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NAEC Meeting Minutes - January 20, 2011

National Institutes of Health
National Eye Institute

Minutes of Meeting

January 20, 2011

The National Advisory Eye Council (NAEC) convened for its one hundred and twenty-seventh meeting at 8:30 am on Thursday, January 20, 2011, at 5635 Fishers Lane, Rockville, Maryland. Paul A. Sieving, M.D., PhD, the Director of the National Eye Institute (NEI), presided as Chair of the Council. The meeting was open to the public from 08:30 am until 10:00 am when the meeting was closed to the public until 10:45 am for the review of grant and cooperative agreement applications. The meeting was again open to the public from 10:45 am until adjournment. Attachment A provides a roster of Council Members.

Dr. Joseph Bonanno
Dr. David Copenhagen
Dr. Donald Gagliano
Mr. Ron Gardner
Dr. Charles Gilbert
Dr. Alberta Orr
Dr. Marco Zarbin

Dr. James Chodosh
Dr. Bernard Godley
Dr. Scott Cousins

Dr. Houmam Araj
Dr. Neeraj Agarwal
Ms. Pamela Bobbitt
Dr. Deborah Carper
Dr. Hemin Chin
Ms. Monique Clark
Ms. Janet Craigie
Mr. Will Darby
Ms. Linda Dingle
Dr. Richard Fisher
Ms. Jerusha Gittlen
Dr. Sheffa Gordon
Dr. Tom Greenwell
Ms. Tina Jones
Mr. Kevin Keating
Dr. Dan Kenshalo
Dr. Natalie Kurinij
Ms. Marilyn Laurie
Dr. Ellen Liberman
Dr. Andrew Mariani
Dr. Loré Anne McNicol
Dr. Jennifer Mehren
Ms. Kathleen Moy
Dr. Lisa Neuhold
Dr. Steven Oversby
Dr. Maryann Redford
Dr. Gale Saunders
Ms. Karen Robinson Smith
Dr. Anne Schaffner
Dr. Eleanor Schron
Dr. Grace Shen
Dr. Paul A. Sieving
Ms. Chantell Stevenson
Dr. Michael Steinmetz
Dr. Santa Tumminia
Mr. David Whitmer
Dr. Cheri Wiggs
Ms. Keturah Williams
Dr. Jerome Wujek

Dr. Michael Chaitin, CSR
Dr. Rene Etcheberrigaray, CSR
Dr. Mary Frances Deutsch, OER
Dr. George McKie, CSR
Dr. Luci Roberts, OD/OER
Dr. Jerry Taylor, CSR
Mr. Kirk Thompson, CSR

Dr. Bobbie Ann Austin, ARVO
Ms. Rebecca Hyder, American Academy of Ophthalmology
Mr. James Jorkasky, National Alliance for Eye and Vision Research (NAEVR)
Dr. Matt McMahon, House Science Committee
Ms. Jennifer O’Neill, Merck
Mr. Rodney Peele, American Optometric Association
Ms. Helen Viskins, American Academy of Optometry

8:30 am

Dr. Deborah Carper, Deputy Director announced that Dr. Sieving was attending an important Institute and Centers Directors meeting and would be at council at the conclusion of this meeting. She thanked the council members for participating in this important advisory function as we begin a new year and the 127th Council meeting.

Dr. Carper introduced a new member of the Division of Extramural Research (DER), Dr. Steven Oversby, who joined the NEI as a program director for clinical trials and epidemiology. Dr. Oversby earned his R.N. from California State University in 1979. He became a Commissioned Officer in the Public Health Service and joined the NIH Clinical Center Alzheimer’s Pharmacology Research Unit as a Psychiatric Staff Nurse in 1987. In 1990, he was promoted to Senior Clinical Nurse in the Schizophrenia Pharmacology Research Unit. He earned his Ph.D. in Clinical Psychology from Newport University in 1991 and next joined the DC Department of Mental Health as a Senior Clinical Nurse Specialist, where he created a new Direct Patient Service Accountability Program. In 2002, he joined the NIH in the National Institute on Drug Abuse as a Program Management Officer in the Center for Clinical Trials Networks and in 2003 was promoted to Health Scientist Administrator with responsibility for the direction and coordination of the Methamphetamine Research Program.

Dr. Carper noted that Dr. Sam Rawlings recently retired from the Division of Extramural Research. He was Chief of the Scientific Review Branch, supervised NEI Scientific Review Officers and coordinated the review of NEI special announcements, clinical trials, K awards, institutional training, core center grants, contracts and other applications. Over the years, he was honored with a Department of Health and Human Services Award for leadership in the reorganization of the Division of Research Grants; a national award from the Hispanic Center of Excellence for faculty development; and, the Public Health Service Citation for Sustained High Quality Performance at NIH. He co-edited two books on sensory function and aging research and at one time served as an assistant Editor of the journal, Vision Research.

On Tuesday, NEI staff attended a ceremony to honor Dr. Robert Wurtz on his receipt of the 2010 $500,000 Neuroscience Prize from the Gruber Foundation. Dr. Wurtz, who is a member of the NEI intramural program, has made major contributions in the fields of visual cognition and cognitive neuroscience. He was the first to record the activity of single neurons in awake, behaving primates, and he characterized the contributions of cortical and subcortical areas in visual processing and eye movement control.

Two other intramural scientists who received prestigious awards in 2010 are: Dr. Rachel Caspi, who received the ARVO Friedenwald Award for her contributions to ocular and systemic immunology and Dr. Brian Brooks, who received the Presidential Early Career Award for Scientists and Engineers, called PECASE. The Presidential PECASE awards are the highest honor bestowed by the U.S. government on outstanding scientists and engineers beginning their independent careers. Brian was recognized for his research on the molecular genetics and developmental studies of uveal coloboma.

There were 85 recipients of the PECASE award, and two were vision scientists. The second was Dr. Doris Tsao, an NEI grantee and assistant professor of biology at the California Institute of Technology. She was recognized for her research on how the brain interprets and transforms visual information into three-dimensional shapes, such as human faces, by using brain imaging and electrical recordings from single neurons.

Lastly, Dr. Carper spoke about the proposed new Center, the National Center for Advancing Translational Sciences (NCATS). The goal of the new Center is to integrate research efforts to accelerate the development and delivery of new and more effective therapeutics. The target launch date is Oct 2011. Initially, the Center will be formed by integrating selected translational research programs now located within the National Human Genome Research Institute, the National Center for Research Resources and the NIH Common Fund. Some of the functions will be to provide a central locus for access to resources, tools, and expertise related to translational medicine, improve the process of therapeutics development, serve as a catalyst for collaborative interactions of government, academic and industry, provide access to services and resources for high-throughput screening, assay development, and train translational research investigators. NEI staff met with Dr. Raganathan, who is coordinating the implementation of NCATS. He is visiting the institutes for input and potential program opportunities in translational research. Public comments are being solicited on the website called Feedback NIH.

Dr. Luci Roberts, Director, Division of Planning and Evaluation in the Office of Planning and Communication of the NIH Director’s Office presented the highlights of the results of the Peer Enhancement Surveys.

NIH began implementing proposed recommendations to enhance the peer review system in September 2008, which continued into the Peer Review Process & Changes phase through summer 2009. The next major milestone was the transition to Shortened/Restructured applications, which began with the January 25, 2010 due date. To ensure NIH continues to “fund the best science, by the best scientists, with the least amount of administrative burden,” the Continuous Review of Peer Review was incorporated into the process.

In May, 2009, the following were implemented: the change to the 1 – 9 Scoring Range, criterion-based scoring, bulleted critiques, and the structured critique template.

Enhanced review criteria involved defining scientific merit was as the overall impact on the research field(s) involved, more emphasis was placed on Investigator(s), and less emphasis on Approach, guidelines for evaluating merit for New and Early Stage investigators were better developed in Investigator(s), guidelines for reviewing clinical research studies and basic technology development were incorporated into Approach, Innovation was redefined to address both paradigm shifts and tests of feasibility, and Clinical & New Investigator applications were clustered into groups.

Surveys were taken of applicants and reviewers, and of Scientific Review Officers (SROs), Program Officers (POs) and Institute Advisory Councils.

The results are based on the following number of respondents: 374 applicants rated peer review system before the changes and 504 applicants rated peer review system after the changes; 221 reviewers rated the peer review system before the changes and 537 reviewers rated peer review system after the changes; 288 SROs and 437 Program Officers POs rated the system after the changes and 291 Advisory Council/Board members rated the system after the changes.

Based on the surveys, the 9-point scoring range is adequate for reviewers and easy for Advisory Council Members to understand. Program Officers rated criterion scores as one of the changes most helpful for advising applicants. Clustering is a positive change brought about by the Enhancing Peer Review Initiative.

Reviewers rated structured critique templates as more efficient than the narrative critique format; however, bulleted critiques are not helpful for understanding the factors that affect the outcome of review. POs and SROs strongly disagreed more often than they strongly agreed that the enhanced review criteria resulted in greater clarity about the strengths and weaknesses of the application.

Council had many comments on the results of the survey and the interpretation of the results, and about the relationship between the overall impact score and the criterion scores. Council also raised the issue of the phasing out of A2 applications. Dr. Roberts stated that although this initiative was part of the recent peer review enhancements, the elimination of A2 was not surveyed but may perhaps be undertaken in future surveys.

Dr. Andrew Mariani, Executive Secretary, proposed the dates of February 2-3; June 14-15 and October 4-5, 2012 for future Council Meetings. He noted that these dates did not conflict with any major scientific or professional society meetings that Council or Staff were likely to attend. These dates were emailed to Council.

10:00 am
The meeting was closed to the public at 10:00 am 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).

Dr. Andrew Mariani, 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.


10:45 am

Dr. Hemin Chin reviewed recent genomics and genetics initiatives at NEI. These included the NEI Ruth L. Kirschstein National Research Service Award (NRSA) Institutional Research Training Grants (T32) for Statistical Genetics and Genome Informatics (RFA-EY-10-001), the NEI Genomic Research Grant on Integrative Data Analysis for Vision Research (R01) (RFA-EY-11-001), and a concept for an R&D contract to create a data-sharing bioinformatics infrastructure was approved at the NAEC meeting (Oct 2010). These three initiatives are interrelated as the training and infrastructure support will benefit the goals of the research initiative.

He then summarized the known genetics and genomics of common eye diseases such as age-related macular degeneration (AMD) with GWAS Data Sets in dbGaP, AMDGen (International AMD Genetics Consortium for Meta-analysis), and targeted sequencing for AMD candidate genes, Primary Open Angle Glaucoma (POAG) including the NEIGHBOR Consortium, the GWAS Data sets in dbGaP, and targeted exomic Sequencing of 300 NEIGHBOR POAG cases, refractive error, i.e., myopia with genotyping completed at CIDR in January, 2011 based on 2000 AREDS samples, 2000 KORA samples (Cooperative Research on Public Health in the Region of Augsburg/Germany) and with meta-analysis planned, and, corneal dystrophy with 3 NEI-funded investigator groups establishing the Fuchs endothelial corneal dystrophy (FECD) GWAS consortium.

Dr. Chin noted that older genome studies have focused on individuals of European ancestry and that these studies haven’t been done on other populations until now because the technology wasn’t available to adequately study the genomics of the other populations. However, more and more data are becoming available and it is now time to propose a concept for an initiative to take a look at African American populations. This is a clear and significant opportunity to make progress. This new initiative would promote collaborations within and outside the vision community utilizing new analytical tools and have a high public health impact considering the current budget climate. NEI should think hard about where we need to target our resources, into an area where it would make a higher impact and a significant public health impact.

In response to a question from Council, Dr. Chin declared that this initiative would not replace what is currently being done but would alert the scientific community to the NEI’s priorities.

Dr. Richard Fisher updated the Council on the current status of program planning which is a collaborative effort between the Office of Program Planning and Analysis (OPPA) and the DER. The NEI has embarked on program planning since the 1970s every 5-7 years and started a new round of planning in 2010. There is a link on the NEI home page (www.nei.nih.gov) to NEI Strategic Planning. On the planning page, there is a box on the right that links to a Request for Information (RFI) for research highlights and for needs and opportunities in vision research. The ongoing planning process consists of three major components.

The NEI Framework for vision research states goals and concepts common to most or all areas of biomedical research in the context of vision research.

Vision Research in 2011: Needs, Gaps and opportunities is intended to be a document assembled by program panel meetings in the various NEI program areas which invites information from the public and the research community.

Ongoing planning workshops will update emerging needs, gaps & opportunities to supplement those identified by planning panels.

The planning panels, to be held at the annual ARVO Meeting in May, will be convened based on the historical major programs of the NEI. The panels are directed by an NEI program director and extramural scientific co-chairs of. They are: Retinal Diseases by Dr. Andrew Mariani with Dr. Marie Burns of the University of California, Davis and Dr. Martin Friedlander of The Scripps Research Institute as co-chairs; Corneal Diseases by Dr. Grace Shen with Dr. Victor Perez, University of Miami and Dr. Eric Pearlman of Case Western Reserve University; Lens & Cataract by Dr. Houmam Araj with Dr. Chris McGahan, North Carolina State University and Dr. Steve Bassnett from Washington University; Glaucoma & Optic Neuropathies by Dr. Neeraj Agarwal with Dr. Rohit Varma from USC and Dr. Don Zack from the Johns Hopkins Wilmer Institute; Strabismus, Amblyopia, and Visual Processing by Dr. Michael Steinmetz with Dr. Richard Anderson from Cal Tech and Dr. Earl Smith from the University of Houston; and Low Vision by Dr. Cheri Wiggs with Dr. William Good from Smith-Kettlewell Eye Research Institute and Dr. Krishnankutty Sathian from Emory University.

In December, 2010, a meeting of the co-chairs and program directors was convened to discuss panel expertise and specific panel membership. Program directors are in the process of completing panel composition. It is expected that a final panel report will be completed next fall, will be given to Council, for approval, and published by the end of 2011.

Mr. William Darby, Chief, Grants Management Branch, Division of Extramural Research reviewed the proposed Council Operating Procedures (COP) for the 2011 Calendar Year (CY) and noted no change from last year’s procedures. The procedures describe the steps in the review of grant applications by Council and have guidelines for NEI Staff to perform certain functions that do not require Council approval. A motion was made and seconded to accept the recommended COP and all voted in favor of the motion.

Mr. Donald Everett, Program Director for clinical trials and epidemiology, presented the bi-annual report to Council certifying compliance with the NIH Inclusion Guidelines as mandated by Congress in 1993.

In order to balance research burdens and benefits, women and minorities must be included in all clinical research studies. Women and minorities must be included in Phase III clinical trials & the trial must be designed to permit valid analysis. Cost is not allowed as an acceptable reason for exclusion. NIH supports outreach efforts to recruit and retain women, minorities, and their subpopulations in clinical studies. Applications with unacceptable plans cannot be funded. The applicant must revise plans to include the appropriate subject populations.

NEI strategies to implement the policy include highlighting the policy on the NEI website, and detailing the policy in all Funding Opportunity Announcements (FOA).

Staff are trained (31 of 31 staff trained) in all new procedures and compliance is documented in the grant files. We collaborate with Office of Research on Minority Health and the Office of Research on Women’s Health to add special populations to clinical trials. There is oversight by the Program Director and the Director, DER. The analyses of the subject populations are monitored in Phase III trials.

Mr. Everett noted that there are no data discrepancies in Population Tracking and NEI studies are often used as model or examples in NIH training programs. Overall there is good representation of women and minority participants in NEI-supported clinical studies. A very small percentage of “unknown” reporting remains to be solved. This is due to several problems that are being resolved. Some of the missing information is from older grants where there was not the ability to enter the information, or where the information can not now be obtained. There is also the problem that ethnic/racial categorization is by self reporting and an increasing number of trial participants are declining to place themselves in the standard groupings.

Ms. Marilyn Laurie, Chief, Financial Management Branch, presented an overview of the NEI’s budget, as of January 20, 2011. The presentation included NEI’s appropriation and budget history, data on Research Project Grants (RPGs) and success rates, FY 2011 appropriation requests, and an ARRA funding status update. She described the distribution of the FY 2010 budget in the Institute to Extramural Research, Intramural Research, and Research Management Services.

Ms. Laurie noted that the NIH had been operating under a series of Continuing Resolutions (CRs), which limit spending to the FY 2010 rate. The current CR runs through March 4, 2011. $294.3 million or 42% of the FY 2010 Appropriation has so far been received. She also stated that the final amount of the 2011 appropriation remains unknown.

Dr. Loré Anne McNicol, Director, Division of Extramural Research, discussed the effects that a reduced NIH appropriation could have on the funding of grants. She began with an historical perspective noting that budgets are cyclical and that 80% of the extramural grant budget is in non-competing awards.

The question arises, “How should reductions be made if there is a reduction in the appropriation?” NEI must follow guidance issued by the President’s Office of Management and Budget (OMB) and by central guidance issued by the NIH Director’s Office for all of NIH.

Other approaches to be considered would include across the board cuts, sunsetting of programs, elimination of grant mechanisms, and grant by grant analysis.

The consequences to be considered are the effects on the new investigator success rate, the breadth of the scientific portfolio, access to new and innovative scientific ideas, the number of grants per individual investigator, and the total number of dollars per principal investigator (PI).

Dr. McNicol asked Council if they thought there were a maximum number of grants an individual PI should be limited to. One Council member replied that 3 was a number where questions could be asked. Another Council member thought there was something implicit in the question that the funding priority would then have something to do with distributing the money as widely as possible instead of on quality. Dr. McNicol replied that the dilemma was to maintain the health of the scientific enterprise while maintaining the excellence of research.

Dr. Mariani asked if there were any general issues and no issues were brought forth.

Dr. Sieving adjourned the meeting at 12:30 pm

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

Andrew P. Mariani, Ph.D.
Executive Secretary
National Advisory Eye Council
Division of Extramural Research
National Eye Institute

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