NAEC Meeting Minutes
Department of Health and Human Services
National Institutes of Health
National Eye Institute
June 11, 1998
The National Advisory Eye Council (NAEC) convened for its eighty-ninth meeting at 8:30 a.m. on Thursday, June 11, 1998, in Conference Room G, Executive Plaza North, National Institutes of Health (NIH), Rockville, Maryland. The Director of the National Eye Institute (NEI), Carl Kupfer, M.D., presided as Chair of the Council. The meeting was open to the public from 8:30 a.m. until 11:30 a.m., followed by the closed session for the review of the intramural research program and grant applications until adjournment at 4:15 p.m. Attachment A provides a roster of Council members.
Council members present:
|
Dr. Anthony J. Adams Dr. David C. Beebe Dr. Constance Cepko Dr. Marian R. Fisher Lt. Col. William J. Flynn (Ex Officio) Dr. Diane L. Hatchell (Ex Officio) Mr. Richard T. Hellner |
Dr. Eve J. Higginbotham Dr. David H. Hubel Dr. Millicent L. Knight Dr. Carl Kupfer (Ex Officio) Dr. Anthony B. Nesburn Dr. David S. Zee |
Council members absent: none
Special Council Consultant: Dr. Dean Bok
NEI Staff Present:
|
Ms. Margie Baritz Ms. Cheryl Contreras Dr. Mary Frances Cotch Mr. Michael Davis Ms. Linda Dingle Dr. Peter A. Dudley Ms. Lois Eggers Mr. Donald F. Everett Ms. Carol Fivozinsky Dr. Maria Y. Giovanni Ms. Carolyn E. Grimes Dr. Ralph J. Helmsen |
Dr. Natalie Kurinij Dr. Ellen Liberman Dr. Andrew P. Mariani Dr. Jack A. McLaughlin Dr. Loré Anne McNicol Dr. Carmen P. Moten Dr. Robert Nussenblatt Dr. Michael D. Oberdorfer Ms. Karen Robinson Smith Ms. Judy Stein Mr. John Whitaker |
Other NIH Staff Present:
Dr. John Bowers, CSR
Dr. Luigi Giacometti, CSR
Dr. Len Jakubczak, CSR
Dr. Carole Jelsema, CSR
Food and Drug Administration Staff Present:
Dr. Ralph Rosenthal
The following members of the general public were present at the open session:
Ms. Joanne Angle, Association for Research in Vision and Ophthalmology
Ms. Lisa Putman, Blue Sheet
Dr. John C. Whitener, American Optometric Association
Open Portion of the Meeting
I. Call to Order and Opening Remarks
Dr. Carl Kupfer, Director, NEI, called the meeting to order and welcomed the Council members and guests. He introduced a new Council member, Dr. Constance Cepko. Dr. Cepko is Professor, Department of Genetics and Howard Hughes Medical Institute, Harvard Medical School. She is a highly-regarded scientist who is interested in the mechanisms that direct the development of the central nervous system (CNS). Dr. Cepko has developed innovative molecular genetic techniques to investigate cell progenitor-progeny relationships in several areas of the CNS, including the retina. She has recently initiated a major effort to understand how the cell environment and other factors interact with retinal progenitors to direct cell fate decisions. Dr. Cepko has extensive experience in the training of graduate students and postdoctoral fellows. She has won a number of awards for her research, including the David O. Cogan Award for Outstanding Young Investigators from the Association for Research in Vision and Ophthalmology (ARVO).
Dr. Kupfer next thanked Dr. Dean Bok who had agreed to participate in the meeting as a Special Council Consultant. Dr. Bok is the Dolly Green Professor of Ophthalmology, Jules Stein Eye Institute, and Professor of Neurobiology, Anatomy, and Cell Biology, University of California, Los Angeles.
II. Confidentiality / Avoidance of Conflict of Interest
Dr. Jack A. McLaughlin, Deputy Director, NEI, and Executive Secretary of the Council, reviewed policies and procedures regarding confidentiality and avoidance of conflict of interest situations. To avoid conflict of interest, members of federal advisory committees must not participate in the discussion of any application or proposal in which they, their spouse, minor child, close professional associate, or organization has a financial interest or affiliation. The Council members were later asked to sign a statement certifying that they were absent during such discussions.
III. Consideration of Minutes of Previous Meeting
The minutes of the January 29,1998 Council meeting were considered next. The minutes were approved as submitted.
IV. Future Meeting Dates
The following dates were agreed upon for future Council meetings:
September 17-18, 1998 [ subsequently changed to one day - September 17 ]
February 4-5, 1999
June 10-11, 1999
September 16-17, 1999
V. Fiscal Year 1998 Budget Overview
Ms. Carol Fivozinsky, Budget Officer, NEI, presented an overview of the budget situation for Fiscal Years 1998 and 1999 (Attachment B). She said that NEI had received a Fiscal Year (FY) 1998 budget of $355.7 million, an increase of 7.3% over the FY 1997 budget. The percentage increase received by NEI was in line with the increases received by most of the other Institutes. The NIH received a percentage increase of about 7.1% overall.
Ms. Fivozinsky next reviewed the FY 1999 President's Budget Request (PB) for NIH and for NEI. The Administration has requested $384.3 million for NEI, representing an 8% increase over FY 1998, compared to an 8.4% increase requested for NIH overall. She said that Dr. Gerald Chader, Chief Scientific Officer of the Foundation Fighting Blindness, had testified before the Labor, HHS Appropriations Subcommittee on January 28, on behalf of ARVO and the Alliance for Eye and Vision Research. His testimony, which was well-received, included a request that the Subcommittee support a 15% increase in the FY 1999 NEI budget. The American Optometric Association had also submitted testimony supporting the 15% increase. Dr. Kupfer testified before the same Subcommittee on March 18. The Senate Appropriations Labor, HHS Subcommittee hearings were held on April 1. Ms. Fivozinsky indicated that considerable enthusiasm had been expressed recently by prominent members of both the House and Senate for a doubling of the NIH budget over the next five years. However, she indicated that a number of factors might preclude such an increase, at least in FY 1999.
VI. Extramural Research Program
Dr. McLaughlin's presentation covered the latest budget estimates for the extramural research program for FY 1998 and the estimates associated with the FY 1999 PB. He pointed out that the overall distribution of funds among the various extramural categories of support in FY 1998 would be similar to that of previous years. Dr. McLaughlin said that the success rate for FY 1998 competing research project grants would be approximately 40%, and that NEI would be able to fund more total grants in FY 1998 than it did in FY 1997.
With regard to the FY 1999 PB, Dr. McLaughlin estimated that the total number of research project grants would increase from 984 in FY 1998 est. to 1005 in FY 1999. The success rate for competing grants should remain relatively high at about 38%. An important assumption of the FY 1999 PB is that competing grants, on average, would not be cut from the study section recommended levels. The overall distribution of funds among the various extramural categories of support in the FY 1999 PB is similar to FY 1998.
VII. VII. Support Of New Investigators
Dr. McLaughlin then reviewed NIH-wide changes regarding support for new investigators (NIH Guide, 11/21/97 and 12/19/97). These changes included the fact that First Independent Research and Transition (FIRST) applications would no longer be accepted by NIH. He said that individuals affected were being encouraged to submit regular (R01) research grant applications clearly identified as being from a new investigator. Dr. McLaughlin said that there was a very strong commitment by NIH to continue its support of new investigators. He indicated that NEI staff would be encouraging new investigators to continue to request five years of support in their applications if warranted by their project, and that NEI intended to fund these applications for five years if the study sections made that recommendation. Dr. McLaughlin said that the peer review criteria would remain the same, but that the emphasis on some of the criteria would shift a bit. More emphasis will be put on feasibility than on preliminary results, on training and research potential than on track record and number of publications, and on evidence of Institutional commitment of space and release time.
VIII. New NIH Career Development Awards
Dr. Maria Y. Giovanni, Division of Extramural Research, NEI, reviewed the recent NIH announcement of three new career development awards designed to attract talented clinicians to the challenges of clinical research and to improve the quality of clinical research training. A detailed description of these awards is available (NIH Guide , 04/06/98). She said that investigators are being encouraged to contact the NEI extramural program staff with questions they may have about these awards. The Council members expressed considerable enthusiasm for these new awards, and for possibly expanding the program to include other target groups.
K23. The Mentored Patient-Oriented Research Career Development Award will support clinicians who have finished their clinical training and need 3 to 5 years of supervised research and study to develop into an independent investigator in patient-oriented research. The program of training will consist of a mixture of didactic and supervised research experiences tailored to the developmental needs of the candidate. As implemented by NEI, the new K23 award is very similar to the existing Mentored Clinical Scientist Development Award (K08), but is targeted at clinicians who directly interact with human subjects in conducting their research. NEI does not impose any special salary cap on either the K08 or the new K23 award.
K24. The Mid-Career Investigator Award in Patient-Oriented Research supports clinical scientists who are within 15 years of their specialty training to allow them protected time to devote to patient-oriented research and to serve as a mentors for beginning clinical investigators.
K30. The Clinical Research Curriculum Award supports institutions as they develop formal curricula designed to impart to new clinical investigators the fundamental skills, methodology, theories and conceptualizations necessary to establish an independent career in clinical research. Institutions with a strong clinical research faculty who are also committed to establishing a clinical research core curriculum are invited to apply (only one application per institution) for these 5 year renewable grants. The National Heart, Lung, and Blood Institute will administer this program for the NIH. The receipt date is October 21, and it is expected that approximately 20 awards will be made by NIH in FY 1999.
IX. NEI Scholars Award Program
Dr. Giovanni next described progress in developing the NEI Scholars Award, a new research career development program. The purpose of the NEI Scholars Award is to provide an opportunity for outstanding new investigators to receive high quality research training in the NEI intramural program and to facilitate their successful transition to an independent research position at an extramural institution. Formal application and peer review procedures have been established, and an announcement of the new program is scheduled for this fall. The Council members expressed strong support for this new program.
X. Inclusion of Children in Research
Dr. Mary Frances Cotch, Ph.D., Division of Extramural Research, NEI, reviewed the subject of a recent NIH announcement (NIH Guide, 3/6/98). NIH has published guidelines for including children in research involving human subjects. Initial applications (Type 1) submitted to NIH on and after the October 1 receipt date are governed by these guidelines, and must describe plans for including or excluding children in the study population of a proposed project. For this policy, a child is defined as "an individual under the age of 21 years." The policy states that children must be included in all human subjects research, conducted or supported by the NIH, unless there are scientific or ethical reasons not to include them.
XI. Update: Program Planning
Mr. Michael Davis, Associate Director for Science Policy and Legislation, NEI, informed the Council members that copies of Vision Research--A National Plan: 1999-2003 and its Executive Summary had been delivered to their hotel the preceding afternoon. He expressed his appreciation to the Chairs, Co-chairs, and members of the program planning panels; to the Co-chairs of Council’s Subcommittee on Planning, Drs. Beebe and Higginbotham, and its members Dr. Adams and Mr. Hellner; to the full Council for its timely review of and commentary on the draft reports; and to the NEI Extramural Program Directors. He said that without the expertise, dedication, patience, and persistence of these people, NEI staff would not have been able to follow the ambitious time schedule that had been set for the plan’s publication.
Dr. Beebe thought that the schedule might have been overly ambitious, and suggested that in the next iteration, more time should be allowed for the review phase of the process. He stated that it had been difficult to adjust his schedule to meet the deadlines and still conduct a thorough review.
Mr. Davis stated that the full shipment of the documents was received the preceding evening from the printing contractor, and that his office would begin distribution of the Executive Summary to all grantees and others involved in the support or conduct of vision research. He also indicated that the contractor is currently converting both documents so that they could be posted on NEI’s internet homepage by the end of the month of June.
XII. Update: Diabetes Research Initiative
Dr. Peter A. Dudley, Division of Extramural Research, NEI, reviewed several aspects of the NIH diabetes research initiative. Following several public meetings to develop an integrated plan for diabetes research, NIH staff released a series of Requests for Applications (RFAs). Of special relevance to NEI, an RFA was published in the NIH Guide (11/21/97), entitled "Microvascular Complications of Diabetes Mellitus." Six million dollars were set aside in FY 1998 for this one-time solicitation, and it is expected that approximately 25 awards would be made. He said that a large number of applications had been submitted by investigators pursuing vision related projects, and credited ARVO for helping to inform the vision research community of this funding opportunity. Applications received in response to this RFA and relevant to the Institute will be reviewed by the Council at its September meeting.
Dr. Dudley also discussed a related Program Announcement (PA) in which the NEI was participating, "Therapeutic Modulation of Angiogenesis in Disease," released by NIH on July 30, and co-sponsored by the National Cancer Institute and the National Heart, Lung, and Blood Institute. The application receipt dates are November 19, 1998, and July 20, 1999. The purpose of this PA is to encourage the translation of basic knowledge of the angiogenic process into therapeutic applications. He said that NEI was ideally positioned for the diabetes initiative and the PA on angiogenesis in that Vision Research--A National Plan: 1999-2003 had just been prepared and that type of research had been highlighted as important areas in need of expansion. The Council was very enthusiastic about each of these initiatives and gratified that the Plan had been put to immediate use.
XIII. Vision Screening & Preschool Children
Dr. Michael D. Oberdorfer, Division of Extramural Research, NEI , said that early in 1998, the Health Services Research Administration (HRSA) had informed NEI that it would be organizing an expert panel on vision screening for the pre-school child and asked for NEI’s assistance. The purpose of the proposed panel is to evaluate scientific and practical issues related to early vision screening, particularly those relating to amblyogenic risk factors. One objective is to promote interdisciplinary interaction among researchers and clinicians to critique, evaluate, and plan screening initiatives and to conduct research. The product will be a working paper describing the type of vision screening program(s) that should be integrated into the health care system, as well as the optimal methods for implementing and evaluating these programs. The dates for the panel meeting are September 10 and 11, and the meeting will be held in the Bethesda area. The Council members indicated that this effort was encouraging in that more science would be brought into this difficult area.
XIV. Brain Molecular Anatomy Project (BMAP)
Dr. Oberdorfer then announced that NEI was working with the National Institute of Neurological Diseases and Stroke, the National Institute of Mental Health, and other neuroscience-related Institutes, on a trans-NIH sponsored interdisciplinary project called the Brain Molecular Anatomy Project (BMAP). BMAP will use state-of-the-art technology and informatics resources to identify all of the genes expressed in the nervous system, and to correlate gene expression patterns with changes in nervous system function. The gene discovery phase will catalog the full repertoire of genes that are expressed at different times and places in the nervous system. The analysis phase will quantitatively compare levels of gene expression in cells as a function of their anatomical location, developmental stage, and disease processes. The Council will be kept informed as specific BMAP initiatives emerge.
XV. Review of Applications from Members of Study Sections
Dr. Loré Anne McNicol, Division of Extramural Research, NEI, presented data regarding the review of applications from members of Center for Scientific Review study sections. Because of conflict of interest concerns, applications from members of study sections are reviewed by review groups other than the study sections on which they serve. Data for the past five years showed that 77% of the grant applications submitted by individuals serving on the Visual Sciences A (VISA) study section were funded. This compares favorably with the overall funding rate of 36% during the same period. The funding rates were somewhat higher for members of the Visual Sciences B (VISB) (88%) and Visual Sciences C (VISC) (89%) study sections. Aggregate data for all applications (from study section members and from non-members) was also reviewed. The data indicated that applicants had a "success rate" of 35% for applications reviewed by one of the three "home" study sections (VISA, VISB, and VISC) and a "success rate" of 38% for applications reviewed by non-"home" study sections or other review groups.
During the discussion, Dr. McNicol said that VISA members had submitted proportionately more applications during their term on study section than did members of the other two study sections, and that proportionately more VISA members held more than one NIH R01-type award. Thus, VISA members were "exposed" to NIH peer review of their applications relatively more frequently than their counterparts on VISB or VISC. It was also determined that members of the VISB study section were often appointed immediately following successful competitive renewal of their grant awards, thus sparing them the necessity of having to submit a renewal application during their four year terms. Other discussion related to the relative merits of review of applications from study section members by ad hoc "special" review groups vs. review by standing study sections with overlapping scientific boundaries. Council members who expressed an opinion favored the practice of review by ad hoc "special" review groups. Council members also inquired about the status of the recently reorganized neuroscience study sections, how the reorganization might affect vision research, and how appropriate study section members are being identified. Dr. McLaughlin said that Dr. Ehrenfeld, Director, Center for Scientific Review, had been invited to attend the September Council meeting and that her attendance would provide another opportunity to discuss these and other peer review issues.
Closed Portion of the Meeting
The next portion of the meeting was closed to the public in accordance with the determination that it was concerned with matters exempt from mandatory disclosure under Sections 552b(c)(4) and 552b(c)(6), Title 5, U.S. Code and Section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. Appendix 2).
XVI. Review of Research and Training Applications
The Council considered 346 research and training applications requesting $378.3 million in total costs. The Council recommended 338 applications with a total cost of $352.6 million. Council members absented themselves from the meeting during discussion of and voting on applications from their own institutions, or other applications in which there was a potential conflict of interest, real or apparent. Members signed a statement to this effect.
XVII. Adjournment
Dr. Kupfer adjourned the meeting at 4:15 p.m. on June 11, 1998.
XVIII. Certification
I hereby certify that, to the best of my knowledge, the foregoing minutes and attachment(s) are accurate and complete.
Jack A. McLaughlin, Ph.D.
Executive Secretary
National Advisory Eye Council
Deputy Director
National Eye Institute
Carl Kupfer, M.D.
Chair
National Advisory Eye Council
Director
National Eye Institute
These minutes will be submitted for the approval of the Council at the September 17, 1998, meeting. Any 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 from:
Ms. Lois M. DeNinno
National Eye Institute
Executive Plaza South, Suite 350
6120 Executive Blvd. MSC 7164
Bethesda, MD 20892-7164
Telephone: (301) 496-9110
FAX: (301) 402-0528
e-mail: lmd@eps.nei.nih.gov
National Advisory Eye Council
National Eye Institute
(Terms end 11/30 of the designated year)
Roster
Anthony J. Adams, O.D., Ph.D. (00)
Dean and
Professor of Vision Science & Optometry
School of Optometry
University of California, Berkeley
Berkeley, CA
David C. Beebe, Ph.D. (98)
Professor of Ophthalmology & Visual Sciences
Washington University School of Medicine
St. Louis, MO
Constance Cepko, Ph.D. (01)
Professor
Department of Genetics
Harvard Medical School
Boston, MA
Marian R. Fisher, Ph.D. (98)
Senior Scientist
Department of Biostatistics
University of Wisconsin
Madison, WI
Mr. Richard T. Hellner (00)
President & CEO
Prevent Blindness America
Schaumburg, IL
Eve J. Higginbotham, M.D. (98)
Professor and Chair
Department of Ophthalmology
School of Medicine
University of Maryland
Baltimore, MD
David H. Hubel, M.D. (99)
John Franklin Enders
Professor of Neurobiology
Harvard Medical School
Boston, MA
Millicent L. Knight, O.D. (99)
North Shore Eye Center
Evanston, IL
Anthony B. Nesburn, M.D. (00)
Director
Ophthalmology Research Laboratories
Cedars-Sinai Medical Center
Los Angeles, CA
David S. Zee, M.D. (99)
Professor of Neurology, Ophthalmology,
Otolaryngology & Neuroscience
Johns Hopkins University
School of Medicine
Baltimore, MD
Special Consultant -- June Meeting
Dean Bok, Ph.D.
Professor
Jules Stein Eye Institute
University of California, Los Angeles
Los Angeles, CA 90095-1763
Ex Officio Members
Donna E. Shalala, Ph.D.
Secretary
Department of Health and Human Services
Washington, D.C.
Harold Varmus, M.D.
Director
National Institutes of Health
Bethesda, MD
Carl Kupfer, M.D. (Chair)
Director
National Eye Institute
National Institutes of Health
Bethesda, MD
Department of Veterans Affairs Representative
Diane L. Hatchell, Ph.D.
VA Medical Center
Durham, NC
Department of Defense Representative
Lt. Col. William J. Flynn, USAF, MC
Department of Ophthalmology
Wilford Hall Medical Center
Lackland Air Force Base, TX
Executive Secretary
Jack A. McLaughlin, Ph.D.
Director, Division of Extramural Research
National Eye Institute
National Institutes of Health
Bethesda, MD
