research funding announcements.
Dr. Heemskerk presented the NINDS Spinal Muscular Atrophy (SMA) project. NINDS recognized that there was a gap in the funding for translational research for rare diseases and novel approaches to more common diseases, which industry does not traditionally support. In order to fill that gap, NINDS decided to select a potential therapeutic approach for a rare disease and oversee the drug development process, treating this as a model for future translational projects. The project has already seen success in the creation of sufficiently novel compounds that NIH was able to obtain two patents available for licensing to industry. Another benefit of the SMA project has been discoveries that will broaden the application of these compounds to other diseases. The Institute is interested in applying the SMA pilot to other disease areas. For further information, see NINDS SMA Project.
The second type of Institute support for translational research is the NINDS Translational Research Program. The program is based on program announcements for investigator-initiated translational research in any neurological-related disease area. There are a number of different funding mechanisms available. There are U01s for cooperative agreements with principal investigators, U54s for specialized centers' cooperative agreements, U24s for resource centers, and an SBIR program for small businesses. The basic features of this program are:
- The project must be milestone-driven.
- NINDS is a partner in the project to ensure consistency with Institute goals.
- There are no set-aside funds for these projects; they must score within the payline.
Dr. Danilo Tagle, Program Director in the Neurogenetics Cluster, described three on-going translational cooperative agreement research projects in three rare diseases: Batten's disease, Niemann-Pick Type C Disease, and Phenylketonuria (PKU).
At the conclusion of the presentations, Dr. Finkelstein pointed out that the SMA project was Institute-initiated and the cooperative agreements that Dr. Tagle presented were investigator-initiated. Both are milestone-driven and allow for staff monitoring. How do these two approaches help guide Institute planning for the future? Council members questioned whether the success of the SMA project could be duplicated as a model for other rare diseases, as the investigators were fortunate to have found promising compounds early in the process. Council affirmed the value of bringing investigators with different expertise together on the SMA project and agreed that the Institute should fund translational research not being supported by industry. They agreed that milestones and staff monitoring were both important.
VII. Concept Clearance for FY 2009 Proposed Initiative
Dr. Ned Talley, Program Director in the Channels, Synapses, and Circuits Cluster, presented the NIH Neuroscience Blueprint Neuroplasticity initiative, "Probes and Instrumentation for Monitoring and Manipulating Nervous System Plasticity." This initiative has been approved by the Blueprint institute directors but also needs one institute Council clearance. Council voted to approve the initiative.
VIII. Report on Council of Councils Meeting
Council member Dr. Gary Westbrook represents NINDS as an ad hoc member of the Council of Councils. It is expected that the Council of Councils will essentially be the Council for the NIH Common Fund. The first meeting was an organizational meeting. The Common Fund is 1.7% of the NIH budget, which is currently $418 million. The goal is to identify and provide funding for trans-NIH initiatives. Dr. Zerhouni made a presentation of the Common Fund goals and emphasized that the projects needed to be broad and transformative. The Council members were organized into subcommittees, which have not met yet. There will be a second full Council meeting in March.
IX. Council Subcommittee Reports
Clinical Trials Subcommittee - Dr. Laura Ment, Chair
The open session included a presentation led by Drs. Hirtz and Janis on a proposed plan to monitor performance and budget expenditures in large NINDS funded clinical trials. The Subcommittee remains aware that enrollment is a significant challenge in clinical trials and is concerned with the rising costs to complete ongoing trials. There are a number of critical organizational activities that occur prior to the start of the trial and enrollment of the first patient that can result in delays in executing the trial, such as: the credentialing and training of sites, obtaining both local and site IRB approval, establishing contracts with each of the performance sites, getting regulatory IND or IDE approval, developing the data collection forms and data management system, etc. The NINDS Clinical Trials Group is working with the investigators and our grants management office to restructure study-related expenditures and the funding of study start-up, providing assistance and incentives to expedite these early steps, and working to streamline the interface with regulatory agencies such as the FDA and CMS.
Specifically, the Clinical Trials Group proposes to develop an individual expenditure plan for each trial and identify variable recruitment-related and fixed infrastructural costs that can be matched to performance milestones. Study expenditures will be linked to study performance milestones, including feasibility analyses with budget restrictions to ensure study related delays can be identified and corrected before significant funds are committed. As necessary, carry-over funds from a previous fiscal year will offset the award of new money in the subsequent fiscal year in order to sustain the trial and ensure progress in performance milestones.
Training, Career Development, and Special Programs Subcommittee - Dr. Francisco Gonzalez-Scarano, Chair
A summary of the success rates for training programs for the first two Council rounds of FY 2008 and trends of all training grant mechanisms for the past three fiscal years were also presented. While fellowship applications have held relatively steady, it appears that career award applications by clinicians are declining. This is particularly evident in the K08 program; the data are not there yet to evaluate the trend for the K23 program, although there has not been any increase to suggest a shift from KO8 to K23 applications.
Dr. Korn also presented an update on the research education program (R25) designed to support research education and experience for residents and fellows. The Subcommittee expressed support for the proposed training period of 9-18 months, and also endorsed the idea that fellows should be supported if they were first supported as residents through the program.
The Subcommittee discussed a proposed change to NIH policy that would limit mentored K funding to a maximum of six years per candidate. Training on institutional career awards (e.g., K12) would count towards this maximum. NINDS and two other Institutes have expressed concern with this proposed policy, indicating that six years of mentored support is not enough to adequately prepare some candidates to compete for independent research support. The committee agreed that maintaining the eight year option, with up to three years of institutional K and five years of mentored K, was critical.
Dr. Landis asked the Subcommittee to comment on whether or not K12 trainees were appropriate candidates for the Pathway to Independence Award (K99/R00) program. After some discussion, the Subcommittee agreed that it was not inappropriate for K12 trainees to be eligible for the K99/R00 program.
Basic and Preclinical Programs Subcommittee - Dr. David Van Essen, Chair
1. Policy Discussions:
- Acceptance of revised applications over $500K
NIH policy requires any application over $500K must be approved by a particular IC. The current NINDS policy is to review large applications for acceptance only in the initial submission, unless the scope or budget is dramatically changed in revised versions. This is changing in response to increased concern about the impact of large grants on the payline. The Subcommittee discussed whether revised (-A1 and -A2) applications over $500K should be accepted automatically or re-evaluated internally for each submission.
Summary Recommendation: Increased stringency for accepting large applications at the stage of first submission and re-consideration of applications for each revision. - Funding cap on new R01s outside of the payline
NINDS is proposing to fund new R01 investigators beyond the payline in order to meet the NIH-wide goal of supporting new investigators. There are a small number of these projects with budgets over $500K, including some clinical trials. This raises some concern about allowing inexperienced investigators to proceed with large projects that might benefit from revision and further review. This is a particular concern for inexperienced investigators proposing clinical studies. The Subcommittee discussed whether there should be a funding cap on R01s for new investigators being considered for funding outside the automatic payline.
Summary Recommendation: All applications from new investigators over $250K should be subject to additional scrutiny by NINDS and, at NINDS discretion, may be required to achieve a score within the payline.
2. Evaluating ongoing NINDS initiatives: developing a process
Based on previous Council recommendations, NINDS is developing a process evaluating ongoing initiatives. Dr. Heemskerk presented background related to the current process and requested the Subcommittee's guidance on evaluation criteria and defining success.
The Subcommittee agreed that, for each new initiative, criteria for success needs to be articulated prospectively and presented to Council as a standard part of the approval process. There must be clear, measurable goals against which the initiative can be evaluated over time. In some cases, it may be useful to standardize the way these criteria are developed to allow Council to evaluate new initiatives on a comparative basis.
For ongoing initiatives, the Subcommittee recommended that the Institute develop metrics for success at the time of renewal. It may be appropriate to implement a mid-course assessment of programs. This would allow the criteria for success to become more specific and measurable. This process could be conducted by staff with a report to Council, or the review itself could be conducted by Council.
X. Overview, Division of Intramural Research
Dr. Alan Koretsky, Scientific Director, NINDS, reviewed the number of staff scientists and fellows, the number of research projects, publications, patents, and staff changes in the Intramural Division. The remodeling of the clinical research center, the Porter Neuroscience Center, and other research space is almost complete. The 2007 Intramural Research Division budget was $147 million, which is approximately 10% of the NINDS total budget. Plans for the future include continuing to recruit outstanding PIs, re-energizing the clinical program, and increasing the level of collaborations among labs. Four overlapping working groups have been created to facilitate collaboration. Efforts to collaborate across NIH will also continue.
XI. Review of the Division of Intramural Research Board of Scientific Counselors' Reports
In closed session, Dr. Koretsky presented the findings and recommendations of the Board of Scientific Counselors based on their review of specific DIR laboratories/units during 2007. The Council discussed the reports of the Board and accepted them.
XII. Council Consideration 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. Prior to the discussion of the grants, Dr. Finkelstein reminded Council regarding conflict of interest and confidentiality as follows:
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.
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.
Research Training and Career Development Programs
The Council reviewed a total of 167 research career development and institutional training grant applications; of this total, 112 applications had primary assignment to NINDS, and 82 of them (73.2%) were recommended for support in the amount of $13.9 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 $4.5 million.
Research Grant Awards
The Council reviewed a total of 2,088 research project and center grant applications; of this total, 1,247 applications had primary assignment to NINDS, and 706 of them (56.6%) were recommended for support in the amount of $215.3 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 $50.5 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 two investigators as Javits awardees.
Small Business Innovation Research and Small Technology Transfer Award Programs
The Council reviewed a total of 158 Small Business Innovation Research (SBIR) and Small Technology Transfer Award (STTR) grant applications; of this total, 99 applications had primary assignment to NINDS and 51 of them (51.5%) were recommended for support in the amount of $9.8 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 $3.9 million.
XI. Adjournment
The meeting was adjourned at 9:45 a.m. on Friday, February 8.
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.
Last updated May 14, 2008
National Institute of Neurological Disorders and Stroke
Home | About NINDS | Disorders A - Z | Research Funding | News From NINDS | Find People | Training | Research
Careers@NINDS | FOIA (NIH) | Accessibility Policy | Contact Us | Privacy Statement
