NINDS Advisory Council Meeting Minutes, May 29-30, 2008
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
PUBLIC HEALTH SERVICE
NATIONAL INSTITUTES OF HEALTH
NATIONAL ADVISORY NEUROLOGICAL DISORDERS AND STROKE COUNCIL
Summary of Meeting1
May 29-30, 2008, 2008
The National Advisory Neurological Disorders and Stroke (NANDS) Council was convened for its 172nd meeting on May 29-30, 2008,
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: May 29, 2008 - 10:40 a.m. to 4:30 p.m.
for the review and discussion of program development, needs, and policy; and
Closed: May 30, 2008 - 8:10 a.m. to 10:45 a.m.
for the consideration of individual grant applications.
Council members present were:
Ms. Susan Axelrod
Mr. Robi Blumenstein
Dr. Lucie Bruijn
Dr. Ralph Dacey (absent 5/29)
Dr. Francisco Gonzalez-Scarano
Dr. Edgar Kenton
Dr. John Loeser
Ms. Prisca Chen Marvin
Dr. Helen Mayberg
Dr. Laura Ment
Ms. Cindy Parseghian
Dr. Timothy Pedley
Dr. John Povlishock
Dr. Caroline Tanner
Dr. David Van Essen
Dr. Gary Westbrook
Dr. Vicky Holets Whittemore
Council Roster (Attachment 1)
Council Members absent:
Dr. Luis Parada
Ex Officio Members present:
Dr. Robert Ruff, Department of Veterans Affairs
Ex Officio Members absent:
Dr. Geoffrey Ling, Department of Defense
Members of the public present for portions of the open meeting included:
Ms. Teresa Wilson, PPD
Mr. Ronald Bartek, Friedreich's Ataxia Research Alliance
Ms. Donna Meltzer, Epilepsy Foundation
Ms. Dane Christensen, Dystonia Medical Research Foundation
Ms. Anne Bettesworth, American Psychological Association
Dr. Howard Federoff, Georgetown University
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. Francois Boller, CSR
Dr. Rene Etcheberrigaray, CSR
Dr. Pat Manos, CSR
Dr. Jay Joshi, CSR
Dr. Christine Melchior, CSR
Dr. Alexander Yakovlev, CSR
Dr. George McKie, CSR
Dr. Seetha Bhagavan, CSR
Dr. Aiden Mayer, CSR
Dr. Peter Guthrie, CSR
Dr. Vilen Movsesyan, CSR
Dr. Biao Tian, CSR
I. Call to Order and Opening Remarks
Dr. Landis welcomed Council members, visitors, and staff to the 172nd meeting of the National Advisory Neurological Disorders and Stroke Council meeting. Dr. Luis Parada was unable to attend this meeting. Dr. Ralph Dacey will attend the second day of Council. This is the last Council meeting for Dr. Francisco Gonzalez-Scarano, Dr. John Loeser, Ms. Prisca Chen Marvin, and Dr. David Van Essen. 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 these members is currently being reviewed by the Department of Health and Human Services, and the new members are expected to be on board by the September meeting.
In keeping with the Institute's policy of inviting chairs of CSR review committees, Dr. Landis introduced Dr. George Richerson, Chair of the CSR Neurotransporters, Receptors, and Calcium Signaling Study Section, who is attending the open session of the Council meeting. Dr. Richerson is Professor of Neurology, Cellular and Molecular Physiology, and Neuroscience at Yale University; Director, Neurology Residence Training Program-Yale-New Haven Hospital; and a staff physician at the VA Hospital in West Haven, Connecticut.
Dr. Landis congratulated Council member Susan Axelrod for her recent award for the Gordon and Llura Gund Volunteer Leadership Award for her role in launching CURE in 1998 and leading the organization to raise $7 million and award more than 50 research grants.
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 today and in closed session to the public tomorrow when individual grants are discussed.
Approval of Council Minutes - Dr. Finkelstein requested, and the Council voted approval, for the February 7-8, 2008, Council meeting minutes.
The following future Council meeting dates were confirmed:
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 140 applications eligible to be expedited for payment, and 102 have been issued.
DER Staff Updates- Dr. Finkelstein introduced the following new staff: Dr. Gary Murray on detail from the Intramural Program is a Program Director with the Neurogenetics Cluster; Dr. Alexander Runko, Program Analyst in the Neurodegeneration Cluster; Dr. Yolanda Vallejo, Program Analyst in the Repair and Plasticity Cluster; and Taek Oh in the Anti-Convulsant Screening Program. Dr. Finkelstein also reported on the upcoming departure of Dr. Katrina Gwinn, Program Director with the Neurogenetics Cluster, who will be taking a position with the Department of Human and Molecular Genetics at Baylor as the Vice Chair of Research.
III. Report of the Director, NINDS
Dr. Landis announced that the NINDS Budget Officer, Mr. Paul Myers, is leaving NINDS at the end of July to move to Wisconsin. He has ably managed the budget responsibilities the last few years and will continue to work on projects for the Institute.
Genetic Information Nondiscrimination Act. The main provisions of this Act, recently signed by the President, are that it prohibits insurers from canceling, denying coverage, or raising premiums based on a genetic predisposition to disease; and it bars employers from using genetic information to adversely affect their employees. The Act will go into effect in 2010. This Act enables the public to pursue genetic testing without fear of negative repercussions.
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.
Training News Update There was no Council Training Subcommittee meeting this round. K99/R00 Awards: NINDS received 160 applications and funded 30 (19% success rate) in FY07 and FY08. Approximately one-third of the applicants and awardees are female. Six already have faculty positions and six have offers. There were only five applications from MDs and ten from MD/PhDs, with success rates of 20% and 10%, respectively.
R25 RFA: The announcement for the NINDS Research Education Programs for Residents and Fellows in Neurology and Neurosurgery has been released. The goal is to support research during residency and fellowships in order to increase the number of residents going into research careers.
Update on NIH Peer Review Report First-rate peer review is a cornerstone of NIH. In light of the increasing breadth and complexity of biomedical science and the fact that trends in funding are increasing the stress on peer review, the NIH Director requested an analysis of the NIH peer review process. The process began in July 2007 and culminated in a draft report in February 2008. The analysis included extensive opportunities for input from the extramural community, public and staff. A Design Implementation Plan was developed in April, and the phased implementation of selected actions will begin in June. The core themes were to: a) ensure the excellence of reviewers, b) ensure fairness and clarity of peer review, c) support for scientists at different stages of their careers, and d) continuous quality control and improvement of peer review. http://enhancing-peer-review.nih.gov/
The trends in R01s funded over the last ten years show a significant decrease in funding of first-time submissions and an increase in funding the second revision of applications. NIH is deliberating whether to address the issue of funding more first submissions in preference to higher-scoring, amended applications, or whether to leave that up to the individual Institutes/Centers (I/Cs).
The Council discussion following Dr. Landis's presentation centered around concern for funding first-time investigators. Dr. Landis stated that one idea is to percentile early-stage investigators separately or not to percentile the applications but to rank them against one another. There was general support for Dr. Westbrook's suggestion to revisit the recommendation to review new PIs separately. Another concern raised by Council was the new proposed limit on number of pages for applications. No final decision has been made.
IV. NIGMS Perspectives on Supporting Innovative Research in Challenging Times
Dr. Jeremy Berg, Director, NIGMS, reviewed NIGMS's mission and organization. One of his Institute's concerns has been the aging of the PI workforce. He described an NIGMS Early Career Investigator Workforce Study and found that investigators average 6.7 years from B.S. degree to Ph.D., 5 years from Ph.D. to Assistant Professor, and 3.6 years to first research grant. NIGMS is engaged in developing strategies to reduce the period from bachelor's degree to first award. The Institute is also involved in two major NIH programs: The NIH Director's Pioneer Award and the New Innovator Award. Both are designed to encourage innovative, high-risk research with potential for high impact.
NIGMS has had a policy to limit funding to well-funded grantees. If an applicant has at least $750,000 of funding from all sources, their high-scoring competitive renewal application will be funded but their high-scoring Type 1 application generally will not. Exceptions to this policy are considered by the NIGMS Advisory Council.
NIGMS just completed its strategic plan, 2008-2012, which is available on their website.
http://www.nigms.nih.gov/About/StrategicPlan/
V. Update on OPASI and Council of Council Meeting
Dr. Gary Westbrook, an ad hoc member representing NINDS on the Council of Councils, reported that the NIH Reform Act 2006 created the Division of Program Coordination, Planning and Strategic Initiatives, which evolved into the Office of Portfolio Analysis and Strategic Initiatives (OPASI). The purpose of OPASI is to help assess, evaluate, and manage the NIH portfolio. The Council of Councils was created to advise the Director on cutting-edge trans-NIH priorities and matters related to OPASI's activities. It also advises on the use of the Common Fund. The Council of Councils has met twice and is still defining its mission and organization. It will be involved in reviewing projects proposed for the NIH Roadmap and in the areas of Public-Private Partnership and the activities of the NIH Foundation.
VI. Status of NINDS Strategic Planning Effort
Dr. Paul Scott, Director, Office of Science Policy and Planning, NINDS, reported that the goal of the current strategic planning effort is to examine how well NINDS programs are currently functioning, where they might be improved, or done differently in the future, as well as to develop a vision for the future of neuroscience research over the next 15 years. The process is organized into five main modules: basic research, translational research, clinical research, and disease research, as well as a separate "Blue Sky" vision module. Input has been sought from a variety of stakeholders: the public, non-profit groups, extramural scientists, industry, and staff. The four research modules' external panels are currently working with the internal NINDS working groups to collect needed data and formulating their recommendations. The reports of these activities, along with the Blue Sky outcomes, will be integrated and developed into the Institute's strategic plan. The process is scheduled for completion in the spring of 2009. There is a steering committee guiding the process, made up of current and former Council members and NINDS staff. A representative from each module will make a presentation today, and Council feedback is encouraged.
Council reconfirmed that voluntary groups have an interest in an ongoing relationship with NINDS. The Institute has sponsored annual meetings with voluntary groups and is considering constituting a smaller group of representatives with whom the Institute would consult on an ongoing basis. Council noted that professional groups and industry representatives are interested in having a role with NINDS, as well. Industry representatives have been involved in the planning process.
Basic Module Planning Panel, Dr. Gary Westbrook
The Basic Module Planning Panel, which Dr. Westbrook chairs, is comprised of a cross-section of basic neuroscience researchers
from academia and industry. Dr. Westbrook is currently working with Dr. Ned Talley, Dr. Heather Rieff, and the NINDS working
group to generate background material for the first strategic planning meeting, to take place in June. Additional requests
for data collection will be compiled during this first meeting, and a second meeting will be held in the fall to review the
data and develop recommendations for the Institute. In preparation for the first meeting, Dr. Westbrook, Dr. Talley, Dr. Rieff,
and others are collecting information about the basic neuroscience research topics currently supported by NINDS as well as
other NIH Institutes. By classifying projects based on themes identified by the Society for Neuroscience (SfN), they hope
to present a broad overview of the basic neuroscience research being funded at NIH. The group will also be considering the
distinction between pure basic research and basic research that has a disease focus. Another method for categorizing the projects
is to use a "Topic Modeling" approach that uses a text-mining algorithm to identify major basic neuroscience topics among
SfN Abstracts and NIH-funded projects. These results will be shared with the planning panel to help with their deliberations.
Council members suggested to Dr. Westbrook that one outcome of the planning effort could be an evaluation of the impact of
the basic science NINDS has funded. Someone else commented that it would be useful if metrics could be developed to guide
decisions on whether to fund a disease-related basic science project. Another suggestion was to perhaps require PIs to build
in key words to help review committees evaluate significance and help categorize the applications. Dr. Westbrook explained
that NIH currently categorizes most applications into one of two categories: 1) basic science, which includes disease-related
basic research as well as "purely basic" science, and 2) applied research, which includes all projects involving human subjects.
Translational Advisory Panel, Dr. Howard Federoff
The panel's charge is to determine the effectiveness of NINDS' translational research, develop recommendations for supporting
it more effectively, and develop criteria for selecting diseases and strategies for future translational investment. The panel
held its first meeting in February where the panel agreed on a definition for translational research, established guiding
principles for the Institute, reviewed current projects, identified the critical issues, and developed a strategy for reviewing
major programs in more depth. The panel is now collecting background material to prepare them for their next meeting to be
held July 31. Dr. Loeser suggested adding behavioral change to the panel's consideration of effective translational research.
Dr. Koroshetz suggested that the panel consider the issue of translating discovery into practice. The issue of behavioral
change is one of the Roadmap projects, which is being led by NIA. Another suggestion was to include modes and strategies for
delivery of new molecules and biologics to their targets.
Clinical Research Advisory Panel, Dr. Caroline Tanner
While focusing on strategies and opportunities that cut across, rather than on individual diseases, the main goal of the panel
is to make recommendations to the NINDS on how the Institute might best support and advance clinical research. The panel has
met twice and organized its discussions around several questions that relate to the Institute's strategies and effectiveness
in funding clinical research and to identify areas for improvement. The following areas of interest were defined: setting
priorities, analyzing the Institute's investment in clinical research, measuring the success of some of its investments, determining
the Institute's role in disseminating research results, and analyzing the roadblocks to successful research. The panel is
in the process of collecting data and creating subgroups to take on specific questions. The subgroups will make recommendations
that will be discussed at a second meeting of the Advisory Panel in the fall of 2008. Subsequently, these will be compiled
into a report that will be presented to the Institute Director and the NINDS Council in February 2009. Dr. Bruijn suggested
that the panel also look at the role of IRBs. Dr. Povlishock suggested also considering projects at the pre-clinical stage
to assess their readiness for full trials
Disease Module, Dr. Tim Pedley
The panel will focus its discussions on three primary questions: 1) How can the Institute best balance the three considerations
of burden of disease, public health impact, and scientific opportunity; 2) what are the most important unmet opportunities
in disease research; and 3) are there opportunities to better coordinate research both within and outside of NINDS? There
are several significant challenges to this charge; among them are the number and diversity of neurological disorders, the
sparse or conflicting data on burden of disease, and defining the panel's scope as distinct from the other planning panels.
Although there is a long list of diseases within the NINDS portfolio, many are shared with other NIH Institutes. The panel
is collecting data on disease funding, using the NINDS coding system, for its first meeting. Council members raised the recommendation
to include the issue of training investigators for the future into the panel's deliberations. Trans-NIH coordination is also
important. The panel should also include the economic cost when evaluating the burden of disease. Dr. Bruijn recommended including
consideration of industry spending on disease in the panel's analysis.
Dr. Landis thanked the panel chairs for their presentations and said she looks forward to the results of their efforts.
VII. Concept Clearance for FY 2009 Proposed Initiative
Council voted to approve the concepts for the following initiatives: 1) Translational Research in Neuromuscular Disease (U01 and R21) presented by Dr. John Porter, and 2) Novel Lentiviral Models of HIV Neuropathogenesis (R01, R21) presented by Dr. May Wong.
VIII. Council Subcommittee Reports
Training, Career Development, and Special Programs Subcommittee- This Subcommittee did not meet this Council round.
Clinical Trials Subcommittee - Dr. Laura Ment, Chair
- Due to the number and complexity of Subcommittee agenda items, the Subcommittee resolved to extend the duration of the meetings
and to ask the Institute to invite ad hoc members to assist with specific scientific issues.
- Dr. Tanner updated the Subcommittee on the progress of the Clinical Trials Advisory Planning Panel. A full presentation will
be made at the Council meeting.
- Dr. Hirtz presented proposed policy changes for financing large Phase III trials that exceed the planned funding period. NINDS plans to make an initial obligation of two to three years for the PI to establish feasibility, which could be followed by the option to request the remaining unobligated funds and additional years by means of a Type 4 award. The Type 4 application will be reviewed administratively by NINDS and by the Data Safety and Monitoring Board (DSMB). Council will be notified of the extension. If additional time is needed to complete the trial, the investigators may submit an application for a Type 2 competing continuation award. The review process will include review by the NINDS NSD-K study section with recommendations by the DSMB. The study section and Council must agree to the continued funding request. This policy will be written up by the NINDS Clinical Trials Group and published in the NIH Guide for Grants and Contracts.
Basic and Preclinical Programs Subcommittee - Dr. David Van Essen, Chair
- EUREKA: A New Review Paradigm. The first year of the EUREKA program, which was designed to solicit and fund innovative research, was deemed a success.
Dr. Alan Willard presented the structure and outcomes of the EUREKA RFA and peer review process. NINDS sought recommendations
for changes from Council in the event the announcement is re-issued. It was noted that in recruiting reviewers, a number of
people were not yet aware of this program, suggesting that there may be more applications submitted once the program is more
well-known. Council suggested publicizing the successful applications so future applicants can get a sense of whether their
ideas may be a good fit for this program. The Subcommittee considered requiring milestones for continued funding, but rejected
the proposal as unsuitable for the EUREKA grants. They also discussed the method of dividing the applications into "score
bins" as opposed to assigning individual priority scores. The method helped expedite the review process, but consensus was
difficult to reach among the reviewers. Reviewers found it helpful to have both a preliminary and a final discussion of each
application. It was also helpful to review all of the applications together, rather than dividing them among Institutes. It
was beneficial to have the reviewers focus on the broad ideas rather than the details of the subject matter. This strategy
also helped keep the number of reviewers to a manageable level.
- NINDS Basic Science Portfolio Analysis. The Basic Science Module of the NINDS Strategic Planning effort is getting underway. Dr. Ned Talley presented a novel computational
methodology for representing the basic grants portfolio. The functionality of this database is in development, and Dr. Talley
solicited Council input for its design. Currently there is no user-friendly system for compiling grant data for analysis and/or
presentation. The system needs to include information on grants across NIH and be based on categories that are relevant to
all neuroscientists.
The SfN has developed a database which uses an algorithm with a number of pre-determined categories to analyze all of its published abstracts. Council members discussed many possible uses and applications for this system. Overall, this method was deemed potentially useful for the planning panel for categorization of projects and looking for patterns that may not otherwise be evident. - Facilitation of Data Sharing by NINDS. Building on prior Subcommittee discussions of the importance of data sharing, Dr. Yuan Liu sought recommendations from the
Subcommittee for NINDS to promote data sharing.
- Develop a set of criteria for different scientific areas. This might be done more efficiently at the journal level if NINDS
could facilitate a set of criteria that a number of neuroscience journals could agree upon and implement.
One obstacle is that standards and best practices vary among investigators. Data are stored in many different forms and places. - Add data management as a review criterion. This is difficult to implement, however, due to the evolving nature of technology.
Investigators should be encouraged to give data management and data sharing serious thought and should be required to propose
a data collection and management plan.
- Training in data management should be improved in neuroscience programs. The ability to utilize bioinformatics is going to
become increasingly important for investigators. NINDS could develop programs that encourage increased training in this area.
- NINDS may also consider making investigators aware that it is allowable in the grant to budget for data archiving.
Data management becomes important to investigators at the intellectual property stage. If PIs are given user-friendly tools to manage their data, they will be more likely to store and share their data. NINDS can assist investigators in identifying which data are useful to share.
- Develop a set of criteria for different scientific areas. This might be done more efficiently at the journal level if NINDS
could facilitate a set of criteria that a number of neuroscience journals could agree upon and implement.
IX. 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, the Council Executive Secretary, who will then refer the questions to the appropriate
staff member for response.
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 143 research career development and institutional training grant applications; of this total,
93 applications had primary assignment to NINDS, and 68 of them (73.1 percent) were recommended for support in the amount
of $8.7 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 Project and Center Awards
The Council reviewed a total of 2,736 research project and center applications; of this total, 1,397 applications had primary
assignment to NINDS, and 780 of them (55.8 percent) were recommended for support in the amount of $240.9 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 $78.3 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, 97 applications had primary assignment to NINDS and 44 of them (45.4 percent) were recommended
for support in the amount of $8.1 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 $3.4 million.
X. Adjournment
The meeting was adjourned at 10:45 a.m. on Friday, May 30, 2008.
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 November 24, 2008
National Institute of Neurological Disorders and Stroke
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