NAEC Meeting Minutes
Department of Health and Human Services
National Institutes of Health
National Eye Institute
NATIONAL ADVISORY EYE COUNCIL
Minutes of Meeting
September 12-13, 2002
The National Advisory Eye Council (NAEC) convened for its one hundred second meeting at 8:30 a.m. on Thursday, September 12, 2002, in Conference Room G, Executive Plaza North, National Institutes of Health (NIH), Rockville, Maryland. The Director of the National Eye Institute (NEI), Paul A. Sieving, M.D., Ph.D., presided as Chair of the Council. The meeting was closed to the public from 8:30 a.m. until 12:15 p.m. for the review of grant applications. The meeting was open to the public from 1:15 p.m. until adjournment at 4:22 p.m. On Friday, September 13, 2002, the meeting was open to the public from 8:30 a.m. until 11:30 a.m. Attachment A provides a roster of Council members.
Council Members Present:
Dr. Ruben Adler|
Dr. Dean Bok
Ms. Patricia A. Cleary
Dr. Martha C. Constantine-Paton
Dr. M. Rosario Hernandez
Dr. Gordon E. Legge
Dr. Mildred M. G. Olivier
Mr. Richard J. Salem|
Dr. P. Sarita Soni
Dr. J. Wayne Streilein
Dr. Larry J. Takemoto
Dr. Karla Zadnik
Lt. Col. J. Brian Reed (Ex Officio)
Dr. Marco A. Zarbin (Ex Officio)
NEI Staff Present:
Ms. Louise Amburgey|
Dr. Mary Frances Cotch
Mr. William W. Darby
Ms. Chris A. Davis
Mr. Michael Davis
Ms. Linda Dingle
Dr. Peter A. Dudley
Ms. Judith Duff
Mr. Donald F. Everett
Mr. Fareed Kassir
Dr. Richard S. Fisher
Ms. Carol Fivozinsky
Dr. Ralph J. Helmsen
Dr. Jeanette Hosseini
Dr. Chyren Hunter
Ms. Tina Jones
Mr. J. Kevin Keating
Dr. Natalie Kurinij
Dr. Ellen S. Liberman|
Ms. Michele Lyles
Dr. Andrew P. Mariani
Dr. Jack A. McLaughlin
Dr. Loré Anne McNicol
Dr. Sheldon S. Miller
Ms. Kathleen Moy
Dr. Michael D. Oberdorfer
Dr. Samuel Rawlings
Dr. Maryann Redford
Ms. Karen Robinson Smith
Dr. Annie E. Schaffner
Dr. Paul Sieving
Ms. Judy Stein
Ms. Marie Watkins
Mr. John Whitaker
Mr. Terry Williams
Other National Institutes of Health (NIH) Staff Present:
Dr. David Armstrong, Center for Scientific Review (CSR)
Dr. Michael Chaitin, CSR
Dr. Mary Custer, CSR
Dr. Tom Johnson, Office of Science Policy, Office of the Director (OD)
Dr. John J. McGowan, National Institute of Allergy and Infectious Diseases (NIAID)
Dr. Chris Melchior, CSR
Dr. Margaret Snyder, Office of Extramural Research, OD
Dr. Brent Stanfield, CSR
Dr. Marcia Steinberg, CSR
Dr. Stephen E. Straus, National Center for Complementary and Alternative Medicine (NCCAM)
Ms. Chris Thomsen, NCCAM
Dr. Elias A. Zerhouni, Director
Other Federal Government Staff Present:
Dr. Wylie Chambers, Food and Drug Administration
Members of the General Public Present at the Open Session:
Ms. Joanne Angle, Association for Research in Vision and Ophthalmology (ARVO)
Mr. Andrew Brecher, Capitol Associates
Dr. Israel Goldberg, Health Research Associates
Ms. Carrie Liken, Salem Saxon, P.A.
Mr. Edward H. McManus, National Alliance for Vision and Eye Research
Mr. Robert Rupp, ARVO
Ms. Lois Schoenbrun, American Academy of Optometry
Dr. Santa Tumminia, Foundation Fighting Blindness
Dr. John Whitener, American Optometric Association
Thursday, September 12, 2002
Closed Portion of the Meeting
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).
Call to Order and Opening Remarks
Dr. Paul A. Sieving, Director, NEI, and Chair of the Council, called the meeting to order and welcomed the Council members to the one hundred second meeting of the National Advisory Eye Council.
Dr. Loré Anne McNicol, Director, Division of Extramural Research (DER), NEI, and Executive Secretary of the Council introduced Scientific Review Administrators (SRA) from the CSR: Dr. Michael Chaitin, Visual Sciences C (VISC), Dr. Mary Custer, Visual Sciences A (VISA), and Dr. Christine Melchior, Visual Sciences B (VISB), Chief, Integrative, Functional. And Cognitive Neuroscience Integrated Review Group.
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.
Review of Research and Training Applications
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.
Future Directions and Research Opportunities at the National Center for Complementary and Alternative Medicine
Dr. Sieving introduced Dr. Stephen E. Straus, Director of NCCAM. Dr. Straus was appointed the first Director of the Center, and he simultaneously serves as Chief of the Laboratory of Clinical Investigation at the NIAID. He received his undergraduate training at the Massachusetts Institute of Technology and his MD from Columbia. He is an internationally recognized expert in clinical research and clinical trials, with extensive experience in basic and clinical studies of conditions for which there are alternative or complementary remedies. These include chronic fatigue syndrome, Lyme disease, AIDS, and herpes virus infections.
Dr. Strauss described complementary and alternative medicine (CAM) as medical and health care practices outside the realm of conventional medicine, which are yet to be validated using scientific methods. He indicated that the mission of NCCAM is to conduct rigorous research on CAM practices, educate and train CAM researchers, and inform consumers and health professionals. The American public makes wide use of CAM therapies in general, and several are commonly applied to ophthalmologic diseases. These include marijuana for glaucoma, herbs for uveitis, "natural" ways of correcting myopia, and micronutrient supplements for macular degeneration. Dr. Strauss indicated that NCCAM supports some vision related research projects involving the evaluation of lutein and zeaxanthin supplementation for age-related macular degeneration, cataracts, and retinitis pigmentosa, and that he looks forward to collaborating with NEI on these and other projects. Dr. Sieving thanked Dr. Strauss for his presentation and expressed enthusiasm for the opportunity to pursue future collaborations.
Open Portion of the Meeting
Welcome and Call to Order
Dr. Sieving welcomed guests attending the open portion of the meeting.
Update on Review of Vision Research at the Center for Scientific Review
Dr. Sieving introduced Dr. Brent Stanfield, Deputy Director, CSR. Dr. Stanfield described the recent CSR reorganization affecting the VISA and VISC study sections. Effective for the October 2002 review cycle, VISA has been included in the Brain Disorders and Clinical Neuroscience (BDCN) Integrated Review Group and VISC has been included in the Cell Development and Function (CDF) Integrated Review Group. He introduced Dr. David Armstrong, Chief of the BDCN IRG, and Dr. Marcia Steinberg, Chief of the CDF IRG. Dr. Stanfield displayed summary statement release data for all three Visual Sciences study sections, covering the past three review cycles. VISB continued its expeditious summary statement production rate, while VISA and VISC demonstrated a marked improvement in this measure following the reorganization. Several Council members indicated that they had observed improvement as they followed summary statement release in the Electronic Council Book, and they complimented the SRAs and CSR senior staff for their efforts.
Dr. McNicol introduced Mr. Andrew Brecher, a new member of the staff of Capitol Associates. Mr. Brecher invited Council members, staff, and visitors to attend a Congressional briefing entitled, "MACULAR DEGENERATION: The Leading Cause of BLINDNESS in Older Americans". The briefing is sponsored by the Alliance for Eye and Vision Research, the Congressional Older Americans Caucus, and the Bipartisan Disabilities Caucus, and will be held September 26, 2002 in the Rayburn House Office Building.
Dr. McNicol introduced a new member of the DER's Grants Management Branch, Ms. Chris A. Davis. Ms. Davis served as a Secretary in the National Institute of Drug Abuse before joining the National Heart Lung and Blood Institute, where she was promoted to Lead Grants Technical Assistant, then Grants Management Specialist Trainee. She next joined the National Institute of Neurological Diseases and Stroke as a Grants Management Specialist. At NEI, Ms. Davis will be taking responsibility for the management of Small Business Innovative Research and Small Business Technology Transfer grants, as well as a portfolio of grants in the area of Retinal Diseases Research. Dr. McNicol indicated her pleasure with the recruitment of an individual with Ms. Davis' experience and training.
Dr. Sieving announced that this is the last Council meeting for four of our council members, Dr. Dean Bok, Ms. Patricia A. Cleary, Dr. M. Rosario Hernandez, and Dr. Larry Takemoto. Dr. Sieving thanked them sincerely for their efforts in behalf of the NEI and of vision research. The success of NEI programs is in very large measure due to the willingness of Council members, who not only spend many hours in preparation for our meetings and other activities, but also sacrifice your private interests to advise us on the planning and operation of our programs. Dr. Sieving presented the outgoing members with certificates and letters of thanks, as well as tokens from the NEI, in recognition of their service.
Consideration of Minutes of Previous Meeting
The minutes of the June 13-14, 2002, NAEC meeting were considered and approved as submitted.
Future Council Meeting Dates
The following dates were previously agreed upon for future Council meetings:
January 23-24, 2003 (the 13th will be a half day meeting for program planning)
June 12-13, 2003
September 11-12, 2003
Council members were asked to continue to keep these dates reserved as they make future plans and obligations. Also, members were asked to bring their calendars to the January meeting, when meeting dates for calendar year 2004 will be determined.
Ms. Carol Fivozinsky, Budget Officer, NEI, presented an overview of the FY2002 NEI budget. During FY2002, the overall NIH budget increased 15%. The NEI received a $582.9 million appropriation, which is a 14.4% increase over FY2001. This marks the fourth year of double digit increases, and the NEI received the second highest percentage increase of the categorical NIH Institutes and Centers, lagging behind only the large increases for the National Institute of Allergy and Infectious Diseases designated for bioterrorism and for international funds for AIDS, tuberculosis, and malaria control. Despite this welcome news, the NEI is still behind in achieving the goal of a doubling of the budget over a five year period.
The FY2003 budgets for the NEI and NIH are currently under consideration. The President's Budget calls for a 15.7% increase in the NIH budget, from $23.6 to $27.3 billion. Such an appropriation would almost achieve completion of the goal of a five year doubling of the NIH budget. The FY2003 NEI budget is recommended for an 8.4% increase from $582.9 to $631.8 million. This percentage increase places the NEI near the median of the various NIH Institutes and Centers. The FY2003 Citizen's Budget for the NEI calls for an appropriation of $692 million , a 19% increase or $109 million over the FY2002 amount. Such a budget would complete the doubling of the NEI budget over the five year period. The Senate markup of the appropriations bill includes a 15.9% increase for the NIH budget and a 9.1% increase for the NEI. The Senate bill and report language would retain the present extramural salary cap at its current level (Executive Level I or $166,700). For the NEI it encourages research on the extent of the problem and economic consequences of visual disease, age-related macular degeneration, bioengineering, diabetic eye disease, health disparities, eye health education, neurodegenerative eye diseases, and Sjögren's Syndrome. It appears that the Labor/HHS appropriation will be handled very late in the budget process and there may be delays, with continuing resolutions.
Ms. Fivozinsky briefly outlined the status of the FY2004 budget request. "Post doubling" percentage increases for the NIH and the NEI will be influenced by the state of the economy and defense issues. The Office of Management and Budget (OMB) request is due in late September, 2002, with the OMB passback scheduled for November. The President's Budget is expected in late January/early February 2003.
Extramural Budget Trends
Dr. McNicol reviewed funding for the extramural research program in FY2002. The NEI anticipates funding approximately 1526 grants, an increase of 12% over FY2001, for an award rate of 39.9%. The double-digit budget increase which the NEI received for FY2002 has permitted an increase in the annual total cost of grants at an average of 6% ($17,000). It also permitted the funding of a number of new scientific initiatives. These include the shared technology enhancement supplement program, strategies to identify the genetic basis of diabetic retinopathy, novel approaches to corneal tissue engineering, an SBIR/STTR technology initiative, and enhancements to the center core grant and the institutional training grant programs The new R03 Small Grants for Pilot Research Program had a strong response in FY2002, averaging approximately 80 applications for each review cycle. In addition, the NEI collaborated with other NIH Institutes and Centers in co-funding research opportunities for studies of ocular melanoma, diabetic complications, bioengineering, autoimmunity, computational neuroscience, global health research, and the social and cultural dimensions of health.
Overview of NIH Electronic Research Administration and the Federal Commons
Dr. McNicol introduced Dr. John J. McGowan, Director of the Division of Extramural Activities, National Institute of Allergy and Infectious Diseases. Dr. McGowan also provides senior program leadership to the NIH-wide electronic grant administration initiative through the Office of Extramural Research of the Office of the Director, NIH. Dr. McGowan briefed the Council on the newly-implemented electronic interface between research institutions and the NIH extramural programs. He described the new NIH internal e-Grant Folder. Beginning in January, 2002, all applications have been scanned into an electronic format which gives NIH staff access to an indexed, text searchable file. This step has prepared the NIH for electronic grant submission, and has built a common process to share information with investigators and institutions. In FY2003, the NIH plans to begin implementation of a process termed the Electronic Streamlined Non-competing Award Process, or E-SNAP. E-SNAP will allow Principal Investigators (PI) to prepare electronic applications for continuation of a grant and it will allow institutions to electronically approve and submit this information to the NIH. Dr. McGowan also outlined the NIH Commons, which will become available to over 2,600 grantee institutions in FY2003. The Commons will permit institutions to submit assurances, certifications, and various reports to the NIH in an electronic format. As institutions and the NIH register individual scientists in the Commons, PIs will be able to access application-specific information such as study section assignment, priority score, summary statement, and notice of grant award. Council members indicated their enthusiasm for systems to speed information exchange between the NIH and the extramural research community.
Concept Clearance: NEI Institutional Clinician Scientist Training Award (K12)
Dr. Chyren Hunter, NEI Training Officer, described a proposed NEI Mentored Clinical Research Scholar Program Award, the K12. The objectives of this initiative would be to train and retain clinicians in clinical vision research investigation, provide clinicians with both didactic coursework and research training in more than one scientific discipline, accommodate candidates with varying levels of research experience, and allow clinician scientists to bring a clinical dimension to the vision research enterprise. The K12 would be an institutional program variant of the individual Clinical Investigator (K08) and the individual Mentored Patient-Oriented Research Career Development Awards (K23). She indicated that the K12 would provide funding for an educational institution to provide analogous career development experiences for clinicians leading to research independence, including a didactic period followed by a period of supervised research experience. Council members indicated that there were many desirable features of the proposed K12 program. But they felt that it would be desirable to reconsider such issues as the appropriate level of effort for candidates, the eligibility requirements, and the duration of the training.
Dr. Sieving adjourned the meeting at 4:22 p.m. on September 12, 2002.
Friday, September 13, 2002
Open Portion of the Meeting
Welcome and Call to Order
Dr. Sieving re-convened the open portion of the meeting on Friday, September 13, 2002, at 8:30 a.m. in Conference Room G, Executive Plaza North, National Institutes of Health (NIH), Rockville, Maryland.
Program Planning Phase I
Mr. Michael Davis, Associate Director for Science Policy and Legislation, NEI, presented a staff proposal for the first step in the program planning process: the preparation of a document similar in organization to "Vision Research - A National Plan: 1999-2003", but more streamlined. Mr. Davis circulated a draft letter to be sent to NEI grantees inviting them to review relevant sections of the Executive Summary of the current plan. The letter asks grantees to provide a brief summary of the most important examples of research progress or advancement in their field over the past five years; assess the relevancy of the current research objectives; and provide suggestions for additions, deletions, or changes where necessary. These responses would be returned to the NEI within one month of the date on the letter. The information provided by the community would be reviewed by the Council, NEI program staff, and experts in the field. A draft of the new plan would be posted on the NEI website and circulated widely for comment before it is finalized.
Council urged Mr. Davis to broaden distribution of the letter to include a wider range of vision scientists and professional organizations, and to use various electronic venues to widen and streamline the process.
Future Directions and Opportunities at the National Institutes of Health
Dr. Sieving introduced the Director of the National Institutes of Health, Elias A. Zerhouni. Dr. Zerhouni had been Executive Vice Dean of Johns Hopkins University School of Medicine and Chair of the Department of Radiology and Radiological Science. He is a member of the National Academy of Sciences' (NAS) Institute of Medicine, has served on the National Cancer Institute's Board of Scientific Advisors At Johns Hopkins, Dr. Zerhouni developed a comprehensive strategic plan for research, helped reorganize the school's academic leadership, and led efforts to restructure the School of Medicine's clinical practice association. He also helped obtain such resources as the university's first microarray core facility; a center on biomedical informatics; and the Institute for Cell Engineering, designed to stimulate the emerging fields of proteomics and stem cell research.
Dr. Zerhouni described the recent "road mapping" process that he instituted, bringing together 100 scientists--ranging from intramural bench scientists to industry researchers--to meet in focus groups. The ground rules, he said, were to identify needed resources, roadblocks, and gaps in knowledge that no single NIH institute could provide in areas such as bioinformatics, molecular libraries, systems biology, and clinical research. He intends to develop action plans for the next three to five years. Dr. Zerhouni stressed the need for strategic leadership to stimulate collaborations for translational research to make sure that our science is relevant to the public. He also expressed his concern for the infrastructure needs of young investigators starting up their laboratories. He announced that he had appointed directors for two institutes: the National Institute of Mental Health and the National Institute on Alcohol Abuse and Alcoholism. Dr. Zerhouni also stated that he has initiated a review of the intramural research program and NIH's management.
Council members asked Dr. Zerhouni his philosophy regarding the National Academy of Sciences study on "The Organizational Structure of the National Institutes of Health." He replied that he felt it was most important for the committee to propose the most efficient organization of his office in order to effectively manage the NIH. On the question of the possible consolidation of some Institutes, Dr. Zerhouni lightheartedly asked Council members for their input as to which Institute they would want the NEI to be merged with. There was at first silence, then smiles from the attendees. Council members were quick to describe the positive impact that the creation of the NEI had on both the quantity and quality of basic and clinical vision research in this country and that they were strongly opposed to merging the NEI with other Institutes.
Program Planning Phase II
Mr. Davis reviewed the second step in program planning, which involves a continuous process of workshops, symposia, and meetings in emerging areas of science. These activities would produce reports to complement and update the document produced in Phase I. Council members proposed many current areas of opportunity, including the mechanism of synapse development and plasticity, the role of Müller cells and microglia in the pathogenesis of retinal degenerations, the inflammatory response to extracellular matrix material as a factor in Age-related Macular Degeneration (AMD), identifying the molecular trigger for cell death in retinal degenerations, visual processing beyond the retina, the chemical mechanism of aging, and the development of animal models of diseases of the visual system. Council members indicated the need to prioritize topics that need a conceptual jump start.
The staff presented a series of planned workshop topics to illustrate possibilities for the second phase of program planning:
Pathophysiology of Ganglion Cell and Optic Nerve Degeneration
Dr. Ellen S. Liberman, Director, Lens and Cataract and Glaucoma Programs, described plans for an NEI-sponsored workshop on this topic to be held on November 12-13, 2002. The objectives of the meeting are to stimulate the exchange of ideas between researchers studying glaucoma and researchers studying other neurodegenerative diseases, to develop initiatives to stimulate new approaches to the study of glaucoma, and to attract new researchers into the field. The conference would develop a white paper for review and consideration by Council, followed by dissemination to NEI grantees. Council members recommended broad distribution of these Phase II activities, perhaps including use of electronic chat rooms and publication in major scientific journals.
Future Directions and Opportunities in Retinal Degeneration Research
Dr. Andrew P. Mariani, Director, Fundamental Retinal Processes Program, presented the Retinal Degeneration Conference, to be held September 30-October 5, 2002, supported under an NEI Conference Cooperative Agreement Grant award. This conference has attracted international experts in the area, as well as provided travel support for new investigators, postdoctoral fellows, and graduate students. The agenda includes two keynote lectures, seven platform sessions, 74 poster presentations, and a summary session on "Future Directions and Opportunities in Retinal Degeneration Research". NEI staff will develop the recommendations from the summary session for consideration by the Council as program planning initiatives.
Role of Inflammation, immunity, and Infection in Multifactorial Eye Disease
Dr. Richard S. Fisher, Director, Corneal Diseases Program, described plans to define the scope and goals of a workshop to develop a scientific initiative in this area. He envisioned including the scientific community in the planning stages of the workshop, inviting scientists from multiple disciplines within vision research, and inviting scientists outside the vision research community who study the role of these processes in other complex diseases. The workshop would be designed to explore the evidence implicating inflammation, immunity, and infection in AMD, glaucoma, diabetic retinopathy, and the dry eye syndrome. Potential topics could include identifying common pathways, factors, and processes that contribute to these diseases and defining new directions for future support to stimulate such studies.
NEI Training Opportunities and Needs
Dr. Hunter presented the need for formal program planning in the area of research training in order to enrich and sustain current vision research programs and to prepare the cadre of scientists at the forefront of emerging scientific areas. She reviewed recent NEI training initiatives in the areas of neuroscience and health disparities research, and proposed specific scientific research training needs in the areas of bioinformatics, bioengineering, computational biology, genomics, and proteomics. She also proposed research training infrastructure needs, including early and latter-stage predoctoral training, transitional support between postdoctoral and independent investigator status, clinical training for basic scientists, recruitment and retention of minority investigators, and research ethics training. Dr. Hunter indicated her intention to perform a series of site visits with leaders in the area of vision research training, in order to engage experts for their views of planning needs and opportunities. She also proposed program planning sessions at the annual meeting of the Society for Neuroscience and of the Association of Neuroscience Departments and Programs to develop recommendations for consideration by Council.
Dr. Sieving adjourned the meeting at 11:30 p.m. on September 13, 2002.
I hereby certify that, to the best of my knowledge, the foregoing minutes and attachment(s) are accurate and complete.
Dr. Loré Anne McNicol, Ph.D.
National Advisory Eye Council
Director, Division of Extramural Research
National Eye Institute
Paul A. Sieving, M.D., Ph.D.
National Advisory Eye Council
National Eye Institute
These minutes will be submitted for the approval of the Council at the January 23-24, 2003 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. Marie E. Watkins
National Eye Institute
Executive Plaza South, Suite 350
6120 Executive Blvd MSC 7164
Bethesda, MD 20892-7164
Telephone: (301) 451-2020
FAX: (301) 402-0528
NATIONAL ADVISORY EYE COUNCIL
NATIONAL EYE INSTITUTE
(Terms end 11/30 of the designated year)
Dean Bok, Ph.D. (02)
Patricia A. Cleary, M.S. (02)
Martha C Constantine-Paton, Ph.D. (03)
M. Rosario Hernandez, D.D.S. (02)
Gordon E. Legge, Ph.D. (03)
Mildred M. G. Olivier, M.D. (04)
Richard J. Salem, J.D. (04)
P. Sarita Soni, O.D. (03)
J. Wayne Streilein, M.D. (04)
Larry J. Takemoto, Ph.D. (02)
Karla Zadnik, O.D., Ph.D. (04)
Department of Defense Representative
Lt. Col. J. Brian Reed, M.D.
Marco Z. Zarbin, M.D., Ph.D.
Tommy G. Thompson
Ruth L. Kirschstein, M.D.
Paul A. Sieving, M.D., Ph.D.
Loré Anne McNicol, Ph.D.