NAEC Meeting Minutes

Dr. Michael Chaitin, CSR
Dr. Carole L. Jelsema, CSR
Dr. Leonard Jakubczak, CSR
Dr. Donald Schneider, CSR

Food and Drug Administration Staff Present:
Ms. Nancy Brogdon

Members of the general public present at the open session:

Ms. Joanne Angle, Association for Research in Vision and Ophthalmology
Ms. Christine Armstrong, American Optometric Association
Mr. Michael Crissman, Association for Research in Vision and Ophthalmology
Ms. Carrie Kovar, American Academy of Optometry
Mr. Edward M. McManus, National Alliance for Eye and Vision Research
Ms. Sara Milo, National Alliance for Eye and Vision Research
Ms. Lois Schoenbrun, American Academy of Optometry

Open Portion of the Meeting

I. Call to Order and Opening Remarks

Dr. Carl Kupfer called the meeting to order and welcomed the Council members and guests.

II. Announcements and Introductions

Dr. Kupfer introduced Dr. Michael Chaitin, the new Scientific Review Administrator of the Visual Sciences A Study Section in the Molecular, Cellular, and Developmental Neurosciences Integrated Review Group at the Center for Scientific Review. He will be replacing Dr. Luigi Giacometti, who has become the Scientific Review Administrator of Special Study Section R, which reviews the vision-related small business grants and regular research grants that need an ad hoc review. Dr. Chaitin came from the University of North Texas Health Sciences Center at Fort Worth. He was Associate Professor in the Department of Anatomy and Cell Biology and the Principal Investigator of an NEI grant studying cytoskeletal proteins in retinal photoreceptors. His doctorate is in Molecular Biophysics from Florida State University, and he did post-doctoral research with Dr. David Papermaster at Yale University and with Council member Dr. Dean Bok at UCLA.

Dr. Kupfer announced that Council members Drs. Constance Cepko and Martha Constantine-Paton were unable to attend the meeting. Mr. Sanford Cloud regretfully resigned from the Council, owing to the growing responsibilities in his position with the National Conference for Community and Justice.

III. Confidentiality / Avoidance of Conflict of Interest

Dr. Loré Anne McNicol, Director, DER, 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 signed a statement certifying that they were absent during such discussions.

IV. Consideration of Minutes of Previous Meeting

The minutes of the February 10, 2000, National Advisory Eye Council meeting were considered and approved as submitted.

V. Future Council Meeting Dates

The following dates were agreed upon for future Council meetings:

September 14, 2000
February 8-9, 2001
June 7-8, 2001
September 13-14, 2001

Council members were asked to hold these dates as they scheduled future events.

VI. Budget Overview

NEI Budget Officer, Ms. Carol Fivozinsky, remarked that FY 2000 is the second year that the NIH (13.9%) and NEI (13.8%) have received double digit increases, putting the NIH on the road to a doubled budget over the five-year period from 1998 to 2003. The Administration transmitted its FY 2001 budget request to Congress in February, 2000. This document proposed an increase of 5.3% for the NEI, and 5.6% for NIH. Dr. Kupfer defended this budget request before the House Labor and Health and Human Services Appropriations Subcommittee (LHHS) on March 1, 2000.

The Alliance for Eye and Vision Research and other vision research advocacy groups adopted a 20% increase budget ($543M) as the NEIÕs FY 2001 CitizenÕs Budget or Professional Judgment Budget. This 20% is the level necessary if NEI is to double its budget over the five-year period. Several individuals and organizations have either testified before the House LHHS Subcommittee, or provided written testimony endorsing the 20% Professional Judgment Budget for the NEI.

Both the House (May 24) and Senate (May 11) LHHS have reviewed the FY 2001 budget requests and marked up their respective appropriations bills. Ms. Fivozinsky presented data comparing the FY 2000 budget to the FY 2001 markups and compared House and Senate actions on the NIH and NEI appropriations. House subcommittee Chairman Porter continues to show very strong support. He believes that funding has not kept up with the scientific opportunities.

Ms. Fivozinsky summarized portions of the bill and report language. The House expressed specific interest and support for research on diabetic retinopathy, health disparities, low vision, and retinal degenerative diseases. Two unusual topics were a request that the Director be prepared to testify at the FY 2002 appropriations hearing on the amount of funding being spent on research for new pharmaceuticals, and that the NEI enhance research into the function of the OA1 protein and potential treatments and cures for ocular albinism. The Senate, in addition, mentioned the need to provide resources for research and prevention of glaucoma for high-risk populations, particularly African Americans. The Senate Committee supported the creation of a National Neuroscience Center at NIH.

Ms. Fivozinsky summarized the outlook for FY 2001. Both Appropriations Committees completed their mark-ups by the end of MayÑwhich is extremely early compared to prior years. However, the President has issued a statement that he would veto a bill that contains some of the funding priorities expressed in the House and Senate appropriations bills.

Planning for the FY 2002 budget cycle has begun at NIH, with discussion regarding the scientific areas to be highlighted in the budget. Next week, NIH Acting Director Dr. Kirschstein and the Institute and Center directors will focus on the preparation of the FY 2002 NIH budget, which is due at the Department this summer.

VII. Activities of the Alliance for Eye and Vision Research

Alliance Executive Director, Mr. Edward B. McManus, described the Alliance's advocacy visits to educate members of Congress regarding the needs of vision research, as well as their support of the Association for Research in Vision and Ophthalmology (ARVO) Contact Congress booth. The Foundation Fighting Blindness also made many advocacy calls.

VIII. ARVO 2000 Symposium

Dr. Ellen S. Liberman, Lens and Cataract and Glaucoma Program Director described the Symposium on Ocular Development and Eye Diseases that the NEI sponsored at the ARVO 2000 annual meeting. This symposium communicated the state of knowledge of transcriptional regulation as it relates to ocular development and disease. Five distinguished speakers linked basic embryology, genetics, and physiological studies with clinical investigations into the molecular bases of eye diseases. Attendance at the Symposium was excellent.

VIX. NIH Biomedical Information Science and Technology Initiative (BISTI) Consortium

Dr. Liberman described this new trans-NIH initiative which provides developmental funding for innovative research in bioinformatics. The NEI will be an active participant in the consortium and encourages applications from vision researchers. General information regarding BISTI is available at http://www.nih.gov/welcome/director/060399.htm and the details of funding mechanisms are available on the NEI website, http://www.nei.nih.gov

X. DNA Microarray Supplements

Dr. Maria Y. Giovanni, Fundamental Retinal Processes Program Director, discussed the outcome of the FY 2000 NEI DNA Microarray Supplement initiative. NEI received 15 applications, which were ranked by a review panel of NEI and National Institute of Mental Health program staff. Ten applications were funded in May, 2000, with a total expenditure of $2.5 million.

XI. Proposed NEI Workshop on Craniofacial Muscle Specialization and Dystrophic Disease

Dr. Chyren Hunter, Oculomotor Systems Program Director, described this proposed workshop. The meeting would examine the unique features of extraocular muscle that make them essential for maintaining visual contact and also make them selectively resistant to (or selective targets of) muscular disease. The topics to be considered will include muscle classification schemes, implications for disease, and mechanisms and models for treatment.

XII. Healthy People 2010

Michael Davis, Associate Director for Science Policy and Legislation, provided an update for Council members regarding the Department of Health and Human Service's Healthy People 2010 initiative. This initiative brings together national, state, and local government agencies; nonprofit, voluntary and professional organizations; businesses; communities; and individuals for the purpose of improving the health of all Americans, eliminating disparities in health, and improving the quality of healthy life.

The Healthy People initiative contains 467 objectives within 28 focus areas or chapters. The NEI shares co-lead responsibilities for a combined Vision and Hearing chapter with the National Institute on Deafness and Other Communication Disorders. This is the first time that vision has been placed so prominently on the national public health agenda. This is a direct result of the combined efforts of many of the voluntary and professional organizations concerned about visual health and their advocacy for inclusion of specific vision-related objectives in the final document.

Healthy People 2010 was launched on January 25, 2000. Since the formal launch, activities have been directed to editing and finalizing the conference version so that a final document can be issued this summer and the formation of a working group to guide the process over the next 10 years. The working group has already had two meetings: one on March 15 in Clearview, Florida, preceding the meeting of the National Eye Health Education Program (NEHEP) partnership and another on May 12 here on the NIH campus. These initial meetings focused on the baseline population data needs for the objectives and on the expectations of the working group members regarding achievement of the objectives.

The next Healthy People Consortium meeting is scheduled for November 11 in Boston, just prior to the American Public Health Association meeting. The theme of this year's meeting is Eliminating Health Disparities. Rosemary Janiszewski, director of the NEHEP, has been asked to accept the Vision Care Section of the APHA Outstanding Project Award for the Healthy People 2010 Vision Objectives in Chapter 28.

XIII. New NIH Requirements: Conflict of Interest, Monitoring of Phase I and II Clinical Trials, And Human Research Participant Protection

Dr. McNicol described three new NIH policy announcements:

The first concerns financial conflict of interest for investigators and institutional review boards (IRBs). The objectivity of researchers is an essential component of scientific research and the basis for public trust. Concerns are raised when financial considerations may compromise or have the appearance of compromising an investigator's professional judgment. Because of the complexity of these issues, the NIH will hold a public consultation on August 15-16, 2000. This forum will afford an opportunity to discuss conflicts of interest pertaining to institutions, individual investigators and IRB members. Additional information is available at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-040.html

The second area involves data and safety monitoring for phase I and phase II clinical trials. Beginning with the October 2000 receipt date, the NIH will require investigators to submit a monitoring plan for phase I and II clinical trials to the funding Institute or Center before the trial begins. At a minimum, all monitoring plans must include a description of the reporting mechanisms of adverse events to the IRB, the Food and Drug Administration, and the NIH. The overall elements of the monitoring plan may vary depending on the potential risks, complexity, and nature of the trial. Grantee institutions with a large number of clinical trials may develop standard monitoring plans for phase I and II trials. But such plans should always be evaluated for appropriateness to the particular investigation. Additional information is available at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-038.html

The third policy pertains to a new requirement for education in the protection of human research participants. Beginning on October 1, 2000, the NIH will require such education for all investigators submitting NIH applications for grants or proposals for contracts or receiving new or non-competing awards for research involving human subjects. Investigators must provide a description of education completed in the protection of human subjects for each individual identified as "key personnel" in the proposed research. While all investigators need education in the basics of human subjects research, some may elect more intensive study if their work involves especially difficult topics or special populations. The NIH does not plan to issue a list of "endorsed" programs, although a number of curricula are readily available to investigators and institutions. Additional information is available at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html

XIV. IMPAC II Electronic Council Book

Dr. McNicol described the features of the newly-released version of the electronic Council book. Council members were provided with a help document and personal access codes.

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).

XV. Review of Research and Training Applications

The Council considered 310 research and training applications requesting $419.9 million in total all year costs. The Council recommended 308 applications with a total all year cost of $407.0 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.

XVI. Adjournment

Dr. Kupfer adjourned the meeting at 2:30 p.m. on June 8, 2000.

XVII. 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.
Acting Director
National Eye Institute

These minutes will be submitted for the approval of the Council at the September 14, 2000, 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