National Eye Institute
National Advisory Eye Council
One Hundred Thirtieth Meeting
February 2, 2012
The National Advisory Eye Council (NAEC) convened for its one hundred and thirtieth meeting at 8:00 am on Thursday, February 2, 2012, at 5635 Fishers Lane, Rockville, Maryland, 20852. 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 08:00 a.m. until 3:00 p.m. The meeting was closed to the public from 3:00 p.m. until adjournment for the review of review of grant and cooperative agreement applications. Attachment A provides a roster of Council Members.
COUNCIL MEMBERS PRESENT:
Dr. Joseph Bonanno
Dr. James Chodosh
Dr. Hollis Cline
Dr. David Copenhagen
Dr. Donald Gagliano
Dr. Bernard Godley
Dr. Jonathan Haines
Dr. John Morrison
Ms. Kathleen Petrillo
Dr. Eric Pierce
Dr. Krishna Sharma
Dr. Sheila West
Dr. Marco Zarbin
COUNCIL MEMBER ABSENT:
Ms. Alberta Orr
NEI STAFF PRESENT:
Dr. Houmam Araj
Dr. Neeraj Agarwal
Dr. Deborah Carper
Ms. Janet Craigie
Mr. William Darby
Mr. Donald Everett
Dr. Richard Fisher
Dr. Shefa Gordon
Dr. Thomas Greenwell
Mr. Dustin Hays
Ms. Jean Horrigan
Dr. Natalie Kurinij
Ms. Marilyn Laurie
Dr. Ellen Liberman
Dr. George McKie
Dr. Loré Anne McNicol
Dr. Jenny Mehren
Dr. Sheldon Miller
Dr. Lisa Neuhold
Dr. Steven Oversby
Dr. Maryann Redford
Dr. Gale Saunders
Dr. Anne Schaffner
Dr. Grace Shen
Dr. Paul Sieving
Ms. Chantell Stevenson
Dr. Michael Steinmetz
Dr. Christopher Thomas
Dr. Santa Tumminia
Dr. Cheri Wiggs
Dr. Jerome Wujek
OTHER NIH/DHHS STAFF PRESENT:
Dr. Michael Chaitin, Center for Scientific Review (CSR)
Dr. Rene Etcheberrigaray, CSR
Dr. David Filpula, CSR
Dr. Peter Guthrie, CSR
Mr. Don Luckett, CSR
Dr. Christine Melchior, CSR
Dr. Richard Nakamura, CSR
Dr. Jerry Taylor, CSR
MEMBERS OF THE GENERAL PUBLIC PRESENT AT THE OPEN SESSION:
Dr. Bobbie Austin, Association for Research in Visions and Ophthalmology (ARVO)
Ms. Shannon Curtis, American Academy of Ophthalmology (AAO)
Dr. Israel A. Goldberg, Health Research Associates
Mr. James Jorkasky, National Alliance for Eye and Vision Research (NAEVR)
Mr. Philip Lee, Results Leadership Group
Dr. Gyan Prakash, AMAR International
Ms. Beth Rada, Xoma
OPEN SESSION OF THE MEETING
CALL TO ORDER AND OPENING REMARKS
Dr. Paul Sieving welcomed all attending the meeting and introduced four new Council members. Dr. Hollis Cline is Professor in the Departments of Cell Biology and Chemical Physiology, The Scripps Research Institute with a Ph.D. from the University of California, Berkeley in Neurobiology. Dr. Jonathan Haines received a Ph.D. from the University of Minnesota in Genetics and is Professor in the Department of Molecular Physiology and Biophysics and Director of The Center for Human Genetics Research, Vanderbilt University School of Medicine. Dr. Eric Pierce received a Ph.D. from the University of Wisconsin, Madison and an M.D. from Harvard Medical School. He is Director of the Ocular Genomics Institute, Massachusetts Eye and Ear Infirmary, and the Department of Ophthalmology, Harvard Medical School. Ms. Kathleen Petrillo is a Partner at Senniger Powers, LLP in St. Louis, Missouri and a graduate of George Mason University’s John Marshall Law School with a J.D.
Dr. Sieving noted several points of interest. The current NEI FY12 budget is $702M and the NIH authorization includes the National Center for the Advancement of Translational Science (NCATS) with a budget of $575M, most of which comes from the dissolution of the National Center for research Resources. Dr. Thomas Insel, Director of the National Institute of Mental Health is Acting Director, NCATS.
The NEI is seeking to fill two positions as associate director. One position is for the Office of International Programs. Several candidates of remarkable qualities have applied. The other associate director position is to head the Office of Science Communications, Public Liaison, and Education. This is an expanded office of public liaison and public information, adding a group of people who are scientists and write clearly about the nature of science for both lay people and the science section in the NY Times, and who also communicate well with constituents in science communities.
The NEI has 550 employees and 270 are government employees. Each year there is a nice event in the fall consisting of an awards ceremony and picnic and next Wednesday is the 3rd NEI All Hands Meeting. The David Cogan Ophthalmic History Society is returning to the grounds of the NIH to celebrate its 25th Anniversary on March 29–April 1 at the National Library of Medicine. The 6th Sayer Lecture, “Self-organization of Neural Structures on Three-dimensional Stem Cell Cultures” will be held on April 16 in the Building 10 Masur Auditorium. There is a presentation on developing iPS cells: a Bridge from Eye Development to Disease on February 21.
During ARVO, on May 8, there will be a tribute to Dr. Carl Kupfer, founding Director of the NEI, at a symposium. See ARVO events on their website for more details.
Ms. Joanne Angle has retired from ARVO as Executive Director and Ms. Iris Rush is the Interim Director.
DISCUSSIONS ON THE FUTURE OF PEER REVIEW
Dr. Richard Nakamura, Acting Director, Center for Scientific Review (CSR), stated that the CSR mission is to see that NIH grant applications receive fair, independent, expert, and timely reviews—free from inappropriate influences—so NIH can fund the most promising research. He noted that CSR reviews 89% of NEI grant applications (N=1,323, 4.6 Study Section equivalents). The NIH peer review process was outlined. As goals, CSR has efficiency of review, improve staff via selection and training, improve reviewers via selection and training, reduce disparities/increase diversity, optimize review referral and SS coverage, and optimize scientific ranking across Study Sections. Regarding the charge of reducing disparities and increasing diversity, Dr. Francis Collins has run a series of meetings and discussions to address these issues on the NIH level. CSR will focus on the last two goals.
He asked, “How are we evaluating our process to improve it?” The key question is what are the relative contributions of applicants, reviewers, and process to rankings that are useful to ICs? In selecting the best science it is necessary to evaluate outcomes. Optimization requires measures of quality. Proxies for quality are bibliometric measures especially citations– best for groupings (reviewers and applicants within study sections) rather than evaluation of individuals. Additional metrics for scientists are rank and community standing, expertise/network, and productivity. Controlling for field of science, interpretation by outstanding scientists, and efforts to track science dynamics (with weight towards current scientific activity rather than 5 year history) are also considered.
Statistics for 144 Study Sections with average number of papers and the average citations/ paper, and, the comparative metrics statistics for 29 Study Sections and the average relative citations and the average relative journal impact factor were presented.
In evaluating outcome quality, preliminary observations using aggregate bibliometric measures were made. Most CSR study sections are associated with productivity exceeding the average for the field. Large SS differences in bibliometric performance were found. Caveats are that these are currently retrospective (at least 5 years), attribution of grant support is optimistic, investigators have non-NIH support, the metrics require extended evaluation themselves, and the need to control for time after completing terminal research degree should be considered.
If group bibliometric differences reflect quality differences, can we determine the sources of the variance? Also, what is the relative contribution of the quality of the reviewers and the quality of the applications?
Problems across Study Sections are the mal-distribution and concentration of high quality applications, ranking is normed to the applications received in an individual Study Section, percentiling assumes equal average application quality across Study Sections. This null hypothesis is disproven. A consequence is that an equal share of the award pool goes to Study Sections with weak or dying science and to the Study Sections with the strongest applications.
Longer term optimization requires examining the structure of CSR. In evaluating the anatomy of CSR, the current map of science (Pubmed & Scopus), and an analysis of the network of study sections are compared. Benefits of these approaches will inform redesign of the study section network, optimize referral of applications to study sections, improve selection of reviewers, and improve staff selection and interactions.
In summary the priorities are to examine all CSR standing Study Sections and SEPs for measures of quality of best scoring applications controlled for field of science, to study distribution of high quality applications, to consider distribution of the most outstanding PIs as reviewers, and to use statistical analysis to examine roles of referral and reviewers. If warranted, CSR will consider remediations such as redistribution of applications in weaker areas, publish measures of “competitiveness,” and provide information to allow adjustment of program award levels. Study the mapping distribution of science and dynamics. Also to evaluate Study Section coverage for grant applications we will consider the following. Is the coverage appropriate? Is there appropriate overlap? Can we improve assignment of applications? Have we distributed highly competitive applications?
Dr. Nakamura was asked about the impact factor of the funded vs. the non-funded grants. He stated a key question is, “are there significant differences in the qualities of the applications that were awarded, which is important for institute portfolios?” CSR wants to help the ICs shape their portfolios. Dr. Chodosh answered that the study section doesn’t fund, and it is up to the institute to develop the science, not the study section, and the output depends on the input which changes by area of science.
Dr. Zarbin questioned the potential disparity between the score and the impact. He suggested that to focus on the composition of the study section is what is going to fix the disparity instead of redistributing applications among the different study sections.
Dr. Sieving thanked Dr. Nakamura for the presentation and turned the meeting over to Dr. McNicol, Executive Secretary, for consideration of meeting minutes and future council dates. Dr. Sieving mentioned that Dr. Andrew Mariani, who had previously served as Executive Secretary of Council, retired at the end of 2011.
MINUTES OF PREVIOUS MEETINGS AND 2013 MEETING DATES
Dr. Loré Anne McNicol stated that the January 2011 Meeting Minutes were emailed to Council in December and having heard no comments or problems asked for a motion to accept. The motion was made, seconded and a vote taken, with all in favor, of accepting. Dr. McNicol noted that the other 2011 Council Minutes were complete and will be sent to Council.
Suggested dates for Council Meetings in 2013 are January 2, 10, 17, 24, 31, JUNE 6, 13, 20, 27, and October 3, 10, 17, 24.
COUNCIL OPERATING PROCEDURES
Mr. William Darby, Chief, Grants Management Branch, reviewed Council Operating Procedures as required annually in compliance with the Public Health Service Act. During the review of applications assigned to the NEI, special Council consideration is given to those applications for which the initial review groups has identified concerns regarding the use of human subjects and vertebrate animal subjects; potential biohazards; and the inclusion of women, minorities and children in research. All applications from foreign institutions, as well as Phase III Clinical Trials within the funding range must also be brought to the Council for special consideration. In addition, those applications which are identified as raising questions regarding the adequacy of initial review, appeals, and are brought to the special attention of Council and well as applications identified by Staff or Council for consideration of high program relevance, and any application that Council Members or NEI Staff feel needs special discussion/consideration. All grievance letters will also be brought to the special attention of Council.
Actions available to Council are to concur or to non-concur with the recommendations of the initial review group, to defer for re-review, or to defer for additional information. Council agrees to delegate certain administrative actions to the staff: approving the appointment of a new Principal Investigator or changing the grantee institution, and providing additional funds when justified.
Appeals: An appeal letter will be accepted only if the letter 1) describes a flaw(s) or perceived flaw(s) in the review process for the application in question, 2) explains the reasons for the appeal, and 3) is based on one or more of the following issues related to the process of the initial peer review: evidence of bias on the part of one or more peer reviewers, conflict of interest, as specified in regulation at 42 CFR 52h “Scientific Peer Review of Research Grant Applications and Research and Development Contract Projects,” on the part of one or more non-federal peer reviewers, or conflict of interest statutes and ethical conduct regulations applicable to federal employees serving as peer reviewers, lack of appropriate expertise within the SRG, factual error(s) made by one or more reviewers that could have altered the outcome of review substantially. A letter that does not meet these criteria and/or does not include the concurrence of the Authorized Organization Representative (AOR) will not be considered an appeal, but rather a grievance. Appeal letters based solely on differences of scientific opinion will not be accepted.
Only two outcomes are possible following consideration of an appeal letter by Council. The Council may concur with the appeal, and recommend that the application be re-reviewed. Or the Council may concur with the SRG’s recommendation and deny the appeal. Although factual errors or other issues may be evident in the review, the Council may determine that these factors were unlikely to alter the final outcome when denying an appeal. If no action is taken by Council, the outcome is equivalent to concurrence with the SRG’s recommendation and denial of the appeal. The recommendation of Council concerning resolution of an appeal is final and will not be considered again by the NIH through this or another process.
Council members were reminded about the proper procedure in responding to contact from applicants.
Council noted that with the newly reorganized study sections, some applications may end up in the wrong study section and wondered if this could be the basis of an appeal. Dr. McNicol replied that there has been a lot of internal moving of applications around and everyone is working hard to get things right. If significant misassignment does occur, it may be handled through the appeal process.
THE FISCAL ENVIRONMENT
Ms. Marilyn Laurie, Chief, NEI Fiscal Management Branch, reviewed the NEI appropriation history from FY2008- 2012. She presented data on the total number of grants including both competing and non-competing awards, and success rates for NEI applications compared to the overall NIH success rate. In FY2011, the last year for which there is complete data, the NEI funded 1290 research grants, 240 training awards, and 43 Research and Development contracts for a total of $606.3M.
In FY2012, there were multiple continuing resolutions that resulted in monthly balancing of accounts and reduced and delayed funding of extramural programs. On December 23, 2011, a final appropriation was voted out. A full year operating plan has been submitted to the Office of Management and Budget (OMB) but has not yet been approved.
The FY 2013 budget has been submitted to DHS and OMB and is due to Congress on February 13, 2012. An appropriation for FY 2013 is not expected until well into the operating year. Operational challenges are being met to implement the President’s executive order for efficiency that directs federal agencies to reduce travel expenses, reduce conference expenses, and freeze the salaries of government employees. Ms. Laurie noted that the NEI continuously evaluates all programs to identify research and administrative efficiencies.
Ms. Laure was asked if NIH sets the intramural overhead or if it is determined another way. Ms. Laurie replied that the NIH does not have an overhead rate like universities and that the NEI tracks expenses separately, including those for Central Services.
MANAGING AND SETTING PRIORITIES
Dr. Paul Sieving discussed program planning and the report, Vision Research Needs, Gaps and Opportunities. This project began more than a year ago and came together at the 2011 at the ARVO meeting with six panels. These six panel reports are the ingredients the NEI and Council members need to identify areas of opportunity, and emerging areas warranting particular emphasis. The NEI is spending about $600M a year, funding roughly 30% of the applications that are submitted. The opportunities are growing by leaps and bounds while our budgets are flat. We hope they will continue to be stable for years to come. It is our job to plan on how we fold all these opportunities into funding. Program priorities are a discrete component of funding. The six panel reports that will be published have the input of 350 responses most of which came through ARVO. So, where do we go with this?
There are other ways to look at science beyond these six panel reports. The NEI also has cross-cutting program in genetics, in immunology. Perhaps we ought to take a discreet look across these panels at the immune system. I’m asking for you to come up with new ways to look at the portfolio. Then discuss what we plan to do next. We need to have a process that integrates all these ideas. We’ll open it up and make it a very transparent and a participant-oriented project having a lot of people looking at this. Let’s have a meeting of 100 leaders in and outside the vision community. Think of this as a national priority including other organizations and agencies such as NSF, DOD, DOE (which has been putting significant money into vision research), the FDA, CMS and other institutes who have an interest in vision, i.e., aging (macular degeneration) and diabetes. Let us think for a moment about where science is going. The Human Genome in 2001 was a large scale project that was a ground breaking effort that has been transformative for science. There is a continuum of science that needs to be funded. What science does this Council think we have to pay attention to?
Dr. Pierce asked if this was a request for help with the planning process of how to identify what might be the best science to fund, or, how to implement a program? Dr. Sieving replied that the issue is the move from the panel reports into some understanding of what constitutes a larger-scale program priority for the NEI and what is an emerging area that we might want to consider for high program relevance. Dr. Sieving said he envisions a bigger, open process with people who are thinking beyond the scale of a single R01.
Dr. West stated that there are six really good panel reports siloed into individual programs but there are not unlimited funds. We need to say where we really want to be in some point in time and what elements will help us to get there. What is the integrated vision for where those reports are going to lead us? We must step out of our respective comfort zones of retina, cornea, etc., to see what is going to take us there.
Dr. Zarbin offered the opinion that one way of looking at the Planning Panel document is to look at who produced it. He stated that the comments from others pointed to an absence of input from people who are not NEI funded investigators. He worried that we don’t have the full complement of scientific input.
Dr. Sieving stated that there are two tasks for today; one is to look at the six panel reports to say yes they are on track or no we need more input. The six panel reports are not plans. The other step is to make sure we look at this carefully and see if there are other things that are obvious that need to be looked at then discuss how to get there.
Dr. Copenhagen said that to have 100 people in a room trying to figure out a plan could be a disaster but on the other hand if you spend an afternoon talking you may come up with more ideas than you know what to do with. One could get groups together to interact, those who are not vested in their own particular projects and talking to evaluate recent development, to brainstorm for new ideas. And not just to generate but to evaluate ideas.
Dr. Chodosh agreed then stated the problem is not the report as it is obsolete as soon as it is written since the science is moving so rapidly. It needs to be dynamic and ongoing by engaging ARVO. Dr. Sieving replied that we need to finish off the panel reports so that they are not totally out of date. Then, think, in fiduciary terms, how to advance scientific research.
REALITIES OF NEW BIOLOGY: MOVING SCIENCE KNOWLEDGE TO DISEASE APPLICATION
Dr. Richard Fisher stated that the document entitled, Needs, Gaps and Opportunities, is to help the NEI identify scientific opportunities, fund the best science, properly direct resources, and attract and train the best and the brightest to vision research. Drs. Jenny Mehren and Dr. Shefa Gordon were acknowledged for collating the panel reports into a single document.
Dr. Fisher explained that one of the issues is the use of six panels and asked, “Why weren’t there panels on genetics or immunology?” Another issue is the way the program directors developed the panels. Council should talk about the specific comments they may have, incorporate these into the report, and then it will be put it on the web to solicit feedback. There is no single way to do planning. If one looks across the NIH much of what is funded is based on the rank of the study sections.
Dr. Morrison remarked that Dr. Fisher mentioned the idea of possibly not presenting this in the six disease groups, or panel reports. He stated that he actually likes the way it is laid out because it helps people understand. But he what he would like to see is something showing the many ways these diseases overlap. For example, when cells die in glaucoma there is an effect on other areas. Glare sensitivity and a lack of contrast are huge problems. He thinks it might be useful to consider where these diseases overlap and impinge upon each other.
Dr. Cline stated maybe a different type of framework could be useful in making more informed decisions. Taking a lesson from industry, we could lay all these ideas out as a pipeline which will allow us to feed into the types of programs that would lead us and allow us to place this in a continuum that would allow us to grow. Dr. Chodosh agreed that this was a transformative suggestion. Then he asked, “Why don’t we set some dates and lay out a framework to cure a disease?” Sometimes we lose focus but this way we stay focused and are more effective.
Dr. Fisher replied that to go forward with these ideas and reformulating the panel reports is not something that could be accomplished in weeks or months. Dr. Chodosh indicated that he was not talking about throwing away the panel reports but about going forward. Dr. West added it may not have to be in each of the six panel reports but it could be in the main overview for vision research. There are two elements. One is the comprehensive knowledge update on a regular basis and the second is the application of that knowledge. Those are two elements that the pipeline feeds and that would be a powerful approach. Dr. Cline said not to throw out the panel reports but to reformulate them. Dr. Pierce stated that something was missing; something was needed to pull all of this together.
Dr. Sieving stated this is not a national plan. This is a six panel report, thoughtfully done and accumulating lots of ideas, and, it needs to go out because it constitutes a data set for the NEI to develop a comprehensive national plan. He asked for a show of hands, yes or no, whether this constitutes the NEI national plan. It was unanimously no.
Mr. Philip Lee began a discussion of goal setting by stating that the objectives at hand start by reviewing the status of “Vision Research Needs, Gaps and Opportunities,” looking across the six panel reports to identify areas of great opportunity and emerging areas warranting particular emphasis. Then we will discuss how to distill NEI research priorities and provide input on topics/areas for the next stage in the process (e.g., workgroups, other approaches).
He voiced the concept of fundamental and disruptive discoveries in biology and noted that the 2001–2011 decade produced extraordinary scientific discoveries that impact the way we conduct research and how we move toward exploring and developing therapies. An example he gave was how the 21st century began with the complete human genome sequencing and gave other examples revolutionizing the search for therapies. The conundrum was how to balance the current NEI science portfolio and budget with burgeoning research opportunities.
He reviewed how NIH applications are judged and funded based on scientific merit, program priorities, and the availability of funds. Identifying research priorities takes into account the six Panel Reports but an NEI Meeting on Integrated National Vision Research Priorities could delineate a non-silo approach to identify emerging areas of opportunity. The format of such a meeting would be “100” vision & non-vision scientists, including other NIH ICs and Federal agencies, professional societies, non-profit research organizations, and advocacy groups.
Mr. Lee suggested several criteria to be considered for priority selection. He included topics such as relevance to visual disorders, high impact/high significance science, innovation for understanding /treating disease and /or for biology, potentially transformative opportunities needing more emphasis like enabling technologies, establishing proof of principle, and emerging areas of science. He remarked that scientific pursuits are a continuum with discoveries that occur along a scale from the large scale Human Genome Project to the individual investigator with the example of Yamanaka and iPS cells.
Mr. Lee asserted that the process needs to be dynamic and on-going, and it cannot be limited to five years. The process should be inspiring, rigorous, and inclusive with big audacious goals. Council asked how this would work. Mr. Lee replied that there is an approach to large meetings called open space technology. It flips the design of the conference and you simply provide the times and the rooms. There are the rules. You go up and write down what topic you want to talk about. Whoever feels energy from that topic can have that conversation and report later. People are having the conversations they want to have and if you’re not happy, you can leave.
This generated much discussion and debate on audacious goals, with ideas on what those goals could be and how this would fit into/complement the panel reports. Council members mentioned cures, diagnostics, therapies, and prevention. Criteria for priority selection were reviewed. Suggestions for goals included the microbiome of the ocular surface, the complete genetic architecture of the eye, epigenetics of age-related eye diseases, neuroplasticity, and regeneration and stem cells. However, it was noted that these are already in the panel report and are not audacious goals. A Council member also stated that these topics are not diseases and are not pathway-based.
In the interest of being dynamic and since the next Council Meeting isn’t until June, a Council Subcommittee/Working Group will meet to keep the ball rolling. They will be the ones Dr. Sieving and others can keep in touch with.
Dr. McNicol mentioned that there needs to be a vote on acceptance of the panel report. There can be no official implementation of the plan if it has not been accepted by the Council. Dr. Zarbin asked if it would it be in Council’s purview to ask that the comments that were made by Drs. Morrison, Dr. West, and Pierce be inserted into the document. Dr. McNicol replied that as amended by Council would be very appropriate. The intention is to incorporate Council’s comments. Dr. Sieving asked for acceptance of the panel reports as amended and it was unanimously accepted. Dr. McNicol assured Council that they would see the amended panel report before it was posted for public comment.
GENERAL COUNCIL DISCUSSION
Council members addressed the issues of study section reorganization in CSR and the review of clinical trials by special emphasis panels convened by the NEI Scientific Review Branch and the continuity of these reviews.
Dr. René Etcheberrigaray discussed the CSR review of grant applications assigned to the NEI. Formerly, these reviews were done in vision-centric study sections based on the anatomical organization of the eye and the visual system. The Study Sections, Anterior Eye Disease (AED), Biology and Diseases of the Posterior Eye (BDPE), Central Visual Processing (CVP), and Cognition (COG), reviewed ~70% - 80% NEI applications, excluding SBIR/STTR & Fellowships. In designing the new Study Sections, the guiding principle was scientific content.
The three new study sections are Diseases and Pathophysiology of the Visual System (DPVS), Biology of the Visual System (BVS), and Mechanisms of Sensory, Perceptual, and Cognitive Processes (SPC). This plan was endorsed by a Working Group in April 2011 and by CSR’s Advisory Council in May 2011. The new study sections were approved by NIH’s Office of Federal Advisory Committee Policy in June and July 2011.
Implementation was informed by new draft guidelines which were used to perform a retrospective sort of the applications from FY2009. The guidelines were then refined. CSR discussed the proposed new study section assignments with the chartered reviewers. The wider scientific community was informed through a presentation to NAEC in June 2011, followed by material posted on CSRs web site and short articles published in the ARVO Insight.
In the refined new system, BVS reviews applications on basic biological studies of the visual system, where the major focus is on elucidation of fundamental mechanisms in normal visual function and/or within the context of disease. DPVS reviews applications using basic and clinical approaches to study the visual system, where the major focus is on etiology, pathophysiology, prevention, diagnosis, and treatment of diseases and disorders. And SPC reviews applications that focus on mechanisms underlying visual perception, attention and other cognitive processes.
Initial results and observations on the functioning of the new study sections show that for BVS there were 90 applications for the May 2012 Council round with 42% “AED” and 58% “BDPE.” DVPS had 103 applications, with 48% “AED” and 52% “BDPE.” SPC had 86 applications for the May 2012 Council round and 74 for the October 2012 Council with even contributions from “COG” and “CVP”.
The advantages in general are the combined member special emphasis panel review, providing more diverse and complete review of applications from members or individuals who submit for continuous submission. No additional special emphasis panels or “sister study sections” are needed. No study section is too small. The advantages in BVS are that all ocular development and regeneration applications are reviewed together, and many of the reviewers with this expertise from both AED and BDPE study more than one ocular tissue/cell type. The advantages in DPVS are that many retinal degeneration applications have an inflammatory component and basic immunologists from AED can help review these applications. Applications proposing development and analysis of imaging for glaucoma (AED) and retinopathies (BDPE) can utilize some of same reviewers. Reviewers with expertise in angiogenesis/neovascularization in corneal disease or retinopathies can cross review to some extent.
SPC was created by merging CVP and COG, two smaller study sections with a large amount of overlap. The expertise previously on the CVP and COG panels was maintained on the new SPC panel. Several ad hoc reviewers were included on the panel which added to the breadth of expertise. The larger panel made it easier to match applications with reviewer expertise. The reviewers worked well together and cooperated to make the merger successful. The review meeting ran smoothly, and the critiques seemed balanced and fair, with a good score distribution.
Dr. Etcheberrigaray stated that a point was made about the small number of MDs on the review panel. CSR hopes to have more MDs participate. Eight to nine of the current reviewers are MDs and there are at least four more being recruited. He asked Council to pass the word to your colleagues who are MDs since Council members are in a position of influence.
Dr. Cline commented that as a result of the reorganization leading to SPC, one of the causalities is that many of the studies of development of the central visual system have been moved to other study sections that do not have expertise in those areas. Dr. Etcheberrigaray asked Dr. Melchior to reply and she stated that there always have been very few developmental applications and there is not a very big presence of molecular-level scientists. Therefore the applications were moved to a more molecular panel. These molecular panels do find reviewers who understand the visual system. Dr. Cline responded they don’t necessarily have the expertise and asked CSR to encourage a greater representation of people who have specific expertise in this area.
Dr. Zarbin noted that the problem of getting reviewers to serve on study sections develops at the institutional level, since the way people get tenure is through accounting instead of impact. If promotions committees defined a factor that service on study sections was a criterion for promotion, it would be easier to recruit reviewers. This would create a new metric and should be a common metric. He stated that no single academic department could do this. NIH senior leaders should raise the issue with the Deans of medical schools. Dr. Copenhagen liked this idea and said that at the University of California, San Francisco, if faculty members were to get a year’s acceleration for tenure based on study section service, there would be no problem filling review committees.
Dr. Copenhagen stated that although he was concerned about the reorganization of the study sections he thought also thought that a good job was being done in getting the appropriate expertise on the new study sections. One perception leading to concern is because the information posted on the CSR web is not up to date. Dr. Etcheberrigaray replied that the meeting roster is up to date at least 30 days before the meeting but there are some adjustments to be made and there are still approvals and delays for the posting of the actual membership roster.
NEI COOPERATIVE AGREEMENT (U10) GRANT FUNDING AND REVIEW: HISTORICAL EXPERIENCE
Mr. Donald Everett reviewed the structure of a typical U10 Cooperative Agreement for a Phase III Clinical T. The study typically includes a Study Chair, a Coordinating Center, Reading Center(s), and enrolling clinics. Over the historical span from FY1978 to FY2011, Research Project Grants (RPG) had an average success rate of 34%, while U10s had a similar success rate of 39%. More recently, however, from FY2005 to FY2011, the average success rate for U10s rose to 46% while the rate for RPGs fell to 27%.
Dr. Anne Schaffner stated that the goals of the NEIs Scientific Review Branch for the review of U10s were continuity of reviewer(s) whenever possible noting that this already occurs about 90% of the time. It is also important to have depth of expertise, ideally a minimum of three subject matter experts. The use of recurrent SEP Members allows some standardization over review cycles. One remaining goal is to set up reviews earlier in the review cycle to better permit inclusion of clinicians. This may be easier now that the Branch has a third Scientific Review Officer on board (as of February 13).
Dr. West stated that this was incredibly informative she was glad to see how the reviews are setup. Mr. Everett noted that the challenge here is to make sure we really get this review right, with good continuity, and appropriate expertise. While there always may not be the same individuals, there is always the appropriate expertise.
Dr. McNicol asked if there were any other general topics that Council would like to raise for discussion. Since none were brought up, the open session of Council was adjourned.
CLOSED SESSION OF THE MEETING – 03:00 pm
The meeting was closed to the public at 3:00 p.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, 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
The meeting was adjourned at 5:00.
I hereby certify that, to the best of my knowledge, the foregoing minutes and attachment(s) are accurate and complete.
Loré Anne McNicol, Ph.D.
National Advisory Eye Council
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
5635 Fishers Lane, MSC 9300
Bethesda, MD 20892-9300
Telephone: (301) 451-2020
FAX: (301) 402-0528