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DRAFT - NAEC Meeting Minutes - October 14, 2022

National Institutes of Health

National Eye Institute
Minutes of the National Advisory Eye Council
One Hundred Sixty-Third Meeting
October 14, 2022

The National Advisory Eye Council (NAEC) convened for its 163rd meeting at 10:00 a.m. on Friday, October 14, 2022. The entire meeting was broadcast by the National Institutes of Health (NIH) videocast system, and all observers and participants, including members of the public, attended virtually. Michael F. Chiang, MD, Director of the National Eye Institute (NEI), presided as Council Chair, and Kathleen C. Anderson, PhD, served as the Executive Secretary. The meeting was open to the public from 10:00 a.m. until 2:30 p.m. The meeting was closed to the public from 2:30 p.m. until 4:00 p.m. for the review of grant and cooperative agreement applications.

Council Members Present:

Dr. Michael Chiang, Chair
Dr. Kathleen Anderson, Executive Secretary
Dr. Terete Borrás
Dr. James Coughlan
Dr. Reza Dana
Dr. Katia Del Rio-Tsonis
Dr. Thomas Gardner
Dr. Mary Elizabeth Hartnett
Dr. Renu Kowluru
Dr. Maureen Maguire
Dr. Benjamin Teller

Ad-Hoc Members Present:

Ms. Janni Lehrer-Stein
Dr. Victor Perez-Quinones

NIH Staff Members Present:

Mr. Shawn Adolphus
Dr. Neeraj Agarwal
Ms. Lisa Applewhite
Dr. Houmam Araj
Dr. Sangeeta Bhargava
Ms. Stephanie Blackford
Mr. Nathan Brown
Ms. Alysia Champagne
Dr. Emily Chew
Mr. Jay Colbert
Ms. Karen Colbert
Dr. Mary Frances Cotch
Dr. Kevin Czaplinski
Ms. Ashley Dash
Ms. Joy Jackson Farrar
Dr. Martha Flanders
Dr. Ashley Fortress
Dr. James Gao
Dr. Mohita Gaur
Ms. Alexandra Gavrilovic
Dr. Nataliya Gordiyenko
Dr. Shefa Gordon
Dr. Tony Gover
Dr. Tom Greenwell
Ms. Lateefah Hill
Dr. Brian Hoshaw
Dr. Jimmy Le
Dr. Paek Lee
Dr. Ellen Liberman
Ms. Renee Livshin
Dr. George McKie
Dr. Sheldon Miller
Dr. Lisa Neuhold
Ms. Jill Payne
Ms. Melanie Reagan
Dr. Maryann Redford
Ms. Carissa Reilly-Weedon
Dr. Jennifer Schiltz
Dr. Grace Shen
Ms. Karen Smith
Dr. Hongman Song
Dr. Afia Sultana
Ms. Sharon Taylor
Dr. Santa Tumminia
Ms. Leslie West-Bushby
Dr. Cheri Wiggs
Dr. Charles Wright
Ms. Maria Zacharias

Others Present Virtually:

Dr. Rinad Beidas, Guest Speaker
Dr. Fernanda Ruiz, Science Writer
Dr. Jennifer K. Sun, Guest Speaker

NOTE: Due to the open videocast format of this meeting, additional NIH staff and members of the public were able to observe the open session of the meeting live and after it had been archived.

Welcome and Introductions

—Dr. Michael Chiang, Chair, NAEC, and Director, NEI

Dr. Chiang called the 163rd NAEC meeting to order and welcomed Council members, members of the NEI research and advocacy community, NEI and NIH staff, and guest speakers. Council members introduced themselves and gave a brief overview of their research areas. Dr. Chiang introduced and welcomed two new Council members Ms. Janni Lehrer-Stein and Dr. Victor Perez-Quinones. Ms. Lehrer-Stein is a retired attorney, disability rights activist, and advocate who has worked with the National Council on Disability and served as policy advisor for presidential, gubernatorial, and state election campaigns. Dr. Perez-Quinones is a Professor of Ophthalmology at Duke University with expertise in ocular inflammation, graft vs host disease, and clinical trials.

Council Procedures and Related Matters

—Dr. Kathleen Anderson, Executive Secretary, NAEC, and Director, Division of Extramural Activities (DEA)

Dr. Anderson reviewed Council procedures and etiquette for the Zoom meeting and Council conflict of interest and confidentiality rules. The open session of the meeting was videocast and will be available on the NIH videocast website.

Dates for future Council meetings are listed on the NEI website. The next NAEC meeting will be hybrid, virtual and held in person, in Bethesda, Maryland on February 3, 2023. Due to a conflict, the meeting planned for October 13, 2023, will be rescheduled.

Minutes of the June and August 2022 NAEC meetings were provided in the Electronic Council Book prior to the meeting. A motion to accept the minutes was made, seconded, and approved unanimously by Council members. The approved minutes will be posted on the NEI website.

Director's Report

—Dr. Michael Chiang

Dr. Chiang commented on the challenge of disseminating NEI’s activities to the community. NEI currently communicates information, such as vision community news and grant opportunities, via social media platforms, including Twitter and Instagram. He encouraged attendees to follow all NEI’s social media accounts.

NEI Staff Updates— Dr. Michael Steinmetz, Director of the NEI Division of Extramural Science Programs (DESP) passed away in July 2022. Dr. Steinmetz joined NEI in 2007 and was involved in several efforts, including the Audacious Goals Initiative (AGI), and played a role in bringing NEI into the NIH Brain Research Through Advancing Innovative Neurotechnologies® (BRAIN) Initiative. During his 15-year NEI career, Dr. Steinmetz’s influence expanded well beyond the Institute. His legacy made a difference in vision and neuroscience programs throughout the National Institutes of Health.

Dr. Kathleen Anderson, Director of the NEI DEA, will also serve as Acting Director of DESP until a replacement is found. Dr. Sangeeta Bhargava will serve as Acting Deputy Director of DESP. Monique Clark, Grants Specialist, was promoted to Team Lead in the NEI Grants Management Branch.

NIH and NEI Leadership—In December 2022, Dr. Anthony S. Fauci will be stepping down as Director of the National Institute of Allergy and Infectious Diseases (NIAID), Chief of the NIAID Laboratory of Immunoregulation, and Chief Medical Advisor to President Biden. The search for the NEI Clinical Director is in progress and follow-up interviews for the NEI Scientific Director are underway. The search for the NEI Executive Officer/Deputy Director for Management is in the final stages and an announcement will be made soon.

NEI Intramural Research Program—The first U.S. patient received autologous stem cell therapy (biodegradable patch) to treat dry age-related macular degeneration as part of a phase I/IIa clinical trial. The NEI Ocular and Stem Cell Translational Research Section developed the patch by converting the patient’s blood cells to induced pluripotent stem cells (iPSCs), programmed the iPSCs to retinal pigment epithelium (RPE) cells, and grew them as a monolayer on the patch. This effort was the culmination of 15 years of research and development.

Regenerative Medicine—Dr. Chiang congratulated the three teams who developed different physiologically competent retinal organoid systems and won the final phase of the 3D Retinal Organoid Challenge (3-D ROC). The winners included Drs. Maria Valeria Canto-Soler (University of Colorado Anschultz Medical Campus), Maria Natalia Vergara (University of Colorado Anschultz Medical Campus), and Wei Liu (Einstein College of Medicine, New York City).

AGI Transplant Immunology Workshop—The AGI Transplant Immunology Workshop was held on July 29, 2022. The purpose of the workshop was to delineate the state of science, define gaps in knowledge, and articulate barriers and opportunities in transplant immunology that may advance retinal and eye transplantation. Dr. Chiang thanked Drs. Kia Washington and Victor Perez Quinones for co-chairing the workshop and expressed excitement for the new initiatives that will emerge.

Neuroscience, Immunology, and Regenerative Medicine Initiatives— Projects in the Ocular Surface Innervation from Cell Types to Circuit Functions Initiative aim to delineate ocular surface innervation from corneal sensation to pain circuits and tearing reflexes. Eight cooperative agreements were awarded. The consortium kickoff meeting is scheduled for October 28, 2022.

A Community Research Resource: Characterization of the Resident Ocular Microbiome is a funding opportunity that aims to develop a community-based resource of microbial data associated with the resident ocular microbiome of healthy individuals. Applications will be reviewed in November and presented to the NEI Council at the February 2023 meeting.

The AMD Integrative Biology Initiative: Discovery of AMD Pathobiology using Patient-Derived Induced Pluripotent Stem Cell (iPSC)-derived Retinal Pigment Epithelium (RPE) was established to determine if patient-derived iPSCs can be used to discover the underlying pathophysiology of age-related macular degeneration (AMD). Four cooperative agreement awards were made.

Neuroscience: Cerebral Visual Impairment—Through the strategic planning process, NEI has become interested in cerebral visual impairment (CVI), which is now the leading cause of untreatable childhood blindness in the U.S. and is associated with prematurity, perinatal brain damage, and oxygen deprivation. NEI recognizes the need for better understanding of the neural basis, as well as tools and guidelines for diagnosis, classification, and management, of this condition. It is important to gain a better understanding of the rehabilitation needs of brain-based versus ocular impairment. This effort will require an interdisciplinary approach that includes neuroscience and structural and functional imaging experts, educators, ophthalmologists, optometrists, and occupational/physical therapists.

Dr. Chiang shared that he and others at NEI attended two meetings with the CVI community in summer 2022. He announced at the meetings that NEI will build a CVI registry to allow researchers to track and better understand conditions, develop treatments, and facilitate recruitment to studies of new treatments and rehabilitation strategies. NEI is working with the CVI community to determine the data points that will be most helpful.

Genes, Environment, Epidemiology: Myopia—Implementation groups established within NEI have identified myopia as an area of interest due to its increasing prevalence. About 33–40 percent of American adults suffer from this condition. It is estimated that by 2050 about 4.8 billion people in the world will suffer from myopia. The ongoing research (genetics, animal models, epidemiology) is limited by self-reporting of clinical and environmental data, which are difficult to quantify.  The National Academies of Sciences, Engineering, and Medicine is launching an NEI-sponsored consensus study of myopia with broad basic science to health disparities objectives that will address epidemic drivers of the rapid increase in myopia prevalence. Dr. Cheri Wiggs and Mr. Donald Everett are participating in this effort. A large public meeting is planned for 2023.

Public Health and Disparities Research—To address the difficulty of COVID test use for people with visual impairment, NEI is collaborating with the NIH Rapid Acceleration of Diagnostics (RADx®) initiative on plans to make COVID tests more accessible to people with vision loss. The White House launched an initiative via the Administration for Community Living (ACL) on increasing the accessibility of COVID tests. Dr. Chiang highlighted the fact that NEI aims to develop a larger footprint in health equity relating to eye and vision care and is in early-phase discussions with the National Institute on Minority Health and Health Disparities (NIMHD) on planning a workshop that will focus on approaches to address health disparities in vision care involving unoperated cataracts and uncorrected refractive error as well as scientific approaches toward understanding the underlying basis for health disparities in vision care.  

Data Science—On May 10, 2022, NEI, the U.S. Food and Drug Administration (FDA), and the Office of the National Coordinator for Health Information Technology (ONC) hosted a Joint Workshop on Promoting Adoption of Ocular Imaging Standards to identify barriers and approaches to widespread adoption of standards for interoperability. As follow-up to this meeting, the American Academy of Ophthalmology and the Association for Research in Vision and Ophthalmology (ARVO) published an editorial endorsing this effort. Ms. Kerry Goetz at the Office of Data Science and Health Informatics (ODSHI) and her group are working with a planning committee on follow-up steps.

Dr. Michelle Hribar, NIH Data and Technology Advancement (DATA) Scholar was hired to develop a common data model for eye care and vision research in collaboration with the Observational Health Data Sciences and Informatics Program.

The White House’s Office of Science and Technology Policy (OSTP) has published a public access memo about access to federally funded research that applies to all federal agencies. This memo states that all publications resulting from federally funded research are to be made freely and publicly accessible in repositories without embargo and the scientific data should be made accessible upon publication. OSTP and NIH are working to ensure that policies are consistent. Further announcements on this topic will be made in the future.

Bridge to AI: OT2 Data Generation Projects—Dr. Chiang provided an overview of the Data Generation Projects for the NIH Bridge to Artificial Intelligence (Bridge2AI) program (OT2). This is an NIH Common Fund project that aims to accelerate use of AI in biomedical and behavioral research. One goal is to generate flagship diverse datasets about human health that can be used by scientists across domains of medicine. This effort integrates an ethics component to reduce bias. This is a collaborative effort which involves the National Center for Complementary and Integrative Health (NCCIH), National Institute of Biomedical Imaging and Bioengineering (NIBIB), National Library of Medicine (NLM), and National Human Genome Research Institute (NHGRI). Four awards were given for data generation projects and three awards were given for a Bridge Center to conduct integration and evaluation activities.

One of the data generation projects that received an award is the Multimodal Atlas of Disease of Artificial Intelligence: Generating Datasets for Pseudotime Mainfolds of Health Trajectories (MAD-AI) project from the University of Washington. Led by Drs. Cecilia Lee and Aaron Lee, this study will collect data from a diverse population (4,000 participants) with varying stages of type 2 diabetes to understand chronic disease progression and recovery. The study aims to harness AI’s power to learn to recognize disease from great volumes of data and generate an AI-friendly hypothesis-agnostic dataset.

Eye on the Future Video Contest—In an effort to increase the interest of underrepresented minority (URM) high school students in science, Ms. Devina Fan and Ms. Maria Zacharias organized the Eye on the Future Video Contest. NEI received over forty submissions and ten high-school teen contest winners visited the NIH campus for a tour and was able to meet performing the duties of the Director of NIH, Dr. Lawrence Tabak and Chief Officer for Scientific Workforce Diversity, Dr. Marie Bernard. Dr. Chiang expressed excitement at organizing this event again in 2023.

Dr. Hartnett asked how will the Eye on the Future Video Contest be advertised in the future to reach interested students. Dr. Chiang confirmed that NEI will aggressively promote the contest throughout social media, meetings, and websites.

NAEC Budget Update—Ms. Karen Colbert, NEI Budget Officer, reported on the estimated spending for Fiscal Year (FY) 2022 and outlined the NIH and NEI budgets for FY 2023. Estimated NEI spending for FY 2022 is as follows: extramural research (including all grant activities and research and development contracts), 83 percent; intramural research, 12 percent; and research support, 5 percent. These funding levels are typical and have remained consistent over time.

Currently in FY 2023, NEI is operating under a Continuing Resolution (CR) effective through December 16, 2022. More information about the FY 2023 budget will be available once the mid-term elections conclude in November 2022. There is no expectation of continuing to operate under the CR for the full year however, once the current CR expires, it is likely that short-term CRs will be put in place as Congress completes the budget process. It is expected that Congress will provide an omnibus bill to fund NEI through FY 2023.

Ms. Colbert presented a comparison of NEI funding levels for FY 2021 through FY 2023. The President’s Budget request ($853,355,000) for FY 2023 is significantly lower than the House ($891,186,000) and Senate ($890,700,000) proposed FY 2023 levels. The House and Senate have proposed 3 percent increases for NEI. The President’s Budget is a planning document and does not establish appropriation. The FY 2024 President’s Budget request also is being developed without having a current appropriation in place.

The House has proposed a $2.5 billion increase for NIH excluding the Advanced Research Projects Agency for Health (ARPA-H), whereas the Senate has proposed a $2 billion increase for NIH including ARPA-H at same level as FY 2022 ($1 billion). The Senate bill also includes a minimum 3.1 percent increase for most NIH Institutes and Centers with targeted increases for priorities such as pain/opioids, health disparities, and environmental health.

Dr. Teller asked if NIH has lobbyists working on behalf of NIH to request more funds. Dr. Gordon responded that federal employees are not allowed to lobby, but various groups lobby on behalf of NIH, including the Ad Hoc Group for Medical Research, which lobbies on behalf of all NIH Institutes. The National Alliance for Eye and Vision Research and the Alliance for Eye and Vision Research (NAEVR/AEVR) educate Congress members on NEI efforts and lobby for additional NEI funding.

 

PROMOTING IMPLEMENTATION AND DISSEMINATION OF CLINICAL RESEARCH

—Dr. Rinad Beidas, Chair, and Ralph Seal Paffenbarger, Professor of Medical Social Sciences, Feinberg School of Medicine at Northwestern University and Dr. Jennifer Sun, Associate Professor, Harvard Department of Ophthalmology

Dr. Chiang noted the implementation and dissemination of clinical research is a great challenge. He reminded Council members that during the last NAEC Council meeting, a question emerged about the gap in dissemination of clinical research. In response to this challenge, NEI Council workgroups will be formed. To kick off this effort, NEI invited special guests Drs. Rinad Beidas and Jennifer K. Sun.

Harnessing Implementation Science to Transform Health and Healthcare — Dr. Beidas is an investigator who conducts implementation science and behavioral economics research and helps organizations use best practices to improve clinical care quality and equity of care and health outcomes.

Dr. Beidas described how her identity as a Middle Eastern immigrant, mother, and community member influenced her perspective on implementation science and how she uses it to advocate for and amplify the needs of communities in pursuit of achieving population health and social justice. Implementation science in conjunction with behavioral economics has given her better insights to help staff, clinicians, leaders, and organizations use best practices with the end goal of improving the quality and equity of care and enhancing health outcomes.

She first became interested in implementation science after finding that young people were not receiving evidence-based practices in the community. This issue reflected a broader field-wide issue, and she believes implementation science can allow the community to move the needle, achieve the promise of scientific discovery, and transform health and healthcare equitably. She encouraged attendees to consider how this discipline might advance NEI’s mission to eliminate vision loss and improve quality of life through vision research.

Dr. Beidas defined implementation science as making sure all people obtain the procedures, approaches, and interventions that work best in their community while ensuring health equity. NIH defines it as the study of methods to promote the adoption and integration of evidence-based practices, interventions, and policies into routine healthcare and public health settings to improve population health. The assumptions and foci of implementation science include conducting the work in partnership with communities, considering clinician behavior within organizational constraints, understanding context and how it relates to success or failure, implementing an evidence-based “thing,” and using specific frameworks, methods, and strategies. It is helpful to distinguish between the evidence-based “thing” that is being deployed and the strategies that are used to deploy it.

The implementation science subway is a heuristic tool developed by Dr. Meghan Lane-Fall and collaborators to help investigators integrate implementation studies. Investigators identify the practice of interest (POI) they would like to implement and determine whether the POI has shown efficacy and effectiveness. In this process, investigators identify which types of studies must be done (e.g., efficacy research, effectiveness studies, mixed-methods studies, design implementation strategies, testing of implementation strategies).

Dr. Beidas provided an overview of the foundational concepts of implementation science by describing various crucial components of implementation science grant proposals, including conceptual models, implementation strategies (i.e., interventions), and measurement and analysis.

 Current implementation science conceptual models were described based on the theoretical approaches used in an implementation science framework developed by Nilsen et al. (2015). This framework places theoretical approaches into three categories: approaches describing and/or guiding the process of translating research into practice (i.e., process models), approaches for understanding and/or explaining what influences implementation outcomes (e.g., determinant frameworks, classic theories, implementation theories), and approaches for evaluation of implementation (e.g., evaluation frameworks). Dr. Beidas related intervention and implementation strategies to outcomes using the framework defined in Proctor et al. (2009). Intervention strategies (evidence-based practice) are different than implementation strategies (e.g., organizational strategies, group/learning strategies). Outcomes include implementation outcomes (e.g., feasibility, acceptability, health equity), process outcomes (efficiency, safety, effectiveness), and health outcomes (e.g., function, symptoms, quality of life). Implementation outcomes are usually the focus of implementation trials.

The Expert Recommendations for Implementing Change (ERIC) project compiled more than 73 discrete implementation strategies, which are the “how” of implementation and can be placed in the following categories: planning (e.g., assessing context before implementation), education (e.g., training), restructuring (e.g., creating new teams), quality management (e.g., audit and feedback), finance (e.g., altering incentives), and policy (e.g., changing liability laws). There are multiple approaches (e.g., concept mapping) to selecting implementation strategies, and they require conducting a needs assessment, consolidating inputs into a working logic model that guides strategy selection, and specifying theory of change and operationalizing strategies. Dr. Beidas noted that prioritizing equity in testing implementation strategies is critical and is achievable by testing the differential effectiveness of implementation strategies in minoritized and marginalized populations, adding additional strategies, and understanding partner perspectives on approaches.

Dr. Beidas reiterated that implementation and health outcomes are distinct and encouraged attendees to look at equity across implementation outcomes and conduct post hoc analysis to identify new inequities that may emerge during the implementation process. Qualitative and mixed methods are foundational and offer nuance and depth in the characterization of implementation outcomes.

 One example of Dr. Beidas’ studies is the Adolescent and child Suicide Prevention and Routine clinical Encounters (ASPIRE) trial. The ASPIRE trial focused on understanding quantitatively the current use of an evidence-based firearm safety practice, S.A.F.E Firearm (POI), and attitudes of clinicians and leaders in two large health systems toward this program (mixed-methods study). Dr. Beidas and her group conducted implementation mapping to design implementation strategies and currently are conducting a hybrid/effectiveness implementation trial to ask whether the less costly and scalable electronic health record (EHR)-based “nudge” is powerful enough to change clinician behavior or whether more intensive and expensive facilitation is needed to overcome implementation barriers. 


Dr. Beidas described applications of implementation science in NEI-funded work. One example is the Implementation of Teleophthalmology in Rural Health Systems Study (I-TRUST) by Dr. Liu (University of Wisconsin) in which the POI is teleophthalmology for diabetic retinopathy. Mixed-methods studies were done to study barriers to implementation of teleophthalmology, and implementation strategies (Implementation for Sustained Impact in Teleophthalmology [I-SITE]) were designed. Currently, an implementation trial is underway to assess the effectiveness of I-SITE vs usual care teleophthalmology for increasing diabetic eye screening rates among eight rural health systems across five states; understand key factors and core implementation components that distinguish high- and low-use rural health systems affect I-SITE implementation; and determine implementation costs.

Other emerging opportunities in vision research and implementation science include using the intersection of data science, AI, and registries to better ascertain implementation outcomes and identify care gaps; leveraging practice-based research networks such as the Diabetic Retinopathy Clinical Research (DRCR) Retina Network; partnering with implementation scientists to produce meaningful team science from bench to bedside; and prioritizing hybrid trials and reporting strategies used earlier on in clinical research.

Dr. Beidas said she is hopeful that the information she shared will generate ideas about how this discipline might advance the mission of NEI to eliminate vision loss and improve quality of life through vision research.

Discussion
Dr. Maguire asked if there were basic implementation strategies, that could be applied universally across different medical disciplines, for disseminating and adopting information.  Dr. Beidas responded that a universal playbook for implementation doesn’t exist but the process she presented consisting of identifying barriers and facilitators, designing strategies, and deploying those implementation strategies is a ubiquitous process across content areas. She advised prioritizing individual-level strategies and using principles from behavioral science or behavioral economics to restructure the environment and to easily facilitate behavioral changes in clinicians and patients. For high-priority points of interest, Dr. Beidas warned that basic implementation isn’t enough because you must also utilize audit and feedback, and organization-level strategies to signal to an organization that the new implementation matters, and adherence is expected.

Dr. Hartnett shared she would like to learn more about implementation science. Dr. Beidas recommended the textbook, Dissemination and Implementation Research in Health: Translating Science to Practice by authors Brownson, Colditz and Proctor and she recommended the journals, Implementation Science and Implementation Science Communications. She shared that NIH and Academy Health are cohosting the 15th Annual Conference on the Science of Dissemination and Implementation in Health, which will be held in December 2022. She advised investigators to partner with implementation scientists.

Dr. Del Rio-Tsonis highlighted the disconnect between basic researchers and clinical researchers to share information and the need for programs to foster collaborative efforts. Dr. Beidas agreed that more needs to be done to bridge the gap between researchers and added that training should be incorporated to build capacity for collaborating.  She acknowledged there is a need for more implementation scientists to meet the demand.

Development, Determination, and Dissemination of Evidence-Based Practices—Dr. Chiang briefly introduced special speaker Dr. Sun, who directs clinical eye research at the Joslin Diabetes Center. She chairs diabetes initiatives at the DRCR Retina Network, which is an NEI-funded collaborative research network, and is Co-Scientific Director for the Mary Tyler Moore Vision Initiative.

Dr. Sun provided an overview of evidence-based practices in ophthalmology—within the context of retinal disease—including how to develop new practices, determine which practices will benefit patients, disseminate information about evidence-based practices, and determine whether these practices are being successfully implemented.

Dr. Sun outlined the Early Treatment Diabetic Retinopathy Study staging system was developed in 1991 to grade retinopathy severity based on retinovascular lesions, as well as the early efforts of the Mary Tyler Moore Vision Initiative. She described efforts in dystrophia retina pigmentosa (DRD) through studies from the DRCR Retina Network, a collaborative network of diverse clinical sites dedicated to scientifically rigorous, impactful clinical research of retinal diseases. Since its conception, the network has conducted 38 multicenter studies with 117 publications, and in 2017, the network’s scope expanded to all retinal diseases. This collaborative network was formed by NEI and includes network chairs, a coordinating center, and clinical sites (389 active investigators, 139 active sites in 29 states and 2 provinces in Canada). Dr. Sun provided an overview of completed network protocols and highlighted the studies performed covering a wide breadth of complications within diabetic eye disease and various severity stages of diabetic retinopathy.

The DRCR develops new practices that can be evaluated for use in clinical care by conducting clinical studies using a multistep protocol development process that begins when the network invites internal or external submitters to present their ideas to the applicable Steering Committee for review. The designated ideas are presented to network investigators, a Steering Committee, as well as an Executive Committee (EC) that prioritizes them based on network resources and public health importance. A Protocol Development Committee is formed, and protocol drafts are reviewed by network investigators and collaborators, designated EC members, the NEI external Protocol Review Committee, and the Data Safety Monitoring Committee (DSMC).

The most recently completed study, Protocol AC, is the first phase III study of step therapy for diabetic macular edema and showed that using bevacizumab first and switching to the more expensive aflibercept if vision remains suboptimal is as effective at improving vision as aflibercept monotherapy. This study has substantial implications for public health cost savings and outlines a standardized retreatment regimen and switching criteria that can be used in clinical care. The Protocol Development Committee developed the AC switch criteria (i.e., detailed flowchart with integrated decision algorithms) that were presented for implementation by the retina community in August 2022 with the hope that the simplified message is easier for clinicians to retain and use. Dr. Sun noted that development of usable practices is strengthened by diverse input and multilayered review, and new treatment algorithms should be rooted in current clinical practice; easily remembered and implemented by clinicians; readily explainable to patients and a lay audience; and translatable across the spectrum of low- to high-resource settings.

To evaluate whether new practices benefit patients, investigators consider evidence in clinical research (e.g., case series and reports, cohort studies, randomized controlled trials). Dr. Sun provided an overview of the current care of diabetic macular edema and diabetic retinopathy and noted that the common approaches to management of patients in this field have been directed by DRCR Network clinical studies and valuable systematic reviews and meta-analyses from organizations such as the Cochrane organization.

The ophthalmology community learns about evidence-based practices via scientific meetings, publications, systematic reviews, society practice guidelines, throwaway publications, press releases, continuing medical education meetings, podcasts, websites, webinars, and social media. The DRCR Retina Network easily tracks scientific meeting presentations, publications, systematic reviews and meta-analyses, and society practice guidelines. It is more challenging to understand how information is disseminated by the other dissemination avenues (e.g., websites, podcasts) that wield large influence on clinical practice and disseminate information of widely varying quality.

To determine whether evidence-based practices are being implemented, investigators rely on surveys, electronic health record databases, medical claims databases, and public health surveillance reporting systems. Personal experience, word of mouth, and web searches have been useful in observing that DRCR Retina Network results are being implemented in clinical practice. DRCR Network results and treatment algorithms are reflected in multiple practice guidelines for diabetic eye care from different organizations (e.g., American Academy of Ophthalmology, American Diabetes Association). DRCR Retina Network studies also have influenced recommended practice guidelines for multiple international societies and are referenced by international groups.

There is a need for standardized approaches to understand how clinical research impacts clinical care because understanding implementation patterns will help define gaps in care that could be addressed to improve visual outcomes and knowing the current practices will help design future clinical studies and trials to further improve care. Consideration should be given to new approaches to determine adoption and uptake of evidence-based practices. One potential approach is NEI’s distribution of a Request for Applications (RFA) to create infrastructure to understand implementation of evidence-based practices in DRD. This effort would involve a collaborative network formed by different stakeholders (e.g., clinical researchers, patients with diabetes) and a pipeline of implementation studies that would inform ongoing trial development in DRD. In time, this effort could be expanded to all areas of ophthalmology.

Dr. Sun commented on the high prevalence of vision loss around the world and noted that efforts such as understanding implementation of best practices to improve practices and clinical care could lead to optimization of vision outcome for all patients. She outlined multiple organizations that have contributed to efforts in DRD and indicated that she is hopeful that additional efforts in implementation science, which will need strong collaborations, will benefit from existing partnerships.

Discussion
Dr. Hartnett commented that organizations such as the DRCR Retina Network are of great value to public health and demonstrate the importance of science (e.g., conducting clinical trials, identifying long-term outcomes, having comparison groups) to academics as well as private practitioners who may largely be influenced by anecdotal evidence but may not know the long-term benefits. Dr. Sun agreed and added that one of the first initiatives of the DRCR Retina Network was to involve community practitioners in addition to academicians. Community practitioners are essential in clinical trials because they enroll the patients needed for the trials. In addition, community practitioners’ participation in clinical research has allowed them to gain an understanding of the importance of standardization and a better understanding of the data. Dr. Sun noted that the integration of discussions about implementation and discussions with community practitioners about clinical trial data would be a good learning opportunity.

Dr. Maguire pointed out that in addition to emphasizing implementation in terms of educating and changing clinicians’ behavior, investigators should also emphasize to clinicians the need to educate patients about taking advantage of and continuing very effective treatments. Dr. Maguire supported her assertion with data she gathered from Medicare that 25% of AMD (Age-related macular degeneration) patients stop treatment after the first injection and 50-60% stop treatment within five years. Dr. Sun agreed and added that loss of patients’ follow-up is an enormous challenge in clinical practice.

Dr. Dana commented that while science is important to optimizing standards for care, there’s still a barrier between determining those standards and implementing them in the real-world where you must also contend with financial and social barriers that affect optimal healthcare to the patients. Dr. Dana used the example of how physicians must often delay patient therapy while trying to convince or waiting for insurance companies to accept coverage for necessary procedures, necessary preventions, or approved drugs. Dr. Sun agreed and noted that the social determinants affecting which patients get care and help are all critical in evidenced based practices.

Dr. Teller asked Dr. Sun how soon in the future will telehealth and telemedicine Artificial Intelligence (AI) be implemented for early detection of diabetic retinopathy. Dr. Sun answered the FDA has approved several AI systems for diabetic retinopathy that are currently in use now and she’s certain they will continue to approve and expand efforts. She noted that many tele-medicine screening initiatives, made scalable by the integration of AI evaluation, are in partnership with health services and they are currently out in the communities performing retinal screenings. She believes five to ten years is a very achievable goal for this approach to be implemented on a global scale. She warned that the challenge may be attaining collaboration across stakeholders and countries to address inequities in healthcare and reach the underserved populations that need this care the most.

 

PORTFOLIO OVERVIEW: Collaborative Clinical Research Program

—Dr. Maryann Redford, Program Director, Collaborative Clinical Research Program, NEI

Dr. Redford provided an overview of the Collaborative Clinical Research (CCR) Program, which supports NEI-funded clinical trials. Dr. Redford, Dr. Sangeeta Bhargava, Mr. Donald Everett, and Dr. Jimmy Le manage the CCR portfolio, which comprises phase III clinical trials, gene and cellular therapy/regenerative medicine trials, research networks, multisite epidemiologic studies, international research projects, and Cochrane systematic reviews.

CCR grant support mechanisms are highly skewed toward Cooperative Agreements (U mechanism), which are utilized by NIH when substantial staff involvement is required. CCR Program Directors regularly participate in multiple activities (e.g., study design, oversight committee meetings) that allow them to monitor studies and provide stewardship. Monitoring committees, including the Data and Safety Monitoring Committee and the Data and Monitoring Committee are outside experts that, in addition to assisting NEI and study leadership in protecting the interest of research participants, monitor study quality, timeliness, and integrity.

The CCR cooperative agreement funding opportunity announcements (FOAs) for collaborative clinical vision research (PAR-21-041, PAR-21-042), early-stage clinical trials involving greater than minimal risks (PAR-22-149), and epidemiology studies (PAR-21-204) solicit applications on design and implementation. Applications are reviewed by an in-house special emphasis panel convened by NEI. NEI Scientific Review Officers (SROs) ensure rigorous review. NEI also offers secondary data analysis (PAR-22-141), clinical research study planning (PAR-22-128, PAR-22-135), and parent (R01s, R21s) funding opportunities to the clinical research community.

NEI supports testing of cutting-edge treatments such as visuomotor prosthetic and stem cell and gene therapy interventions. Two NEI-funded stem cell studies are being supported by the Regenerative Medicine Innovation Project (RMIP). NEI also supports several multicenter clinical trials across the U.S. that private industry does not support (e.g., Endothelial Thickness Comparison Trial, Diabetes Endothelial Keratoplasty Study, Myopia Progression and Soft Contact Lens Myopia Control). Most NEI-funded clinical studies use both academic and private practice-based enrollment centers and, increasingly, international sites, which enhances enrollment and accelerates the translation of research to practice. NEI funds studies that address vision issues across the lifespan (e.g., AMD in elderly patients, uveitis in juveniles, spectacle correction in children) and public health issues at the international scale in Ethiopia, Nepal, and Niger.

NEI also supports two research networks: the Pediatric Eye Disease Investigative Group (PEDIG) and the DRCR Retina Network. Both PEDIG and the DRCR Retina Network are open collaborative networks. PEDIG studies involve 300 pediatric ophthalmologists and optometrists and have influenced clinical pediatric care worldwide. Dr. Redford highlighted the DRCR Retina Network’s rigorous protocol development process, the large teams supporting all 398 practitioners involved in studies, and the support garnered from 17 industry and foundation partners. She also emphasized the influence the DRCR Retina Network studies have had on clinical practice.

NEI-supported epidemiologic studies and systematic reviews include the Study of Latinos Ojos (SOL Ojos) and Cochrane Eye and Vision (CEV). SOL Ojos is an ancillary eye study to the National Heart, Lung, and Blood Institute (NHLBI)-supported Hispanic Community Health Study/Study of Latinos (HCHS/SOL) that will leverage prospective phenotypic and genotypic parent study data for Latino participants of diverse origins and presents an opportunity to examine relations among eye conditions and novel cardiovascular disease, biomedical, and sociocultural risk factors.

Dr. Redford concluded by praising the Ocular Hypertension Treatment Study for having three articles ranked as the top three with significant impact on clinical glaucoma care by the American Glaucoma Society.

Discussion
Noting her experience as both a clinical investigator and a past member of the DSMC, Dr. Maguire expressed that the collaborative studies operate on high-levels due to the involvement of the best investigators from different disciplines. She pointed out Dr. Redford’s presentation which showed the number of publications and influences produced from the collaborative studies demonstrate their value. She also praised the DSMC for its diversity by including members who are separate from the collaborative studies to provide expert advice and oversight.

Dr. Dana thanked NEI for their efforts to fill an important niche by supporting clinical research studies that are typically overlooked by private industries for investments due to their lengthy research time. Dr. Redford commended Dr. Dana for overcoming the challenges of conducting a limbal stem cell deficiency study by leveraging the NHLBI-funded program Production Assistance for Cellular Therapies (PACT) to conduct preliminary pre-clinical work.

Dr. Del Rio-Tsonis asked how the SOL Ojos study connects with difficult-to-reach populations and how will the data be implemented to improve the vision of the community. Dr. Redford explained that NEI leverages extensive work already done by NHLBI to recruit diverse populations of Latinos. NEI will assess the conditions gathered from comprehensive exams and determine how they correlate with systemic and genetic data already available. NEI will assess implementation if significant conditions and disparities are found.

Dr. Borras highlighted the importance of the Ocular Hypertension Treatment Study as a resource that was of tremendous help to the glaucoma field. Dr. Redford thanked Dr. Borras and pointed out that publications from other NEI-supported glaucoma studies also placed in the top 10 publications with significant impact on clinical glaucoma care ranked by the American Glaucoma Society.

PORTFOLIO OVERVIEW: Research Training and Workforce Development

—Dr. Neeraj Agarwal, Program Director, NEI

Dr. Agarwal presented an overview of the current NEI training portfolio comprising 257 total active grants, including individual fellowships (F30, F32, F32), mentored career development grants (K08, K23, K99/R00), and institutional training grants (T32, T35, K12).

Dr. Agarwal presented a comparison of NEI’s fellowship and research grants portfolios through the 2012–2022 period, organized into the six cores of the NEI research program: retina; cornea; lens; glaucoma; strabismus, amblyopia, and visual processing (SAVP); and low vision. The percentage of SAVP NEI fellowships (43%) is larger than that of SAVP NEI research grants (23%), whereas the percentages of retina NEI fellowships (43%) and research grants (44%) are similar. The other programs (cornea, lens, glaucoma, low vision) constitute 10 percent of the NEI fellowship portfolio.

Dr. Agarwal outlined the fellowship success rate for FY 2017–2022 as calculated by dividing the number of awarded fellowships by the number of submitted applications. The success rate of F30s is higher than that of F31s and F32s throughout this period. It will be important to determine how many F30 awardees (MD/PhD candidates) enter ophthalmology residency programs. FY 2015 and FY 2016 data show that 50 percent of F30 awardees entered ophthalmology residency programs. The R01 success rate by F32 (postdoctoral fellowship) awardees for FY 2012–2022 is 40 percent (12 F32 awardees with funded R01s of 30 applicants). K99 awardees are not factored into this calculation. For this period, 16 F32 awardees obtained K99 awards. The success rates of FY 2022 active institutional training grants are as follows: 100 percent for K12; 63 percent for T32; and 100 percent for T35. Currently, the total number of active institutional training grants are 10 K12s, 30 T32s, and 11 T32s.

The percentages of K career development grants awarded by NEI’s and the research grants portfolios through the FY 2012–2022 period (organized into the six cores of the NEI research program) are similar except for the glaucoma program. An overview of success rates of K awardees (K08, K23, K99) for FY 2017–2022 shows the success rate for these awards is higher than NIH rates. The R01 success rates of K awardees for FY 2012–2022 are 49 percent for K08; 55 percent for K23; and 59 percent for K99.

Other trans-NIH training initiatives include the following:

The NEI Loan Repayment Program (LRP) aims to attract health professionals to careers in research by paying investigators’ educational debt and provides up to $50,000 for debt payback and accrued IRS taxes. NIH grant support is not required, and applicants must be U.S. citizens or U.S. permanent residents and can apply multiple times. The deadline for the LRP is November 17, 2022. LRP has four categories of loan repayment (e.g., pediatric research, clinical research, health disparity, Research in Emerging Areas Critical to Human Health). The funding rate for the NEI LRP for FY 2022 is higher (87%) than the NIH LRP funding rate (59%). The total award amount for FY 2022 is $1.3 million. The LRP analysis by degree for FY 2017–2021 (140 total funded applications) shows 41 percent were MD: MD/PhD; 31 percent were Doctor of Optometry (OD): OD/PhD; and 28 percent were PhD.

Discussion
Dr. Coughlan asked Dr. Agarwal’s thoughts on young investigators preferring to apply for R21 grant mechanisms rather than R01 grant mechanisms because they believe R21s are easier to get since there’s no requirement for pilot data but pointed out statistics show that R21s are more competitive and harder to get than R01s. Dr. Agarwal agreed with Dr. Coughlan and shared that many young investigators often contact him with the belief that R21s are easier to acquire than R01s but he confirmed that is not necessarily the case.  At NEI. success rates for R01 applicants are higher than for R21 applicants. Dr. Agarwal noted the following benefits of R01s: investigators have the advantage of an Early-Stage Investigator (ESI) status; their R01s are reviewed with other applications from ESIs; less emphasis is placed on preliminary data; and they have up to five years of funding with an R01 versus only 2 years with a R21.

Dr. Anderson highlighted that NEI has one of the highest success rates for ESIs applying for R01s and added that ESIs are also eligible to apply for the Stephen I. Katz Early-Stage Investigator Research Project Grant .

Dr. Del Rio-Tsonis thanked Dr. Agarwal specifically, for providing information about the trans NIH initiative, Blueprint Diversity Specialized Predoctoral to Postdoctoral Advancement in Neuroscience (D-SPAN) award in a prior Council meeting. She shared that her graduate student applied and successfully received the grant, but she expressed her concern that her student only learned about the grant because the Council member was privileged to the information through the Council presentation.  She asked how NEI promotes funding opportunities to potential candidates. Dr. Agarwal responded he and others at NEI promote these funding opportunities at different meetings and on the NIH and NEI web.  He also encourages potential candidates to contact him with questions.

Dr. Chiang thanked Dr. Del Rio-Tsonis for pointing out the challenge of effectively promoting training opportunities. NEI has been using social media for promotion of such opportunities. Dr. Chiang encouraged Council members to share ideas on how to reach potential candidates and to promote funding opportunities with their community. Potential approaches include recruiting awardees to share the information with potential candidates who may not utilize social media. Career development award information will be shared during a possible future K Award Symposium. Dr. Kowluru suggested that social media may be the best way to promote the opportunities.

CONCEPT CLEARANCE

NEI Center Core Grant for Vision Research (P30) Renewal

—Dr. Ellen Liberman, Program Director, DESP, NEI

Dr. Liberman presented a concept clearance for the renewal of the NEI P30 Center Core Grant for Vision Research (PAR-20-051). The goal of these institutional Center Core Grants is to build research infrastructure within an institution for the purpose of providing technical support to groups of NEI R01-funded investigators. The Core grant supports the cost of shared resources rather than individual R01 grants, creating an economy of scale for institutions that have intensive vision research. In addition, institutions benefit from promotion of a collaborative environment and cost-effectiveness. Grants are required to have an administrative core and three or more resource and/or service cores.  Applicant institutions must have a minimum of eight active R01s to be eligible. Any researcher at the institute can use the core facilities.

Discussion

Discussants Drs. Borrás and Moore expressed strong support for the renewal, noting the importance of providing instruments and resources that are beyond the reach of individual R01 grant budgets. A suggestion was made to consider supporting a smaller core center grant for institutions that have less than eight R01s. Council members also recommended updating the examples of the cores provided in the rationale as the need for machine shops has diminished with the advent of 3D printing. Dr. Liberman agreed that the language in the funding opportunity should be updated to reflect new technologies available and resources needed to support those.

A motion to approve the concept was made, seconded, and approved unanimously.

PORTFOLIO OVERVIEW: Research Training and Workforce Development

—Dr. Neeraj Agarwal, Program Director, NEI

Dr. Agarwal presented an overview of the current NEI training portfolio comprising 257 total active grants, including individual fellowships (F30, F32, F32), mentored career development grants (K08, K23, K99/R00), and institutional training grants (T32, T35, K12).

Dr. Agarwal presented a comparison of NEI’s fellowship and research grants portfolios through the 2012–2022 period, organized into the six cores of the NEI research program: retina; cornea; lens; glaucoma; strabismus, amblyopia, and visual processing (SAVP); and low vision. The percentage of SAVP NEI fellowships (43%) is larger than that of SAVP NEI research grants (23%), whereas the percentages of retina NEI fellowships (43%) and research grants (44%) are similar. The other programs (cornea, lens, glaucoma, low vision) constitute 10 percent of the NEI fellowship portfolio.

Dr. Agarwal outlined the fellowship success rate for FY 2017–2022 as calculated by dividing the number of awarded fellowships by the number of submitted applications. The success rate of F30s is higher than that of F31s and F32s throughout this period. It will be important to determine how many F30 awardees (MD/PhD candidates) enter ophthalmology residency programs. FY 2015 and FY 2016 data show that 50 percent of F30 awardees entered ophthalmology residency programs. The R01 success rate by F32 (postdoctoral fellowship) awardees for FY 2012­­–2022 is 40 percent (12 F32 awardees with funded R01s of 30 applicants). K99 awardees are not factored into this calculation. For this period, 16 F32 awardees obtained K99 awards. The success rates of FY 2022 active institutional training grants are as follows: 100 percent for K12; 63 percent for T32; and 100 percent for T35. Currently, the total number of active institutional training grants are 10 K12s, 30 T32s, and 11 T32s.

The percentages of K career development grants awarded by NEI’s and the research grants portfolios through the FY 2012–2022 period (organized into the six cores of the NEI research program) are similar except for the glaucoma program. An overview of success rates of K awardees (K08, K23, K99) for FY 2017–2022 shows the success rate for these awards is higher than NIH rates. The R01 success rates of K awardees for FY 2012­–2022 are 49 percent for K08; 55 percent for K23; and 59 percent for K99.

Other trans-NIH training initiatives include the following:

The NEI Loan Repayment Program (LRP) aims to attract health professionals to careers in research by paying investigators’ educational debt and provides up to $50,000 for debt payback and accrued IRS taxes. NIH grant support is not required, and applicants must be U.S. citizens or U.S. permanent residents and can apply multiple times. The deadline for the LRP is November 17, 2022. LRP has four categories of loan repayment (e.g., pediatric research, clinical research, health disparity, Research in Emerging Areas Critical to Human Health). The funding rate for the NEI LRP for FY 2022 is higher (87%) than the NIH LRP funding rate (59%). The total award amount for FY 2022 is $1.3 million. The LRP analysis by degree for FY 2017–2021 (140 total funded applications) shows 41 percent were MD: MD/PhD; 31 percent were Doctor of Optometry (OD): OD/PhD; and 28 percent were PhD.

Discussion
Dr. Coughlan asked Dr. Agarwal’s thoughts on young investigators preferring to apply for R21 grant mechanisms rather than R01 grant mechanisms because they believe R21s are easier to get since there’s no requirement for pilot data but pointed out statistics show that R21s are more competitive and harder to get than R01s. Dr. Agarwal agreed with Dr. Coughlan and shared that many young investigators often contact him with the belief that R21s are easier to acquire than R01s but he confirmed that is not necessarily the case.  At NEI. success rates for R01 applicants are higher than for R21 applicants. Dr. Agarwal noted the following benefits of R01s: investigators have the advantage of an Early-Stage Investigator (ESI) status; their R01s are reviewed with other applications from ESIs; less emphasis is placed on preliminary data; and they have up to five years of funding with an R01 versus only 2 years with a R21.

Dr. Anderson highlighted that NEI has one of the highest success rates for ESIs applying for R01s and added that ESIs are also eligible to apply for the Stephen I. Katz Early-Stage Investigator Research Project Grant .

Dr. Del Rio-Tsonis thanked Dr. Agarwal specifically, for providing information about the trans NIH initiative, Blueprint Diversity Specialized Predoctoral to Postdoctoral Advancement in Neuroscience (D-SPAN) award in a prior Council meeting. She shared that her graduate student applied and successfully received the grant, but she expressed her concern that her student only learned about the grant because the Council member was privileged to the information through the Council presentation.  She asked how NEI promotes funding opportunities to potential candidates. Dr. Agarwal responded he and others at NEI promote these funding opportunities at different meetings and on the NIH and NEI web.  He also encourages potential candidates to contact him with questions.

Dr. Chiang thanked Dr. Del Rio-Tsonis for pointing out the challenge of effectively promoting training opportunities. NEI has been using social media for promotion of such opportunities. Dr. Chiang encouraged Council members to share ideas on how to reach potential candidates and to promote funding opportunities with their community. Potential approaches include recruiting awardees to share the information with potential candidates who may not utilize social media. Career development award information will be shared during a possible future K Award Symposium. Dr. Kowluru suggested that social media may be the best way to promote the opportunities.

GENERAL COUNCIL DISCUSSION

Dr. Anderson opened the floor for general discussion by Council members. 

Dr. Del Rio-Tsonis shared her concerns about Data Management and Sharing specifically, the risk of shared data being scooped prior to publication. She asked whether the shared data could have an embargo placed on it until it is published. Dr. Chiang noted her concern is a common one heard by NEI, and he will circulate resources on the Data Management and Sharing Policy provided by Dr. Mike Lauer, during the 161st NAEC meeting in June 2022, which contains detailed information to help address many concerns. 

Dr. Chiang expressed that the question of when to release data is a common one. He believes the research community is at a crossroads. Scientifically, the culture is that the output of a research project is the publication. He believes that both the publication and the data are equally important outputs. This issue will be solved as the data are viewed as being as important an output as the publication. To truly value data sharing and team science, the research community will have to recognize the current unequal value of data and publications.

Dr. Hartnett expressed concern for the lack of clarity in the Data Management and Sharing Policy of what data needs to be shared. Dr. Chiang clarified that not all data needs to be shared according to the official NIH policy but one of the goals of Data Management and Sharing is to get away from the statement, “data will be shared upon request” or similar statements. He advised her to speak to Program Officers and he assured her that resources will be circulated amongst the community discussing the issue in detail.

Dr. Coughlan commented he has gained an interest in data sharing licenses and would like to learn more about them. He views adding data sharing licenses to data as a benefit because they legally mandate users of the data to attribute the investigators, plus there are various levels of the license that can impose other stricter requirements. Dr. Coughlan questioned how restrictive of a data license can investigators choose for data funded by NIH, and he used the example of licenses that prohibit the commercialization of data. Dr. Chiang responded that NEI has received similar questions in the past about Creative-Common versus Apache licenses. With prior queries, they were unable to find any guidance about this issue, but he will follow up to see if there are new developments. He shared that NEI worked with Dr. Marco Zarbin (Editor-in-Chief of Translational Vision Science and Technology) on creating a publication type that represents datasets or software libraries to get credit after datasets or code are published. Emily Chu also has implemented this concept within ophthalmology science. Dr. Chiang noted that these conversations originated from discussions with Editor-in-Chiefs of major vision journals, and he hopes we all can create a culture within the vision community that focuses on the benefits of data sharing. 

Dr. Borras inquired, since experiments are continuous and produces data that is continuous, at what point do you share the data; do you share it in the middle of research or wait, for example, another 2-3 years until the end. Dr. Chiang provided Dr. Borras with the link to the best guideline in the Data Management and Sharing Policy that addresses her issue. 

Dr. Del Rio-Tsonis asked whether there is a plan to include a budget for implementation of the Data Management and Sharing Plan in mechanisms that have a strict budget cap (e.g., R15, R21). Dr. Anderson indicated that she would seek advice on this issue. She added that investigators do not have to submit a modular budget with their funding applications (e.g., R01) to be competitive. Investigators should request the needed funding, including the funding needed to share data. Dr. Del Rio-Tsonis asked whether the data repositories will be curated or managed in a manner that would align with the Data Management and Sharing Policy. Dr. Chiang pointed out that investigators must ensure that collected data are interpretable by others so that they are useful. He hopes the Data Management and Sharing Policy stimulates conversations about this effort in the community. Examples of appropriate data repositories include generalist repositories that are publicly available (e.g., figshare). Information on these repositories will be circulated to the group. Templates of data sharing management plans for different types of data will be provided in the future. 

Drs. Anderson and Chiang thanked attendees and Ms. Lehrer-Stein and Dr. Perez-Quinones for their participation. Dr. Chiang concluded that he looks forward to future discussions on implementation and dissemination of clinical research findings.

OPEN SESSION ADJOURNMENT

Dr. Anderson adjourned the open session of the Council meeting at 2:30 PM.


CLOSED SESSION

This portion of the meeting was closed to the public in accordance with the determination that this session concerned 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, USC Appendix 2). 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 were asked to sign a statement to this effect.

REVIEW OF APPLICATIONS

NAEC members considered 514 research and training grant applications on which NEI was the primary Institute; these applications requested a total of $185,625,500 (direct costs year 01). The Council also considered 111 applications on which another Institute/Center was primary and NEI was secondary. These applications requested a total of $127,504,212 (direct costs year 01). The Council concurred with the Institutional Review Group recommendations on these 625 applications.

ADJOURNMENT

The 163rd meeting of the National Advisory Eye Council was adjourned at 4:05 p.m. on October 14, 2022.

CLOSED SESSION ATTENDEES

Council Members Present:

Dr. Michael Chiang, Chair
Dr. Kathleen Anderson, Executive Secretary
Dr. Terete Borrás
Dr. James Coughlan
Dr. Reza Dana
Dr. Katia Del Rio-Tsonis
Dr. Mary Elizabeth Hartnett
Dr. Renu Kowluru
Dr. Tirin Moore
Dr. Benjamin Teller

NIH Staff Members Present:

Dr. Neeraj Agarwal
Dr. Houmam Araj
Dr. Sangeeta Bhargava
Mr. Nathan Brown
Dr. Kevin Czaplinski
Mr. Donald Everett
Dr. Martha Flanders
Dr. Ashley Fortress
Dr. James Gao
Dr. Nataliya Gavrilovic
Dr. Shefa Gordon
Dr. Tony Gover
Dr. Tom Greenwell
Ms. Lateefah Hill
Dr. Brian Hoshaw
Dr. Alicia Kerr
Dr. Paek Lee
Dr. Kristine Mackin
Dr. Barbara Mallon
Dr. George Mckie
Dr. Lisa Neuhold
Dr. Maryann Redford
Dr. Jennifer Schiltz
Dr. Grace Shen
Ms. Karen Smith
Dr. Hongman Song
Dr. Santa Tumminia
Dr. Afia Sultana
Dr. Cheri Wiggs
Ms. Keturah Williams
Dr. Charles Wright

CERTIFICATION

These minutes were submitted for the approval of the Council. All corrections or notations were incorporated. We hereby certify that, to the best of our knowledge, the foregoing minutes and attachment(s) are accurate and complete.

______________________________________

Michael F. Chiang, MD
Chair
National Advisory Eye Council

______________________________________

Kathleen C. Anderson, PhD
Executive Secretary
National Advisory Eye Council

Last updated: January 6, 2023