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Home » About NEI » The National Advisory Eye Council (NAEC), Minutes June 19, 2008

NAEC Meeting Minutes

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

NATIONAL ADVISORY EYE COUNCIL
Minutes of Meeting

June 19, 2008

The National Advisory Eye Council (NAEC) convened for its one hundred nineteenth meeting at 8:30 am on Thursday, June 19, 2008, at the Grand Hyatt Washington Hotel, Washington, DC. Paul A. Sieving., M.D., Ph.D., the Director of the National Eye Institute (NEI), presided as Chair of the Council. The meeting was closed to the public from 8:30 am until 12:30 pm for the review of grant and cooperative agreement applications. On Thursday, June 19, 2008, from 2:00 pm until 4:00 pm, the meeting was open to the public. Attachment A provides a roster of Council members.

COUNCIL MEMBERS PRESENT:

Dr. Scott W. Cousins
Dr. Charles D. Gilbert
Dr. Mae O. Gordon
Dr. Gunilla Haegerstrom-Portnoy
Dr. David E. Holck
Dr. Lenworth N. Johnson
Dr. Todd P. Margolis
Dr. Mary C. McGahan
Dr. Earl L. Smith, III
Dr. Val C. Sheffield
Dr. Richard A. Stone
Dr. Marco A. Zarbin

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COUNCIL MEMBER ABSENT:

Mr. Ronald J. Gardner and Dr. Juan I. Korenbrot

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AD HOC COUNCIL MEMBER PRESENT:

Dr. David R. Copenhagen

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NEI STAFF PRESENT:

Dr. Neeraj Agarwal
Dr. Houmam Araj
Dr. Bobbie Austin
Dr. Deborah Carper
Dr. Hemin R. Chin
Dr. Mary Frances Cotch
Ms. Janet Craigie
Mr. William W. Darby
Mr. Kenneth Frushour
Ms. Jerusha Gittlen
Dr. Shefa Gordon
Dr. Chyren Hunter
Dr. Karl John
Dr. Natalie Kurinij
Ms. Marilyn Laurie
Dr. Wei Li
Dr. Ellen S. Liberman
Dr. Andrew P. Mariani
Dr. Jack A. McLaughlin
Dr. Loré Anne McNicol
Dr. Sheldon S. Miller
Dr. Michael D. Oberdorfer
Dr. Samuel C. Rawlings
Dr. Maryann Redford
Dr. Grace L. Shen
Dr. Annie E. Schaffner
Dr. Paul A. Sieving
Dr. Michael A. Steinmetz
Dr. Santa Tumminia
Dr. Jerome R. Wujek

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OTHER NIH STAFF PRESENT:

Ms. Sylvia Braxton, Division of Extramural Activities Support (DEAS)
Dr. Michael H. Chaitin, Center for Scientific Review (CSR)
Mr. Francis Costello, Office of Budget, Office of the Director (OD), NIH
Ms. Mary Frances Deusch, Office of Policy for Extramural Research Administration, Office of Extramural Research, OD, NIH
Dr. Judith Finkelstein, CSR
Dr. Holly Krull, National Heart Lung and Blood Institute
Dr. George McKie, CSR
Ms. Marilyn Smith, DEAS
Dr. Jerry Taylor, CSR

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MEMBERS OF THE GENERAL PUBLIC PRESENT AT THE OPEN SESSION:

Mr. James Jorkasky, National Alliance for Eye and Vision Research (NAEVR)
Ms. Lori Methia, ARVO
Ms. Elaine Richman, Richman Associates

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THURSDAY, JUNE 19, 2008

CLOSED PORTION OF THE MEETING

8:30 am

The meeting was closed to the public at 8:30 a.m. 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. Appendix2).

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 the 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.

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.

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REPORT OF THE AD HOC COMMITTEE FOR ADMINISTRATIVE REVIEW OF THE NEI SCIENTIFIC DIRECTOR

REPORT OF THE BOARD OF SCIENTIFIC COUNSELORS

REVIEW OF RESEARCH AND RESEARCH TRAINING APPLICATIONS

OPEN PORTION OF THE MEETING

2:30 pm

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CALL TO ORDER AND OPENING REMARKS

Dr. Paul A. Sieving, Director, NEI, and Chair of the Council welcomed Council members, staff, and guests to the one hundred nineteenth session of the NAEC. He announced several recent changes at the NEI. Dr. Jack McLaughlin, NEI Deputy Director, will retire at the end of this summer, after 32 years of service to the NEI. Dr. Sieving reviewed Dr. McLaughlin’s many contributions to the Institute and presented him with a plaque in recognition of outstanding service. Dr. McLaughlin stated he is going to miss the NIH and that it would always be a part of his life. He stated that people are first rate and the NEI is in good hands. Dr. Sieving stated that Dr. Lore Anne McNicol will serve as acting Deputy Director in the interim. Several staff members have received major awards recognizing their accomplishments. Dr. Joram Piatigorsky received the 2008 Helen Keller Vision Award. Drs. Emily Chew and Rick Ferris were among the 2008 awardees of the Alcon Research Institute, as was ad hoc Council member Dr. David Copenhagen. Dr. Lore Anne McNicol received the Presidential Rank Award.

In other NEI news, Dr. Sieving mentioned that Dr. Richard S. Fisher has been named Acting Director of the Office of Program Planning and Analysis, and that Dr. Chyren Hunter is leaving the NEI to take the post as Deputy Director of the Division of Extramural Activities at the National Institute on Aging.

Dr. Sieving asked Dr. Deborah Carper to give a quick overview of the 2008 Conference on Cell Replacement in the Inner Ear. She indicated that this was a multi-disciplinary conference to enhance deafness research. This 4-day conference was held at the Hyatt Regency in Bethesda, Maryland, and served as a forum to stimulate research in regeneration biology of the cochlea, vestibule, and primary neural pathways. The Deafness Research foundation has a summary report on their website at www.drf.org/crs_workshops/2008/conferenceprogram.htm.

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BUDGET OVERVIEW

The NEI Budget Officer, Marilyn Laurie, provided an update of the FY2009 President’s budget. The NIH received a 0.1% increase to $667.8 M from $667.1M. However, with today’s economy, there is an actual decline of buying power.

Council members inquired as to how much were salaries taken into account in the budget. Ms. Laurie stated that salaries accounted for 4.6% of the budget for 2006/2007. She described the Biomedical Research Price Index the market basket of inputs into biomedical research. Dr. Gilbert stated the report could be adjusted. Marilyn Laurie explained that these things will be taken into consideration. She further discussed the FY2008 appropriation and the FY2009 Presidents budget and the percentage of funding changes, as well as the Research Project Grant (RPG) Success Rate history. She stated that the NEI is presently working to close out FY2008, and will begin execution of the FY2009 budget on October 1, and then begin working on FY2010 budget development.

Council members asked whether RPGs are all competitive R01 grants and Dr. McNicol described the various grant mechanisms which make up that category. In response to a question whether the NEI is mandated to fund a certain number of competitive RPGs, Dr. McNicol informed that this was correct, and explained that central NIH has taken a much larger portion of that activity. Dr. Sieving added that each institute has a history and that the NEI places the greatest emphasis on individual investigator-initiated research.

Council members discussed the problems of indirect costs in periods of flat budgets. Dr. McLaughlin added that having been around 30 years, that he has heard these types of discussions and this is something for the study sections to review. He discussed the political reality of state schools against private schools and that at some level principle investigators are free to move where they could get more bang for their buck but even that doesn’t happen. Thus, the session continued with various members adding comments regarding the current budget dilemma.

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NEI EXTRAMURAL REPORT

Dr. McNicol provided an overview of recent extramural activities. As she will assume the duties as Acting Deputy Director for the NEI upon Dr. McLaughlin’s retirement, she also noted that Dr. Chyren Hunter would be leaving the NEI. She announced that Dr. Neeraj Agarwal will be the new Training Officer, Dr. Andrew Mariani will be Acting Executive Secretary of the NAEC, Dr. Hemin Chin will be Acting Director of the Division of Extramural Activities, and Dr. Ellen Liberman will supervise program activities.

Dr. McNicol presented the details of the Transformative R01 Program, which is a competition open to transformative ideas from all relevant fields with no cost limit per project. She discussed highlighting program needs by raising awareness and fostering brainstorming of reviewers on new topics and areas of research. She hopes the vision research community will be able to come in under these topics. Implementation committees will be put together to increase awareness in the communities and a small committee of institute and center directors who will oversee this process. The proposal is for a different type of R01 that will be in essay format but overall this project is still in development and needs to be fleshed out more before we see funding opportunities for this program. Several Council members had questions regarding further details surrounding this proposed idea of a new style of R01 and where the funding for this project would come from and what were NEI’s plans to get involved. Dr. McNicol explained that this is as expansion of a program which had been developed by the National Institute of General Medical Sciences. It would be funded through the Roadmap.

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UPDATE ON THE NIH COUNCIL OF COUNCILS

Council member Dr. Lenworth Johnson, NEI’s representative to the Council of Councils (COC), discussed what he had gathered from Dr. Zerhouni was that he had a mandate to change the NIH from the way it has been doing business. The NIH has supported 122 Nobel Laureates and Congress has doubled NIH funding over past five years, but there was a question of what diseases have been cured and of what has been accomplished. The Transformative R01 Program’s concept is to identify and fund highly innovative, high risk persons who will transform science. Dr. Zerhouni wants the NIH to do these new innovative awards and look at things from that perspective. To look at science from different countries and try to see how do you manage science. In October there will be a conference to look at science and its outcomes and try to do a deductive reasoning.

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FUTURE COUNCIL MEETING DATES

Dr. McNicol noted that future meetings are scheduled for a day and a half, and asked that members keep those dates free on his/her calendar. The following dates have been agreed upon:

September 12, 2008
January 22-23, 2009
June 18-19, 2009
September 24, 2009

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CONCEPT CLEARANCE: TYPE I DIABETES SMALL BUSINESS INITIATIVE

Dr. Jerome Wujek, Research Resources Officer, presented the concept of a funding opportunity entitled “Innovative Educational and Ocular Screening Initiatives to Improve Detection of Diabetic Retinopathy”. He explained that the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) expects to receive a special appropriation of $2M for FY2009 that is earmarked for research on Type I diabetes. The NIDDK has requested NEI participation to target the preparation of better educational programs to encourage adequate vision screening of Americans with Type I diabetes. These patients are at increased risk of developing diabetic retinopathy, which is the third leading cause of blindness in the US. The NEI proposes to address this goal through the Small Business Innovation Research (SBIR) program. He provides some examples of research goals for this initiative and discussed the level of support that would be appropriate: Phase I feasibility studies could request up to $100,000 total costs for one year, while Phase II projects could request up to $600,000 total costs per year for two years.

Council members voted unanimously to approve the concept.

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OCULAR GENETICS PRIORITY SETTING

Dr. Hemin R. Chin, Director, Ocular Genetics Program, provided an overview of ocular genetics research supported by the NEI. Total funding for the extramural program is $30 M, divided into human familial - $12.3; human population – $5.9; and non-human - $11.8.

In the area of monogenic eye diseases, the extramural programs support investigator-initiated research projects. The intramural research program includes the eyeGENE Network, a research resource which provides genetic information to patients, and stimulates the development of genetic therapies and gene-based clinical trials.

In the area of eye diseases with complex genetic bases, the NEI provides special resources to accelerate gene discovery through Genome-wide Association Studies. Funds for such large-scale projects can be provided through the Center for Inherited Disease Research (CIDR) which gives supplemental genotyping funds to individual investigators with research projects funded by the NEI. Vision researchers account for 28 of the 226 projects which have been funded through CIDR. Support can also be given through trans-NIH genomic and genetic activities such as the Genes, Health, and Environment Initiative (GEI). Dr. Chin also briefly described the new NIH data sharing policy and the dbGap database of genotype and phenotype (http://dbGaP.nih.gov).

Dr. Chin described some of the challenges for the future if we want to deliver on the promise of genetics and stimulate the pace of genetic discovers. There is a need to harmonize phenotypes, both across vision research and the NIH as a whole. Many of the confirmed disease variants account for only small increases in risk. The majority of risk facts occur in non-protein coding regions. We have little or no understanding of molecular pathophysiology.

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ENHANCING PEER REVIEW AT THE NIH

Dr. McNicol gave an update on this trans-NIH activity. She described the four core priorities that have emerged during the project and summarized the recommendations that are being considered for implementation:

  1. Engage the best reviewers.
    • Require review service from all Principal Investigators (PI) with three or more grants and/or over ½ million in NIH support.
    • Compensate reviewers by providing $250,000 supplements to their grants
    • Set up an NIH-wide program to train reviewers.
    • Increase the flexibility of service
  2. Improve the quality and transparency of review.
    • Modify the scoring system to a seven point scale.
    • Re-rank applications at the close of the review meeting.
    • Restructure the summary statement to align with the rating criteria.
    • Shorten the application to 12 pages.
    • Give a score to grants which are triaged.
  3. Ensure balanced and fair reviews across scientific fields and scientific career stages and reduce burden on applicants.
    • Provide a retrospective review for established PIs.
    • Create a “transformative R01” mechanism.
    • Reduce the need for re-submissions by re-balancing the success rate.
    • Cluster the review of early stage investigators (ESI) in a study section.
  4. Develop a permanent process for continuous review of peer review.
    • Allow applicants to submit prebuttals.
    • Institute an editorial board, two-stage review process.
    • Implement high band width electronic review
    • Create a new entity within OPASI to oversee continuous review of review.

Dr. McNicol indicated that emerging details about the study will be available at http://grants.nih.gov/grants/peer/peer.htm

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GENERAL COUNCIL DISCUSSION

Dr. Johnson provided an additional update on the COC meeting which occurred over March 31-April 1, 2008. He stated that Dr. Zerhouni asked the group to think about advancing the frontier of science and the best use the common fund. This year, the Fund is 1.7% of the NIH overall budget ($3-5 M); in the future it will grow to as much as 5%.

Dr. Johnson described the organization of the new group which is assisting Dr. Zerhouni with the Common Fund. Dr Alan Krensky is the head of the new Division of Program Coordination and Planning and Strategic Initiative. At a previous NAEC meeting we had a presentation by Dr. Tim Hayes, whose group is developing the analysis tools that will help determine the scientific areas where grant funding is awarded. Dr. Betsy Wilder is the leader of the Division of Strategic Coordination; this section is coming into being and moving further along. The most important area may be the Division of Evaluation and Systematic Assessments headed by Dr. Deb Duran. It is important to know how to properly assess whether the programs you have are really effective Defining success in science is difficult and has obvious political ramifications. But it is important to attack these management problems.

Next, Dr. Johnson described a COC presentation by Dr. Larry Tabak on translational programs and public private partnerships in the NIH Foundation. Finally, regarding the Roadmap, he stated that there are recommendations to support obesity and inflammation research.

Dr. McNicol asked how often the Council of Councils meets. Dr. Johnson stated that Congress mandated three times a year but we went down to two. He stated that his term is for two years.

Council members raised the issue regarding animal investigators at Berkeley who were being harassed and stated that the university administration seemed more focused on financial compliance and regulation than on protecting the researchers. Members indicated that at one of the universities a van was firebombed, and inquired whether there were some mechanisms for the NIH to stimulate the universities the same way they do with the threat of a financial audit. Dr. McNicol pointed out that the NIH is developing a toolkit for responding to incidents where investigators have been threatened. She introduced Dr. Mike Oberdorfer, director, Strabismus, Amblyopia, and visual Processing program, who is working with the NIH on these matters. Dr. Oberdorfer explained that a year ago the NIH Deputy Director for extramural Research came before this Council to discuss these issues. NIH is taking a more active roll. The toolkit is an emergency response and it is aimed at assisting universities and appropriate offices to be aware that these incidents are occurring. Dr. Oberdorfer discussed an article in Nature with a bar graph showing a number of incidents all around the country. He stated that to his knowledge is not something the homeland security is interested in but that the FBI is very interested in this situation. Council members suggested that the NIH might consider preparing Public Service Announcements to educate the general public regarding these issues.

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ADJOURNMENT

Dr. Sieving adjourned the meeting at 4:00 pm

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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 were submitted for the approval of the Council; all corrections or notations were incorporated. A complete, printed copy of the Council minutes, including attachments, may be obtained from:

Ms. Janet L. Craigie
National Eye Institute
Suite 1300
5635 Fishers Lane, MSC 9300
Bethesda, MD 20892-9300
Telephone: (301) 451-2020
FAX: (301) 402-0528
e-mail: craigiej@nei.nih.gov

06/26/2008


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Attachment A

NATIONAL ADVISORY EYE COUNCIL
NATIONAL EYE INSTITUTE

ROSTER

(Terms end 11/30 of the designated year)

Roy W. Beck, M.D., Ph. D. (06)
Jaeb Center for Health Research
Tampa FL 33647

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

Eileen E. Birch, Ph.D. (07)
Retina Foundation of the Southwest
Dallas TX 75231

Gunilla Haegerstrom-Portnoy,OD, Ph.D.
Associate Dean for Academic Affairs
School of Optometry (09)
University of California
Berkeley, CA 94720

Barrett G. Haik, M.D. (07)
Department of Ophthalmology
College of Medicine
University of Tennessee Health Science Ctr
Memphis TN 38163

Lenworth N. Johnson, M.D. (08)
Professor of Ophthalmology & Neurology
University of Missouri
Columbia, MO 65212

Juan I. Korenbrot, Ph.D. (09)
Department of Physiology
University of California, San Francisco
San Francisco, DA 94143

Todd P. Margolis, M.D., Ph.D. (08)
Professor of Ophthalmology
Director, F. I. Proctor Foundation
San Francisco, CA 94122

Earl L. Smith, III, O.D., Ph.D. (08)
Dean, College of Optometry
University of Houston
Houston, TX 77204

Lois E. H. Smith, M.D., Ph.D. (06)
Department of Ophthalmology
Harvard Medical School
300 Longwood Ave
Boston MA 02115

Mriganka Sur, Ph.D. (07)
Department of Brain & Cognitive Sciences
Massachusetts Institute of Technology
Cambridge MA 02139

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

Department of Defense Representative
Lt. Col. David E. Holck M.D.
Chief, Reconstructive, Orbit, and Ocular Oncology Services
Wilford Hall Medical Center
Lackland Air Force Base, TX 78236

Dept .of Veterans Affairs Representative
Marco A. Zarbin, M.D., Ph.D.
New Jersey Veterans Admin. Hospital
Newark, NJ 07103

Ex Officio Members
Michael O. Leavitt
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

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