NINDS Advisory Council Meeting Minutes, May 28-29, 1998
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I. CALL TO ORDER AND OPENING REMARKS | |
VII. SCIENTIFIC PRESENTATION: "Visualizing the Neurochemistry of Pain" | |
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II. COUNCIL PROCEDURES AND RELATED MATTERS | |
VIII. NIAMS AREAS OF COMMON INTEREST WITH NINDS | |
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III. REPORT OF THE ACTING DIRECTOR, NINDS | |
IX. REPORT ON THE GENETICS WORKING GROUP | |
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IV. REPORT OF THE DIRECTOR, DIVISION OF EXTRAMURAL ACTIVITIES | |
X. COUNCIL CONSIDERATION OF PENDING APPLICATIONS | |
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V. INCLUSION OF CHILDREN AS SUBJECTS OF RESEARCH | |
XI. OTHER | |
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VI. OVERVIEW AND NEW DIRECTIONS IN PAIN RESEARCH | |
XII. ADJOURNMENT |
- DEPARTMENT OF HEALTH AND HUMAN SERVICES
- PUBLIC HEALTH SERVICE
- NATIONAL INSTITUTES OF HEALTH
- NATIONAL ADVISORY NEUROLOGICAL DISORDERS AND STROKE COUNCIL
Summary of Meeting1
May 28-29, 1998
The National Advisory Neurological Disorders and Stroke Council was convened for its 142nd meeting on May 28, 1998, in Building 31, Conference Room 6, National Institutes of Health, Bethesda, Maryland. Dr. Audrey S. Penn, Acting Director of the National Institute of Neurological Disorders and Stroke (NINDS), served as Acting Chairperson.
In accordance with Public Law 92-463, the meeting was:
Open: May 28, 1998 - 8:35 a.m. to 4:20 p.m.
for the review and discussion of program development, needs, and policy; and
Closed: May 29, 1998 - 8:35 a.m. to 11:40 a.m.
for discussion and consideration of individual grant applications.
Council members present were:
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Council members absent were:
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Council Roster (Attachment 1)
Ex officio members present:
- Dr. John Booss, Department of Veterans Affairs
- Dr. Andrew Dutka, Department of Defense
1For 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.
Special guests present for portions of the meeting included:
- Dr. Patrick Mantyh, University of Minnesota
- Dr. Stephen Katz, Director, National Institute of Arthritis and Musculoskeletal and Skin Diseases
Members of the public present for portions of the meeting included:
- Mr. David McCoy, Executive Court Reporters, Inc.
- Ms. Rebecca Spieler, The Blue Sheet
- Dr. Sharon Moss, American Speech and Hearing Association
- Ms. Melinda Kelley, Paralyzed Veterans of America
- Ms. Raychel Bartek, FA Parent
- Mr. Ron Bartek, FA Parent
- Mr. Steve Landers, American Heart Association
NINDS employees present for portions of the meeting included:
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Other Federal employees present for portions of the meeting included:
- Dr. Paul. Scott, OD
- Ms. Sheryl Sato, NIDDK
- Dr. David Simpson, CSR
- Dr. Herman Teitelbaum, CSR
- Dr. Joe Marwah, CSR
- Dr. Brent Stanfield, CSR
- Dr. Larry Stanford, CSR
- Dr. Kathleen Michels, FIC
- Dr. Carl Banner, CSR
I. CALL TO ORDER AND OPENING REMARKS
Dr. Audrey S. Penn
Dr. Audrey S. Penn, Acting Director, NINDS, welcomed the Council members, guests, and staff to the 142nd Council meeting.
II. COUNCIL PROCEDURES AND RELATED MATTERS
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 February 12-13, 1998, were considered and accepted as written.
C. Consideration of Dates for Future Council Meetings
- September 17-18, 1998 (Thursday and Friday)
- February 11-12, 1999 (Thursday and Friday)
- May 20-21, 1999 (Thursday and Friday)
- September 23-24, 1999 (Thursday and Friday)
III. REPORT OF THE ACTING DIRECTOR, NINDS
Program Project (P01) and Center (P50) Awards
Dr. Penn drew the attention of the Council to the table and graphs that contained descriptive data from several NIH institutes about the amounts awarded for program project and center grants. Very few of the awards made by the institutes that do not cap the size of the award were larger than the upper limit of the range of award sizes made by the institutes that do have a cap on the size of the award. This suggests that, if the NINDS rescinded the budgetary cap for program project and research center grants, the impact on the NINDS budget would not be major.
Several members of Council favored dropping the cap, because it tends to limit creativity and collegial interactions before they even begin. The initial review group can recommend the deletion of a sub-project or other types of budgetary cuts, if necessary. Program projects are crucial funding mechanisms for the translational research that is now so important.
Long Range Planning
The NINDS has not used a formal, long range planning process in the past. Among several incentives for doing so now is the tangible reward that Dr. Varmus has provided to areas of priorities that have been carefully formulated and clearly articulated. "'Chance favors the prepared' . . . institute."
The NINDS planning process will develop an explicit scientific vision. The vision will be a source of direction and inspiration, but the NINDS wants to ensure that the planning process also identifies tangible goals that, step by step, can be achieved. Thus, the planning process also will address, as necessary, how the NINDS does business, e.g., develops and implements programs.
The planning process will be an institute-wide endeavor, administered by NINDS planning and evaluation staff (Science Policy and Analysis Branch). NINDS scientific staff (intramural and extramural) and administrative staff will be asked to contribute to the planning process. "Outside" sources of expertise will also be invited to participate.
Comments from Members Regarding the Planning Process
In response to Dr. Penn's request for general comments, several members of the Council expressed agreement that long term planning could have great value for the NINDS. They recognized the power of a clearly articulated statement of mission in the context of communications, e.g., with Congress and the public. Expressing priorities in writing can prevent misunderstandings and provide a clear context for the day-to-day conduct of business. Furthermore, setting and articulating priorities would put the NINDS in a state of readiness for unanticipated opportunities. In general, the members were enthusiastic about planning for leadership in the 21st century, a leadership that actively seeks productive partnerships with industry, universities, and the public.
The members expressed strong support for the Council playing a key role in the planning process, but recognized that productivity and efficiency often are served better by smaller groups. Several members suggested organizational schemes in which the Council would serve as some sort of guiding board over six or seven working groups, with perhaps, a member of the Council chairing each working group.
Council members emphasized the importance of obtaining input into the planning process from outside of the NINDS. They stated that the NINDS and the Council should welcome the education that other sources can provide, and that such interactions also would be an opportunity to educate others about the NINDS.
The Council identified the following sources as desirable contributors to the NINDS planning process: other NIH institutes, scientists with expertise in areas of science relevant to the mission of the NINDS but underrepresented in the NINDS portfolio, professional societies, patient advocacy organizations, and lay members to represent constituencies such as the Hispanic community.
Members suggested several ways to include professional and patient advocacy organizations in the planning process, such as arranging formal discussions with representatives of the organizations, formalizing existing liaisons between members of the Council and professional organizations, and increasing the involvement of Council members in regional activities, e.g., giving talks to various groups in different areas of the country.
The Council members strongly supported the idea that the ultimate "product" of the planning process should be action. A document which would communicate the vision to the public would be needed. Also, to ensure action, a more detailed internal document should be written, setting tangible goals towards which progress could be measured.
Suggested Topics for the Working Groups
Council discussion addressed the types of topics that would be appropriate for the planning process, especially because most contemporary issues cut across traditional categorical boundaries. Also noted was that the danger of each group becoming a lobby for a specific field is reduced, if the mandate of each group is broad enough. Another suggestion was to define two tiers of committees. Within broadly-based (e.g., research training) 'standing' committees, sub-committees could be formed and dissolved as needed to address specific issues.
Most of the suggestions for working group topics were for either areas of science thought ready for rapid progress or for areas thought to be neglected compared to their importance. In addition to identifying specific topics, several members emphasized that curiosity-driven research, translational research, and clinical research are all valuable and, in fact, depend upon each other for their own progress.
Translational Research:
T here is a need for a working group on translational research because of the inadequacy of the identification of advances in basic research that could be translated into patient care. The NINDS could play a valuable role by providing a forum for communication among relevant areas of basic research, clinical research, and clinical practice. Interest was expressed in the translation of the new findings in basic immunology and in areas pertinent to the early development of the brain and developmental disorders.Clinical Trials:
C linical trials might benefit from a more proactive stance by the NINDS. The NINDS has the perspective to identify needed trials and the expertise to encourage and/or participate in the design with the clinicians who have the clinical expertise and access to the patient populations.Council members also suggested the following areas of science to be addressed by the working groups:
- neural repair and plasticity; rehabilitation, especially cognitive and reintegration of function
- the behavioral sciences and cognitive neuroscience
- single gene mutations in humans; gene therapy, especially methodology to insert genes
- epigenetic, environmental, and longitudinal research
Medical Economics:
S everal members thought it was important for the planning process to recognize and address relevant aspects of medical economics. The financing of health care and the support of research by for-profit organizations have become significant factors in the research community through which the NIH pursues its mission. Also, specific aspects of medical economics, such as calculations of relative costs and benefits of different therapies, can provide additional data for consideration in the planning process.'Business Practices' of the NINDS:
S ome interest was expressed in having a working group, perhaps in collaboration with working groups of other institutes, to address common issues such as the quality of referral and initial review. There was also interest in addressing ways in which the NINDS could most effectively implement identified priorities. It was suggested that a working group could examine how the NINDS could attract and/or develop an applicant pool with the knowledge and interests requisite to doing the research needed to advance knowledge in priority areas. Also, it was suggested that a working group could explore how NINDS staff could take a more proactive role in fostering clinical trial research.Dissemination of Information about the NINDS:
Specific audiences for the information were not mentioned, but members generally agreed that communications should be addressed. At the end of the discussion, it was noted that a consideration of ethics will be inherently part of every topic assigned to a working group. Ultimately, the planning will affect individual subjects and individual patients. Ethical reasoning, creativity, logic, and practicality are all relevant tools in the planning process.Council was thanked for their contributions and told that a focus group would be formed to determine the working groups and the program planning process.
Patient-Oriented Research Training and Career Development Programs
Dr. Penn reminded Council that Dr. Varmus had established a committee to design programs to support the development of patient-oriented researchers. The committee, which was comprised of NIH Institute directors and chaired by Dr. Steven Katz, designed three NIH-wide programs, all of which have been announced in the NIH Guide.
The K23 mentored award is a five-year award to support the career development in patient-oriented research of an investigator, just after his or her medical (or equivalent) specialty training. The K24 award, also a five-year award, is to support up to 50 percent effort of mid-career level clinicians so that they can conduct patient-oriented research. The K30 institutional award will support the development of a training program in patient-oriented research within the context of an institutional research training program.
Dr. Joseph Drage, Training and Special Programs Officer, emphasized that the K23 and K24 programs are ongoing programs with receipt dates of July 1, October 1, and February 1. However, the NIH initiated the K30 program with a request for applications for one receipt date (in October 1998).
Dr. DeVivo added that the training subcommittee is continuing to discuss the need to foster more patient-oriented research. The subcommittee has discussed the use of debt forgiveness for extramural clinical researchers, tracking the career progression of trainees, how to bridge the gap from residency to opportunity to apply for a K08 or K23 award, and opportunities to work with non-Federal organizations that share an interest in clinical research.
Specialized Neuroscience Research Programs at Minority Institutions
Dr. Alfred Gordon, Special Initiatives and Developmental Programs Officer, described the program that the NINDS is initiating to foster optimal development of the research in neuroscience at minority institutions. This program is a joint effort with the Office of Research on Minority Health and the National Center for Research Resources. Dr. Gordon emphasized that NINDS staff will provide active program advice and assistance to the awardees, so a cooperative agreement funding mechanism is being used. Although the institutional commitment to these awards is essential to success, NINDS staff can help the organizations shape a comprehensive framework for current and planned research, facilitate opportunities for collaborations with NIH-funded researchers at research intensive organizations, and support the pilot studies necessary for successful competition for NIH awards.
Many institutions have sent one or two letters of intent. The receipt date for applications is February 10, 1999. (The RFA is available at http://www.nih.gov/grants/guide/rfa-files/RFA-NS-99-001.html)
Copies of the slides used in Dr. Penn's discussion are attached as Appendix 1.
IV. REPORT OF THE DIRECTOR, DIVISION OF EXTRAMURAL ACTIVITIES
A. Program Announcements
Dr. Atwell reminded Council that they had received a number of Program Announcements and Requests for Applications since the last meeting and asked if they wished to continue receiving them. Council was very much in favor of continuing to receive the announcements.
B. Electronic Council Book
Council members still receiving summary statement books were encouraged to use the Electronic Council Book for future meetings. The Council will be informed about the upgrades of the Electronic Council Book as they are implemented during the next year. Anticipated upgrades include the following: an e-mail link from each application to the health scientist administrator to whom the application was assigned; a link from each application to the roster of the initial review group to which the application was assigned; and the addition of more online information about the NINDS program class codes to enable searches of subsets of NINDS programs.
C. Reports Book
Dr. Atwell called Council's attention to the Reports Book, which lists the funding and interim actions (the category of actions authorized by the General Council Recommendations) since the previous Council meeting.
V.INCLUSION OF CHILDREN AS SUBJECTS OF RESEARCH
Dr. Wendy Baldwin, Deputy Director for Extramural Research, NIH, discussed the policy and guidelines for including children as subjects in research conducted or funded by the NIH (NIH Guide for Grants and Contracts, NIH Policy and Guidelines on the Inclusion of Children as Participants in Research involving Human Subjects, March 6, 1998). The House of Representatives, the Senate, and the associations that represent the medical pediatric community feel strongly that too many of the drugs and other treatment modalities used to treat children have not been tested on children.
The goal of the NIH policy is to ensure collection of the data needed to assess, for adults AND children, treatment modalities for diseases, disorders, and conditions that affect both adults and children. Also, the policy is compatible with the existing policies and regulations that provide protection of children in research.
Most of the clinical studies funded by the NIH have not included children as subjects, unless the research was addressing a specifically pediatric issue. Now, the NIH will require awardees and intramural researchers to include children in the subject population, unless one or more of the exclusions enumerated in the policy apply. For example, the new policy does not supersede existing statutes, regulations, and policies. Other situations are more complex, such as if the number of subjects in the subject pool becomes a limiting factor.
The policy will go into effect for applications for new awards (Type 1), proposals for new contracts, and new intramural research projects "submitted for receipt dates after October 1, 1998" (ibid.). The applications and proposals to which this policy applies must include, within the research plan, the section "Participation of Children." The policy requires the applicant to address several topics about the plans to include or exclude children as subjects. The initial review groups will assess, for each application for the support of research on human subjects, whether or not the plan and rationale for including or excluding children is "acceptable" or "unacceptable."
Council members asked Dr. Baldwin how the NIH was going to address the difficult issues of informed consent of children, particularly when the child has nothing to gain by being a subject.
VI. OVERVIEW AND NEW DIRECTIONS IN PAIN RESEARCH
Dr. Cheryl Kitt, Health Scientist Administrator, Division of Convulsive, Infectious, and Immune Disorders reported that pain, by some measures, is the leading neurological complaint in the United States. It is the subject of continuing emphasis within the pain research community and within the scientific community at large. A recent Harris Poll reported that 2/3 of the American workforce of 80 million people, suffers from pain conditions, and that 19 percent of these workers suffer from chronic pain. NIH, through its Cost of Illness report, indicated that approximately 1/3 of the US population is affected by chronic pain conditions; with an estimated $100 billion dollars spent per year on health care, compensation, and litigation. The most common reason women seek medical attention is for chronic pain conditions. Recent epidemiological studies of pain indicate that women are more likely than men to report more temporary and persistent pain, more severe pain, more frequent pain and pain of longer duration than men. The most common chronic pain conditions that afflict women are: migraine headaches; oral/facial pain, including temporomandibular disorders; musculoskeletal pain, including myofascial pain and fibromyalgia; abdominal pain; and pelvic pain. One of the most important papers related to women and pain published in the last few years, focused on sex differences in opiate analgesic responses. The results indicated that both Nalbuphine and Butorphanol produced significantly greater analgesia in females undergoing surgery for removal of third molars as compared with males.
In order to stimulate pain research, the NIH has established the NIH Pain Research Consortium; NIH Extramural Staff Pain Staff Workgroup; NIH Pain Interest Group and held a number of pain-related workshops and symposia. Many of these events have had significant follow-up including: Program Announcements, Requests for Applications and Meeting Reports. The Program Announcement: "New Directions in Pain Research: I," will solicit research proposals in the following scientific areas: quantitative trait locus analysis; molecular genetics of pain; signal transduction pathways; second messenger systems; imaging; neural plasticity and pain; gender and hormonal influences on pain. NINDS and NIH have had a major commitment to pain research and will continue to do so in the coming years. Future directions for pain research will include fostering and establishing new Trans-NIH pain initiatives; establish NIH-technology/pharmaceutical partnerships; focus on translational medicine: basic pain research-clinical applications; and convening of "New Directions in Pain Research: II- Clinical, Behavioral and Social Issues." From these efforts, the NIH is in a position to influence how pain is approached within the basic and clinical research settings.
VII. SCIENTIFIC PRESENTATION: "Visualizing the Neurochemistry of Pain"
Dr. Patrick Mantyh, Professor, Department of Preventive Sciences, University of Minnesota, reported that within the past decade there has been a revolution in our ability to visualize the interaction between neurotransmitters and their receptors. Using confocal microscopy and digital imaging techniques, we have been able to show that following a painful stimulus a specific set of neurotransmitters is released in the spinal cord to signal pain. The released neurotransmitters (one of which is substance P or SP) binds to their receptors (in this case the substance P receptor or SPR) which is expressed on the surface of the post-synaptic neuron. The binding of SP to the SPR induces a dynamic translocation of both the SPR and SP from the outside (plasma membrane) to the inside (cytoplasm) of the post-synaptic neuron. Aside from providing a pharmacologically specific view of the population of neurons activated by the release of a neurotransmitter in response to a painful stimulus, these data suggest that receptor internalization can provide a specific portal of entry into populations of neurons expressing the receptor that undergoes internalization. Building on these observations, Dr. Mantyh described how his laboratory has recently used intrathecal infusion of a SP-toxin conjugate to target and destroy specific populations of spinal cord neurons involved in the ascending conduction of severe pain and hyperalgesia. Thus, in the SP-toxin treated animals the response to severe and hyperalgesia pain are significantly diminished, whereas responses to mild pain and non-nociceptive stimuli remain intact. These data not only provide significant insight into the neurochemistry of pain but suggest that this therapy can be utilized to develop new therapies aimed at blocking the generation and maintenance of intractable chronic pain.
VIII. NIAMS AREAS OF COMMON INTEREST WITH NINDS
Dr. Stephen Katz, Director, National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), spoke about the value of areas of common interest and collaborations between NIAMS and NINDS. Among the NIH institutes, there are many research areas that are relevant to the mission of more than one institute. Occasionally, some parties have expressed concern that these areas of overlap might be duplications that waste resources. However, as from within different fields of science, each institute approaches diseases and basic biological processes from different perspectives. Such differences can lead to the design of different experiments, which in turn, yield different findings. It is the sum of those differences that ultimately helps to solve the biological and medical challenges faced by the NIH. Therefore, the overlap among institutes is important.
Collaborations between or among institutes can take many forms, including planning and sponsoring conferences, program announcements, requests for applications, and other mechanisms. Such collaborations can foster the hybridization of conceptual and technological advances among relevant fields of research, thus realizing the potential vigor and benefit of the diversity within the apparent redundancy.
Dr. Katz provided some specific examples of successful collaborations to illustrate his more general remarks. The first example he used was the area of pain, in which NIAMS is interested because pain characterizes many chronic musculoskeletal diseases and disorders, including fibromyalgia. Fibromyalgia is a rheumatic disorder that causes some people with this disorder to experience an increased sensitivity to pain. The Pain Consortium brought together several NIH institutes that have an interest in pain. Just over one year ago, the NINDS, the Office of Research on Women's Health (ORWH), the Office of Alternative Medicine, and the National Institute of Allergy and Infectious Disease (NIAID) co-sponsored a conference about fibromyalgia. The conference involved clinicians who had experience with fibromyalgia patients and basic researchers from the fields of pain, neuroendocrinology, and sleep. As a result of the conference, the NIAMS, the National Institute of Dental Research, NINDS, Office of Alternative Medicine, Office of Behavioral and Social Sciences Research, and the ORWH issued an RFA (AR-98-006) in March 1998 entitled "Basic and Clinical Research on Fibromyalgia" for exploratory research and research projects on various aspects of fibromyalgia.
Sometimes, simply discussions between two institutes can have beneficial consequences. Last year, extramural staff from NINDS and NIAMS met to discuss overlapping areas of interest in the extramural programs. NINDS supports most of the research on muscle activation and control, while NIAMS supports most of the research on muscle development and contractile properties. Both institutes support significant amounts of research on excitation - contraction coupling and diseases. However, it became apparent that neither institute supports a large amount of research on the genetic muscular dystrophies and myotonias or the inflammatory myopathies, despite the interest of both institutes in these areas. Therefore, NINDS and NIAMS issued a program announcement (PA-98-044) in March 1998 entitled, "Pathogenesis and Therapy of Muscular Dystrophies."
Autoimmunity is another area of common interest between NIAMS and NINDS. NIAMS is interested in the underlying processes of rheumatic and several skin diseases. An autoimmunity consortium of NINDS, NIAMS, and NIAID has been formed to foster research to determine why certain autoimmune diseases occur predominantly in women.
The NIAID, NIAMS, NIDDK, NHLBI, NINDS, and ORWH issued an RFA (AI-98-006) in May 1998, entitled "Hyperaccelerated Award/Mechanisms in Immune Disease Trials" for studies to be affiliated with clinical trials of basic immune mechanisms. The estimated total funds, direct and indirect costs, available for the first year of support for all awards made under this RFA in fiscal year 1999 will be $2.8 million, and it is anticipated that 11-12 awards will be made.
Discussion followed among Dr. Katz and the council members regarding research interests and how priorities are set.
IX. REPORT ON THE GENETICS WORKING GROUP
Dr. Judy Small
Dr. Judy Small, Health Scientist Administrator, Division of Fundamental Neuroscience and Developmental Disorders reported that the role of the Genetics Working Group is to advise the Director, NINDS, concerning current and future directions in genetics research. Members of this group serve as representatives for trans-NIH coordination of genetics initiatives. The group also serves as a setting for informal communication within the Institute on genetics research issues. Among the many NIH-wide activities that the members participate are the Brain Molecular Anatomy Project (BMAP), the Brain Tumor Genome Anatomy Project (BT-GAP), the Center for Inherited Disease Research (CIDR) and the Genomics Focus Group. The Genetics Working Group has discussed a number of topics, including Gene Therapy Genetics of Complex Diseases, Functional Genomics, Mouse Molecular Genetics, and Bioethics. The NINDS has co-sponsored three Requests For Applications (RFA) that will be supported by many NIH Institutes, "Genomic Resources for the Zebrafish" (NIDDK), "Methods for Discovering and Scoring Single Nucleotide Polymorphisms" (NHGRI), and "Quantitative Methods to Map Genes for Complex Diseases" (NIMH).
The Brain Molecular Anatomy Project (BMAP) was initiated with the goals of identifying and mapping all of the genes expressed in the nervous system. This is a joint initiative with NIMH and also has participation of NHGRI, NEI, NIA, NIAAA, NICHD, NIDA, NIEHS, NIGMS. A BMAP workshop, sponsored by NINDS and NIMH, was held the end of March 1998. The participants represented academia, private industry and the NIH. There were many recommendations that came out of the workshop to guide the NIH in priority setting for this project. Dr. Varmus has provided $2 million in support for FY 98. The NINDS and NIMH have issued a joint request for contract proposals to begin feasibility studies and development of technology for the BMAP project.
In discussion following the presentation, several council members spoke of their approval for the BMAP project, along with some concerns that the project might duplicate the work of the Human Genome Project. The BMAP project will be focused on neurobiology first, and genomics second, so that the projects can proceed in parallel and BMAP can benefit from the technology development and tools developed by the genome project.
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 28 research career development grant applications; of this total, 24 applications had primary assignment to NINDS, and 19 of them (79.2 percent) were recommended for support in the amount of $1.4 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 $1.0 million.
B. Research Grant Awards
The Council reviewed a total of 938 research grant applications; of this total, 613 applications had primary assignment to NINDS, and 417 of them (68.1 percent), which recommended for support in the amount of $92.4 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 $28.4 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 eight investigators as Javits awardees.
The Council expressed concern that the NINDS perhaps would benefit from making more Javits Awards and providing more widespread publicity about the extraordinary excellence of the Javits awardees. There was a discussion comparing the Javits award to the MERIT award and the financial management implications of long (greater than three or four years) award periods.
C. Special Program Actions
The Council reviewed a total of 115 Small Business Innovation Research (SBIR) and Small Technology Transfer Award (STTR) grant applications; of this total, 69 applications had primary assignment to NINDS and 43 of them (62.3 percent) were recommended for support in the amount of $4.9 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 $2.5 million.
The Council reviewed a total of 10 Academic Research Enhancement Awards (AREA) applications; of this total, 6 applications had primary assignment to NINDS, and 2 of them (33.3 percent) were recommended for support in the amount of $0.2 million direct costs. It is not anticipated that NINDS will be able to pay any of these applications.
XI. OTHER
At Council's request, the NINDS will provide an annual report of the paid special considerations at each February Council meeting, starting in 1999.
Council asked for clarification of their role in the new appeal process. Dr. Atwell briefly described the roles of NINDS staff, including the responsibility of staff to work closely with applicants, especially new applicants, to ensure that they know about NIH and NINDS programs and policies. Dr. Atwell assured Council that their role is, as it has been, to identify any concerns they have about any application and to notify her as much before the Council meeting as possible. It was recognized that this would be easier if summary statements were available earlier.
Dr. Heros raised the topic of research training, during and after residency training. This is an important issue for the clinical specialties because support for such training is needed to develop a greater number of and more highly skilled clinical researchers.
XII. ADJOURNMENT
The meeting was adjourned at 11:40 a.m. on Friday, May 29, 1998.
We certify that, to the best of our knowledge, the foregoing minutes and attachments are accurate and complete.
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- 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 September 09, 2008
National Institute of Neurological Disorders and Stroke
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