NAEC Meeting Minutes

Department of Health and Human Services
National Institutes of Health
National Eye Institute

February 8, 2001

The National Advisory Eye Council (NAEC) convened for its ninety-seventh meeting at 8:30 a.m. on Thursday, February 8, 2001, in Conference Room G, Executive Plaza North, National Institutes of Health (NIH), Rockville, Maryland. The Acting Director of the National Eye Institute (NEI), Jack A. McLaughlin, Ph.D., presided as Chair of the Council. The meeting was open to the public from 8:30 a.m. until 11:45 a.m., followed by the closed session review of grant applications until adjournment at 3:30 p.m. Attachment A provides a roster of Council members.

Council members present:

Dr. Dean Bok
Dr. Constance Cepko
Ms. Patricia A. Cleary
Dr. Martha C. Constantine-Paton
Dr. Gordon E. Legge
Dr. Marco A. Zarbin (Ex Officio)
Mr. Richard J. Salem
Dr. P.Sarita Soni
Dr. J. Wayne Streilein
Dr. Larry J. Takemoto
Dr. Karla Zadnik

Council members absent:

Lt Col. William J. Flynn (Ex Officio)
Dr. M. Rosario Hernandez
Dr. Mildred M. G. Olivier

NEI staff present:

Ms. Margie Baritz
Ms. Felicia Brice
Ms. Olive P. Childers
Mr. William W. Darby
Mr. Michael Davis
Ms. Lois M. DeNinno
Ms. Linda Dingle
Dr. Peter A. Dudley
Ms. Lois Eggers
Mr. Donald F. Everett
Dr. Richard S. Fisher
Ms. Carol Fivozinsky
Dr. Ralph J. Helmsen
Dr. Jeanette Hosseini
Dr. Chyren Hunter
Dr. Natalie Kurinij
Ms. Darlene Lee
Dr. Ellen S. Liberman
Dr. Andrew P. Mariani
Dr. Jack A. McLaughlin
Dr. Loré Anne McNicol
Dr. Richard L. Mowery
Ms. Kathleen Moy
Ms. Angelia G. Neal
Dr. Michael D. Oberdorfer
Dr. John P. SanGiovanni
Ms. Jane Schriver
Ms. Karen Robinson Smith
Ms. Judy Stein
Dr. Deborah Sweet
Mr. John Whitaker
Ms. Cheryl Wild
Dr. Graeme Wistow

Other National Institutes of Health (NIH) staff present:

Dr. Michael Chaitin, CSR
Dr. Carole L. Jelsema, CSR
Dr. Leonard Jakubczak, CSR
Dr. Anne Schaffner, CSR

Food and Drug Administration staff present:

Ms. Nancy C. Brogdon
Dr. Wiley Chambers

Members of the general public present at the open session:

Mr. Michael Crissman, Association for Research in Vision and Ophthalmology
Dr. Israel Goldberg, Health Research Associates
Ms. Hainii Shiferaw, The Blue Sheet
Dr. Paul A. Sieving, University of Michigan
Dr. Santa Tumminia, Foundation Fighting Blindness
Dr. John Whitener, American Optometric Association

Open Portion of the Meeting

I. Call to Order and Opening Remarks

Dr. Jack A. McLaughlin, Acting Director, NEI, and Chair of the Council, called the meeting to order and welcomed the Council members and guests.

II. Announcements and Introductions

Dr. McLaughlin announced that three new members were present for their first Council meeting. Mr. Richard J. Salem, J.D., is the founder and senior partner of the law firm Salem Saxon, P.A., of Tampa, Florida. He specializes primarily on structuring business and financial transactions in the United States, Canada, Great Britain, and Europe. Mr. Salem has extensive community, national, and international experience as a volunteer working on behalf of individuals who are disabled. He has served as Chair of the Board of Trustees for the Florida School for the Deaf and the Blind and is a Member of the Board of the National Organization on Disability. Mr. Salem founded the organization, Enable America!, a political action committee working to reduce the unemployment rate among individuals with disabilities.

J. Wayne Streilein, M.D., is President and Director of Research of the Schepens Eye Research Institute in Boston, Massachusetts. He is an internationally-recognized expert on corneal diseases who has published extensively in the broad areas of ocular immunology and immune tolerance. Dr. Streilein has held an NEI MERIT award and served on many programmatic advisory committees for both the NEI and the National Institute of Allergy and Infectious Diseases.

Karla Zadnik, O.D., Ph.D. is Professor, College of Optometry, at the Ohio State University. She is a senior investigator who heads several major, multicenter clinical studies and has published extensively in the areas of myopia and refractive error. Dr. Zadnik has received many honors and awards for this work, including the Fry Award of the American Academy of Optometry. She has been active in establishing community- and school-based vision screening programs and served on the White House Conference on Aging.

Dr. McLaughlin introduced two special guests, Dr. Maurice Rabb and Dr. Paul A. Sieving. Dr. Rabb is Professor of Clinical Ophthalmology at the University of Illinois. Dr. Rabb was a member of the National Advisory Eye Council from 1990 to 1993. He is currently serving as a member of the NIH Director's Council of Public Representatives.

Dr. Paul Sieving is the director-designate of the National Eye Institute. Dr. Sieving is the Paul R. Lichter Professor of Ophthalmic Genetics and director, Center for Retinal and Macular Degeneration, at the Department of Ophthalmology and Visual Sciences, University of Michigan Kellogg Eye Center, Ann Arbor. Dr. Sieving will join the NEI in late spring.

Dr. Loré Anne McNicol, Director, Division of Extramural Research (DER), NEI, and Executive Secretary of the Council introduced Dr. Jeanette Hosseini, who has joined the NEI as a Scientific Review Administrator in the Scientific Review Branch. Dr. Hosseini worked as a research medical technologist at the NIH Clinical Center for 13 years. In 1996 she received her Ph.D. in Physiology from the Uniformed Services University of the Health Sciences, on studies of the effects of inflammation on cholinergic smooth muscle contraction in the gastrointestinal tract. She then returned to the Clinical Center, working part time on the Microbiology Service while she pursued experience in scientific administration in the Review Branch of the National Heart Lung and Blood Institute and on the Program Staff of the NIH Office of Dietary Supplements. The DER is very pleased to have Dr. Hosseini on board for the review of the applications in response to new NEI program initiatives.

III. Confidentiality / Avoidance of Conflict of Interest

Dr. McNicol 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 signed a statement certifying that they were absent during such discussions.

IV. Consideration of Minutes of Previous Meeting

The minutes of the September 14, 2000, NAEC meeting were considered and approved as submitted.

V. Future Council Meeting Dates

The following dates were agreed upon for future Council meetings:

June 14-15, 2001 (the 15th will be a half day meeting)
September 13-14, 2001
February 14-15, 2002
June 13-14, 2002
September 12-13, 2002

VI. Budget Overview

Ms. Carol Fivozinsky, Budget Officer, NEI, presented an overview of the FY2001 NEI and NIH budgets. After operating under a series of 21 continuing resolutions, on December 29, 2000, the NIH received an FY2001 appropriation of $20,312,735, which is a 14.0% increase over FY2000. Within this budget, NEI received a $60.8 million (13.5%) increase over FY2000, marking the third year of double digit increases. However, the NEI received the lowest percentage increase among the NIH Institutes and Centers, and is falling behind the goal of achieving a doubling of the budget over a five year period.

The FY2001 NIH appropriation bills and conference reports stressed the importance of genetic approaches to retinal and other blinding eye diseases. In another portion of the report language, Congress addressed the returns on the public investment in basic research. Legislation raised the salary cap for extramural investigators, provided increased funds for the facilities construction grant program, funded the intramural National Neurosciences Research Center, established a National Center for Minority Health and Health Disparities Research, and established a new National Institute of Biomedical Imaging and Bioengineering.

The $511 million NEI appropriation is distributed among extramural grants and research and development contracts ($451 million), the Division of Intramural Research ($45 million) and Research Management and Support ($15 million). The FY2001 extramural funds include $426 million for research grants, $9.8 million for research training, and $15 million for research and development contracts.

The FY2002 budgets for the NEI and NIH are being prepared. The administration's "blue print" budget is expected to be released on February 19; the full budget will be submitted to Congress in April.

VII. Extramural Budget Trends

Dr. McNicol reviewed budget trends for the extramural research program in FY2001. During the series of continuing resolutions, no new program initiatives were funded and no supplemental awards were made. Competitive grants, on average, were funded at the FY2000 level. Continuing grants, on a grant-by-grant basis, were issued at or below the FY2000 level. With the final appropriation, the continuing grants were revised to the committed level.

For FY2001, the NEI will fund approximately 1631 grants, 71 more than it funded in FY2000. The double-digit budget increase which the NEI received for FY2001 will permit an increase in the annual total cost of grants by an average of 8% ($23,450). The NEI intends to fund a number of new scientific initiatives and to co-fund several trans-NIH collaborations. These include a second round of DNA microarray supplements; various genomic resources, including a vision genetic website; small grants for pilot research; national programs of excellence in biomedical computing; collaborative research on therapy for visual disorders; clinical research on the ocular complications of diabetes; consolidated neuroscience training grants; and training in clinical research in minority institutions. In addition, the NEI will collaborate with other NIH Institutes and Centers in co-funding research opportunities in studies of ocular melanoma, diabetic complications, bioengineering, and autoimmunity.

VIII. Council Operating Procedures

Mr. William W. Darby, Grants Management Officer, reviewed the NAEC operating guidelines. Council members approved the guidelines and endorsed the elimination of special Council attention for applications constituting an investigator's third NIH R01-type grant. NEI staff will continue to review such applications before funding to determine that the Principal Investigator has sufficient effort to devote to the project and that the project does not overlap with previously funded applications.

VIX. 2001 Biennial Advisory Council Report Certifying Compliance with Inclusion Guidelines

Dr. McNicol reviewed NIH policy regarding the inclusion of women and minorities as subjects in clinical research, and presented the strategies used by the NEI to ensure compliance. Members noted that one important strategy for enrolling minorities is ensuring adequate numbers of minority investigators. Council members reviewed FY1998 inclusion data for all NEI-funded grants and for Phase III Clinical Trials, and unanimously certified that the NEI is in compliance with the NIH inclusion guidelines.

X. Public Health Service (PHS) Policy on the Responsible Conduct of Research

Mr. Donald F. Everett, Group Leader, Clinical Trials, presented the PHS Policy on Instruction in the Responsible Conduct of Research, published on December 1, 2000. The policy requires that institutions offer a program of instruction that shall be completed by all key personnel involved with PHS-supported research. Mr. Everett reviewed the timetable for implementation of the policy, the core areas of instruction to be included in the course, and the flexibility permitted to the institution.

XI. NIH Director's Council of Public Representatives (COPR)

Dr. Maurice Rabb, one of 20 current members of COPR, described the organization and role of this group. COPR was chartered in 1998 and charged to provide a forum for discussing issues affecting the broad development of NIH policy, programs, and research goals, and advising the NIH Director on these matters. The COPR also advises and assists the NIH in enhancing public participation in NIH activities, increasing public understanding of the NIH, and bringing the views of the public forward for discussion with, and to the attention of, NIH leadership. The COPR meets approximately two times a year for one or two days. COPR, with its role in enhancing communications and addressing broad public issues acts as a partner to the Advisory Council to the Director, which has a strong research emphasis. Dr. Rabb described the expertise and interests of the COPR members, and discussed some specific activities of the group. These include attending the trans-NIH budget retreat, working with the NIH Peer Review Oversight Group, participating on a committee reviewing Institute Directors, and serving on the Government Performance and Results Act Review Committee.

XII. Nih Strategic Plan to Reduce and Ultimately Eliminate Health Disparities

Dr. McNicol reviewed the draft NIH strategic plan produced by the Office for Research on Minority Health, noting that the document presents a more focused definition of health disparities and articulates a single goal: to promote the development and transfer of research-based information from biomedical, behavioral, and social sciences for use by health professionals, communities, and others in working toward the elimination of health disparities. The objectives of the plan are organized into three areas: research, research infrastructure, and public information and community outreach. Dr. McNicol reviewed NEI activities within each of these objectives. Council members felt it would be valuable to consider the details of all NEI programs and policies regarding the recruitment and training of minority individuals and individuals with disabilities. An overview of this subject will be presented at the June 14-15, 2001 meeting for additional Council discussion.

XIII. Ocular Genomic Resources Website

Dr. Graeme Wistow, Chief, Section on Molecular Structure and Function, Division of Intramural Research, NEI, presented the website he is developing to organize ocular genomics and bioinformatics resources for the broader vision research community. The creation of such a visual system website was considered a high priority at the NEI Functional Genomics Workshop held in September, 1999. Dr. Wistow indicated that eye tissues have been relatively neglected in large scale Expressed Sequence Tag (EST) projects. His group has prepared high quality cDNA libraries from micro-dissected eye tissues. These will be available as a resource for gene discovery, EST analysis, the preparation of visual system-specific DNA microarrays, and the collection of eye-expressed DNA sequences. He has organized this material as annotated web pages and integrated it with existing protein and disease data bases. A Steering Committee made up of three extramural vision scientists has been appointed to advise Dr. Wistow regarding issues of access, distribution, and accretion. It is anticipated that the site will be publicly available later this year. Council enthusiastically endorsed this project.

XIV. Collaborative Research on the Therapy of Ocular Disorders

Dr. Peter A. Dudley, Director, Retinal Diseases Program, described the publication of this Program Announcement, which had been given concept clearance at the September, 2000, NAEC meeting. The full text is available on the internet at http://grants.nih.gov/grants/guide/pa-files/PAR-01-022.html This initiative supports collaborative multidisciplinary research focused on the development of novel therapies to restore or prevent the loss of function due to visual disorders.

XV. Workshop on Genetics of Diabetic Retinopathy

Dr. Dudley described the workshop which the NEI convened in September, 2000, to explore whether recent advances in genetic research increased the opportunity for understanding the genetic predisposition to the development and progression of diabetic retinopathy. A multidisciplinary group of clinicians, epidemiologists, statistical geneticists, and molecular geneticists examined the existing evidence for genetic factors influencing the development of diabetic retinopathy. They also determined whether recent work on the development of diabetic nephropathy provided approaches which could be exploited for studies of diabetic retinopathy. The workshop identified a set of nine collaborations to pursue and research studies to develop and implement. The Council concurred with these proposals. The recommendations will be published on the NEI website and will form the basis of future program initiatives.

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 309 research and training applications requesting $415.5 million in total all year costs. The Council recommended 268 applications with a total all year cost of $370.1 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. McLaughlin adjourned the meeting at 3:15 p.m. on February 8, 2001.

XVIII. Certification

I hereby certify that, to the best of my knowledge, the foregoing minutes and attachment(s) are accurate and complete.

Loré Anne McNicol, Ph.D.
Executive Secretary
National Advisory Eye Council
Director, Division of Extramural Research
National Eye Institute

Jack A. McLaughlin, Ph.D.
Chair
National Advisory Eye Council
Acting Director
National Eye Institute

These minutes will be submitted for the approval of the Council at the June 14-15, 2001, meeting. Any corrections or notations will be incorporated into 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@nei.nih.gov
02/21/01

Attachment A

National Advisory Eye Council
National Eye Institute

Roster
(Terms end 11/30 of the designated year)

Dean Bok, Ph.D. (02)
Professor of Neurobiology and Ophthalmology
University of California, Los Angeles
Los Angeles, CA 90095-1763

Constance Cepko, Ph.D. (01)
Professor of Genetics
Harvard Medical School
Boston, MA 02115

Patricia A. Cleary, M.S. (02)
Senior Research Staff Scientist
The George Washington University
Rockville, MD 20852

Martha C. Constantine-Paton, Ph.D. (03)
Professor of Biology
Massachusetts Institute of Technology
Cambridge, MA 02139

M. Rosario Hernandez, D.D.S. (02)
Associate Professor of Ophthalmology and Visual Sciences
Washington University
St. Louis, MO 63110

Gordon E. Legge, Ph.D. (03)
McKnight Distinguished University Professor of Psychology
University of Minnesota Twin Cities
Minneapolis, MN 55455-0344

Mildred M. G. Olivier, M.D. (04)
President and CEO
Midwest Glaucoma Center, P.C.
Hoffman Estates, IL 60194

Richard J. Salem, J.D. (01)
Senior Partner
Salem, Saxon, and Nielsen, P.A.
Tampa, FL 33602

P. Sarita Soni, O.D. (03)
Professor of Optometry & Visual Science
Indiana University
Bloomington, IN 47405

J. Wayne Streilein, M.D. (04)
President and Director of Research
Schepens Eye Research Institute
20 Staniford ST
Boston, MA 02114

Larry J. Takemoto, Ph.D. (02)
Professor of Biology
Kansas State University
Manhattan, KS 66506

Karla Zadnik, O.D., Ph.D. (04)
Professor
College of Optometry
Ohio State University
Columbus OH 43210-1240

Department of Defense Representative

Lt. Col. William J. Flynn, USAF, MC, M.D.
Department of Ophthalmology
Wilford Hall Medical Center
Lackland Air Force Base, TX 78236

Department of Veterans Affairs Representative

Marco Z. Zarbin, M.D., Ph.D.
New Jersey Veterans Admin. Hospital
Newark, NJ 07103

Ex Officio Members

Tommy G. Thompson
Secretary
Department of Health & Human Services
Washington, DC 20201

Ruth L. Kirschstein, M.D.
Principal Deputy Director
National Institutes of Health
Bethesda, MD 20892

Chair

Jack A. McLaughlin, Ph.D.
Acting Director
National Eye Institute
National Institutes of Health
Bethesda MD 20892

Executive Secretary

Loré Anne McNicol, Ph.D.
Director
Division of Extramural Research
National Eye Institute
National Institutes of Health
Bethesda, MD 20892