NAEC Meeting Minutes - June 21, 2019

National Advisory Eye Council
One Hundred Fifty-Second Meeting
June 21, 2019

• Videocast

The National Advisory Eye Council (NAEC) convened for its one hundred and fifty-second meeting at 8:30 am on Friday, June 21, 2019 at the Conference Center at 6700B Rockledge Drive, Bethesda, Maryland, 20892. Paul A. Sieving, MD, PhD, the Director of the National Eye Institute (NEI), presided as Chair of the Council, Anne E. Schaffner, PhD, as Executive Secretary, and Michael Steinmetz, PhD, as Director of Extramural Science Programs. The meeting was open to the public from 8:30 am until 1:00 pm. The meeting was closed to the public for a session from 1:45 pm until 03:30 pm for the review of confidentiality and conflict of interest procedures, grant and cooperative agreement applications, and a Board of Scientific Counselors report.

Dr. Eduardo Alfonso
Dr. Jose-Manuel Alonso
Dr. Katia Del Rio-Tsonis*
Dr. Thomas Glaser
Dr. Jane Gwiazda*
Dr. Mary Elizabeth Hartnett
Dr. Dennis Levi
Dr. Carol Ann Mason
Dr. Louis Pasquale
Dr. Sylvia Smith
Dr. Mary Ann Stepp
Dr. Benjamin Teller*
Dr. Russell Van Gelder

*Ad hoc members

Mr. Shawn Adolphus
Dr. Neeraj Agarwal
Dr. Steven Becker
Dr. Sangeeta Bhargava
Ms. Sylvia Braxton
Ms. Monique Clark
Mr. Jay Colbert
Ms. Ashley Dash
Ms. Kathryn DeMott
Ms. Linda Dingle
Ms. Courtney Dodson
Dr. Lesley Earl
Mr. Don Everett
Dr. Martha Flanders
Dr. Ashley Fortress
Mr. Aquila Gilmore
Ms. Kerry Goetz
Dr. Shefa Gordon
Dr. Thomas Greenwell
Mr. Dustin Hays
Ms. Terri Holmes
Dr. Brian Hoshaw
Dr. Jimmy Le
Dr. Ellen S. Liberman
Ms. Renee Livshin
Dr. George Ann McKie
Dr. Lisa Ann Neuhold
Dr. Maryann Redford
Ms. Karen Robinson-Smith
Dr. Anne E. Schaffner
Dr. David Schneeweis
Dr. Peter Shan
Dr. Grace L. Shen
Dr. Paul A. Sieving
Dr. Michael Steinmetz
Ms. Chantelle Stevenson-Brown
Mr. Brian Trent
Dr. Santa Tumminia
Ms. Keturah Williams
Ms. Veronica Van Wagner
Ms. Leslie West-Bushby
Dr. Cheri Wiggs
Mr. Chuck Wright
Ms. Maria Zacharias

Dr. Michael Chaitin, CSR
Dr. Bruce Reed, CSR
Dr. Peter Guthrie, CSR
Dr. Kirk Thompson, CSR
Dr. Paek Lee, CSR

Mr. Israel Goldberg, Health Research Associates
Mr. James Jorkasky, NAEVR (National Alliance for Eye and Vision Research)
Ms. Marisa Lavine, ARVO (Association for Research in Vision and Ophthalmology)
Dr. Anitha Pasupathy, University of Washington

8:30 am

Dr. Paul Sieving, NEI Director

The Director welcomed new Council members, Dr. Katia Del Rio-Tsonis from Miami University in Oxford, OH, Dr. Benjamin Teller, a local optometrist with offices in Chevy Chase, MD and Washington, DC, and Dr. Mary Elizabeth Hartnett from the University of Utah in Salt Lake City, UT.  He thanked Dr. Jane Gwiazda, from the New England College of Optometry, for returning as an ad hoc member.

Dr. Sieving mentioned a recent meeting on pediatric retina, organized by Dr. Hartnett and supported in part by an NEI R13 grant.  It combined topics in both basic and clinical retina. Pediatric retina is a growing field. Diseases are different in the pediatric population and often have a genetic component.  

Dr. Sieving discussed changes to NEI staff. Veronica Van Wagner served as Chief of the Extramural Administrative management Branch at the NEI and retired after 37 years of service at the NIH. Teresa Magone is a new staff MD who will be Chief of the Ophthalmology Consult Service, a position formerly held by Rachel Bishop. Dr. Magone completed her medical degree at the Johann Wolfgang Goethe University Medical School in Frankfurt, Germany and worked previously at the NEI with the late Robert Nussenblatt. Most recently she was Assistant Chief of Ophthalmology at the VA Hospital in Washington, DC. Dr. Kapil Bharti was awarded tenure at the NIH. Dr. Bharti did undergraduate work in Biophysics, received his PhD at the Johann Wolfgang Goethe University in Frankfurt, Germany, and began his work in the NEI as an Earl Stadtman tenure-track fellow. He developed an interest in stem cell biology, particularly of the retinal pigment epithelium (RPE). He is preparing for a Phase 1 clinical trial using human iPSC-derived RPE tissue. Two additional Earl Stadtman tenure-track fellows were hired. Han-Yu Shih, PhD, was in the NIAMS laboratory of John O’Shea, a world-class immunologist. She is interested in chromatin architecture and factors responsible for inflammation in neuro-degeneration. Hendrikje Nienborg, MD, PhD, was educated at Oxford University in the UK, worked in the Laboratory of Sensorimotor Research (LSR) a decade ago, then held positions at the Salk Institute and the Centre for Integrative Science at Tübingen University. She was recruited back to the LSR and will start work there in October. This brought to four, the number of remarkable young women the NEI has recruited for tenure track positions.

Dr. Sieving commended the efforts of the late Paul Sheehy for his admirable job as the Director of the DEA. Dr. Anne Schaffner has agreed to accept the job of Acting Division Director, and Dr. Brian Hoshaw has taken over as the Chief of the Scientific Review Branch, the position previously held by Dr. Schaffner.

Several NEI personnel were the recipients of recent awards. Emily Chew, MD, PhD, and Director of the Division of Epidemiology, received an award from the St. Louis Society for the Blind for “commendable service in eyesight research, ophthalmology, vision sciences and related social services.” Johnny Tam, PhD, a tenure-track investigator in the area of adaptive optics and optical imaging, received the Alcon Research Institute Award. Rob Hufnagel, MD, PhD, and Chief of the Ophthalmic Genetics Laboratory, received start-up grant support from the Knights Templar Foundation. Lev Prasov, MD, PhD, a clinical fellow, received the Alcon Young Investigator Award and a grant from the Knights Templar Foundation. Oussama M’Hamdi, PhD, a postdoctoral fellow, also received a Knights Templar Foundation grant.

The Director commented on several presentations on the meeting agenda including a budget report from Mr. Aquila Gilmore. Dr. Sieving mentioned several ways that Congress can increase NIH funding. Since each IC is a line item in the budget, the amount for each IC can be raised by a set amount. Another way is to fund special needs at specific institutes, such as Alzheimer’s research at the NIA  The NEI has benefitted from two initiatives, BRAIN and the 21^st Century Cures Act/Regenerative Medicine. NEI grantees have competed successfully for money from both of these initiatives. Dr. Steve Becker will report on the Audacious Goals Initiative (AGI) and update the Council on projects funded through 3 separate initiatives on functional imaging, factors supporting new retinal cell growth, and translational model development.   The 5 teams from the AGI functional imaging consortium gave updates on their projects at a workshop at the 2019 ARVO meeting in Vancouver, BC. Dr. Martha Flanders, a Program Director, will be reviewing grants in her portfolio, Visual Processing. The portfolio analysis will be followed by a basic science presentation by Dr. Anitha Pasupathy, an Associate Professor at the University of Washington who works on awake, behaving monkeys. Her research evaluates the V4 region of the brain and how we discern shape and texture in object recognition.

Dr. Sieving concluded his remarks by mentioning challenges the NIH and NEI were currently facing. The AOA facilitated a meeting with Dr. Sieving, Dr. Jerome Adams, the Surgeon General, and U.S. Rep. Cathy McMorris Rodgers (R-WA). The AOA has a 2020 initiative to encourage Americans to get a comprehensive eye exam. The NEI is hosting a workshop on June 28^th, 2019, at 6700B Rockledge Drive that will address endpoints for clinical trials for neuro-ophthalmic diseases such as glaucoma, intracranial hypertension, multiple sclerosis, etc.  Discussion will center on previous clinical trials, lessons learned, and next steps for future trials. One current contentious area that affects the NIH is human fetal tissue research. New restrictions have been enacted by HHS. Some are specific for intramural research, but some extend to the extramural community. Another area of concern was the stem cell clinics, particularly in Florida. One, US Stem Cell, is offering treatments for retinal disease by autologous injection of bone marrow cells into a patient’s eye. A federal court ruled that the FDA has purview over these types of injections. Hopefully, this will afford patients more protection, since several people have been blinded by this intervention. Eye Bonds or HR 2620 was reintroduced May 9, 2019 by US Reps. Sanford Bishop (D-GA) and Cathy McMorris Rodgers (R-WA) and was referred to the House Energy and Commerce Committee. The idea was originally conceived by Karen Petrou, co-founder and managing partner at Federal Financial Analytics; Ms. Petrou specializes in finances and has retinitis pigmentosa. The purpose was to champion ways to support/fund translational eye research. The NEI would be involved in the evaluation of applications for this support. The fate of this endeavor will take some time to play out. There has also been concern at the NIH that some translational animal models have not been reproducible. This issue was brought before the Advisory Council to the Director.  A final mention was made of a new Initiative, Healthy People 2030, coordinated by HHS. Dr. Shefa Gordon is the NEI representative who is identifying key objectives and targets from a vision perspective. They include preschool screening and comprehensive eye exams, issues that have practical public health ramifications.

Dr. Sieving entertained questions from Council members. One member asked about earmarks in the Eye Bonds bill. There was nothing in the way of front of the eye research, which raised concerns about how that might affect the research community. The same member also asked if Dr. Sieving saw any unintended consequences of the bill, such as whether a funding windfall might cause a backlash that would result in a reduction of funding to the NEI. Dr. Sieving agreed that there was concern about a backlash and the fact that if research failed, then the government would have to provide a guarantee for the private monies that had been put up for the research. Regarding the first question, the language was the result of Congressional and industry drafting. The NEI was not consulted. However, Dr. Sieving felt that those earmarks would have some benefit. There is already a robust industry looking at dry eye and tear solutions, and those endeavors are easier to take to commercial success. The diseases mentioned (retinal degenerative diseases, Usher syndrome, vision injury due to trauma, glaucoma and optic nerve diseases) are biologically much more difficult to deal with. The Council member was concerned about how that list was derived since it also mentioned a very rare disease called Morning Glory syndrome. Dr. Sieving emphasized that the Eye Bonds were not to support discovery biology but an “end stage pipeline” for therapeutic interventions.

Dr. Anne Schaffner, Executive Secretary and Acting Director, Division of Extramural Affairs

The Executive Secretary asked that Council members sign the pre- and post-conflict of interest statements, at the appropriate time. She also asked for comments and corrections to the January 2019 Council minutes. There were none, and the minutes were unanimously approved.

Mr. Aquila Gilmore, Deputy Budget Officer, Office of the Director

Mr. Gilmore presented an overview of the fiscal year (FY) 2019 budget a few points on the 2020 FY budget. NIH received a $2 billion (B) increase, bringing its program level up to $39.1 billion.  NEI received a $24.2 million (M) increase, bringing its funding level to just over $796.5M, a 3.1% increase over 2018. He emphasized that the NEI operating budget was lower than the appropriation due to rescissions and transfers that occur during the FY.  The 21^st Century Cures Act provided Congressional money for Precision Medicine and BRAIN Initiatives, Cancer Moonshot and Regenerative Medicine. Additional funds were projected through FY 2026; however, funds are not available until appropriated by Congress each FY and cannot exceed what was originally authorized for each FY. The total cap through 2026 is $4.8B. The NEI budget contributed, prior to 2019, to the BRAIN and Regenerative Medicine Initiatives.  Over the past four fiscal years the NIH and NEI have received substantial budget increases. Mr. Gilmore emphasized that buying power (as a result of inflation) has not kept pace with budget increases, which is why budget increases don’t translate into increases in new awards.  Buying power is essentially the same as it was in the early 2000s. NEI RPG success rates (defined by # of unique, competing RPGs funded/ # applications received) continue to outpace the overall NIH rate.  In FY 2018 it was 20% for the NIH and 27% for NEI. Eighty-five percent (85%) of the NEI’s operating budget goes to fund extramural research activities. Mr. Gilmore presented the figures for the 2019 budget by funding mechanism. Funding for RPGs represent $494.7M or 62% of the total $793.8M operating budget. Funding for small business, research centers, other research, training grants and R&D contracts brings the total to $676.5M or 85%. Intramural research receives $87.7M (11%) and RMS is $29.6M or 4%. 

Mr. Gilmore then presented what was known regarding the 2020 budget. The President’s budget request was released on March 18, 2019. Appropriations hearings were held by the House and Senate in April with Dr. Francis and other IC Director’s testifying before the 2 groups. The House passed a minibus bill covering HHS and Defense giving the NIH a $2B increase and the NEI a $39M increase (4.9 % for most ICs) over FY19 appropriations. The Senate was expected to vote at a later date. A “Special Diabetes Program Reauthorization Act of 2019” was introduced by Rep. Diana DeGetto (D-CO). The program was initially established in 1997 as a result of advocacy by the Juvenile Diabetes Foundation. It increases mandatory funding from $150-200M for diabetes research. This is especially important for the NEI because it also provides $2M annually to co-fund the Diabetic Retinopathy Clinical Research Network (DRCR.net). Mr. Gilmore provided contact information for the NEI’s Financial Management Branch. One Council member asked if the budget increases were similar to other NIH ICs.  The answer was yes, there is parity after one considers any special or mandatory set-asides, special programs or priorities that each IC might have to consider. 

Dr. Steven Becker, Special Assistant and Audacious Goals Initiative (AGI) Program Coordinator, Office of the NEI Director

Dr. Becker presented the draft of a 2019 status update document that encompassed all AGI activities since its inception in 2013. He began with a brief history of the initiative, which was spurred by advances in transplantation, regeneration and success with reprogramming and differentiation of induced pluripotent stem cells. The initiative began with a series of workshops and town hall meetings that resulted in the generation of 4 RFAs to develop 1) non-invasive imaging technologies of the visual system (U01), 2) new regeneration factors (U01), and 3) translational models (U24 and R21). Consortia were created that were comprised of the PIs funded for the cooperative agreements in each area—Functional Imaging, Discovery, and Translational Models. The draft report included a number of tables that described the funding objectives of the RFAs, how the specific aims of each project fulfilled the objectives, and links to relevant publications from the consortia. The Discovery projects generated omics datasets; that data is currently housed courtesy of Dr. Michael Dyer at St. Jude Children’s Research Hospital in Memphis, TN. It will eventually be opened up to the wider research community. Future directions included bringing together vision researchers from other R01 and R21projects with AGI consortia members, investigating ways to disseminate new imaging methods and technology (perhaps using the BRAIN Initiative as a template), and exploring barriers to transplantation, specifically immunological factors. Dr. Becker encouraged feedback from the Council members on the draft report. Council members asked if the AGI information as well as more basic science information was being prepared for a more public venue. Dr. Becker said that the draft report will provide a foundation for all the stakeholders, perhaps in a different format.  The Communications group at the NEI will synthesize the information and come up with important and perhaps unique “take-aways”  for different audiences. It was suggested by Council members that YouTube videos or videos prepared for doctors’ offices might be good teaching tools for a lay audience. A council member with previous experience with creating videos on OCT mentioned that focus groups with diverse membership in terms of age and vision knowledge should view any material and provide feedback. Some people’s perceptions of the OCT videos were unexpected, e.g. some people found them frightening, some were offended, etc. Other Council members opined that depending on the audience, other means of communication such as print material, or TV spots should be considered, especially for an older audience. AGI accomplishments should also be presented to the broader scientific community since so much of it is cutting edge of regenerative medicine. Dr. Becker responded that intramural scientists conducting AGI-relevant work have been included in workshops, and extramural guest speakers spend part of their day visiting intramural labs. In-house expertise has been leveraged for the NIH-wide Regenerative Medicine Innovation Project (RMIP). That comment from Dr. Becker provided a segue to his presentation on the RMIP.

Dr. Becker presented information on the FY18 and FY19 RMIP awards. The first year awarded a total of $2M for competitive revisions. An NEI grantee studying limbal cell deficiency, Markus Frank, received an award. The following year $30M was available. The list of awardees from a U01 RFA was pending, but several vision researchers were on the list.  [Names of awardees were subsequently released in July 2019 and included 3 vision researchers all working on stem cells: Alan Marmorstein, Jeffrey Stern and Stephen Tsang.] Two unique features of the RMIP awards is the requirement for matching funds and a Regenerative Medicine Innovation Catalyst (RMIC, which is a cell characterization program available to RMIP investigators), to catalyze the efficient development of safe and effective adult stem cell-based therapies. This is a form of deep fingerprinting, beyond that required by the FDA that will also provide assistance for the development of clinical grade products that meet FDA requirements and provide storage and dissemination services for characterization results and clinical data. An RMIP clinical trial FOA will be re-issued with an estimated publication date of July 12, 2019. Dr. Becker mentioned several NEI-sponsored regenerative medicine events at the Fall 2019 Society for neuroscience meeting. There is a symposium Wednesday, October 23, 2019, on new approaches to vision restoration and an evening social Sunday, October 20, 2019, on brain and retinal organoids. Paul Sieving added a comment that the AGI status update needed refining and encouraged Council members to contact him personally with ideas for approaching different target audiences. 

Dr. Martha Flanders, NEI Program Officer, Central Visual Processing

Dr. Flanders gave an overview of a number of portfolios subsumed under the title of SAVP, Strabismus, Amblyopia and Visual Processing that included Development and Regeneration (Tom Greenwell), Central Visual Processing (Martha Flanders), Oculomotor Systems, Strabismus and Amblyopia and Sensory Neuro-Ophthalmological Disorders (Houmam Araj), and Perception and Psychophysics and Myopia and Refractive Error (Cheri Wiggs). A pie chart illustrating the number of RPGs awarded in 2018 in various areas of vision research showed that SAVP is the second largest group after retinal diseases. Recently, the number of funded grants decreased slightly, but that was due to BRAIN Initiative funding for several PIs in SAVP portfolios. Within SAVP, the Central Visual Processing (CVP) portfolio is the largest (> 60%).  Dr. Flanders gave a snapshot of the Development and Regeneration (DR) portfolio, which included axon guidance, synaptogenesis, synaptic patterning and plasticity. More complex visual functions and neuronal computation transition into the CVP portfolio. Grantees in DR are focused on axon guidance factors, both attractants (e.g., VEGF, Sema6D, NrCAM and Plexin-A1), and repellents (e.g., ephrinB2 and Shh) and receptors involved in synaptogenesis (like PirB Rs and MHC factors). A recent study by Michael Fox revealed that the function of complex synapses, versus the simple 1-on1 synapses, was control of more complex visual tasks. A practical implication of the finding was that any effort to regenerate axons would require the correct synaptic patterns. A 2-photon imaging study of On/Off and directional cells in the retina that form synapses with LGN neurons (Chen and Andermann, Cell) revealed a pooling of information among feature invariant neurons, what the authors called fine-scale functional logic.  Calcium imaging, of individual dendritic spines in the V1 area of the visual cortex (Wilson et al., Nature) in mouse can map neuronal activity and directional preferences. These phenomena lay the groundwork for neuronal plasticity. 

Dr. Anitha Pasupathy, Associate Professor, University of Washington

Dr. Martha Flanders introduced the speaker. Dr. Pasupathy has a background in Electrical Engineering. She did her PhD with Ed Connors at Johns Hopkins in the primate visual system. This was followed by a post-doc at MIT with Earl Miller and a position at the University of Washington.

Dr. Pasupathy began her talk with an acknowledgement of NIH support for her work including a training grant and vision core grant. The overarching goal of her work is an understanding of how the visual cortex supports our ability to recognize objects and understand visual scenes. This actually represents a very complicated computational problem for artificial networks, referred to as deep networks. Even recent advances in fast computing GPUs (graphic processing unit) and machine learning cannot totally compensate for adversarial objects placed close to an object of interest, the latter of which is often misclassified by these artificial networks as a result. A primate or human brain would not make this mistake. Research has determined that the brain can extract information from a scene that a network cannot. All of this processing takes place in the visual pathway. Area V1 neurons are sensitive to local orientation and spatial frequency. As one moves through the ventral visual pathway the receptive fields of neurons become larger and more complex. Dr. Pasupathy’s work focused on V4, an area heavily interconnected with visual and frontal areas, where neurons have a broad response latency and lesions result in form, color and attentional deficits. Several strategies have been adopted to look at area V4. The first is using more complex stimuli that are controlled and nature-inspired (2D shapes with added blur, texture depth and occlusions). The second is model evaluation--feed responses to these stimuli into new or use previously developed models, and then validate the models with more natural stimuli. The third is technology development such as adaptive optics (AO), 2-photon and 3-photon imaging. Dr. Pasupathy then presented data for 3 advances that came out of the lab. The first involved how the visual system deals with occluded stimuli. Responses of neurons in V4 decrease with increasing amounts of occlusion. Her experiments showed that the brain is able to recognize occluded structures via feedback connections from the ventrolateral prefrontal cortex (PFC). This was accomplished by a sequential shape discrimination task. PFC neurons responded with greater responses to the occluded stimuli, the exact opposite of responses in V4. About 40% of V4 neurons respond accordingly after a small time delay just behind the time delay in the PFC (150 msec). A further test was to perturb GABA activity optogenetically in the PFC. This reduced sensitivity of neurons in V4. The second advance was showing that V4 neurons lie along a continuum from strong tuning for boundary versus strong tuning for texture with some neurons tuned to both attributes. Tuning for shape and texture were separable, and texture selectivity emerged later than shape selectivity, indicating 2 parallel computations that inform responses.  The challenge is to determine how the local inputs into V1 inform responses in V4. The third advance was setting up 3-photon imaging with the use of calcium indicator dyes in the macaque to visualize neurons being recorded from deep within the cortex. This will be important for fine tuning models and being able to predict responses in the recorded neurons, especially during the course of learning. The studies will be critical to understand perceptual impairments due to dysfunctions of the occipitotemporal pathway (agnosias) and diminished communication between visual and frontal cortex (autism). The studies are likely to generalize across all of cortex. 

Several questions were posed to the speaker. One was the difference between the two types of neurons seen in V4—the double-peaked versus the single-peaked. Could the double-peaked be some sort of modulation? Dr. Pasupathy responded that there may be a continuum between the two types and their response depends on how far they are from the neuron(s) receiving direct cortical input to V4. Another question involved what creates visual memory, and if the quality of life for children with visual disorders who undergo surgery could be improved. The traditional view has been that short-term memory resides in circuits outside the visual cortex and a more distributed network for longer-term memory. More recent work has looked at oscillatory interactions between visual and other areas that may be encoding visual memory. A question was asked about what controls central vision versus eccentric (peripheral) vision. Dr. Pasupathy said that her research is amenable to looking at that issue and would involve sampling at different eccentricities to see how the signals progress. The impact of aging on neuronal responsivity was also posed as a future avenue of study. There are researchers at the University of Washington who have a background in vision looking at changes in the hippocampus with aging, and collaborations with them could examine changes in circuitry with aging. A Council member asked about a future paradigm shift involving ensemble recordings as opposed to single electrode recordings. Dr. Pasupathy responded that the 3-photon studies and single cell recordings actually complement each other. It’s difficult to get single neuron resolution with the multi-arrays, and the 3-photon imaging currently doesn’t have great temporal resolution. An ideal situation would be to record from an array of neurons, see how they are arranged and what their preferences are regarding shape and texture. Temporal resolution is a big problem. Would channel rhodopsin and calcium imaging allow one to look at structural connectivity, e.g. axons going from V4 to PFC? Dr. Pasupathy said that anatomical tracing has not revealed much, and they see only very sparse connections. Many cortical-cortical connections may go through the pulvinar. Her lab designed an experiment using an anterograde tracer in the PFC and retrograde tracer in V4 to look at convergence in the pulvinar, but it was not successful. Combined anatomical and physiological studies will be important to relate neuronal properties with physiological characteristics. 

Dr. Anne Schaffner, Executive Secretary and Acting Director, Division of Extramural Affairs

Dr. Schaffner provided background information on irregularities that arose regarding the NIAAA’s MACH trial that resulted in a new NIH policy to have a public discussion of PARs (Program Announcement Reviewed in an Institute). Council members were given access to a list of all the PARs that the NEI sponsors with live links and descriptions of their purpose. She asked if members had any questions or comments regarding the list of PARs. Several questions were answered by the following information: all the PARs have expiry dates, but the NEI intends to renew them every 3 years. The US-India PAR is open to any US institution and any Indian institution. There are several types of R21s. The one NEI R21 PAR is for secondary data analysis. The Council members were unanimous in their approval of the NEI-sponsored PARs. 

One member mentioned that the NIH Director, Dr. Francis Collins, has refused to participate in any all-male panels and wanted to know the NEI’s response to that. Dr. Sieving said that the NEI supports that stance. The same person asked about the “new” definition of a clinical trial (CT) and how that was working. Dr. Michael Steinmetz said that some confusion in the community is the result of the many different FOAs and whether they allow a CT. The NEI can no longer publish our own Program Announcements that would allow for CT-optional. CSR has allowed applications to come through that were submitted on an incorrect FOA, and program staff can help investigators determine the correct FOA for their research question. 

There was an update from Dr. Carol Mason on the situation involving certain Congresspeople and the use of NHPs. Rep. Cory Booker (D-NJ) proposed a bill that didn’t get anywhere, but there continues to be those that object to the use of NHPs. Another angle came from the BRAIN 2025 document, spearheaded by Bill Newsome and Cori Bargmann, and currently being updated by John Maunsell and Catherine Dulac at Harvard. It was put online for comment. There was an accompanying neuroethics document that dealt with ethical considerations for the BRAIN Initiative. Somehow, language was inserted into both documents calling for more and stricter guidelines for the use of NHPs. This resulted in a petition, spearheaded by Michele Basso and Tony Movshon and signed by over 300 researchers and users of NHPs (many funded by NEI), objecting to the language and its insertion into the document. Jeffery Sachs, a bioethicist and Co-Chair of the neuroethics subgroup has been a long-time objector to the use of NHPs and was instrumental in barring the use of chimpanzees. This created a stir in the scientific community. Dr. Steinmetz mentioned that the document was presented to the ACD (Advisory Committee to the Director), and they did not accept the report. It went back for revision, but the final outcome was not known. A Council member also asked about a report he thought was requested by NABR (National Association for Biomedical Research) asking about the use of NHPs in NIH intramural laboratories. Dr. Sieving said that the only record he was aware of regarding NHP usage was for the purposes of space planning. Dr. Shefa Gordon in the NEI OD mentioned that in the House appropriations language there was report language that requested from the NIH a list of projects using NHPs, likely with names redacted. The NIH is strongly in support of the use of NHPs in research.  That language was inserted by Rep. Lucille Roybal-Allard (D-CA). 

There was a question about the moratorium on the use of human fetal tissue (HFT) and funds for research in alternative sources. Are these funds available and how is it divvied up among the ICs? Dr. Steinmetz replied that there are no central resources. The NEI published a notice that anyone in our portfolio using HFT (about 15 grantees) can apply for a supplement to look at alternative tissue sources. A Council member asked if the moratorium would affect suppliers of HFT. The answer was yes, since the concern is how that supplier obtained the tissue. The current arrangement is that any new grant that proposes the use of HFT will go through an ethics board, convened by HHS, that will decide if the research can go forward. Language in the current House bill proposes to block that. A Council member asked about restrictions on the use of canines. Dr. Steinmetz responded that there were no NIH efforts to restrict their use.

A Council member asked about the NIH’s All of Us program and whether there would be a potential biobank that could provide invaluable data on vision-specific diseases like glaucoma. Dr. Sieving had no update on that question. 

Another question was asked about NEI’s support of early stage investigators. Dr. Steinmetz said that the institute has been very generous in that respect. In 2018, we funded everyone in the “at-risk” category up to the 35^th percentile and gave bridge funding to those above that percentile. The NEI has the best record among the NIH ICs for supporting early stage investigators. 

There was a question regarding the timeline for the re-evaluation of vision-related study sections at CSR. Dr. Steinmetz said that Cluster 11, which includes BVS and DPVS, will happen in the summer of 2019 and the results would be available in the Fall. 

The Open Session was adjourned by Dr. Sieving at 1:00 PM.

DoD Representative position is vacant