National Institutes of Health
National Eye Institute
National Advisory Eye Council
One Hundred Twenty-ninth Meeting
October 13, 2011
The National Advisory Eye Council (NAEC) convened for its one hundred and twenty-ninth meeting at 8:30am on Thursday, October 13, 2011, at 5635 Fishers Lane, Rockville, Maryland,
20852. Paul A. Sieving, M.D., Ph.D., the Director of the National Eye Institute (NEI), presided as Chair of the Council. The meeting was open to the public from 08:30a.m. until 12:55 p.m. The meeting was closed to the public from 02:00p.m. until adjournment for the 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. David Copenhagen
Dr. Scott Cousins
Mr. Ron Gardner
Dr. Donald Gagliano
Dr. Charles Gilbert
Dr. John Morrison
Dr. Krishna Sharma
Dr. Sheila West
Dr. Marco Zarbin
COUNCIL MEMBERS ABSENT:
Dr. Bernard Godley
Ms. Alberta Orr
NEI STAFF PRESENT:
Dr. Houmam Araj
Dr. Neeraj Agarwal
Ms. Stephanie Benjamin
Ms. Pamela Bobbitt
Dr. Deborah Carper
Ms. Monique Clark
Ms. Janet Craigie
Ms. Linda Dingle
Mr. Donald Everett
Dr. Richard Fisher
Dr. Shefa Gordon
Dr. Tom Greenwell
Mr. Dustin Hays
Ms. Jean Horrigan
Ms. Tina Jones
Mr. Kevin Keating
Dr. Daniel Kenshalo
Dr. Natalie Kurinij
Ms. Marilyn Laurie
Dr. Ellen Liberman
Dr. Andrew Mariani
Dr. George McKie
Dr. Matthew McMahon
Dr. Lore Anne McNicol
Dr. Jenny Mehren
Ms. Kathleen Moy
Dr. Lisa Neuhold
Dr. Steven Oversby
Dr. Maryann Redford
Dr. Gale Saunders
Ms. Karen Robinson-Smith
Dr. Anne Schaffuer
Dr. Eleanor Schron
Dr. Grace Shen
Dr. Paul Sieving
Ms. Chantel I Stevenson
Dr. Michael Steinmetz
Dr. Christopher Thomas
Dr. Santa Tumminia
Ms. Keturah Williams
Dr. Jerome Wujck
OTHER NIH/DHHS STAFF PRESENT:
Dr. Michael Chaitin, Center for Scientific Review (CSR)
Ms. Mary Frances Deutsch, Office of Extramural Research
Dr. Samuel Edwards, CSR
Dr. Rene Etcheberrigaray, CSR
Ms. Michelle Feige, Office of Human Research Protections (OHRP)
Dr. Nataliya Gordiyenko, CSR
Dr. Sally Rockey, Office of the Director
Ms. Samantha Smith, OHRP
Dr. Kirk Thompson, CSR
MEMBERS OF THE GENERAL PUBLIC PRESENT AT THE OPEN SESSION:
Ms. Joanne Angle, Association for Research in Vision and Ophthalmology (ARVO)
Dr. Bobbie Ann Austin, ARVO
Ms. Shannon Curtis, American Academy of Ophthalmology (AAO)
Mr. James Jorkasky, National Alliance for Eye and Vision Research (NAEVR)
OPEN SESSION OF THE MEETING
CALL TO ORDER AND OPENING REMARKS
Dr. Mariani welcomed all attending and briefly outlined the agenda for the day.
FY2012 BUDGET: CONTINUING RESOLUTION
Ms. Marilyn Laurie, Chief, Financial Management Branch, NET, presented an update on the budget beginning with a five year appropriation history. Funding for FY2011 was $701M. Over $600M was allocated to the Division of Extramural Research for research and research training grants and less than $100M was allocated for intramural research and research management and support. Ms. Laurie noted that for FY 2012, the NIH was currently operating on a continuing resolution until November 18, 2011 at a reduced level from FY20I0.
For FY2013, the budget is in the initial formulation stage. Major considerations include an OMB Directive to project scenarios with 5% and 10% reductions, the Budget Control Act of 2011, the Super Committee’s recommendations or an automatic $1.5T cut, and the 2012 elections. Dr. Cousins asked if Ms. Laurie could assume an across the board cut, what will that mean for the NEI? Ms. Laurie replied that a 10% reduction would be approximately $70M.
NEI LOAN REPAYMENT PROGRAM
Dr. Neeraj Agarwal reported on the NIH Loan Repayment Program (LRP) at NEI for FY2011. He noted that the LRP is intended to attract health professionals to careers in research. NIH grant support not required. The program is for two years and up to $35K payback of qualified educational debt is allowed, plus tax payments at 39%. They are renewable, if eligibility criteria continue to be met. The candidates must perform patient-oriented clinical research; devote a minimum of 50% effort for two years; and be a United States citizen, U.S. national , or, permanent resident. The application is available online. The NIH will repay educational loans backed by the U.S. Government and educational loans from accredited U.S. academic institutions and commercial lenders. The NIH will not repay home equity loans, loans consolidated with another individual (i.e. spouse, child), PLUS loans, delinquent loans, loans in default; or loans not current in repayment. Dr. Agarwal presented data on the number of loans repaid by the NEI for FY2011. A total of 37 applications were received and 32 applications were funded for an 86% success rate.
Dr. Bonanno asked why applicants were not eligible if they went into medicine and Dr. Agarwal replied that the program is designed to attract clinicians to research. Dr. Copenhagen asked why some did not get the loan repayment. Dr. Agarwal explained that some do not qualify because their loans do not qualify, or, they score poorly in review.
NEI SMALL BUSINESS REGULATORY ASSISTANCE PROGRAM PILOT
Dr. Matthew McMahon introduced a pilot NEI Small Business Regulatory Assistance Program as an extramural grant program for companies that have developed vision products. These products are produced in three phases. The first is to provide a prototype. The second phase is funded to develop the idea into a product. Phase three, commercialization, is not funded by the NEI , and firms must obtain outside funding. Many companies develop drugs or other devices that need approval from the FDA. Some companies do not have experience with the FDA and often will not get approval. The new program will provide companies with 30 hours of high-quality consulting by a firm so they can develop a step-by-step regulatory plan to achieve approval through the FDA. This program is modeled on a program established by the National Cancer Institute (NCI) last year. The NEI is collaborating with NCI to provide efficiency on the financial side by working with a consulting company already under contract. The NEI is hoping to release the request for applications by February 2012 and to provide funding in March 2012.
When asked what problems SBIR grantees encountered, Mr. McMahon replied that many companies working on drug studies do not understand the requirements for toxicity or other data the FDA requires. Good manufacturing and laboratory practices are strict and many times the grantees think they understand only later to find out their data are not acceptable to the FDA. Also, there are many regulatory routes companies can take. Early on the company makes a decision which direction to go and this affects which regulatory approval process. Dr. Copenhagen asked whether the NEI picked the consultant. Dr. McMahon replied that Regulatory Affairs Associates is the consulting firm the NEI is using for the pilot, as they have expertise. This way the contract is much simpler and is easier to get up to speed with a company who has experience running this type of program. To be eligible for the regulatory assistance, the company can have an NEI-funded phase I or II SBIR in the past two years.
Dr. Zarbin asked if it is an elective to get this type advice at the first part of the process and Dr. McMahon replied that the consulting is separate from the award. Dr. Zarbin stated beginning with the end in mind would be useful, at the beginning of the process. He thought the value of the advice is diminished by the structure of the program the NEI is providing. Dr. McMahon stated it is a trade off as there are some SBIRs that don’t make it all the way through.
Dr. Wujek noted there has been an increase in companies applying whether they were start-ups, engineers, or larger companies. Some companies are quite green and really need the help. One company had gone through phase I but made an error with the FDA with their data. Some companies are well established and oth.ers may have their own consultants. However, there are those who may have only been around the last five years who do need help. Many companies can benefit and that is a part of the NEI process, to establish who could benefit the most given.
Dr. West inquired about the average cost of the award is and Dr. McMahon replied that the awards provide 30 hours of consulting, not money, but it is estimated to cost approximately $1 0K. Dr. Bonanno asked Dr. Wujek how he notified the current awardees and Dr. Wujek replied that he goes through the ARVO newsletter and other venues to advertise availability.
OFFICE OF SCIENCE COMMUNICATIONS, PUBLIC LIAISON, AND EDUCATION: NEWS AND UPDATES
Dr. Deborah Carper discussed updates from the NEI Office of Science Communications, Public Liaison, and Education (OSCPLE). She noted that today, October 13, was World Sight Day, an international day of awareness bringing attention to blindness and visual impairment. World Sight Day was started in 1998 by VISION 2020, a global initiative of the World Health Organization and the International Agency for the Prevention of Blindness. Dr. Carper also reviewed other national vision health observances held or to be held in 2011. These include Healthy Vision Month, May 2011, an NEI to elevate vision as a health priority and promote comprehensive dilated eye exams using social media, radio and print.
New initiatives from OSCPLE are the Oral History Initiative, exhibits, interactive web pages, science reporting on new studies and treatment trials, and the National Eye Health Education Program (NEHEP) planning objectives for the next five years. Dr. Carper asked Council members to participate by arranging to do oral and or written interviews, as several vision researchers have already done. She noted that NEHEP is on Facebook, Twitter, and has sponsored six YouTube videos.
Dr. Zarbin stated that July would be a good month to have a vision health observance on firework injuries. He thought this would be a good step towards preventing eye trauma. Dr. Carper asked the Council members to please contact her with suggestions.
NEW FINANCIAL CONFLICT OF INTEREST REGULATIONS
Dr. Sally Rocky, Deputy Director for Extramural Research, NIH, discussed the new conflict of interest regulations. She noted that relationships between academic investigators and industry are important because the public benefits from collaborations to develop products that promote individual and public health. Academic researchers do most of the basic research that underpins much of the advances in medicine. Industry often builds on that basic research to develop therapeutic drugs and devices. Therefore, it is essential not to stifle these relationships.
Maintaining objectivity in research is equally important because it preserves the public trust, promotes the integrity of the institution, the investigator, the data, and the DHHS/NIH. Maintaining objectivity in research provides transparency. Therefore, in 1995 HHS published regulations to promote objectivity in research. With regard to Financial Conflict of Interest (FCOI) Regulations, HHS is the only agency that has regulations governing financial conflicts of interest of extramural investigators. These regulations establish standards that provide a reasonable expectation that the design, conduct, and reporting of research will be free from bias resulting from investigator FCOI.
Dr. Rocky noted that Significant Financial Interest (SFI) is any financial interest of the investigator (and those of the investigator’s spouse and dependent children) that reasonably appears to be related to the investigator’s institutional responsibilities. This includes anything of monetary value, such as: salary, consulting fees, honoraria, equity, and intellectual property rights. FCOI is an investigator’s SFI that the Institution determines could directly and significantly affect the design, conduct, or reporting of PHS-funded research.
The recent environment has been influenced by media reports of NIH as ‘unapologetic’ and
‘laissez faire.’ The issue received attention in Congress when Senator Grassley on 1/18/08 stated, “Universities receive NIH dollars with the understanding that they will manage their researchers’ conflicts of interest. … Universities need to take this issue more seriously, and the NIH should monitor its grants more closely for this problem.” Senator Grassley and others continue to announce cases of alleged financial misconduct by investigators. The FY2009 Appropriations
Bill called for NIH to strengthen oversight of extramural FCOI and gather input from the public. HHS published an Advanced Notice of Proposed Rulemaking in May 2009 requesting comment on whether the regulations should be amended. A Notice of Proposed Rulemaking (NPRM), proposing significant revisions to the regulations, was published in May 2010.
The Final Rule on FCOJ Regulations was published in the Federal Register on August 25, 2011. Implementation will be no later than 365 days after publication of the final rule in the Federal Register. In the interim, institutions must comply with 1995 regulations, revise policies, establish procedures for compliance, and train their investigators. The NIH will provide training materials for extramural community and NIH staff, and expand the FCOI reports database.
Major changes to the regulations include defining SFI with a minimum threshold of $5,000. All SFIs related to investigators’ institutional responsibilities must be disclosed to the institution and the institutions are responsible for determining whether SFIs relate to PHS-funded research and are financial conflicts of interest (FCOI). Before spending funds for PHS-supported research, an institution shall ensure public accessibility of information on certain SFIs that the institution has determined are related to the PHS-funded research and are FCOI, via a publicly accessible Web site or by a written response to any requestor. FCOI training is required for investigators before engaging in PHS-funded research, every four years thereafter.
REFORMING REGULATIONS ON HUMAN SUBJECTS
Ms. Michelle Feige, Office of Human Research Protections (OHRP), spoke on an Advance Notice of Proposed Rulemaking (ANPRM) on Enhancing Protections for Research Subjects and Reducing Burden, Delay and Ambiguity for Investigators. OHRP provides leadership in protection of the rights, welfare, and well-being of subjects involved in research conducted or supported by DHHS. They also develop educational programs and materials, maintain regulatory oversight, and provide advice on ethical and regulatory issues. Suggestions and comments in the ANPRM will not be implemented without further notice and comment.
As background, Ms. Feige noted it has been 20 years since the “Common Rule” was adopted. Since then, the landscape of research activities has changed dramatically, raising the question, “Is the current regulatory framework adequate and appropriate?” Indications of a need for revision has come from the Institute of Medicine, the U.S. Government Accountability Office, and a 2001 Report of the National Bioethics Advisory Commission. Specific areas of concern include: inadequate calibration of review processes, inefficiencies of review by multiple IRBs, problems with informed consent, changed nature of risks/benefits, and lack of regulatory harmonization. Proposed changes include: refinement of risk-based protections streamlining IRB Review of Multi-Site Studies, improving consent forms, improving data collection to enhance system oversight, and clarifying regulatory requirements.
Currently, the Scope of Regulations applies to non-exempt human subjects research conducted or supported by the Common Rule agency, or if an institution has “checked the box.” The proposal is to require domestic institutions that receive Federal funding from Common Rule agency for research with human subjects to extend protections to all research studies conducted at their institution.
Dr. Morrison asked what the time line was and Ms. Feige that they are trying to fast track but sometimes these things can take years. Dr. Chodosh stated there are many institutes that have a religious orientation that do not take federal funding. Then he asked what level of regulation do they have for human research? Ms. Feige stated hopefully they will have their own policies or
state or local laws may be applicable but for some institutes that do not get federal funding there are no regulations.
Dr. Zarbin raised the issue of the impact of these requirements on research by medical residents which is a requirement of their residency and which is often conducted under a timeline that does not allow a full lRB review prior to commencing the research. Perhaps OHRP can enable a department chair in some way to become responsible to review those projects. Ms. Feige replied that she thought that was a good comment and that Dr. Zarbin might want to send it in. Dr.
Zarbin then stated that in his institute, resident research would get an expedited review as it’s
actually an internal departmental review process.
Dr. Gordon stated Ms. Feige had mentioned that the regulations only applied to institutes that received federal funds. He then asked if a biotech company conducted a clinical trial using human subjects, if the FDA would not consider them. Ms. Feige answered that if it doesn’t fall under the FDA regulation and doesn’t get federal funding, these regulations will not apply.
DIRECTOR’S REPORT AND REMARKS
Dr. Paul Sieving welcomed Dr. Sheila West to the Council and thanked her for her willingness to spend her time advising the NEI on matters of business. Dr. West comes from Johns Hopkins
and is a professor of ophthalmology and epidemiology. When not at Johns Hopkins she can be found in Africa working on trachoma. Her work netted her recognition from the Gates Challenge Award. He then recognized and thanked the three members of Council who’s terms of appointment end this year, Mr. Ron Gardner, from the National Federation of the Blind, Dr.
Scott Cousins, from Duke University Medical Center, and Dr. Charles Gilbert from the Department of Neurobiology at the Rockefeller University and they were presented with certificates of recognition signed by the Secretary, DHHS.
Dr. Sieving introduced Dr. George Ann McKie, who is now a program director for the Ocular Infection, Inflammation, and Immunology Program. Dr. McKie has a doctorate in veterinary medicine from University of Missouri and did training at the University of Wisconsin. She is among a handful of ophthalmic veterinarians in the country.
Dr. Sieving stated that Ms. Marilyn Laurie had presented numbers in which the Senate took away $200 million and the House gave NIH a billion more and somewhere in the middle the NIH hopes for the actual budget. The Senate expressed support for the National Center for Advancing Translational Sciences (NCATS) that Dr. Frances Collins is proposing, whereas the House did not.
The NCATS mission is to further opportunities for translational science. The emphases will be on tools, methods and technologies. We will hear from the community that translational science will take away their research opportunities, but that is not the case. There is great public and Congressional interest in transforming basic medical science into treatments, therapies and cures for people with medical needs and that driving force is not going to go away.
Dr. Sieving directed attention to the Common Fund, begun under Dr. Zerhouni as the Roadmap
Initiative, for opportunities that provide a strategic and nimble approach to address key roadblocks in biomedical research that impede basic scientific discovery and its translation into improved human health. In addition, these program s capitalize on emerging opportunities to catalyze the rate of progress across multiple biomedical fields. Common Fund programs are expected to transform the way a broad spectrum of health research is conducted.
Finally, the Lasker-Bloomberg Public Service Award for 2011 went to the Clinical Center (CC) of the National Institutes of Health. The budget of the CC is about $350 million. The CC has about 95,000 patient visits a year and 7,000 inpatients for exploratory medical intervention. There have been major discoveries made in the CC providing innovative therapies to treat a variety of diseases. Of relevance to the CC is the difficulty of funding the CC. It is funded by taps to the institutes and as healthcare costs rise, it is increasingly difficult to pay for the clinical research which undergirds the very essence of the NIH. The Lasker-Bloomberg Award is recognition that NIH has unique opportunities and a depth of resources unmatched by all but a few medical programs across the country and the world.
STATUS OF PROGRAM PLANNING
Dr. Richard Fisher discussed the status of program NEI Program Planning, 2011. The aim is to update the 2004 plan 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. An RFI was issued asking what are the most significant scientific discoveries in vision research that have occurred since 2004, and what are the most significant scientific research needs, gaps, and opportunities that should be addressed by the NEI.
There were 75 responses to the RFI from 8 groups including ARVO, AOA , DRCR, PEDIG, etc. The ARVO response was from 300 members and trustees and it was 71 pages in length, organized by ARVO Scientific Sections, Anatomy and Pathology; Biochemistry and Mol Biology, Clinical Research/Epidemiology, Cornea, SAVP, Glaucoma, Immunology and Microbiology, Lens, Physiology/Pharmacology, Retinal Cell Biology, Retina, Psychophysics, and Neurophysiology.
NEI Planning Panels were Retinal Diseases, Corneal Diseases, Lens and Cataract, Glaucoma and Optic Neuropathies, Strabismus, Amblyopia, and Visual Processing, and Low Vision and Blindness Rehabilitation. The overall charge was look at the field broadly and not just their own lab and funding, and to consider carefully all comments received from the RFI. Sixty-eight extramural scientists, DER program staff, and OPPA staff participated.
The Panel Reports consist of an Introduction, Highlights of Recent Progress, and Needs, Gaps, and Opportunities. Target audiences for the Plan are researchers and professional organizations, NEI Staff and NAEC, public/ private foundations, patient advocacy groups, and Congress. OPPA is converging on the notion that the needs gaps and opportunities are more targeted to the researchers and the rest will be more accessible to the public.
The next steps now that the Panel Reports are completed are the addition of introductory text, sidebars, etc. The NAEC will receive the draft in November/December. A public draft will be posted for comment and then the Plan will be published and posted on the web.
It was thought that there would be a draft before this meeting but it is not completed yet. Before putting it to the public, we wanted your input of what we have and where do we go from here. Once the reports are complete, it may not be a 2011 plan, we will be generating introductory text and get the draft to Council.
Dr. Chodosh stated that it is a difficult task to identify the existing strengths and unmet needs. We identified ocular pain as one. There are gaps that require attention, if not funding. It’s a moving target. What you identify right now may be different in a year or two and how can the plan be relied upon with the inherent conflicts of interest of the responding community? The plan could be obsolete in a year. Has there been any progress in making the plan more living,
dynamic and changing? Dr. Fisher replied that outside of workshops there’s been nothing
specific a bout identifying new opportunities.
Dr. Zarbin stated he was surprised not to see regenerative medicine as a section of the plan and that might be a mistake. Dr. Fisher replied that regenerative medicine was certainly part of many sections of the plan. It was not omitted. The sections of the Plan are based on the six NEI Program Areas. ARVO has 15 areas. Dr. Zarbin then stated those things are going to change.
“Communication is a big deal and this will undermine the quality of the work you are doing if you communicate it properly. The boxes are not making any sense anymore and might need to be addressed.” Dr. Fisher stated this is something we talked about. It’s important for us to convey clearly in the beginning that we get the message out of how the NEI is organized and what it means.
Dr. Chodosh stated there should be a process that is more dynamic. Each year or month there could be edits as science is changing rapidly. How we think about something sends a message. Should we have a process which is least interval-oriented and more on going? You talked about that last time but what came out of it? Dr. Fisher stated time has passed. I think if this is a common thread maybe there needs to be more discussion outside of this particular meeting, maybe a subset would want to have a discussion. It depends on the sense of the Council.
Dr. Cousins stated that the program relevance issues have to be educated by the five-year plan and real time discussions of how this body could translate the strategic plan, not changing what is generally funded, but by choosing a handful of topics.
Dr. Gagliano was interested in how the retrospective analysis would be framed about what has happened and what the impact was, which could be an indicator for the future. Dr. Chodosh asked Dr. Fisher if he has looked at the past plans to see if they were useful. Dr. Fisher replied that an analysis of past plans has not been done. The question is, “how does one measure success?”
GENERAL COUNCIL DISCUSSION
Dr. West raised the issue of the review of clinical trials by Special Emphasis Panels convened by
the NEI Review Branch. Her concern was that since only a single resubmission of an application was now allowed, applicants had only one chance after the initial review, and if the review panel was not a standing study section but rather a Special Emphasis Panel, the reviewers might be different raising new and different concerns, not previously identified in the fi rst review, and
there would be no chance to address these new concerns. She asked, “Can we look at and understand how these special study sections are put together and if there is some mechanisms that we can explore so that the same people or most of the same people will see the application through this process.” Clinicians who do this research would then have some reassurance that new issues and concerns would not be raised.
Dr. Copenhagen asked if these applications were reviewed by regular CSR panels. Dr. West stated, no, they are reviewed by NEI not CSR so these can be to some extent managed by the NEI because they are convened by the NET. Dr. Zarbin asked, “Do we think the people who review it initially are not the same ones who review it again, and do we think that is a cleansing process or a destruction process?” I understand what you are saying but maybe it is good to have others looking at it.
Dr. Cousins stated that it is double jeopardy, being tried for the same crime. Unless there is a major flaw, reviewers should not micromanage the details of the grant. He wondered whether the study section chairs are managing their sections as well as they can.
A Council Member stated that when we send in papers, the journal wants the same ones who reviewed it the first time to review it the second time. Why is the way we review grants different? Someone pointed out that there are difficulties dealing with physicians with busy schedules and getting them back to meetings. Dr. Anne Schaffner replied that the NEI does try to provide continuity in review but there are, sometimes, problems encountered as conflicts with the original reviewers may arise in the resubmission or that the original reviewers are no longer able to return to do a review.
Dr. West said she appreciates the issues Dr. Schaffner raised when there is a Special Emphasis Panel but these problems likely would not arise if there were a standing committee with 3 to 4 year tenure. If possible, some statistics looking at what has been done over the past five years and how often applications are looked at by a completely different group would be useful. You have all the data and I sense this is worthy of further investigation. Dr. Mariani stated that the data could be gathered and provided to Council.
Dr. Schaffner added that when the pros and cons of having a standing study section to review clinical trials, it is not practicable because of the very small number of trials, the breadth of the science, and variability. The issue of continuity cannot be guaranteed even with a standing committee as a portion of the members rotate off every year and new members take their place. She noted that the Review Branch works closely with program staff to determine the appropriate expertise necessary for the review of these applications.
Dr. Sieving stated, evidently, people are saying they feel something has occurred unfairly. He asked. “Is this common?” and noted that there aren’t very many so it cannot be too frequent.
Dr. Chodosb said that it is a complaint that the people on study sections are generally not well trained in clinical research, and may not understand the questions. What I hear is frustration with
the process. The two reviews might not be the issue but rather the reviewers assigned to the panel. He stated that having a different panel review a resubmission is a disaster. Dr. Cousins
said a consistent chair could bring in the review history and enforce the same ground rules. Dr. Chodosh agreed.
Dr. West asked for a follow up on the discussion and some ideas for solutions and Dr. Sieving affirmed that there will be a follow up at the next Council meeting.
Another issue was raised by Dr. Zarbin about the review of the NEI’s Translational Research (R24) grants. He received an email about the review of one such application with only a single ophthalmologist on the review panel. This was a source of anxiety and he asked how this grant could be reviewed appropriately with only one ophthalmologist on the panel. He added that there was a CSR study section with only one ophthalmologist, and another, AED, with but three ophthalmologists. His concern was with the review of translational research and whether good reviews could result with so few ophthalmologists on the study sections.
He said that Dr. McNicol went back and looked at the R24 review panels and the types of applications reviewed and that the number of ophthalmologists varied from 50% to a much smaller percentage. His question was what can be done to change people’s behavior? Is there a way to enforce this, a regulation that can be made?
Dr. Morrison stated he thought this related to the issue of medical doctors being unable to take time out of their busy schedules to get involved. Dr. Zarbin replied that people don’t care about how hard it is to do this, it must be done. If the study section doesn’t have the proper composition then it isn’t a study section.
Dr. Morrison asked if the NEI could make it more attractive or possible for a medical doctor to take the time to serve on these committees. Study sections meet on the west coast once a year but flexibility is needed in allowing people to participate. Dr. Zarbin replied be has served via teleconference and that worked very well. Dr. Morrison answered that he had done so also but he did not find it to be as good of a process as attending in person. Allowing medical doctors to rotate through the study sections on a periodic basis could be a solution.
Dr. McNicol stated that the R24s cover an incredible range of science and that physicians are not always the experts. The expertise on the R24 study sections is chosen to match the science of the R24s. Dr. Zarbin replied that, if he were the one ophthalmologist on the study section and a grant involved anything else besides the retina, it not be a good process. It would be in this case that all the grant applications had to fall within the clinical expertise of one expert.
Dr. Bonanno stated experts should be required to serve on study sections as a condition of
getting a grant. Dr. Mariani replied that this has been discussed but unfortunately there is no way
to implement such a policy.
Dr. Zarbin then asked if CSR bad any ideas on how to address this. Dr. Chaitin replied that CSR was now reorganizing the vision-related study sections and he also reviewed the process and requirements for selection of study section members including conflict of interest issues.
Dr. Zarbin asked first, if the change in the way the study sections are being reorganized will address this issue; second, if there are resources to provide a list of reviewers, and third, should he respond to those who raised this issue or should someone else from the NIH do this?
Dr. Mariani replied that with the reorganization of the vision-related study sections there is the opportunity to strengthen the clinical expertise on the study sections. Dr. Chaitin noted that there was an extensive data base of experts to draw upon as reviewers. Dr. Sieving said he would speak with Dr. Zarbin about how to respond to those who raised the issue with him.
CLOSED SESSION OF THE MEETING – 2:00 pm
The meeting was closed to the public at 2:00 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 IO(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
The meeting was adjourned at 3:00pm
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.
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
FAX: (301) 402-0528
NATIONAL ADVISORY EYE COUNCIL NATIONAL EYE INSTITUTE
(Terms end 11/30 of the designated year)
Joseph Bonanno, O.D., Ph.D. (12)
School of Optometry
800 E. Atwater Avenue
Bloomington, IN 47405
(812) 855-4440 Fax: (812) 855-7045
James Chodosh, M.D., MPH (12)
Department of Ophthalmology
Massachusetts Eye and Ear Infirmary
Harvard Medical School
243 Charles Street
Boston, MA 02114
(617) 573-6398 Fax: (617) 573-4324
David R. Copenhagen, Ph.D. (13)
Departments of Ophthalmology and
University of California
School of Medicine
San Francisco, CA 94143-0730
(415) 476-2527 FAX: (415) 476-6289
Scott W. Cousins, M.D. (11)
Professor and Director
Department of Ophthalmology and
Duke University Medical Center
2351 Erwin Road, DUMC Box 3802
Durham, NC 27705
(919) 684-9010 Fax (919) 684-9016
Ronald J. Gardner, J.D. (11)
National Federation of the Blind
132 Perunan Lane
Bountiful, UT 84010
Charles D. Gilbert, M.D., Ph.D. (11)
Department of Neurobiology
1230 York Avenue
New York, NY 10065
(212) 327-7670 Fax (212) 327-7844
Bernard F. Godley, M.D., Ph.D. (13)
Professor and Chair
Department of Ophthalmology and Visual
University of Texas Medical Branch
301 University Boulevard
Galveston, TX 77555-1106
(409) 747-5413 FAX: (409) 747-5435
John C. Morrison, M.D. (14)
Department of Ophthalmology
Casey Eye Institute
Oregon Health and Science University
3375 Southwest Terwilliger Boulevard
Portland, OR 97201
(503) 494-3038 FAX: (503) 494-3075
Alberta Orr (12)
Rehabilitation Research and Training Center on Blindness and Low Vision
Mississippi State University
3104 Royal Gable Drive
Dallas, TX 75229 (212) 442-0980
K. Krishna Sharma, Ph.D. (14)
Departments of Ophthalmology and Biochemistry
Mason Eye Institute
1 Hospital Drive, EC 213
Unviersity of Missouri – Columbia
Columbia, MO 65212
(573) 882-8478 FAX: (573) 884-4100
Sheila K. West, Ph.D. (14)
Department of Ophthalmology
Wilmer Eye Institute
Johns Hopkins University
600 North Wolfe Street; 129 Wilmer Building
Baltimore, MD 21205
(410) 955-2606 FAX: (410) 955-0096
Marco A. Zarbin, M.D., Ph.D.
Professor and Chairman Department of Ophthalmology
UMDNJ–New Jersey Medical School
6th Floor, 90 Bergen Street
Newark, NJ 07103
(973) 972-2036 Fax (973) 972-2068
Donald A. Gagliano, M.D. (Colonel)
Director, Vision Center of Excellence
(210) 632-81 80