NINDS Advisory Council Meeting Minutes, May 20-21, 1999
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I. CALL TO ORDER AND OPENING REMARKS | |
VI. UPDATE ON NEUROSCIENCE REVIEW IN THE CENTER FOR SCIENTIFIC REVIEW (CSR) | |
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II. REPORT OF THE ASSOCIATE DIRECTOR FOR EXTRAMURAL RESEARCH | |
VII. NEUROLOGICAL RESEARCH: AT THE CROSSROADS | |
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III. REPORT OF THE DIRECTOR, NINDS | |
VIII. NINDS INTRAMURAL ACUTE STROKE PROGRAM | |
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IV. PROSPECTS FOR NEUROLOGICAL RESEARCH TRAINING AT ACADEMIC HEALTH CENTERS | |
IX.. COUNCIL CONSIDERATION OF PENDING APPLICATIONS | |
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V. BIOETHICS ISSUES | |
X. ADJOURNMENT |
- Update on Council Expedited Review Process
Dr. Atwell reported on the results of the pilot program to issue expedited awards using a small group of Council members This pilot program was approved at the February 1999 Council meeting. A subset of Council members approved a list of applications within the payline for this Council round for expedited review. Ninety three grants were awarded prior to this Council meeting thus saving approximately four months of wait time for the principal investigators.
Dr. Atwell also briefly reported on the new modular grant application and award process which was discussed at the previous Council meeting. With regard to the percentage of NINDS applications that would be eligible for the simplified application and award situation, it is better than expected. She indicated that for the current round, 80 to 85 percent of applications for eligible mechanisms had, in fact, requested less than $250,000 in any year and would, therefore, be eligible to submit a modular application. Of those within the 80 percent payline that would be awarded in that fashion, it was a little bit lower--75 to 80 percent. This represents a substantial amount of the workload that will be covered by this procedure.
III. REPORT OF THE DIRECTOR, NINDS
Dr. Fischbach opened by stating he would address the status of the NINDS planning process, discuss the recent reorganization of the extramural program, and provide information about the NINDS FY 2000 budget. He reported that the congressional appropriations hearings were favorable for NIH; however, the final FY 2000 appropriation bill has not been passed yet. A delegation of six to seven congresspersons and 40-50 staff visited NIH in April. Five Institute/Center Directors took part in the program, which included a joint presentation by Dr. Fischbach and Dr. Steven Hyman, Director, National Institute of Mental Health.
Planning
Dr. Fischbach updated the Council on the planning process. He briefly reviewed the process so far, mentioning that since the last Council meeting, the draft plan had been discussed with NINDS staff, circulated to over 250 advocacy organizations for comment, and revised as a result of comments from both staff and the public. The revised plan has been circulated at several scientific meetings. The revised plan incorporates many of the public comments, and also includes an appendix listing the major categories of neurological disorders. Dr. Fischbach then briefly reviewed the document, highlighting examples of the planning panels' recommendations.
Dr. Fischbach next reviewed the results of a meeting held in late April of the planning panel chairs. At the meeting, it was decided that the panels should continue to meet, but with more focused goals and suggestions for implementation. In addition, it was recommended that new mechanisms be created for funding innovative translational research and for increasing access to gene array and imaging technologies, and that NINDS consider a core grants program. In response to a question, Dr. Fischbach stated that he thought that each panel might have as much as a one-third turnover in membership each year.
Overall, Council members were supportive of the plan, and suggested that it be made more widely available. Several questions were asked relating to other NIH Institutes' planning activities.
Reorganization of the Extramural Staff
Dr. Fischbach reminded Council that the former five divisions had already been consolidated into four divisions under Dr. Hall. In order to get a more uniform organization and expand the role of each program director, the extramural divisions have been abolished, and "clusters" of programs loosely representing the areas in the NINDS strategic plan have been formed.
Dr. Fischbach believes that this change will optimize implementation of the strategic plan, allow for intellectual development and outreach, and facilitate program management. This seems to be an opportune time to reorganize, since the extramural staff has just moved to the new Neuroscience Center, Dr. Michael Walker will be retiring, new program directors are being hired, and there will be increased emphases on technical development, expanded clinical trials, and infections of the nervous system. Dr. Robert Baughman has become the Associate Director for Technical Development, Dr. John Marler the Associate Director for Clinical Trials, and
Dr. Floyd J. Brinley the Associate Director for Infections of the Nervous System and Autoimmune Diseases. The clusters will include program directors, administrative and support persons, grants review staff, and representatives from the Office of the Director Science Policy and Communications/Public Liaison offices. A steering committee will oversee the clusters. It is anticipated that the reorganization and hiring of new staff will result in a decrease in the number of grants each program director manages, allow them to communicate better with the extramural community, and increase their involvement in the planning process. The program directors will be encouraged to interact with more than one cluster.
The Council members had at their places handouts that listed all the workshops and staff initiatives (PAs, RFAs, RFPs) during FY 98-99. Recently, at NIH there has been increased use of these solicitations, especially RFAs.
Budget Update
The NINDS FY 1999 appropriation was $903 million, 78 percent of which was investigator-initiated grants. Ten percent was for the NINDS intramural program, 3 percent for Institute and extramural program direction, 3 percent for contracts, and 5 percent for training. The President's FY 2000 budget is $921 million.
The NINDS has increased its success rate to 35 percent, and reduced its downward negotiation from 10 percent to 5 percent. A total of $10 million has been awarded so far in FY 1999 for the popular administrative (infrastructure) supplement program.
NINDS currently maintains a $750,000 cap on multicomponent grants; however, Dr. Fischbach revisited the issue of increasing funding caps to possibly $1 million. Council discussed the effect of instituting such an increase, speculating how it would affect the numbers of grants, indirect costs and its impact on investigators and clinical trials. There was general agreement that the present funding cap should be increased.
Copies of the slides used in Dr. Fischbach's presentation are attached as Appendix 1.
IV. PROSPECTS FOR NEUROLOGICAL RESEARCH TRAINING AT ACADEMIC HEALTH CENTERS
NIH Training Issues
Dr. Walter Schaffer, NIH Research Training Officer, Office of Extramural Programs, Office of the Director, updated the Council on the draft report of the NIH Training Advisory Committee's Postdoctoral and Graduate Student Issues Subcommittee. He emphasized that the report's recommendations are preliminary and that the subcommittee was currently seeking comments from the NIH Institutes. The report lists several concerns regarding training: the production rate for new Ph.D.s is too high, workforce entry rates are driven by labor needs, training does not fully address market needs, training takes too long, and given this, income and benefits are too low.
Dr. Schaffer showed statistics regarding the increase in the number of new Ph.D.s since 1980 along with the relatively flat level of training support since then. He noted that the number of National Research Service Award (NRSA) fellowships supported has remained constant, while the number of research assistantships supported by research grants has doubled. He stated that NIH policy in effect encourages this since research assistantships bring in more money to the institution than NRSAs. Given estimates that NIH grants support 25 percent of students, 50 percent of postdocs, and 25 percent of the entire biomedical workforce, there is a real potential for NIH to influence the process.
Dr. Schaffer then outlined the report's goals for federal support of training. These included increasing the number of NRSA awards to approximate parity with the number of research assistantships (RAs), having NRSA support prior to admission to candidacy and RA support after admission, having comparable benefit levels for both NRSAs and RAs, expanding the number of institutional training grants, seeking assurances that pre- and postdoctoral training be focused on training and not used just as a means of employment, limiting training support to 5 years of predoctoral and 6 years of postdoctoral support, tracking career outcomes to evaluate training effectiveness, and giving trainees full disclosure regarding the nature of training, etc. In addition, the use of transitional career awards (e.g., K22) without institutional affiliation should be expanded, and NIH should support a mechanism for retaining excellent research trainees as staff at the expiration of training.
During the discussion period, Council members expressed concerns regarding how foreign students would be supported in their first few training years, since they are not eligible for NRSAs, and that the 6 year cap on postdoctoral support could adversely affect some trainees, particularly women who take a temporary leave to have children. In addition, they took issue with Dr. Schaffer's statement that institutions use the research assistantship mechanism more, pointing out that most principal investigators are reluctant to use grant money to support first and second year students. They also questioned his assertion that the NRSA mechanism leads to better career outcomes, pointing out that this may simply be because smarter students tend to receive these awards in the first place.
Academic Medical Centers at the Millennium: Threats and Opportunities
Dr. Timothy Pedley, Chairman, Department of Neurology, The Neurological Institute of New York, Columbia University, discussed how the evolving changes in health care have affected research training in neurology, and concomitantly reduced the number of physician investigators.
Because of new scientific advances, the field of neuroscience is increasingly focused on therapeutic interventions. Historic problems have been solved, and a host of new issues has arisen. This is a time of great excitement; however, limitations placed on academic medical centers by managed care are a cause for concern. Several aspects are affecting the field of neurology: training, resident education and the disappearing physician-scientist. The problems identified include decreased reimbursement from the universities to the neurology departments, and decreased time for resident teaching. Collegial relationships have also deteriorated. At the same time, concerns about income and workloads have increased. Managed care has affected the traditional role of the physician as a patient advocate. Numerous factors are blamed for the decrease in the number and quality of students choosing to pursue a career in neurology, including the length of training and large debt load. In order to attract the best and brightest from medical schools into neurology, institutions need to maintain a high quality faculty that is visibly engaged in research. Institutions must have an integrated neurological education core for all medical students including preceptors. Additionally, sufficient subspecialty electives should be available. Reports show that more than 20 percent, and up to 40 percent in some settings, of M.D./Ph.D. students write their theses on some aspect of neuroscience. These students should be cultivated to consider physician researcher careers. Dr. Pedley emphasized that the changes in research training have been caused by societal and political decisions in the health arena; he, therefore, suggested that working through the political system to impact these decisions might result in a more positive milieu for training greater numbers of highly qualified research neurologists.
NANDS Council Training Committee Recommendations
Dr. DeVivo reported on the recommendations of this committee regarding clinical training. As background, he noted that managed care has changed the clinical research climate, making debt burden more of a pressing problem, and negatively affecting the career choices of new physicians. In addition, the award system is not attractive, with caps on stipends and increasing demand on faculty time, resulting in less opportunity to supplement stipends.
The committee's recommendations centered on modifying the existing K08 Mentored Clinical Scientist Development Award and the K02 Independent Scientist Award to make them more appealing and more effective. The specific recommendations can be found on the handout provided by Dr. DeVivo. Briefly, they included changes in eligibility requirements, length of awards, percent effort towards research, salary and research allowance increases, and waiver of tenure-track requirements (for the K02). It was felt these recommendations would increase the awards' flexibility, allow for 100 percent effort towards research, and make salary and research support more comparable to other sources.
During the discussion period, Council members questioned the necessity and feasibility of one of the features of the research support recommendation, that support would not be lost if the principal investigator subsequently received an R01. Members felt that this might be perceived as "double-dipping." Other members pointed out that the report's recommendations would not work for neurosurgeons, since they cannot be expected to put 100 percent effort towards research at the expense of surgical experience. It was suggested that this point be modified to allow for clinical experience that was directly related to their research interests. In general, Council members were enthusiastic about the report. Dr. Fischbach announced that he would form a committee of three neurologists and three neurosurgeons to write another report based on the current report, but taking into account the concerns of the neurosurgeons.
Update on National Bioethics Advisory Commission (NBAC) Reports and Related Activities
Ms. Lorraine Fitzsimmons, Program Analyst, Legislative and Analysis Branch, NINDS, reviewed the current status of the NBAC reports on: 1) informed consent in research involving persons with impaired decision making capacity; 2) research using human biological materials; and 3) stem cell research.
1) Since the informed consent report was discussed at the February 1999 NANDS Council, it has been sent to the National Science and Technology Council (NSTC) for consideration and action. The NSTC requested comments, including planned agency actions in response to the report, from all the agencies that are signatories to the Common Rule (the regulations at 45CFR46 addressing the protection of human subjects). The NIH response noted serious concerns with the scope of the report; the proposed new DHHS oversight panel; issues surrounding capacity assessment and measurement; and provisions involving prospective authorization and the authority of legally authorized representatives, especially with regard to research involving greater than minimal risk with no direct benefit. On March 11, NIH issued interim "Points to Consider" when conducting research involving persons who may have impaired decision making capacity; the "Points" document has been posted on the NIH/OER home page and sent to the White House. A copy of the "Points" document was distributed to Council.
Dr. Posner distributed and discussed briefly a joint letter from the American Academy of Neurology and the American Neurological Association to the White House expressing concerns with the NBAC report, and asking that no actions be taken to implement the recommendations until a broader base of input has been obtained from the neurology community and from advocates for potentially affected patients with neurological disorders. Two commentaries on the NBAC report that appeared in New England Journal of Medicine, [340: 1427-30; 1430-34] were summarized, and Dr. Posner indicated that a letter might be sent to the NEJM similar to that sent to the White House.
A copy of the May 4 letter from the NBAC Chair, Dr. Harold Shapiro, to the President was distributed. The letter promises a more comprehensive report on the protection of human subjects generally, with recommendations for changes in the federal system.
2) Several key recommendations among the 25 contained in the most recent draft of the NBAC report on human biological materials, dated May 9, 1999, were summarized, including the blanket classification of all coded materials as identifiable and, therefore, subject to informed consent; restrictions on "general releases" for research and on prospective informed consent for research purposes; and provisions involving medical records privacy. The report is expected to be finalized for the June meeting of NBAC, and a more detailed discussion was promised at a future NANDS Council meeting.
3) An orientation was provided to the current bar on the use of NIH funds to conduct human pluripotent stem cell research; the high level of Congressional interest in, and opposition to, embryo-derived stem cell research; the status of NBAC activities on this topic in response to a November 14, 1998 request from the President; and the guidelines being developed by a subcommittee of the Advisory Committee to the [NIH] Director (ACD) for the use of pluripotent stem cells in research funded by the NIH. The latter will be published in the Federal Register for comment once finalized.
UPDATE ON NEUROSCIENCE REVIEW IN THE CENTER FOR SCIENTIFIC REVIEW (CSR)Dr. Robert Baughman, currently the Director, Division of Fundamental Neuroscience and Developmental Disorders, updated the Council on neuroscience review in CSR He noted that CSR has formed a Panel on Boundaries for Scientific Review to perform a CSR-wide review of study sections. Neuroscience is off the table due to the recent reorganization it underwent. In
addition, a Neuroscience Initial Review Group (IRG) Evaluation Working Group is being established to determine how well the reorganization is going.
There have been many complaints recently regarding the lateness of summary statements. This is due to several factors, including understaffing of Scientific Review Administrators (SRAs) and Grant Technical Assistants (GTAs), software problems, extra study section and Special Emphasis Panel (SEP) meetings, and an increase in the number of specialized grant reviews (for RFAs etc.). CSR hopes to have these problems fixed in time for the September 1999 review round.
Another issue CSR is currently dealing with is improving the reviewer pool. Among the ideas being considered is creating new reviewer categories (regular - three meetings per year over four years; senior - five meetings per year over three years.; special expert members brought in only when needed and shared across IRGs; and "special needs" members), and giving reviewers incentives, such as an extra year of grant support.
CSR is also working on ways to improve the review process, including developing better criteria for reviewing exploratory research and novel technology and instrument development, getting study sections to concentrate on the importance of the research as opposed to the adequacy of methods, and reconsidering the issue of whether and/or how many revisions to a grant should be allowed.
Finally, CSR is studying the need for a separate neurogenetics study section, and the range of research that such a section would cover.
During the discussion period, Council members strongly voiced their concerns about the present situation, expressing their disappointment with the slow pace of change. They felt that this was a crisis, and that NIH should be giving it top priority. It was decided that Dr. Fischbach would speak with Dr. Varmus and express the Council's concerns. Representatives from CSR and study sections commented that part of the problem was in the lack of adequate planning by CSR for the reorganizations of the Neuroscience study sections, resulting in not enough staff support for many of the new study sections.
Other Council members pointed out the difficulty of getting physician scientists to serve on study sections due to their time demands. In addition, it was recommended that the study section chairs take a larger role in recruiting members, since they were likely to be more persuasive than the SRAs. Other members supported the concept of a Neurogenetics study section.
VII. NEUROLOGIC RESEARCH: AT THE CROSSROADS
Dr. Michael Walker, Director, Division of Stroke, Trauma, and Neurodegenerative Disorders began by directing Council's attention to the close of the Decade of the Brain, recognizing that during the last ten years more therapies for neurological disorders have been developed than in the forty years preceding. He quoted that we have been "doing the thing right and doing the right thing." This is especially true when applied to clinical trials. He then presented data from a recent clinical trial that seems to typify some of the conundrums in trial design and results.
A trial is warranted when the efficacy of a treatment is uncertain or in equipoise; therefore, the conditions, principles and framework for designing and carrying out clinical trials are critical. As an example, he presented the trial of the implantation of human fetal cells into the brains of patients with advanced Parkinson's disease. Preliminary data suggested that this type of procedure would improve these patients, but the definitive, controlled trial using sham surgery, had not been done. Two ethical issues were involved: the use of human fetal tissue, and the sham surgery for the control group. Dr. Walker briefly described the randomization of patients, the two centers involved, and some of the tests and results. The outcome measures were crafted by the investigators and approved by peer review. The patients were followed for one year after the surgery, after which they were informed whether they received the fetal cells or were in the control group. At that time, the patients in the control group were offered implant surgery, if desired. It may have been helpful to continue evaluations for more than one year; however, the protocol specifications were followed. A straightforward evaluation of the results showed no difference in improvement between those that received the fetal cell implants and those in the control group. However, secondary analyses using age distribution showed a statistical benefit of the implant in younger patients.
Dr. Walker concluded that additional clinical trials need to be done, and NINDS should take a leadership role in planning these and all clinical trials relating to neurological disorders. We should send a clear signal to the research community, indicating which clinical problems need to be addressed, and why. The NINDS needs to encourage visionary planning, setting tangible goals and clear outcomes, and then delegate the responsibility to the investigators.
VIII. NINDS INTRAMURAL ACUTE STROKE PROGRAM
Due to time constraints, the scientific presentation to be given by Dr. Stephen Warach, Chief, Section on Stroke Diagnostics and Therapeutics, Stroke Branch, Division of Intramural Research, NINDS, will be carried over to the September 1999 Council meeting.
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 applications for which there were concerns about human subjects, including appropriate representation of women and minority subjects, or laboratory animals.
A. Research Training and Career Development Programs
The Council reviewed a total of 32 research career development grant applications; of this total, 22 applications had primary assignment to NINDS, and 20 of them (90.9 percent) were recommended for support in the amount of $2.0 million first-year direct costs. It is anticipated that, of the research career development grants competing at this Council, NINDS will be able to pay first-year direct costs of approximately $1.4 million.
B. Research Grant Awards
The Council reviewed a total of 1,151 research grant applications; of this total, 709 applications had primary assignment to NINDS, and 483 of them (68.1 percent) were recommended for support in the amount of $112.5 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 $47.2 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 at each Council meeting during the fiscal year, and from these nominations the awardees are selected at the June Council. At this meeting, the Council recommended ten investigators as Javits awardees.
C. Special Program Actions
The Council reviewed a total of 155 Small Business Innovation Research (SBIR) and Small Technology Transfer Award (STTR) grant applications; of this total, 74 applications had primary assignment to NINDS and 51 of them (68.9 percent) were recommended for support in the amount of $9.0 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 $1.1 million.
The Council reviewed a total of 17 Academic Research Enhancement Awards (AREA) applications; of this total, 6 applications had primary assignment to NINDS, and all 6 (100 percent) were recommended for support in the amount of $0.4 million direct costs. It is anticipated that NINDS will be able to pay first-year direct costs of approximately $0.2 million.
The meeting was adjourned at 11:35 a.m. on Friday, May 21, 1999.
We certify that, to the best of our knowledge, the foregoing minutes and attachments are accurate and complete.
We certify that, to the best of our knowledge, the foregoing minutes and attachments are accurate and complete.| 9/21/99 |
_______________________________ Constance W. Atwell, Ph.D. Executive Secretary National Advisory Neurological Disorders and Stroke Council Associate Director for Extramural Research National Institute of Neurological Disorders and Stroke |
| 9/21/99 |
_______________________________ Gerald D. Fischbach, M.D. Chairperson National Advisory Neurological Disorders and Stroke Council Director National Institute of Neurological Disorders and Stroke |
Committee Management Specialist
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.
- A complete, printed copy of the Council minutes, including attachments, may be obtained by contacting:
- Mrs. Ruth Linn
- Committee Management Specialist
- National Institute of Neurological Disorders and Stroke
- Neuroscience Center, Suite 3309
- 6001 Executive Boulevard, MSC 9531
- Rockville, MD 20852-9531
- (301) 496-9248
- (301) 402-4370 FAX
- ruth_linn@nih.gov
Last updated August 13, 2008
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