NAEC Meeting Minutes - September 11-12, 2003

DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
National Eye Institute

NATIONAL ADVISORY EYE COUNCIL
Minutes of Meeting

September 11-12, 2003

The National Advisory Eye Council (NAEC) convened for its one hundred fifth meeting at 8:30 a.m. on Thursday, September 11, 2003, in Conference Room H, 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 open to the public from 8:30 a.m. until 1:00 p.m. the meeting was closed for the review of grant applications and the report of the NEI Board of Scientific Counselors from 1:15 p.m. until adjournment at 4:53 p.m. On Friday, September 12, 2003, 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. Suraj P. Bhat
Dr. Martha C. Constantine-Paton
Dr. Gordon E. Legge
Dr. Mildred M. G. Olivier
Mr. Richard J. Salem
Dr. Lois E. Smith

Dr. P. Sarita Soni
Dr. J. Wayne Streilein
Dr. Janey Wiggs
Dr. Karla Zadnik
Lt. Col. J. Brian Reed (Ex Officio)
Dr. Marco A. Zarbin (Ex Officio)

COUNCIL MEMBER ABSENT:

Dr. Roy Beck

NEI STAFF PRESENT:

Ms. Louise M. Amburgey
Dr. Deborah Carper
Dr. Hemin R. Chin
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
Dr. Richard S. Fisher
Ms. Carol Fivozinsky
Dr. Donita Garland
Dr. Ralph J. Helmsen
Mr. Tom Hoglund
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
Ms. B. Jill Payne
Dr. Samuel Rawlings
Dr. Maryann Redford
Dr. Jean Paul SanGiovanni
Dr. Grace L. Shen
Ms. Karen Robinson Smith
Dr. Paul Russell
Dr. Annie E. Schaffner
Dr. Paul Sieving
Ms. Judy Stein
Ms. Marie Watkins
Mr. John Whitaker

OTHER NATIONAL INSTITUTES OF HEALTH (NIH) STAFF PRESENT:

Dr. David Armstrong, Center for Scientific Review (CSR)
Dr. Michael Chaitin, CSR
Dr. Mary Custer, CSR
Ms. Lora Kutkat, Office of the Director, NIH
Dr. Chris Melchior, CSR
Dr. Brent Stanfield, CSR
Dr. Marcia Steinberg, CSR

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. Luke Condra, Salem Saxon, P.A.
Mr. James Jorkasky, Alliance for Eye and Vision Research
Mr. Robert Rupp, ARVO
Ms. Lois Schoenbrun, American Academy of Optometry
Dr. Santa Tumminia, Foundation Fighting Blindness
Ms. Helen M. Viksnins

THURSDAY, SEPTEMBER 12, 2002

OPEN PORTION OF THE MEETING

CALL TO ORDER AND OPENING REMARKS

Dr. Jack A. McLaughlin, Deputy Director, NEI, and Acting Chairman of the Council, called the meeting to order and welcomed the Council members to the one hundred fifth meeting of the National Advisory Eye Council.

Dr. McLaughlin announced that this is the last Council meeting for three Council members, Drs. Martha C. Constantine-Paton, Gordon E. Legge, and P. Sarita Soni. Dr. McLaughlin thanked them sincerely for their efforts in behalf of the NEI and of vision research. He indicated that 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 their private interests to advise the NEI on the planning and operation of our programs. Dr. McLaughlin presented the outgoing members with certificates and letters of thanks, as well as tokens from the NEI, in recognition of their service.

MOMENT OF REMEMBRANCE

At 8:46 a.m. the Council observed a moment of silence to remember and honor those the Nation lost on September 11, 2001. Members and guests took this opportunity to reflect on how individuals here and throughout the world have responded and continue to respond in this time of national challenge.

INTRODUCTIONS

Dr. McLaughlin introduced Mr. James Jorkasky, the newly appointed Executive Director of the Alliance for Eye and Vision Research.

CONFIDENTIALITY / AVOIDANCE OF CONFLICT OF INTEREST

Dr. Loré Anne McNicol, Director, Division of Extramural Research, 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.

EXTRAMURAL ANNOUNCEMENTS

Dr. McNicol announced that Ms. Marie Watkins, the NEI Committee Management Officer, has retired after 26 years of government service. She was a dear and respected colleague, and the extramural staff wishes her well. Dr. McNicol next introduced Ms. Karen Tolson, who will be serving as the acting Committee Management Officer. Karen has been a Committee Management Assistant with the NEI for this past year. She will be working with council members regarding their honoraria, travel arrangements, and reimbursement.

Dr. McNicol directed members’ attention to the table folder material which contains the agenda, roster, and seating chart, followed by hard copies of background materials and the slides for the various presentations for this meeting. Visitors’ copies were also available at the table situated at the side of the room. Council members were presented with copies of the recent report of the National Research Council of the National Academies, “Guidelines for the Care and Use of Mammals in Neuroscience and Behavioral Research”. The guidelines are also being distributed in a CD-ROM format. The NEI provided partial support for the preparation of this report, and also wishes to acknowledge Drs. Nelson Garnett, Office of Laboratory Animal Welfare, and Margaret Snyder, Office of Scientific Affairs in the Office of the Director of the NIH, who provided the funds for print copies.

CONSIDERATION OF MINUTES OF PREVIOUS MEETING

The minutes of the June 5-6, 2003, NAEC meeting were considered and approved as amended.

FUTURE COUNCIL MEETING DATES

The following dates were previously agreed upon for future Council meetings:

February 5-6, 2004
June 10-11, 2004
September 9-10, 2004

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 February meeting, when meeting dates for calendar year 2005 will be determined.

COUNCIL PROCEDURES

Dr. McNicol indicated that pursuant to Public Law 92-463, today’s meeting will be closed to the public this afternoon from approximately 1:00 pm to 5:00 pm for the review of grant and cooperative agreement applications and for the review of the Intramural Research Program. Thereafter, the meeting will be open to the public.

Dr. McNicol reminded the Council that 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, or close professional associate or organization has a financial interest or affiliation. Council members will be asked to sign a statement certifying that they were absent during such discussions. Dr. McNicol indicated that applicants are not to call Council members directly regarding applications being considered by Council. Any such contacts should be forwarded to the appropriate NEI staff member.

BUDGET OVERVIEW

Ms. Carol Fivozinsky, Budget Officer, NEI, reviewed the NEI FY2003 budget, which is $633M. This represented a 9.2% increase over the Fy2002 budget. Ms. Fivozinsky presented an overview of the FY2004 NEI budget. The President’s Budget calls for a $27.7B budget for the NIH, a 2.5% increase over the FY2003 appropriation, and a $648.3M budget for the NEI, a 2.4% increase over the FY2003 appropriation. The House appropriations committee has voted appropriations identical to those of the President’s budget, while the Senate has recommended $28.0B for the NIH (3.7% increase) and $657.2M for the NEI (3.8% increase). Ms. Fivozinsky indicated that a conference committee will now deliberate on resolving these recommendations.

Ms. Fivozinsky reviewed particular areas of emphasis in the House committee appropriation language. These included research on the genetics of retinopathy, the ocular complications of juvenile diabetes, and ocular albinism. The Senate committee language included emphasis on research in diabetic retinopathy, degenerative eye diseases, glaucoma, health disparities, neurofibromatosis, and ocular albinism. The Senate also commended NEI efforts aimed at the revitalization of the intramural research program to pursue opportunities related to neurodegenerative and genetic forms of vision loss and other complex human eye diseases.

Ms. Fivozinsky also provided an overview of the FY2004 citizen’s budget. This budget is $711M, and is the amount recommended by the vision research community. It would complete the doubling of the NEI budget over the six year period 1998-2004, and place the Institute’s budget on a path to triple over a ten year period.

Mr. James Jorkasky described a letter to the conference committee which has been signed by a large number of House members. This letter proposes an 8-10% increase in the NIH budget for FY2004

EXTRAMURAL BUDGET TRENDS

Dr. McNicol provided an update of funding for the extramural research program in FY2003. The budget provided $625.1 M, which represents a 7.2% increase over the level for FY2002. Dr. McNicol reviewed the level of support for research project grants (RPGs). Both competing and total RPGs increased In FY2003 compared with FY2002. The NEI will make 321 competitive awards and 1204 total awards, historically the largest numbers ever supported. The success rate is 33.5%, down from 40.6% in FY2002. This decrease can be directly attributed to a large increase in the number of applications submitted. In FY2003 there were 959 RPGs submitted, compared to 761 in Fy2002, marking a 26% increase.

Dr. McNicol reviewed the Center Core Grant program. The number of awards remained constant while the average cost increased from $525,000 to $542,000, a 3% increase.

In FY2003, the NEI initiated the Vision Research Infrastructure Development Awards program. Eleven applications were submitted, and eight were funded, for a total investment of $2,506,399.

HEALTH INSURANCE PORTABILITY AND ACCOUNTABILITY ACT (HIPAA) AND THE NATIONAL STANDARDS TO PROTECT THE PRIVACY OF PERSONAL HEALTH INFORMATION

Dr. McNicol introduced Ms. Lora Kutkat, who serves as a health science policy analyst in the Office of Science Policy and Planning within the Office of the Director of the NIH. At the NIH she focuses on policy issues concerning research ethics as they pertain to human subjects. Ms. Kutkat has been engaged in helping the health research community understand the Privacy Rule - Federal standards developed to satisfy the Administrative Simplification provisions of the Health Insurance Portability and Accountability Act. She is also the NIH representative to the Department of Health and Human Services Privacy Committee.

Ms. Kutkat reviewed the implications of HIPAA for biomedical research. She indicated that the purpose of the Privacy Rule is to protect the privacy of individually identifiable health information by establishing conditions for its use and disclosure by a health plan, health care clearinghouse, and certain health care providers. For research, the Privacy Rule permits covered entities to use and disclose protected health information under certain circumstances. She presented examples, such as individual authorization (which may be part of an informed consent document), processes to de-identify protected health information (by removing specific identifiers from a data set), and “grandfathered” research.

IMPACT OF HIPAA REGULATIONS ON NEI MULTICENTER CLINICAL TRIALS

Mr. Donald Everett, Director, collaborative Clinical Research Program, discussed the effects of HIPAA regulations on NEI-supported multicenter clinical trials. He indicated that most studies had consent documents and/or de-identified data sets which were compliant with HIPAA regulations. In a few cases, study coordinating centers have adapted their operating procedures in order to be HIPAA compliant. Overall, these studies have taken appropriate steps to protect patient privacy.

LOW VISION WORKSHOP REPORT

Dr. Gordon Legge distributed material regarding an NEI-sponsored seminar on Research Opportunities in Low Vision that was held in Boston, MA on June 16, 2003. The goal of the workshop was to bring to the attention of the scientific community opportunities for research and funding in the area of low vision. An organizing committee of eleven nationally prominent experts in the field developed the program. It was aimed at young investigators and researchers not yet involved in low vision research in order to bring to their attention the types of basic science research needed to measure and understand low vision and develop rehabilitation strategies. The seminar was successful in attracting a wide audience, and generated considerable interest.

CONCEPT CLEARANCE: NEI CAREER TRANSITION AWARD (K22)

Dr. McNicol presented data showing historical trends in the number of young investigators applying for NEI R01 grants. For the past twenty years, the numbers have fallen dramatically. In FY1980, 24% of NEI R01 applicants were 36 years old or younger. By FY2000, applicants in this age range had fallen to 3% of the total.

Dr. Chyren Hunter, NEI Training Officer, presented a proposed program aimed at supporting young investigators during their transition from a mentored postdoctoral position to an independent research career. The award supports two separate phases: The first, Scholar Development Phase, would provide up to three years of mentored career development training in either an extramural or an NEI Intramural Research Program laboratory. The second, Faculty Transition Phase, would provide up to two years of research support at an extramural institution to which the Scholar has been recruited as full-time tenure track faculty or the equivalent.

Council was enthusiastic with the concept of the K22 program. They suggested the NEI consider a similar means to support the transition of clinician scientists holding K08 or K23 career development awards.

CONCEPT CLEARANCE: CONE PHOTORECEPTOR CELL BIOLOGY WORKSHOP

Dr. Andrew Mariani, Director, Fundamental Retinal Processes Program, described a proposed NEI-supported workshop, to be chaired by Dr. Ruben Adler, examining the cell biology of cone photoreceptor cells. Dr. Mariani indicated that although these cells are critical for most high contrast vision, there are large gaps in our knowledge of their biology, particularly in animal models.

Council was enthusiastic with the concept of this workshop.

PROGRAM PLANNING UPDATE

Mr. Michael Davis, Associate Director for Science Policy and Legislation, described the final steps in the preparation of the Program Plan. Council members had submitted their comments by early July, and these were incorporated into the draft document. The Plan was circulated to over 70 professional and patient advocacy organizations for comments. These were submitted by the end of August, and the draft was revised in light of these responses. Copy editing of the plan has been completed, and the remaining hurdles are final layout and design work, followed by Departmental clearance. Mr. Davis indicated that he felt the Plan would be released within four weeks.

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).

WELCOME AND CALL TO ORDER

At 1:15 pm, Dr. Sieving welcomed staff attending the closed portion of the meeting.

INTRODUCTIONS

Dr. McNicol 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.

REVIEW OF THE INTRAMURAL RESEARCH PROGRAM

Council considered the report of the February, 2003, meeting of the Board of Scientific Counselors (BSC), which reviewed the Laboratory of Mechanisms of Ocular Diseases. Council concurred with the recommendations of the BSC.

REVIEW OF RESEARCH AND TRAINING APPLICATIONS

Council considered research and research training grants. 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.

ADJOURNMENT

Dr. Sieving adjourned the meeting at 4:53 p.m. on September 11, 2003.

FRIDAY, SEPTEMBER 12, 2003

OPEN PORTION OF THE MEETING

WELCOME AND CALL TO ORDER

Dr. Sieving re-convened the open portion of the meeting on Friday, September 12, 2003, at 8:30 a.m. in Conference Room G, Executive Plaza North, National Institutes of Health (NIH), Rockville, Maryland.

OPEN SESSION

OVERVIEW OF CURRENT ACTIVITIES OF THE NEI

Dr. Sieving opened a dialog with council members to describe the broad areas of current activity for the NEI. In the programmatic area, staff are exploring the establishment of a genotyping network, preparing an AMD phenotype consensus workshop, and planning for expanded research space at the Porter Neuroscience complex and the Twinbrook area. In the area of communications, Dr. Sieving introduced Mr. Tom Hoglund, a science writer who has joined the NEI. Mr. Hoglund will be describing NEI initiatives for the summer newsletter of the Society for Neuroscience and preparing material for the annual meeting of the American Academy of Ophthalmology to encourage collaboration between NEI and corporate eye care companies. The clinical staff has developed a new medical retinal clinical fellowship which will provide sabbatical opportunities for outstanding clinician scientists. Dr. Sieving indicated the NEI’s interest in expanded cooperation with the World Health Organization through its International Council of Ophthalmology. And he described his own research interests exploring the possible role of neuroprotective agents in the treatment of retinal degenerative diseases, such as retinoschisis.

DISCUSSION OF PEER REVIEW ISSUES

Dr. McNicol gave an historical review of NIH grant scoring systems: approval/disapproval; approval/not recommended for further consideration; and scored/unscored. She next introduced Dr. Brent Stanfield, Deputy Director of the Center for Scientific Review (CSR). Dr. Stanfield was present as a resource to provide background and answer any questions council members might have. He described the benefits of the present streamlined scoring system, and also commented on the disadvantages. The CSR Advisory Council will be discussing these concerns and exploring ways to improve the system. Dr. Stanfield also described an internet-assisted review system which permits prior identification of those applications which elicit a significant disparity in scores among reviewers.

A Council sub-committee, chaired by Dr. Bhat, presented a white paper describing concerns with the present triage process. The group felt that the crux of the problem lies in the fact that the priority score is critical for the applicant. When no score is given, an applicant loses information which could guide the preparation of a revised proposal. Council recommended that triage process be changed so that “lower half” applications would be scored. Dr. Stanfield indicated that he would make the Council’s position known during CSR’s discussions of the triage system.

ADJOURNMENT

Dr. Sieving adjourned the meeting at 11:30 p.m. on September 12, 2003.

CERTIFICATION

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.
Executive Secretary
National Advisory Eye Council
Director, Division of Extramural Research
National Eye Institute

Paul A. Sieving, M.D., Ph.D.
Chair
National Advisory Eye Council
Director
National Eye Institute

These minutes will be submitted for the approval of the Council at the February 5-6, 2004 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. Karen R. Tolson
National Eye Institute
Suite 1300
5635 Fishers Lane, MSC 9300
Bethesda, MD 20892-9300
Telephone: (301) 451-2020
FAX: (301) 402-0528
e-mail: ktolson@nei.nih.gov

09/14/2003

Attachment A

NATIONAL ADVISORY EYE COUNCIL
NATIONAL EYE INSTITUTE

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

Ruben Adler, M.D. (05)
Department of Ophthalmology
600 N Wolfe St Maumenee 519
Johns Hopkins University School Med.
Baltimore MD 21287-9257

Roy W. Beck, M.D., Ph. D. (06)
Jaeb Center for Health Research
Suite 350, 15310 Amberly Drive
Tampa FL 33647

Suraj P. Bhat, Ph.D. (06)
Department of Ophthalmology
Jules Stein Eye Institute
100 Stein Plaza, BH623
Los Angeles CA 90095-7000

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

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. (04)
Senior Partner
Salem, Saxon, and Nielsen, P.A.
Tampa, FL 33602
Lois E. H. Smith, M.D., Ph.D. (06)
Department of Ophthalmology
Harvard Medical School
300 Longwood Ave
Boston MA 02115

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

Janey L. Wiggs, M.D., Ph.D. (06)
Department of Ophthalmology
Massachusetts Eye and Ear Infirmary
243 Charles Street
Boston MA 02114

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

Department of Defense Representative
Lt. Col. J. Brian Reed, M.D.
Chief, Vitreoretinal and Uveitis Services
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

Elias A. Zerhouni, M.D.
Director
National Institutes of Health
Bethesda, MD 20892

Chair
Paul A. Sieving, M.D., Ph.D.
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