NINDS Advisory Council Meeting Minutes, February 11-12, 1999

DEPARTMENT OF HEALTH AND HUMAN SERVICES
PUBLIC HEALTH SERVICE
NATIONAL INSTITUTES OF HEALTH
NATIONAL ADVISORY NEUROLOGICAL DISORDERS AND STROKE COUNCIL
Summary of Meeting¹
February 11-12, 1999

The National Advisory Neurological Disorders and Stroke (NANDS) Council was convened for its 144th meeting on February 11, 1999, in Building 31, Conference Room 6, National Institutes of Health, Bethesda, Maryland. Dr. Gerald Fischbach, 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 11, 1999 -- 8:40 a.m. to 5:05 p.m.

for the review and discussion of program development, needs, and policy; and

for the review of the Board of Scientific Counselors' Reports and discussion and consideration of individual grant applications.

Council members present were:

Council members absent were:

Dr. Carla Shatz

Council Roster (Attachment 1)

Ex Officio Members present:

Dr. John Booss, Department of Veterans Affairs
Dr. Andrew Dutka, Department of Defense

Members of the public present for portions of the open meeting included:

Ms. Raychel Bartek, Friedreich's Ataxia Parent
Ms. Andrea Castrogiovanni, The American Speech and Hearing Association
Mr. Tom Hogan, The Blue Sheet
Ms. Margaret Calvano, Epilepsy Foundation
R. D. Broadwell, Brain Injury Association

NINDS employees present for portions of the meeting included:

Other Federal employees present for portions of the meeting included:

Dr. Joe Marwah, CSR
Dr. David Simpson, CSR
Dr. John Bishop, CSR
Dr. Brent Stanfield, NIMH
Dr. Joanne Fujii, CSR
Dr. Michael Lang, CSR
Dr. Rochelle Small, NIDCD
Dr. Elliott Postow, CSR
Dr. Carl Banner, CSR
Dr. Daniel Kenshalo, CSR
Dr. Bernard Driscoll, CSR
Dr. Jay Joshi, CSR
Ms. Kristina Borror, OD
Dr. Emmeline Edwards, NSF

I. CALL TO ORDER AND OPENING REMARKS

Dr. Fischbach welcomed the Council members, guests, and staff to the 144th Council meeting. He introduced the following new Council members: Dr. Uta Francke, Professor of Genetics, Howard Hughes Medical Institute and Stanford University School of Medicine; Ms. Kathleen Hunter, Chief Executive Officer, International Rett Syndrome Association; Dr. Julian Hoff, Professor and Head, Section of Neurosurgery, Department of Surgery, University of Michigan; Mr. Morton Kondracke, Executive Editor and Columnist of Roll Call, and Dr. Richard Tsien, George D. Smith Professor, Department of Molecular and Cellular Physiology, Stanford University School of Medicine. He also introduced Dr. David Pleasure, Professor of Pediatrics, Children's Hospital of Philadelphia, as a special visitor to the Council meeting.

With regard to NINDS personnel news, Dr. Fischbach reported that Mr. Edward Donohue is the new Director, Division of Extramural Activities, Dr. John Marler is the Acting Director, Division of Clinical Trials and Experimental Therapeutics, and Dr. Alfred Gordon, Acting Director, Office of Special Programs in Neuroscience.

II. REPORT OF THE ASSOCIATE DIRECTOR FOR EXTRAMURAL RESEARCH

Dr. Constance Atwell, Associate Director for Extramural Research, NINDS, introduced the Grants Management Specialists who have recently joined the Grants Management Branch: Ms. Tina Carlisle, Ms. Denise Chatman, Ms. Angela Eldridge, Mr. Jerome Lofton, Ms. Kimberly Pendleton, Ms. Rita Rollins-Hickey, and Ms. Sheila Simons.

A. Council Procedures

Government in the Sunshine Act and Federal Advisory Committee Act:

These Acts require the DHHS to open to public observation as many advisory committee meetings as possible, including the meetings of the National Advisory Councils. The Council meeting, therefore, was open to public observation except when grant applications were being reviewed, at the times previously specified in these minutes. Notice of the date and place of the Council meeting was published in the Federal Register thirty days prior to the meeting.

Conflict of Interest:

The regulations concerning conflict of interest were reviewed, and 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 did not participate in the discussion of, or vote on, an application from any organization, institution, or any part of a university system, except for those which have multi-campus institution waivers or are specifically designated as separate organizations under 18 U.S.C. 208(a), of which they are an employee, consultant, officer, director or trustee, or in which they have a financial interest.

B. Consideration of Minutes of Previous Meeting

The minutes of the Council meeting of September 17-18, 1998, were considered and accepted as written.

C. Consideration of Dates for Future Council Meetings

D. Program Announcements

Dr. Atwell mentioned the Program Announcements (PAs) and Requests for Applications (RFAs) that NINDS published in the NIH Guide and mailed to members of the Council since their last meeting. The relatively large number of PAs and RFAs is one indication of the increasing amount of responsibility that NIH, including NINDS particularly, is accepting for leading biomedicine to needed discoveries and applications.

E. Reports Book

Dr. Atwell reminded the members of Council that the Reports Book was available. The Reports Book for this meeting included a list of all funding actions since the previous Council meeting, the annual summary of interim actions taken by staff in Fiscal Year 98, and the list of applications designated High Program Priority in Fiscal Year 98 and the status of each.

F. Council General Recommendations

Each January/February, the Council considers the general guidelines for administrative actions that may be taken by Program staff without prior approval by Council. One addition in the Council General Recommendations was suggested by staff. Staff is proposing to initiate a one-year pilot to issue expedited awards using a small group of Council members. Following discussion, Council concurred with this recommendation. A copy of the amended Council General Recommendations is attached as Appendix 1.

G. Modular Grants

Dr. Atwell discussed the new modular grant application and award process which was announced in the December 15, 1998, NIH Guide, as a means to allow the investigators and reviewers to focus more on their science and less on budgetary details. The NIH invites comments from investigators, reviewers, applicant organizations, and NIH staff during the first year of implementation (address comments to modulargrants@nih.gov). Based on the comments, the NIH may refine the process, and later, will formally assess the modular processes.

Applicants must configure budget requests for annual direct costs up to $250,000 in multiples of $25,000. The modular format for applications will be required NIH-wide, as follows:

• April 1999 receipt dates for Small Business Technology Transfer grants, Phase I (R41) and Small Business Innovation Research grants, Phase I (R43).
• May 25, 1999, receipt date for Academic Research Enhancement Awards (R15).
• June 1, 1999, receipt date for new and competing-renewal research project grants (R01), small grants (R03), and exploratory/developmental grants (R21).

Applications that request more than $250,000 direct costs for any budget year and applications for any activity code not in the list above will continue to use standard application procedures.

H. Jacob Javits Neuroscience Investigator Award

At its October 1998 meeting, the NANDS Council approved a change in the administration of the Jacob Javits Neuroscience Investigator Award. (The award has consisted of a seven-year project period.) The award would be an initial project period of four years, after which, based on an administrative review, NINDS staff may award an additional project period of three years. Dr. Atwell reported that the Council Review Committee concurred with the implementation plan prepared by NINDS staff. A copy of the revised NINDS policy on Javits Investigator Awards is attached as Appendix 2.

I. Clinical Trials Planning Grants

The rapid rate of discovery in basic and translational research has increased the NINDS' opportunity to support soundly designed and well-executed clinical trials. The NINDS is a steward of public funds that the United States Congress appropriated to support the research that ultimately might have the most positive impact on maintaining and/or restoring the health of the nervous system. Therefore, in addition to more opportunity, the NINDS has a greater responsibility to choose wisely in which clinical trials of which therapeutic approaches to invest. The NINDS considers scientific merit and program priority when making all types of awards. However, the investment of time and money in a clinical trial is usually much more than for other types of research. Thus, the amount of wisdom, knowledge, and commitment that the NINDS brings to deciding which clinical trials to support (and in the land of a finite budget, which clinical trials will not receive NINDS funding), can hasten or sabotage the medical advancements that the NINDS wants to foster.

The Council Review Committee, at its meeting the evening before, discussed processes by which the NINDS could make decisions about which applications for planning a clinical trial and which applications for a full-scale clinical trial to fund. Dr. Atwell presented the recommendations developed by the Council Review Committee:

• The Council should examine every application for a clinical trial planning grant, regardless of the priority score/percentile that the Initial Review Group (IRG) assigned.
• The Council should recommend the relative priority for funding of each application for a clinical trial planning grant. In that process, the Council may recommend lower priority to specific applications with scores within the 'payline' than to other applications with scores beyond the 'payline.'

Funding of an application for a planning grant carries with it the commitment of the NINDS to fund the ensuing competitive renewal application for the full clinical trial, if the IRG concludes that the research proposed in that application is technically meritorious.

J. Women and Minorities as Subjects in Clinical Research

Council is required every two years to review the NIH and NINDS part of the report for tracking the inclusion of women and minorities as subjects in clinical research. The Council members had received in advance of the meeting the report for NIH prepared by the Office of Research on Women's Health and the report of the Recruitment Data for NINDS Clinical Studies for Fiscal Years 1995 and 1996. Dr. Atwell pointed out that the studies funded by the NINDS are recruiting appropriately diverse populations of subjects successfully. Council concurred with this report.

III. REPORT OF THE DIRECTOR, NINDS

Dr. Fischbach opened by describing the meeting of the Council Review Committee. The group consisting of Mr. Abendroth, Dr. Choi, Dr. DeLong, Dr. DeVivo, Dr. Ojemann, and Dr. Tsien, meets the evening before the Council meeting to discuss selected issues in order to more succinctly present these to the full Council.The NINDS budget for Fiscal Year 1999 increased 16 percent over the Fiscal Year 1998 budget, which equates to a $120 to $125 million increase. Most of this will be for centers, program projects and R01 grants. The Institute funded three Parkinson's Disease Centers of Excellence in Fiscal Year 1998 as mandated by the Udall Act. An RFA for additional Centers has been reissued. There will be an increase in the training budget, mostly allocated to stipend increases. The Division of Intramural Research will also get increased funds, but its budget will remain about the same percentage of the total Institute budget. The NINDS Research Management and Support budget, which includesstaff support and salaries, is less than 3 percent of our total budget, which is too little, Dr. Fischbach believes. NINDS has fewer program directors relative to other Institutes, so in the coming year the Institute will recruit eight to ten new program directors. It is expected that the success rate for grants will rise from 29 percent to as high as 35 percent. The downward negotiation for grant awards will be reduced from 10 percent to 5 percent. For the first time, $10 million has been set aside for grantee equipment and infrastructure needs.

Stimulated by Dr. Varmus' announcement on areas of emphasis, the NIH issued a record number of RFAs last year. Mindful of supporting only the best research, NINDS has been selective in cosponsoring new RFAs.

Dr. Choi asked about budget prospects for Fiscal Year 2000 if the NIH funding reverts to the 2.4 percent increase proposed in the President's budget. Dr. Fischbach indicated that there will be a drop in the number of new grants, and a resulting fall in the payline.

The large budget increase in Fiscal Year 1999 has prompted Congressional interest in how the funds will be used. This underscores the importance of the Institute's recently undertaken planning process.

Dr. Fischbach then presented an update on the strategic planning process. He emphasized that the process will help guide the future of neuroscience research, particularly in neurological diseases.

To review, seven planning groups were formed in the areas of: Neurodegeneration; Neurogenetics; Channels, Synapses, and Circuits; Neurodevelopment, Plasticity, and Repair; Cognition and Behavior; Glia and other Non-neuronal Cells; and Experimental Therapeutics and Clinical Trials. These topics were formulated at a meeting at Woods Hole this past summer, and approved by Council in September 1998. The topics of these panels were intentionally broad to provide a starting point to address all 600 diseases under the aegis of NINDS.

Council members raised a general question about the change in the mission statement found in the draft document - and the replacement of the word "disorders" with the word "disease." A discussion ensued, with some members arguing for retaining the change and others members arguing to revert back to the original statement. Another suggestion was to use both terms in the statement.

Dr. Fischbach informed the Council that the draft report they were provided with at the meeting is not a final report, but an outline of the panel reports.

The subsequent planning process timeline includes sending out a summary of the report to public advocacy groups and the neuroscience community for comment and presenting the summary to Congress at the annual appropriations hearings (March 1999). The first full report, to be published in May, will be about 40 pages in length and will include color photographs. This report will be the first step in an on-going process of Institute planning. The initial plan is viewed as helping shape priorities over the next two to three years.

The title of the planning draft is "Neuroscience at the New Millennium." Dr. Fischbach related to Council the sense of exhilaration that was a part of the planning panel meetings - panel members seemed genuinely honored to be taking part in this process, and were very interested in continuing to participate in the process as it evolved. In addition, program staff will be intensely involved in the process of implementation.

The planning process identified seven initial goals. They are:

1. to attack neurodegenerative disorders over the lifespan. A lifespan view is important, as is identifying common mechanisms of degeneration.
2. define brain communication and organization. This includes all levels from channels and synapses on up to cognition and behavior.
3. promote nervous system development and repair.
4. analyze glia and other non-neuronal cells.
5. support infrastructure and resources. This is a key recommendation, and will need careful consideration, as it may require the need for tradeoffs with other important initiatives.
6. create a premier intramural national neuroscience center.
7. expand clinical trials and therapeutics.

Each of these goals had subtopics, which Dr. Fischbach reviewed with Council.

Concerning neurodegeneration, he emphasized that NINDS wanted to be ambitious, and cure Parkinson's disease within ten years. Council members inquired what was meant by "cure," and Dr. Fischbach defined it as stopping or reversing the course of the disorder. Several Council members questioned whether it was a good idea to be so definitive about this. This led to discussion about the importance of not overstating what can be done and thereby raising expectations that may not be met. This could then lead to a backlash from the voluntary groups. Most members thought that it was important to be optimistic, and have the overall goal be a cure, but to not be specific in terms of promising a specific date when this will occur.

In terms of development, Dr. Fischbach pointed out that before we can repair neural circuits, we need to understand them. The best example of a circuit ripe for more analysis is the spinal cord.

Regarding glia, he pointed out that there is much we don't know about them, and that this panel was extremely happy to have the importance of this topic.

In terms of clinical trials, he reminded Council that NINDS has adopted new planning and pilot grant mechanisms. He also indicated that the process will include making choices of selected areas to emphasize. One topic would be better delivery of agents to the brain, and it will be important to collaborate with industry on this.

Council members pointed out that the attitude of the neuroscience community needs to be changed from viewing industry as only profit-motivated to being seen as valuable partners. Neuroscience needs to harness the energy of industry, find areas where academia and industry can work together, and give industry incentives to do so. One way would be to collaborate with the private sector early in the process - this might help industry get drug approval from the FDA - a strong incentive for collaboration.

Dr. Fischbach pointed out that providing specialized resources and support for collaborative endeavors was discussed by all the panels. However, putting more funds toward resources may result in reductions in other areas.

In terms of the intramural program, Dr. Fischbach updated Council on plans to construct a new building complex in collaboration with NIMH to house neuroscience research at NIH. He showed architectural drawings of the proposed new complex.

Copies of the slides used in Dr. Fischbach's presentation are attached as Appendix 3.

Following introductory remarks by Dr. Atwell, Dr. Lillian Pubols, Chief of the NINDS Scientific Review Branch, presented an overview of the review process, focusing on some frequently asked questions. The Center for Scientific Review (CSR) referral office assigns grants to institutes by a multi-stage process, with extensive written guidelines. Applications are subsequently assigned for review to an institute's review branch or CSR's Initial Review Group (IRG) and study section. The Scientific Review Administrator (SRA) is critical before, during and after the review process. One particularly important aspect of the SRA's job is the need to balance many factors in selecting and evaluating reviewers.

Dr. Elliot Postow, Director of the CSR Division of Molecular and Cellular Mechanisms, reviewed the neuroscience study section reorganization process. Reviewers' philosophy had to change somewhat to cope with the additional grant mechanisms added after integration. The success rates and score distributions from the first two rounds of review indicate that NINDS grants appear to be succeeding about as expected. Median success rates were perhaps slightly better than other institutes, but with no dramatic deviations. Likewise, score distributions, though variable, were perhaps slightly better on average than other CSR study sections in approaching the goal of a 300 median score.

Dr. Postow then addressed the issue of evaluation, which was promised as an integral part of the reorganization. CSR obtained a grant from the NIH evaluation fund and appointed an external advisory committee, but that committee focused almost exclusively on psychometric issues. CSR is forming a second committee with more stakeholder involvement, including participation of Institute staff and extramural scientists. However, several factors confound attempts to evaluate the effects of the reorganization per se. These include simultaneous changes in scoring practices and new review criteria, as well as SRA vacancies and the temporary appointment of reviewers.

Dr. David Pleasure, Professor of Pediatrics at the Children's Hospital of Philadelphia, described his impressions as a chair of a new neuroscience study section. Although he supported the idea of the reorganization, he noted some problems in execution. One problem is the mixing of R01 and postdoctoral applications in the same study sections. While some study sections handle the different criteria for review well, others do not, and assignment of postdoctoral applications to a subset of review groups might be more effective. The review groups are also struggling with the new criteria regarding innovation. There is one very serious problem: the review process cannot work well without very good SRAs who have adequate support, and there are too few SRAs, with too little support.

The extensive Council discussion focused mainly on two issues. First, there was general agreement that recruiting and supporting good people to be SRAs is critical to the NINDS mission, especially given the Institute's emphasis on investigator-initiated grants. Second, the Council agreed that not only the fairness of review of clinical research, but also the perception of the review process among young people considering a career path in research is critical. The reorganization has moved toward one goal of the NIH Director's Panel on Clinical Research, that is assigning clinical grants to study sections that see a reasonable proportion of clinical grants. However, it is not yet clear whether clinical and translational research is being fairly evaluated. The discussion also explored more broadly the plight of physician-scientists. Dr. Fischbach suggested that a small working group of Council members collect relevant data and make the case for any recommendations.

V. NATIONAL BIOETHICS ADVISORY COMMISSION REPORT

Ms. Lorraine Fitzsimmons, Program Analyst , Science Policy and Analysis Branch, NINDS, and Dr. John Booss, NANDS Council Member and Director of Neurology Service, Veterans Administration Medical Center, West Haven, Connecticut, reported on the National Bioethics Advisory Commission (NBAC) Report: "Research Involving Persons with Mental Disorders That May Affect Decision making Capacity." This report was produced pursuant to Executive Order 12975 which directs the Commission to consider the protection of the rights and welfare of human research subjects. In the report NBAC considers how ethically acceptable research can be conducted with human subjects who suffer from mental disorders that may affect their decision making capacity; whether additional protections are needed; and, if so, what they should be and how they should be implemented. Although existing Federal regulations for research involving human subjects have provided special protections for certain populations that are regarded as particularly vulnerable, persons with mental disorders who may have impaired capacity to make decisions, and therefore to give voluntary informed consent, have not received special protections. The NBAC proposes a number of recommendations, some in the form of requirements that would require changes in the language of the Common Rule or changes and additions to the Code of Federal Regulations.

The implications of the report for clinical neurology and neurosurgery research are extensive. Unfortunately, however, input was neither invited nor received from researchers and patient groups other than those representing psychiatric disorders. Other than being included within the "dementia" category of patients, neurological disorders such as Alzheimer's disease and other neurodegeneration, vascular disease, and traumatic brain injury are not specifically considered in the report. Many other concerns were discussed, including the categories of risk, the membership requirements of review boards, and capacity assessment. If the recommendations of the report are implemented, several possible negative effects may result for neuroscience research. It was suggested that the neuroscience community may be alerted to these concerns at the several national workshops and conferences to be held in the near future.

VI. ACCESS TO PRIMARY DATA VIA THE FREEDOM OF INFORMATION ACT (FOIA)

Dr. Wendy Baldwin, Director of the Office of Extramural Research, Office of the Director, NIH, reported on the implications of a notice of proposed rule making from the Office of Management and Budget concerning Freedom of Information Act (FOIA) provisions as they apply to information produced by a grantee. The Omnibus 1999 Appropriations bill from Congress directed the Office of Management and Budget (OMB) to amend rules to extend the FOIA to "require Federal awarding agencies to ensure that all data produced under an award will be made available to the public under the [Act]." Following legislative intent, the OMB has confined the data release to published data used by the Federal Government in developing policy or rules. The proposed rule indicates that the awarding agency should make the data available through the procedures established under the FOIA. However, several important issues remain to be clarified.

We are now in a 60-day public comment period on the Notice of Proposed Rule Making. During this period, individual researchers, research institutions and Federal agencies have an opportunity to seek clarification of different aspects of this proposed rule. Some questions that might be asked include: How broad is the definition of data? How would costs of compliance be recouped? Are protections for privacy under FOIA sufficient? When do data in a publication have to be released, and what "publications" are included-only formal peer-reviewed publications or notes for a verbal presentation?

VII. SCIENTIFIC PRESENTATION: "THE INTERACTION OF SPIDER TOXINS WITH ION CHANNELS"

Dr. Kenton Swartz, Chief, Molecular Physiology and Biophysics Unit, Division of Intramural Research, NINDS, reported that the orchestrated activity of ion channel proteins enable the nervous system to generate and propagate the electrical signaling that ultimately allows us to sense and respond to our environment. Ion channels are integral membrane proteins that when open allow ions, for example sodium, potassium or calcium, to cross the cell membrane. The goal of his research is to define the molecular composition of specific ion channels and to understand what they normally do and how they do it. Many drugs used to treat neurological and psychiatric disorders derive their efficacy from their ability to alter the activity of ion channels. Their research objectives should, therefore, help to define specific channels as therapeutic targets and to develop drugs against them.

The identification of genes encoding ion channel proteins has revealed a tremendous diversity of ion channels. Dr. Swartz is interested in understanding how the specialization of particular ion channels allows them to fulfill specific physiological functions.

While this research addresses fundamental questions about the mechanics of voltage-dependent gating, it also has recently begun to reveal clinically useful ways to alter the behavior of voltage-gated ion channels. For example, in an attempt to localize the region of the channel to which one specific toxin binds, they discovered a point mutation that switched the effect of the toxin from inhibiting channel opening to facilitating channel opening. This is an important result because it suggests that by interacting with the voltage-sensing domain of voltage-gated ion channels they can modify channel activity in a multidirectional fashion. Most existing drugs can only 'inhibit' the activity of voltage-gated ion channels. Drugs that open voltage-gated potassium channels, in particular, could be very useful in a variety of conditions involving hyperexcitibility, including the brain damage that ensues after a stroke and the aberrant discharging of neurons in epilepsy. Their results suggest specific ways to design regulatory molecules whose effects on specific channels can be precisely tuned.

VIII. OVERVIEW, DIVISION OF INTRAMURAL RESEARCH

Dr. Story Landis, Director, Division of Intramural Research, NINDS, gave the annual update about the intramural programs. The Division of Intramural Research receives about 10 percent of the NINDS budget to support the laboratories of 55 independent investigators. Each independent investigator manages a laboratory that engages other scientific, technical, and administrative staff, but the variability among the sizes of each laboratory is large.

Some of the research is very basic, such as that of Dr. Ron McKay, who studies features of stem cells that might be useful for treating certain neuro-degenerative diseases. Other research, such as the work of Dr. Roscoe Brady using enzyme replacement therapy on Gauchet's Disease and Fabrey's Disease, has more immediate and direct clinical significance. The findings of the research of Dr. Karen Nelson might significantly reduce the occurrence and/or severity of cerebral palsy. She found that giving magnesium during the birth process to high-risk, low birth-weight infants decreases the likelihood that cerebral palsy would occur.

The NIH intramural programs face some very tough competition when trying to recruit the most talented researchers in biomedical and behavioral research. The NIH has had two rather unique features that are attractive to many researchers. At NIH, a researcher can gamble on a long-shot, i.e., pursue avenues of research that are very interesting and important, but that might not seem feasible to the researcher whose laboratory, even job, depends upon obtaining and renewing extramural support from NIH and/or other sources. For clinical researchers, an attractive feature of the NIH has been the Clinical Center, a hospital that does not need to generate income from patient care. The Clinical Center admits only research protocol patients, and thus, the Clinical Center staff and management can focus on the special needs of a research hospital.

The task that the NINDS assigned to Dr. Landis when she was hired three and one-half years ago was to improve the working environment of the NINDS intramural program. The objectives have been to recruit the most outstanding, creative scientists and to provide an intellectually stimulating research environment that will foster the ideas and energy that lead to the most meaningful kinds of productivity. Dr. Landis then described what the NINDS intramural program has accomplished under her leadership.

Innovations:

The Marks & Cassell Report mandated changes for all of the NIH intramural programs. Every institute must use open searches to fill faculty positions. The NINDS has worked hard to ensure that their searches are open and fair, and furthermore, to ensure that outstanding applicants will be attracted. The NINDS also modified the tenure track system so that the NINDS could more clearly articulate and more fairly apply the requirements and processes for promotion.

Independent investigators at NIH can be at a disadvantage when competing with a principal investigator of an NIH extramural grant for an academic position because usually the principal investigator can transfer the grant support to the hiring organization, but the intramural scientist leaves NIH empty-handed. The NINDS is now making it possible for an intramural researcher who receives an offer of employment from another organization to take up to two years' salary and their equipment with them to the new organization.

The NINDS established the "Competitive Fellowship Program" for which postdoctoral fellows within the NINDS can compete. The fellow must prepare and submit an application for a National Research Service Award fellowship award. A scientific review group (a.k.a., study section) administered by the Scientific Review Branch, NINDS, reviews the applications. The Competitive Fellowship Program provides postdoctoral support for only some of the applicants. However, the Competitive Fellowship Program provides valuable experience in preparing an application for ALL of the applicants.

Creating community:

Dr. Landis wants to foster more communication and collaboration among the laboratories, because such interactions can generate intellectual vitality and scientific progress. To facilitate such collaboration, she offered approximately $500,000 of support for a meritorious research project that substantially involved investigators from different disciplines. A few groups of investigators already have responded to her offer and others are preparing to do so.

Dr. Landis also wants to foster productive interactions between the intramural and extramural programs and staff. She would like to encourage intramural scientists to take a six to twelve month sabbatical to work within the extramural programs. Similarly, she would like to welcome extramural scientific staff to the intramural laboratories for a sabbatical.

Faculty.

During the past year, eight positions have become vacant due to retirements and, in one case, death. These vacancies provide the flexibility needed for revitalization and the initiation of new programs and priorities.

Suburban Hospital is a county trauma center and probably will be designated a county stroke center. The NINDS has established a contract with them that will enable NINDS to do more research about acute neurological trauma.

IX. REVIEW OF THE DIVISION OF INTRAMURAL RESEARCH BOARD OF SCIENTIFIC COUNSELORS' REVIEWS

In closed session, Dr. Landis presented the findings and recommendations of the Board of Scientific Counselors based on their review of three laboratories and two branches of the Division of Intramural Research.

X. 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 68 training and research career development grant applications; of this total, 57 applications had primary assignment to NINDS, and 53 of them (93.0 percent) were recommended for support in the amount of $7.4 million first-year direct costs. It is anticipated that, of the training and research career development grants competing at this Council, NINDS will be able to pay first-year direct costs of approximately $4.1 million.

B. Research Grant Awards

The Council reviewed a total of 985 research grant applications; of this total, 653 applications had primary assignment to NINDS, and 431 of them (66.0 percent) were recommended for support in the amount of $94.7 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 $39.5 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 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 nominated three investigators as potential recipients of this award.

C. Special Program Actions

The Council reviewed a total of 94 Small Business Innovation Research (SBIR) and Small Technology Transfer Award (STTR) grant applications; of this total, 64 applications had primary assignment to NINDS and 47 of them (73.4 percent) were recommended for support in the amount of $7.1 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 $1.5 million.

The Council reviewed a total of 7 Academic Research Enhancement Awards (AREA) applications; of this total, 7 applications had primary assignment to NINDS, and 5 of them (71.4 percent) were recommended for support in the amount of $0.4 million direct costs. It is anticipated that NINDS will be able to pay all $0.4 million of these applications.

XI. ADJOURNMENT

Prior to adjournment, Drs. Fischbach and Atwell were thanked for a very interesting and rewarding meeting. The meeting was adjourned at 11:50 a.m. on Friday, February 12, 1999.

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.