The National Advisory Eye Council (NAEC) convened for its one hundred twenty-fifth meeting at 8:30 am on Thursday, June 17, 2010, at The Melrose Hotel, 2430 Pennsylvania Avenue, NW, Washington, D.C. 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 11:00 am for the review of grant and cooperative agreement applications, and for the review of the Board of Scientific Counselors Report, Laboratory of Retinal Cell and Molecular Biology, Laboratory of Molecular and Developmental Biology, and Unit on Perception and Action. On Thursday June 17, 2010 from 11:00 am until 1:15 pm, the meeting was open to the public.
COUNCIL MEMBERS PRESENT:
Dr. Joseph Bonanno
Dr. James Chodosh
Dr. David Copenhagen
Dr. Scott W. Cousins
Dr. (Col.) Donald Gagliano
Dr. Charles D. Gilbert
Dr. Bernard Godley
Dr. Mae O. Gordon
Dr. Mary C. McGahan
Ms. Alberta Orr
Dr. Val C. Sheffield
Dr. Marco A. Zarbin
COUNCIL MEMBERS ABSENT:
Mr. Ronald Gardner
Dr. Richard Stone
NEI STAFF PRESENT:
Dr. Houmam Araj
Dr. Deborah Carper
Dr. Hemin R. Chin
Ms. Janet L. Craigie
Mr. Will Darby
Dr. Rick Fisher
Ms. Jerusha Gittlen
Dr. Shefa Gordon
Dr. Tom Greenwell
Dr. Dan Kenshalo
Ms. Marilyn Laurie
Dr. Ellen S. Liberman
Dr. Andrew Mariani
Dr. Loré Anne McNicol
Dr. Jenny Mehren
Dr. Lisa Ann Neuhold
Dr. Samuel C. Rawlings
Dr. Maryann Redford
Dr. Merlyn Rodrigues
Dr. Annie E. Schaffner
Dr. Eleanor Schron
Dr. Grace L. Shen
Dr. Paul A. Sieving
Dr. Sarah Sohraby
Mr. Mark Stevens
Dr. Santa Tumminia
Mr. David Whitmer
Dr. J. R. Wujek
OTHER NIH STAFF PRESENT:
Dr. Michael Chaitin, Center for Scientific Review (CSR)
Dr. Mary Frances Deutsch, Office of the NIH Director (OD)
Dr. Rene Etcheberrigaray, CSR
Mr. Blair Feldman, OD
Dr. George McKie, CSR
Dr. Jerry Taylor, CSR
MEMBERS OF THE GENERAL PUBLIC PRESENT AT THE OPEN SESSION:
Dr. Andrea Baruchin, Foundation for NIH
Ms. Joanne Angle, Association for Research in Vision and Ophthalmology (ARVO)
Dr. Bobbie Austin, ARVO
Mr. James Jorkasky, National Alliance for Eye and Vision Research
Ms. Rebecca Hyder, American Academy of Ophthalmology
Ms. Lori Methia, ARVO
Ms Wendy Yu, National Disability Rights Network
Thursday, June 17, 2010
CLOSED PORTION OF THE MEETING
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. 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.
REVIEW OF RESEARCH, RESEARCH TRAINING, AND COOPERATIVE AGREEMENT APPLICATIONS
REVIEW OF THE BOARD OF SCIENTIFIC COUNSELORS REPORT, LABORATORY OF RETINAL CELL AND MOLECULAR BIOLOGY, LABORATORY OF MOLECULAR AND DEVELOPMENTAL BIOLOGY, AND UNIT ON PERCEPTION AND ACTION.
OPEN PORTION OF THE MEETING
DIRECTOR’S REPORT AND OPENING REMARKS
Dr. Paul Sieving convened the open session of the 125thational Advisory Eye Council (NAEC) by welcoming those attending and wishing then a good morning. He congratulated Dr. Deborah Carper on her appointment as Deputy Director of the Institute. He also congratulated Dr. Rachel Caspi of the NEI’s Laboratory of Immunology for receiving the Friedenwald Award from the Association for Research in Vision and Ophthalmology (ARVO) and noted how the award recognizes, in a broader sense, the science of the NEI’s Intramural Research Program. Dr. Sieving noted that this was the third year for the Champalimaud Award, the 2nd largest world wide science award, second only to the Nobel Prize, and it is an award for vision research. He encouraged those in the vision community to take advantage of this opportunity at the next call for nominations.
Dr. Sieving noted the recent increase in the budget of between 2-3%. Due to the current economic downturn, the future in terms of funding for NIH is unknown. The numbers of grantees supported by the NEI has dropped over the past decade by 4-5%. He thanked the Division of Extramural Research (DER) under Dr. Loré Anne McNicol for handling the difficult decisions and for its work with the American Recovery and Reinvestment Act (ARRA) funds that amounted to $174 million dollars for the NEI. He also pointed out that the vision research community has scored very well on the special NIH-wide ARRA opportunities noting that a number of vision applications have scored the highest in certain mechanisms. For the transformative R01’s, a vision application scored best.
Five years ago, the first gene found using the new international hap map was for AMD, complement factor H. This gene numbered either 8 or 9 of genes identified for complex genetics. In 2006, a 2nd gene in AMD was identified, and again vision science was well represented in the difficult task of recognizing genes. Moving forward to 2007, all in the span of 12 months, something very fundamental was happening in opportunities for gene discovery for diseases. From February 2008, to the end of 2009, there were 650 genome wide association studies (GWAS) studies that were published. The NEI and the vision research community have been active players and leaders in genetics.
Dr. Hemin Chin has been appointed Associate Director for Ocular Genetics and has been instrumental in the establishing genetics initiatives such as the NEI Glaucoma Human genetic collaboration (NEIGHBOR), a consortium of clinicians and geneticists who will ultimately contribute data from more than 4000 individuals (2000 primary open-angle glaucoma cases and 2000 controls). The NEIGHBOR consortium consists of 22 investigators at 12 institutions throughout the United States. The consortium investigators will use harmonized clinical definitions for glaucoma phenotypes and the identical genotyping technology platform thereby increasing the statistical power for discovering genetic factors associated with glaucoma. In parallel with NEIGHBOR, the GLAUGEN consortium (Gene-Environment interactions in glaucoma) will collect data from 2400 individuals (1200 POAG cases and 1200 controls). The GLAUGEN consortium is a component of the NIH Gene-Environment Initiative (GEI) established to identify the relationships of environmental exposures to gene-trait associations in common, complex diseases. NEIGHBOR and GLAUGEN are using standardized definitions for glaucoma that will enable researchers to combine data across the consortia. Together, these two consortia will initiate large-scale, GWAS for identifying genetic variants associated with POAG, as well as many gene-gene, and gene-environment interactions.
Dr. Chin was also able to get AMD research groups together to pool their GWAS data for metanalysis. While several genetic factors have been identified, larger cohorts will ne needed to move forward. The field of genetics is alive and well in the vision community, summarized Dr. Sieving.
Two articles in the New York Times bemoan the fact that 10 years after the human genome was identified there are very few cures, commented Dr. Sieving. One can predict that the process of genetics is galloping forward and the next stage will be cell biology. Once the biological pathways deciphered, this information will ultimately move toward new treatments. The difficulty is that these are large and costly ventures. The infrastructure has to be anticipated and built, and no one wants to do this at the cost of the investigator-initiated R01 grant but the dilemma is that we cannot easily do both.
Dr. Sieving announced that Dr. Raynard Kington, Principal Deputy Director, NIH and formerly Acting Director, NIH would soon be leaving and efforts were underway to recruit a replacement. Dr. Harold Varmus, Director of NIH from 1993 to 1999 and currently President of Memorial Sloan-Kettering Cancer Center has been appointed by the President as Director of the National Cancer Institute.
As a comment on Dr. Sieving’s mention of the news articles on the ten year anniversary of the Human Genome, Council noted that there are 12 treatments that are in the clinical trials, based exclusively on the genetic findings of the vision research community. Council emphasized that patients are getting treatment and this should be publicized because it is a story of success unlike the recently mentioned negative press.
REPORT ON COUNCIL OF COUNCILS
Dr. Mae Gordon, an NAEC member and a member of the NIH Council of Councils, spoke about the role of the Council of Councils. She described the four External Advisory Committees to the NIH Director. The Advisory Committee to the NIH Director has a focus on program development, resource allocation, NIH administrative regulation and policy, and other aspects of NIH policy. It is co-chaired by the NIH Director and was established to assist the Office of the Director, NIH, in the making of major plans and policies, especially those related to the allocation of NIH funds and resources.
The NIH Director’s Council of Public Representatives (COPR) is a federal advisory committee, made up of members of the public, who advise the NIH Director on issues related to public input and participation in NIH activities, the NIH research priority setting process, and public outreach programs and efforts.
The Scientific Management Review Board was authorized by the NIH Reform Act of 2006. The NIH Reform Act provides certain organizational authorities to HHS and NIH officials regarding NIH Institutes and Centers and the Office of the Director. The purpose of the Scientific Management Review Board is to advise HHS and NIH officials on the use of those organizational authorities.
The Council of Councils was established by The NIH Reform Act of 2006. The Council is made up of approximately 30 members, selected from NIH Institutes and Centers (IC) Advisory Councils, representatives nominated by the Office of the Director, program offices, and broad lay representation, including a member of the NIH Council of Public Representatives. The Council advises the NIH Director on matters related to the policies and activities of the Division of Program Coordination, Planning, and Strategic Initiatives (DPCPSI). The Council also acts as an external advisory panel to the IC Directors during the “concept approval” stage of the NIH Common Fund initiative review process. The concept approval stage involves the consideration of a list of potential trans-NIH initiatives developed by the DPCPSI staff after receiving input from multiple sources. The information provided to the Council by DPCPSI staff could include deliverables, timetables, and projected costs for each initiative. The recommendations from the Council will then be considered by the DPCPSI Director and the IC Directors.
The NIH Common Fund supports a series of cross-cutting, trans-NIH research programs including Bioinformatics and Computational Biology, Clinical Research Training, Clinical and Translational Science Awards (CTSAs), Epigenomics, Genotype-Tissue Expression (GTEx), Global Health, High-Risk Research, NIH Director’s Pioneer Award, NIH Director’s New Innovator Award, Transformative R01 Program, Human Microbiome Project, Interdisciplinary Research, Knockout Mouse Phenotyping, Library of Integrated Network-Based Cellular Signatures (LINCS), Molecular Libraries and Imaging, Nanomedicine, National Technology Centers for Networks and Pathways (TCNPs), PROMIS: Clinical Outcomes Assessment, Protein Capture Reagents, RAID: Rapid Access to Interventional Development, Regulatory Science, Science of Behavior Change, Structural Biology, and Translational Applications of Stem Cells.
The Council of Councils will meet July 1, 2010 to consider concept approval for the HMO Research Collaborative put forward by NHLBI, Health Economics Research for Health Care Reform put forth by NIA, the NIH Director’s Independent Fellows Program put forth by NIGMS, and, Research in Support of the Workforce, put forth by the Office of Extramural Research.
The Council of Councils will continue to look for new opportunities in biomedical research at the NIH strives to avoid a post-ARRA letdown. It will look at reinvigorating the Common Fund with an emphasis on innovation such as the Pioneer Awards, the New Innovator Awards, and the Transformative R01’s. Other issues to be considered are assessing the results of the current innovations in peer review, and training programs.
There are challenges in disease research because the many disease diagnoses lack phenotypic precision, the dynamic, temporal course of disease is not well characterized, and epigenetic factors are not in the disease model because exposures are not measured. Dr. Gordon finished by stating that the challenges are great but this is a fabulous time to be doing research.
The question was asked by Council, “How does the Council of Councils get input from other Councils because there does not appear to be a structure for that?” Council also inquired if the Agenda for the Council of Councils can be known in advance so that the NAEC can be thinking ahead?
The Agenda for Council of Council meetings may be found on the DPCPSI website,
NEI OUTREACH: OPHTHALMOLOGY AWARENESS AND UNDERREPRESENTED MINORITY MEDICAL STUDENTS
Dr. Loré Anne McNicol, Director of Extramural Research, NEI, began her remarks by noting that for nearly 30 years the NIH has been developing and monitoring programs to increase the diversity of the science of the workforce but recently there have been some legal challenges. The Congress has a lot of interest in these issues and has encouraged the NIH to increase diversity but has not said “how” to do this. The NIH will be broadening the language in the diversity programs to do a better job. Increasing the diversity of the biomedical research workforce begins with training.
The research training programs supported by the NEI are the F32 Individual Postdoctoral Fellowship, the T32 Institutional Training Grant: Pre- and Post-doctoral, the K08, K23 Individual Clinician Scientist Career Development Award, theK12 Institutional Career Development Award, and the K99/R00 Pathways to Independence.
NEI Diversity-specific Grant Programs are the F31 Individual Predoctoral Diversity Fellowship, and Administrative Supplements to Promote Diversity in Health-Related Research for High School students, College students, Graduate students, Postdoctoral fellows, and more senior Investigators.
In FY2009 the NEI made 25 awards for Diversity Supplements. One-half were for pre-doctoral students and one- half were for postdoctoral students.$1,573,684 The total cost of the awards was $1,573,684, roughly 10% of the NEI’s annual expenditure on administrative supplements.
The NEI’s Special Outreach Programs include a partnership with the Journal for Minority Medical Students where the articles stress opportunities and present role models, and the NEI’s Conference Grant to the NMA Ophthalmology Section that sponsors the Rabb-Venable Award in Ophthalmology for medical students and residents.
The NMA Ophthalmology Section in collaboration with the American Academy of Ophthalmology recently produced a video titled, “Ophthalmology: Making a Difference.” This video was produced to increase awareness of ophthalmology among underrepresented minority medical students and as a tool to generate more interest with a goal of increasing workforce diversity in the specialty. The video presentation was well received by Council.
Council asked if there was any outreach to Hispanic medical students and the answer was that
The NMA is not just African-American but has an extremely broad membership and the NEI would like to engage as many organizations as possible.
Discussion focused on how best to distribute the video so that it would have its intended impact. While conventional institutional avenues were mentioned it was also suggested that YouTube be considered.
PROPOSED RULE MAKING: PROMOTING OBJECTIVITY IN RESEARCH (FINANCIAL CONFLICT OF INTEREST)
Dr. Ellen Liberman, Acting Director, Vision Research Program, Division of Extramural Research, reviewed recently proposed rules governing conflict of interest for recipients of NIH grants. The NIH is currently in the process of updating its regulations governing financial conflict of interest. Extramural research has been governed by two different Regulations, 42 CFR Part 50 subpart F (PHS-funded grants) and 45 CFR Part 94 (PHS-funded contracts) since 1995. These regulations are aimed at ensuring that the design, conduct, or reporting of research funded under NIH grants, cooperative agreements and contracts will not be biased by any conflicting financial interest of the investigators responsible for the research.
A significant financial interest (SFI) is anything of monetary value, including but not limited to: salary or other payments for services (e.g., consulting fees or honoraria), equity interests (e.g., stocks, stock options or other ownership interests), and intellectual property rights (e.g., patents, copyrights and royalties from such rights). A financial conflict of interest (FCOI) occurs when and SFI could directly and significantly affect the design, conduct, or reporting of NIH funded research.
The investigator is responsible for submitting financial disclosure statements, a listing of SFIs that would reasonably appear to be affected by the research for which funding is sought, and in entities whose financial interests would reasonably appear to be affected by the research, and, to comply with all Institutional requirements.
The Institution must review the information and make a determination if SFI represents a FCOI, and the Institution must report to NIH prior to expending funds or within 60 days of identifying a new interest, that a FCOI has been determined and it has been managed, reduced or eliminated.
Problems occur when the investigator does not correctly identify an SFI, does not fully disclose interests to his/her Institution, fails to comply with management plan put in place by the Institution after an FCOI is identified, and/or fails to update financial disclosures.
Potential issues at the level of the grantee Institution are policy issues when the Institutional policy does not comply with the regulation and/or institutional officials do not follow the policy consistently, SFIs are not correctly identified as conflicts, FCOI management where the planned strategy is not sufficient to manage, reduce or eliminate conflict or the implementation of management plan is not enforced, and in reporting to the NIH when the FCOI is identified and managed, reduced or eliminated but not reported to the NIH or not reported in a timely manner.
NIH may at any time inquire into the Institutional procedures and actions regarding conflicting financial interests in NIH-funded research, including a requirement for submission of, or on site review of, all records pertinent to compliance. NIH may decide that further corrective action is needed or that the Institution has not managed, reduced, or eliminated the conflict in accordance with requirements. If necessary, NIH may suspend funding until the matter is resolved.
Since the existing rules were promulgated in 1995, biomedical and behavioral research has grown in complexity, interactions among Government, research institutions, and the private sector have increased, and public scrutiny has grown. All these factors have raised the question whether a more rigorous approach is required to strengthen investigator disclosure, management of financial conflicts, and Federal oversight. Because of the paramount importance that biomedical and behavioral research be conducted with the highest standards of integrity and be free of bias, an Advanced Notice of Proposed Rulemaking (ANPRM) was issued in May 2009 soliciting comments on potential changes to the existing rules.
Specifically, the NIH requests comments on “Proposed Amendment of Regulations on the Responsibility of Applicants for Promoting Objectivity in Research for which Public Health Service Funding is Sought and Responsible Prospective Contractors” - NIH Guide – NOT-OD-09-099 published May 8, 2009 (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-09-099.html), published in the Federal Register (Vol. 74, No. 88) on May 8, 2009. A 60-day comment period will close July 7, 2009. To date 78 comments have been received and all comments are posted at: http://www.regulations.gov/search/Regs/home.html#docketDetail?R=NIH-2008-0002.
Comment were solicited on various topics including, expanding the scope of regulation and disclosure of interests, definition of “Significant Financial Interest,” identification and management of conflicting interests by institutions, assuring institutional compliance, requiring institutions to provide additional information and broadening the regulations to address institutional conflict of interest. A trans-NIH committee considered the comments and the regulation in general, and drafted a Notice of Proposed Rulemaking proposing comprehensive changes to the regulations.
Promoting Objectivity in Research for which Public Health Service Funding is Sought and Responsible Prospective Contractors was published in the Federal Register, May 21, 2010 (http://edocket.access.gpo.gov/2010/pdf/2010-11885.pdf). A 60-day comment period will end July 20, 2010. The NIH will carefully consider comments in drafting the final rule which we anticipate publishing before the end of this year.
Major proposed changes to the regulations are: Significant Financial Interest (SFI) with a minimum threshold of $5,000 generally applies to payments and/or equity interests, includes any equity interest in non-publicly traded entities, and exclusions include income from seminars, lectures, or teaching, and service on advisory or review panels for government agencies or institutions of higher education; investigator disclosure includes all SFIs related to investigators’ institutional responsibilities, and Institutions are responsible for determining whether SFIs relate to PHS-funded research and are financial conflicts of interest (FCOI); and reporting to PHS Awarding Component (NIH) includes current requirements, along with the value of the financial interest, the Nature of FCOI, e.g. equity, consulting fees, travel reimbursements, honoraria, and description of how FCOI relate to PHS-funded research, and key elements of the institution’s management plan.
Before spending funds for PHS-supported research, an institution shall post on a publicly-accessible website information on certain SFIs that the institution has determined are related to the PHS-funded research and are a FCOI. The scope includes SBIR/STTR Phase I applications. FCOI training is required for investigators before engaging in PHS-funded research, and every two years thereafter.
Council questioned the “$5,000 rule”, and if that mean that if one had a TIAA-CREF retirement fund invested in a domestic stock fund, wouldn’t one have to figure out which companies have a conflict of interest with one’s organization? An example would be an investigator who has a pending patent and writes a grant application to NIH to push the technology forward. How is that conflict of interest reconciled? Would one now need a management plan? Wouldn’t there be a series of highly variable processes that apply to one’s investment pool?
Dr. Liberman replied that the change is only in the threshold and that the FCOI must be managed, not eliminated. The plan for management is determined by the institution and the reporting will be more extensive than it currently is. Dr. McNicol added that managing the FCOI will be an institutional responsibility, much like the responsibility of the institution to establish an Institutional Review Board to manage Human Subjects Research.
Dr. Mariani reminded Council members that a Nature News Brief (Nature 485: 407, 2010) and a Commentary in the Journal of the American Medical Association, by Drs. Sally Rockey and Francis Collins, Published Online, May 24, 2010 (doi:10.1001/jama.2010.774) concerning the proposed rule making were available in the Electronic Council Book.
CONCEPT CLEARANCE: INITIATIVE TO SUPPORT DATA ANALYSIS AND THE DEVELOPMENT OF BIOINFORMATIC TOOLS FOR LARGE SCALE GENETIC AND GENOMIC DATA FOR VISION RESEARCH
Dr. Hemin Chin presented an outline of the goals of genetics research to fully dissect inherited component of diseases including gene-gene and gene environment interactions, and epigenetics in order to identify high risk populations, and to develop specific preventive and therapeutic measures applicable to individualized medicine. Genomics at the Population Scale has progressed from the small-scale GWAS discovery of CFH for Age-related Macular Degeneration in 2005 to over 779 GWAS discoveries published as of March 20, 2010.
Gene Discovery for common diseases can be done by an hypothesis-based approach for candidate genes or hypothesis-independent approaches using linkage scans (families) or GWAS. GWAS identifications will lead to hypothesis-based investigations into biological pathways. He then reviewed the current NEI GWAS Data sets currently in dbGaP, including AREDS 1 (2006), AMD-MMAP Cohort Study (2009), and Whole Genome Association Twin Study of Myopia and Glaucoma risk factors (2009). On-going GWAS studies to be completed in 2010 are GENEVA GLAUGEN and NEIGHBOR for POAG, OHTS, and Refractive Errors. Future initiatives will include targeted and exomic sequencing for AMD and POAG, and the Training Program in Computational Biology and Statistical Genetics (T32).
He discussed a Concept for an Initiative to support genetic and genomic analyses for complex eye diseases that will encompass meta-analyses utilizing existing genetic/genomic and epidemiology data (cross-laboratories and cross-institutions), harmonization of phenotypic ascertainments incorporating new diagnostic tools, and data sharing and the development of analytic tools for genomic resources.
Council was highly enthusiastic about initiatives for the development and improvement of bioinformatics tools to improve analysis and suggested an emphasis on novel study design. Large data sets are needed to avoid loss of information and methods to improve the power in smaller sets would be welcome. The also thought that harmonization of data sets would maximize the information from the data collected.
Council wanted to know the mechanism planned for the proposed initiative, and how much it would cost since it would involve a lot of manpower. Dr. Chin relied that a mechanism was not predetermined, and Council’s advice would be used to prepare a detailed plan. Council unanimously approved the Concept.
Dr. Richard Fisher presented Council with two papers: one is the NEI Planning Workshop Agenda, Ocular Pain and Sensitivity, set for September 2010; the other is the NEI Workshop Process.
The Ocular Pain and Sensitivity workshop will be held September 30 through October 1, 2010 and co-chaired by Drs. Todd Margolis and Carlos Belmonte. Dr. Fisher noted that eight of the nine participants are from outside the NIH. With regards to pain it is hoped that this workshop will serve as a model for future research and to bring in persons outside of vision research. This will also be placed on the NEI’s website to enhance our participation with the public to give everyone a sense in what our approach is in developing grants and topics that are important to research.
The NEI Program Planning Workshop Development Process is an important component of the NEI’s ongoing strategic planning process and will be a series of workshops developed by the Office of Program Planning and Analysis (OPPA), a component of the Office of the NEI Director, in collaboration with the Division of Extramural Research and other NIH Staff, according to D4r. Fisher. The purpose of the workshops is to provide recommendations to the NEI regarding new scientific opportunities and/or address unfunded areas of biomedical science that are applicable to any area of vision research. The number and frequency of workshops will be based on need and the availability of funds.
These workshops are not open scientific meetings. The intent is to invite 10-20 participants with specific expertise related to the overall workshop topic. Each workshop will produce a set of recommendations for the NEI encompassing near-term needs and opportunities. Workshop recommendations will be published on the NEI website and included as an integral component of ongoing NEI planning. It is expected that some, but not all, workshops will lead to development of specific funding initiatives or other actions by NEI staff.
OPPA will solicit suggestions for workshop topics from the vision research community and other stakeholders such as patient advocacy groups, private foundations, and NEI and other NIH staff. For each topic under consideration, OPPA will prepare a one-page overview that includes background, state-of-the-science, description of the new opportunity or need, and suggested expertise for workshop attendees.
Workshop topics will be accepted at any time, and developed in concert with other NEI initiatives as they arise. Periodically, OPPA staff and NEI Extramural Program Directors will meet to discuss workshop topics and other potential initiatives. Each concept will be discussed and prioritized. The most compelling initiatives will be presented to the National Advisory Eye Council for concept clearance recommendations to the Director, NEI. Topics approved by the Director will be developed jointly by OPPA and DER staff. Typically, OPPA and DER staff will collaborate in identifying participants and editing reports.
Council commented that the Ocular Pain and Sensitivity Workshop had come along very nicely. Council also opined that if workshops were held in proximity to Council Meetings, members could stay on to attend the workshops.
GENERAL COUNCIL DISCUSSION
Council raised the issue of clinician scientists on study sections because their viewpoint on translational research is valuable and it often appears to be lacking in reviews. One problem appears to be the amount of time required for study section service not being compatible with the demands of the clinical duties and the laboratory research of the clinician scientist. Council suggested extending the time on grants for study section members as a remedy to the problem and as a reward for service. Dr. McNicol replied that if the grants of study section members were extended, it would affect the ability to fund other grants.
Council then discussed the concept of what is translational research and how best to foster translational research. Infrastructure, training, review emphasizing high risk/high reward research over incremental findings, involving more translational researchers in review, and the involvement of clinicians in research in spite of busy clinical schedules were mentioned as concepts that could move translational research forward.
Dr. Sieving adjourned the meeting at 1:15 pm
I hereby certify that, to the best of my knowledge, the foregoing minutes and attachment(s) are accurate and complete.
Dr. Andrew P. Mariani, Ph.D.
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
5635 Fishers Lane, MSC 9300
Bethesda, MD 20892-9300
Telephone: (301) 451-2020
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