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NAEC Meeting Minutes - February 11, 2022
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<span>NAEC Meeting Minutes - February 11, 2022</span>
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<div class="c-jump-menu__intro">On this page:</div>
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<a class="c-jump-menu__item" href="#section-id-18953">Council, Staff, and General Public Present</a>
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<a class="c-jump-menu__item" href="#section-id-18957">Welcome and Introductions</a>
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<a class="c-jump-menu__item" href="#section-id-18959">Council Procedures and Related Matters</a>
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<a class="c-jump-menu__item" href="#section-id-18961">Director’s Report</a>
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<a class="c-jump-menu__item" href="#section-id-18963">Portfolio Overview</a>
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<a class="c-jump-menu__item" href="#section-id-18965">Concept Clearances</a>
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<a class="c-jump-menu__item" href="#section-id-18967">General Council Discussion</a>
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<a class="c-jump-menu__item" href="#section-id-18969">Open Session Adjournment</a>
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<a class="c-jump-menu__item" href="#section-id-18971">Closed Session</a>
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<a class="c-jump-menu__item" href="#section-id-18973">Review of Applications</a>
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National Eye Institute
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<p><strong>National Institutes of Health</strong><br><strong>National Eye Institute</strong><br><strong>Minutes of the National Advisory Eye Council</strong><br><strong>One Hundred Sixtieth Meeting</strong><br><strong>February 11, 2022</strong></p><ul><li><a href="https://videocast.nih.gov/watch=44313"><strong>Videocast</strong></a></li></ul><p>The National Advisory Eye Council (NAEC) convened for its 160<sup>th</sup> meeting at 10:00 a.m. on Friday, February 11, 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 Chiang, MD, Director of the National Eye Institute (NEI), presided as Council Chair, and Kathleen Anderson, PhD, served as Executive Secretary. The meeting was open to the public from 10:00 a.m. until 1:30 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.</p>
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Council Members Present
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<p>Dr. Michael Chiang, Chair<br>Dr. Kathleen Anderson, Executive Secretary<br>Dr. Jose-Manuel Alonso<br>Dr. Terete Borras<br>Dr. James Coughlan<br>Dr. Reza Dana<br>Dr. Katia Del Rio-Tsonis<br>Dr. Thomas Gardner<br>Dr. Mary Elizabeth Hartnett<br>Dr. Renu Kowluru<br>Dr. Maureen Maguire<br>Dr. Tirin Moore<br>Dr. Mary Ann Stepp<br>Dr. Benjamin Teller</p>
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NIH Staff Members Present
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<p>Mr. Shawn Adolphus<br>Dr. Neeraj Agarwal<br>Mrs. Lisa Applewhite<br>Dr. Houmam Araj<br>Ms. Cynthia Best<br>Dr. Sangeeta Bhargava<br>Ms. Stephanie Blackford<br>Ms. Holly Blake<br>Mr. Nathan Brown<br>Ms. Monique Clark<br>Mr. Roland Colbert<br>Ms. Karen Colbert<br>Dr. Mary Frances Cotch<br>Dr. Kevin Czaplinski<br>Ms. Ashley Dash<br>Dr. Sunit Dutta<br>Dr. Martha Flanders<br>Dr. Ashley Fortress<br>Dr. James Gao<br>Ms. Alexandra Gavrilovic<br>Dr. Susan Gillmor<br>Ms. Kerry Goetz<br>Dr. Nataliya Gordiyenko<br>Dr. Shefa Gordon<br>Dr. Tony Gover<br>Dr. Tom Greenwell<br>Mr. David Higgins<br>Ms. Lateefah Hill<br>Dr. Brian Hoshaw<br>Dr. Jimmy Le<br>Dr. Paek Lee<br>Dr. Ellen Liberman<br>Ms. Renee Livshin<br>Dr. Barbara Mallon<br>Dr. George McKie<br>Dr. Lisa Neuhold<br>Ms. Barbara Payne<br>Dr. Maryann Redford<br>Ms. Amberlynn Reed<br>Ms. Carissa Reilly-Weedon<br>Dr. Jennifer Schiltz<br>Dr. David Schneeweis<br>Dr. Grace Shen<br>Ms. Karen Smith<br>Dr. Hongman Song<br>Dr. Michael Steinmetz<br>Dr. Santa Tumminia<br>Ms. Leslie West-Bushby<br>Dr. Cheri Wiggs<br>Ms. Nora Wong<br>Dr. Chuck Wright<br>Mr. Michael Wright</p><p><strong>Others Present Virtually:</strong></p><p>Ms. Leigh Cook<br>Ms. Kathy Sedgwick, Science Writer</p><p>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.</p>
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Welcome and Introductions
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<p><strong>Dr. Kathleen Anderson, Executive Secretary, NAEC, and Director, Division of Extramural Activities (DEA); Dr. Michael Chiang, Chair, NAEC, and Director, NEI</strong></p><p>Dr. Chiang called the 160<sup>th</sup> NAEC meeting to order and welcomed Council members, members of the NEI research and advocacy community, NEI and NIH staff, guest speakers, and the research and advocacy community. Dr. Anderson welcomed new Council members Drs. Reza Dana, Maureen Maguire, and Tirin Moore, who had served in an <em>ad hoc</em> capacity during the October 22, 2021 Council meeting. She acknowledged retiring Council members Drs. Jose-Manuel Alonso and Mary Ann Stepp. Each Council member introduced themselves and gave a brief overview of their research areas.</p>
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Council Procedures and Related Matters
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<p>Dr. Anderson reviewed Council procedures and etiquette for the Zoom meeting. The open session of the meeting was videocast and will be available on the <a href="https://videocast.nih.gov/watch=44313">NIH videocast</a> website.</p><p>The next Council meeting will be held virtually on Friday, June 17, 2022. Dates for future Council meetings are listed on the <a href="/about/advisory-committees/national-advisory-eye-council-naec/national-advisory-eye-council-naec-meetings">NEI website</a>. An additional Council meeting will be held in August 2022 to review applications submitted to two NEI-issued Requests for Applications (RFAs) considered for funding in Fiscal Year 2022.</p><p>Minutes of the October 2021 NAEC meeting were provided in the Electronic Council Book prior to the meeting. A motion to accept these minutes was made, seconded, and approved unanimously by Council members. The approved minutes will be posted on the NEI website.</p>
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Director’s Report
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<p><strong>Dr. Michael Chiang</strong></p><p><strong>Changes at NIH</strong>—Dr. Francis Collins stepped down as NIH Director in December 2021. A <a href="https://www.nih.gov/farewell-dr-francis-collins">tribute to Dr. Collins</a> is available on YouTube. Dr. Lawrence Tabak is the White House appointment to replace Dr. Collins as Acting Director.</p><p><strong>NEI Leadership Changes</strong>—Dr. Chiang expressed appreciation for the work of Dr. Brian Brooks, who retired as NEI Clinical Director but is continuing as Principal Investigator and Chief of the Ophthalmic Genetics & Visual Function Branch (OGVFB). He also acknowledged the hard work of other NEI staff, including Mr. Russ O’Donnell and Drs. Emily Chew, Teresa Magone, and Santa Tumminia.</p><p>Dr. David Schneeweis has been acting NEI Scientific Director since the retirement of Dr. Sheldon Miller in 2019. Applications for this position closed January 31, 2022, and NEI will begin interviews soon.</p><p><strong>Acknowledgments and Awards</strong>—Dr. Chiang congratulated NEI grantee Dr. Nancy Kanwisher, McGovern Institute for Brain Research at the Massachusetts Institute of Technology, who received the 2022 National Academy of Sciences Award in the Neurosciences for groundbreaking work on the functional organization of the human brain. Dr. Kanwisher is credited with co-discovering and characterizing the fusiform face area in the brain, a region specifically engaged in the perception of faces.</p><p>Dr. Robert Hufnagel, Chief of the Ophthalmic Clinical Genetics Section of the OGVFB in the Division of Intramural Research (DIR), has been named NEI’s 2021 Lasker Clinical Research Scholar. Commander Angel Garced, NEI Senior Nurse Consultant/Clinical Trial Coordinator, was deployed to the Northern Navajo Medical Center in January, working alongside the center’s medical personnel to help treat COVID-19 patients.</p><p><strong>NEI-funded Research Highlights</strong>— Dr. Cecilia Lee and NEI-mentored career awardee Dr. Aaron Lee at the University of Washington School of Medicine conducted <a href="https://jamanetwork.com/journals/jamainternalmedicine/fullarticle/2786583">a study of over 3,000 individuals with cataracts</a>. The results indicate that post-surgical risk of dementia from any cause was nearly 30 percent lower among adults who had surgery than in those who did not.</p><p>NEI intramural researchers Drs. Ruchi Sharma and Kapil Bharti developed an Induced Pluripotent Stem Cell (iPSC)-derived model of geographic atrophy that provides a framework using iPSC-RPE cell lines to model complex disease.</p><p>Awardee Dr. Krzysztof Palczewski at the University of California, Irvine used Cryo-Electron Tomography (Cryo-ET) to observe the precise spacing of discs in rod outer segments (ROS), improving understanding of the pathologies of gene mutations in the ROS membrane. <a href="https://elifesciences.org/articles/72817">The data</a> show that gene mutations could lead to disruption of ROS structural integrity and compromise retina viability in diseases such as retinitis pigmentosa.</p><p><strong>NEI Strategic Plan, 2021–2025</strong>—The <a href="/sites/default/files/2021-12/NEI-StrategicPlan-VisionForTheFuture_508_edit.pdf">NEI Strategic Plan</a> (Plan) was published in parallel with editorials in leading peer-reviewed ophthalmology and optometry journals that summarize the plan. The Strategic Plan outlines priorities over the next five years and includes seven crosscutting areas of emphasis to foster collaboration within the community and join mechanistic science with clinical applications. Dr. Chiang briefly outlined current and planned NEI activities related to several areas of emphasis.</p><p>Projects related to the <strong>Regenerative Medicine</strong> area of emphasis include the <a href="/about/goals-and-accomplishments/nei-research-initiatives/regenerative-medicine/amd-integrative-biology-initiative">Age-related Macular Degeneration (AMD) Integrative Biology Initiative</a> for studies using patient-derived iPSC lines to characterize cellular phenotypes and functional features. NEI also is setting up review panels and judges for the 3-D Retina Organoid Challenge (<a href="/about/goals-and-accomplishments/nei-research-initiatives/3-d-retina-organoid-challenge-3-d-roc">3-D ROC</a>), a prize competition to develop a physiologically competent three-dimensional retina organoid model. The final submission deadline for 3D-ROC is June 1, 2022. Under the <a href="/about/goals-and-accomplishments/nei-research-initiatives/audacious-goals-initiative">Audacious Goals Initiative</a> (AGI), NEI issued <a href="https://grants.nih.gov/grants/guide/notice-files/NOT-EY-22-002.html">NOT-EY-22-002</a> to encourage novel research that incorporates newly identified factors into new or existing models of visual systems regeneration.</p><p>The NEI <a href="https://www.nei.nih.gov/about/goals-and-accomplishments/nei-research-initiatives/anterior-segment-initiative">Anterior Segment Initiative</a> (ASI) is supporting current programs related to the <strong>Immune System and Eye Health</strong> area of emphasis including a recent RFA to explore neuronal cell types, cell-to-cell interactions, and peripheral and central circuitry involved with normal anterior segment homeostasis (<a href="https://grants.nih.gov/grants/guide/rfa-files/RFA-EY-21-004.html">RFA-EY-21-004</a>) and a Notice of Special Interest (NOSI) for the Identification and Development of New Biomarkers and Effective methods to Diagnose Dry Eye Disease (DED) (<a href="https://grants.nih.gov/grants/guide/notice-files/NOT-EY-21-007.html">NOT-EY-21-007</a>). Other activities included the NEI ASI Symposium: Ocular Surface Microbiome—Best Practices for Low Biomass Research and the <a href="/sites/default/files/2022-02/ASI_Wrksh_EC_Summary_2022-01-31_1800_508.pdf">Immunity and Inflammation in the Anterior Segment of the Eye Workshop</a>.</p><p>Current programs related to the <strong>Genes to Diseases Mechanisms</strong> area of emphasis include participation in the Accelerating Medicines Partnership® <a href="https://www.nih.gov/research-training/accelerating-medicines-partnership-amp/bespoke-gene-therapy-consortium">Bespoke Gene Therapy Consortium</a> (BGTC) that is designed to develop platforms that ease roadblocks to gene therapy development for ultra-rare diseases. The BGTC aligns with NEI’s mission to accelerate paths to gene therapy for monogenic disorders relevant to NEI (e.g., Usher syndrome, Albinism) and facilitate scale-up of industry partners offering manufacturing capabilities and expertise as in-kind contributions.</p><p>NEI signed on to funding opportunities related to the <strong>Public Health & Disparities Research</strong> area of emphasis to improve research for persons with multiple chronic conditions, adults with Type 2 Diabetes, and immigrant populations as well as measures and methods and patient-clinician relationships. In addition, NEI is participating in Phase III of the NIH <a href="https://orwh.od.nih.gov/in-the-spotlight/all-articles/radx-nih-initiative-supports-research-diagnosing-covid-19-underserved">RADx-UP Initiative</a> to decrease barriers to COVID testing in vulnerable populations. In addition, NEI released <a href="https://grants.nih.gov/grants/guide/notice-files/NOT-EY-22-010.html">NOT-EY-22-010</a> to address accessibility inequities with COVID home-based testing for individuals who experience visual impairment.</p><p><strong>Community Partnerships to Advance Science for Society (ComPASS)</strong>—In January 2022, the NIH Council of Councils approved the concept for <a href="https://dpcpsi.nih.gov/sites/default/files/2.10PM-Cf-Concept-COMPASS-Zenk-Gordon-FINAL-508.pdf">ComPASS</a>, a program to facilitate and implement a cross-Institute and Center framework for health equity structural intervention research. The program aims to catalyze, deploy, and evaluate community-driven interventions and partnerships to reduce health disparities. Dr. Michael Steinmetz represents NEI on the ComPASS Working Group.</p><p><strong>Diversity, Equity, Inclusion and Accessibility (DEIA)—</strong>The NIH Office of the Director released a Request for Information (RFI) <a href="https://grants.nih.gov/grants/guide/notice-files/NOT-OD-22-061.html">inviting public comment</a> on the framework for the NIH-Wide Strategic Plan for DEIA. NIH-wide activities and events related to DEIA include the UNITE Initiative’s Power of an Inclusive Workplace Recognition Project and the Scientific Workforce Diversity Seminar Series — hosted by NIH Chief Officer for Scientific Workforce Diversity (COSWD) Dr. Marie A. Bernard — to galvanize the wider scientific community around the success of cohort recruitment models geared toward enhancing DEIA for faculty. Dr. Chiang noted that DEIA standards must be included in all calendar year 2022 performance plans across NIH.</p><p>NEI is participating in an NIH-wide NOSI <a href="https://grants.nih.gov/grants/guide/notice-files/NOT-OD-22-057.html">NOT-OD-22-057</a> to offer administrative supplements to outstanding mentors who have demonstrated commitment to enhancing DEIA in science. Funds will support additional research within the scope of the parent grant to develop curricula or training activities to enhance mentor training, foster the research career development of additional trainees, and/or fill additional trainee slots.</p><p>NEI’s DEIA Strategic Plan is in phase 3, which includes continuing Council sessions, defining strategic pillars, establishing strategy groups, developing a strategic plan for 3–5 years, and preparing for organizational DEIA kickoff.</p><p><strong>Data Science Updates—</strong>Following the October 2021 Council discussion on barriers to research involving images and a need for ocular imaging standards, NEI issued an RFI for input on ocular imaging standards (<a href="https://grants.nih.gov/grants/guide/notice-files/NOT-EY-22-008.html">NOT-EY-22-008</a>). The NIH Office of Data Science Strategy Artificial Intelligence/Machine Learning Consortium to Advance Health Equity and Researcher Diversity (<a href="https://datascience.nih.gov/artificial-intelligence/aim-ahead">AIM-AHEAD</a>) Program will study how to use artificial intelligence (AI) to address challenges of health disparities and minority health by developing diverse data sets, detecting bias, and emphasizing the role of objective image data in AI research. An advisory committee co-chaired by Dr. Chiang currently is being formed. A Virtual Community Building Convention was held February 16–18, 2022, to learn from the community, stakeholders, and those who work at all levels in diverse settings that reduce disparities and promote equality.</p><p><strong>NEI Programs, Training, and Workplace</strong>—The NEI Clinician Scientist Reviewer Program aims to increase the pool of early-career clinician scientists to serve as reviewers for NEI and encourage clinician scientists from diverse backgrounds to apply. NEI also established the Diversity in Vision Research & Ophthalmology summer program for students in college and graduate and professional schools. Applications for the Program still are being accepted. In March 2021, NEI started the NEI DEIA Council to focus on workplace issues within the Institute.</p><p><strong>NIH Brain Research Through Advancing Innovative Neurotechnologies</strong><em><strong><sup>®</sup></strong> </em><strong>(BRAIN) Initiative</strong>—Statistics for fiscal year (FY) 2021 show that 20 to 25 percent of the BRAIN portfolio deals with vision research, and another 20 percent is research conducted by NEI grantees who are doing non-vision research. This highlights how closely visual neuroscience is tied to the larger neuroscience community.</p><p><strong>NIH Blueprint Updates</strong>—The <a href="https://neuroscienceblueprint.nih.gov/neurotherapeutics/bpn-biologics">NIH Blueprint Neurotherapeutics Network for Biologics</a> (BPN-Biologics) is a new network for neuroscience that focuses on large biologic macromolecules (e.g., proteins, antibodies), gene- and cell-based therapies, and other novel emerging therapies (e.g., microbial and microbiome therapies) from optimization to Phase I clinical testing.</p><p><strong>NEI Budget Update</strong>—NEI is operating under a Continuing Resolution (CR) that expires on February 18, which means that the Institute is operating under the FY 2021 budget. A new CR is expected, but the timeframe for approval of a federal budget for FY 2022 is unclear.</p><p><strong>Discussion</strong></p><p>Council members asked about inclusion of children as vulnerable populations in research and commented on data sharing and harmonization incentives. Dr. Chiang noted that NEI is building relationships with the National Institute of Child Health and Human Development at the intersection of children and vision. Dr. Anderson noted that the NIH Office of Data Science Strategy (ODSS) is providing detailed compliance guidance for investigators. The <a href="https://datascience.nih.gov/about/odss">ODSS website</a> includes a list of general repositories where data can be stored. An ODSS representative can be invited to provide more detail at a future Council meeting.</p>
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Portfolio Overview
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<p><strong>Low Vision and Blindness Rehabilitation: Dr. Cheri Wiggs, Program Director of Low Vision and Blindness Rehabilitation, Division of Extramural Science Programs (DESP), NEI</strong></p><p>Dr. Wiggs presented an overview of the NEI low vision and blindness rehabilitation portfolio, which focuses on expanding opportunities for people who are blind or have low vision and aligns with NEI’s mission to eliminate vision loss and improve quality of life through vision research.</p><p>Visual impairment includes low vision due to lack of light detection; congenital conditions or advanced age; and ocular or cortical impairments.</p><p>The program encompasses basic science (studies on behavioral and perceptual neural systems affected by vision impairment); applied and translational science (assessments and intervention development and evaluation); and technology development (accessibility devices and early-stage technologies).</p><p>Dr. Wiggs described encouraging trends and future directions. Categories are less discrete in that basic science is being exported to applied settings and technology development is having an impact on assessments and rehabilitation strategies. Work is advancing through collaborations and integrated teams across many fields (e.g., engineers, vision scientists, rehabilitation specialists). Access to data and technology related to low vision and blindness rehabilitation is growing.</p><p><strong>Discussion</strong></p><p>Council members commented on progress in assisting individuals with disabilities, building a proactive channel between NEI and impactful media to promote feasible changes, increasing awareness of NEI funding in this area, and identifying optimal methods for targeting individuals with low vision. It was noted that the lack of a rich history and precedents for this understudied area leads to lower application scores due to disparate reviewer opinions.</p><p><strong>TRANSLATIONAL RESEARCH PROGRAM—Dr. Tony Gover, Program Director, Bioengineering and Technology and Cornea Injury and Repair, DESP, NEI</strong></p><p>Dr. Gover described the NEI Translational Research Program (TRP) on Therapy for Visual Disorders (<a href="https://grants.nih.gov/grants/guide/pa-files/PAR-20-319.html">PAR-20-319</a>). Applications for these R24 awards should focus on producing preclinical data that support an investigational new drug (IND) or investigational device exemption (IDE) application to the U.S. Food and Drug Administration (FDA). Applicants may request up to $1.5 million per year total direct costs for 5 years.</p><p>During FY06–21, NEI made 20 awards, for a total investment of $175,368,286. More than half of these awards (55%) have closed, leaving 45 percent still active. TRP awards have produced 850 published articles, 15 patents, 8 IND/IDE approvals, 7 active clinical trials, and 1 FDA approved product.</p><p>Dr. Gover described three specific TRP projects: <a href="https://reporter.nih.gov/search/-oz8zOsu30OxC_Y2nMmfXQ/project-details/7907709">Transscleral Drug Delivery for Retinal Disorders</a>, <a href="https://www.grantome.com/grant/NIH/R24-EY023937-03">Photo-switchable Channel Blockers for Treatment of Blindness</a>, and <a href="https://reporter.nih.gov/search/QOi1alLCBkisfVGpGSYQ3w/project-details/9265464">rAAV-CNGB3 Gene Therapy for Achromatopsia: Translational Research Studies</a>.</p><p>NEI continues to support innovative and productive researchers to translate medical products to the clinic. Numerous NEI and NIH programs support translation research for NEI extramural investigators. Investigators should reach out to Program Officers to determine the best translational opportunity.</p><p><strong>Discussion</strong></p><p>Typically, these applications involve significant requirements for submission of plans to develop technology beyond specific aims. Applications with a well-planned regulatory strategy have minimized risk.</p><p><strong>TRIENNIAL REPORT ON THE INCLUSION OF WOMEN AND MINORITIES IN CLINICAL TRIALS—Dr. Hongman Song, Program Analyst, DESP, NEI</strong></p><p>Dr. Song summarized NEI’s triennial report certifying compliance with NIH policy on inclusion guidelines for the period 2019–2021. Gender, race, and ethnicity of participants enrolled in NEI-supported extramural and intramural clinical research studies were representative of the United States population during this 3-year period. Data for 2021 show broad age distributions in clinical trials. NEI strategies to achieve compliance include communication, education, training, documentation, tracking, monitoring of Phase III trial analyses, and Program Director oversight.</p><p><strong>Discussion</strong></p><p>One council member asked about differences between males and females for different trials and disorders. Dr. Song noted that this analysis was not performed for specific diseases but could be done in the future. Dr. Song also clarified that the data included both intramural and extramural studies. Another council member asked for the rationale for separating Hispanics from other ethnicities. Dr. Song indicated that this is how NIH classifies ethnicity and that this is separate from racial identity. One member asked about whether there was data about compliance from the different groups. Dr. Song noted that program officers are required to monitor compliance in individual trials and that they have seen no significant differences in compliance among the groups.</p>
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Concept Clearances
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<p><strong>NEI Research Grant for Vision-Related Secondary Data Analysis (Reissue)— Dr. Sangeeta Bhargava, Program Director, DESP, NEI</strong></p><p>Renewal of the NEI Research Grant for Vision-Related Secondary Data Analysis (<a href="https://grants.nih.gov/grants/guide/pa-files/PAR-19-260.html">PAR-19-260</a>), was proposed. The Program Announcement with special review criteria (PAR) encourages submission of applications to conduct secondary analyses of existing vision-related data resources. Proposals will take advantage of the wealth of data generated by NEI’s extensive portfolio of clinical trials and large-scale epidemiology research projects. Applications may be related to, but must be distinct from, the specific aims of the original data collection and may be used to develop new statistical methodologies or test hypotheses. Grants must not be used to support the collection of new data.</p><p><strong>Discussion</strong></p><p>Discussants Drs. Maguire and Harnett reported that this Funding Opportunity Announcement will support new methodology in alignment with NEI’s mission of data transparency.</p><p>A motion to approve the concept was made, seconded, and approved unanimously.</p><p><strong>NEI Clinical Research Study Planning Grant (Reissue)—Dr. Jimmy Le, Program Director, DESP, NEI</strong></p><p>Renewal of the NEI Clinical Research Study Planning Grant (<a href="https://grants.nih.gov/grants/guide/pa-files/PAR-19-231.html">PAR-19-231</a>), which expires this year, was proposed. The proposed PAR would employ an R34 grant mechanism to support planning of collaborative clinical research on eye and vision conditions, which would permit early peer review of the proposed study rationale, provide support for the development of a detailed Manual of Procedures (MOP), and support the development of other essential study elements. The grant may not be used to generate data on the effects of any proposed intervention. Funding of a planning grant also does not guarantee nor imply funding for any subsequent competitive application for the support of a full-scale collaborative clinical study.</p><p><strong>Discussion</strong></p><p>Concept discussants Drs. Maguire and Gardner commented on the value of preliminary screening of clinical studies that prevent researchers from investing in a project that may not succeed. Planning grants are important for new clinical research groups that have not already established ongoing research.</p><p>A motion to approve the concept was made, seconded, and unanimously approved.</p><p><strong>BRAIN Multi-Council Working Group (MCWG) Update—Dr. Tirin Moore</strong></p><p>Dr. Moore is the NEI representative on the BRAIN® Initiative MCWG. He highlighted key information from the Working Group’s January meeting. BRAIN Director Dr. John Ngai’s <a href="https://www.cell.com/cell/fulltext/S0092-8674(21)01387-8">commentary</a>, “BRAIN 2.0: Transforming neuroscience,” described the Initiative’s new phase and three large new projects that promise to transform neuroscience research and treatment of human brain disorders.</p><p>Dr. Moore mentioned three upcoming BRAIN-sponsored workshops:</p><ul><li>April 18-19, 2022: <a href="https://web.cvent.com/event/ee008f21-b5ae-439b-8c6f-dfecae325002/summary?RefId=2022BrainAcrossLifespan">The Brain Across the Lifespan: Tools and Technologies for Measuring the Changing Brain</a></li><li>March 1-2, 2022: <a href="https://braininitiative.nih.gov/news-events/events/brain-behavior-quantification-synchronization-workshop?search-term=News%20Events%20event%20brain%20behavior%20quantification%20synchronization%20workshop">Brain Behavior Quantification and Synchronization Workshop</a></li><li>June 21, 2022: <a href="https://brainmeeting.swoogo.com/2022/home">8<sup>th</sup> Annual BRAIN Initiative Meeting</a></li></ul><p>The MCWG approved a brain functional imaging and technology development concept to address priority areas from the 2025 Brain Report and seeks to improve high-resolution functional magnetic resonance imaging by an order of magnitude and analyze naturalistic behaviors. <a href="https://braininitiative.nih.gov/funding/funding-opportunities?combine=&field_program_tid%5B%5D=13">Current BRAIN initiatives can be found here</a>.</p><p><strong>Retiring Council Member Remarks—Drs. Jose-Manuel Alonso and Mary Ann Stepp</strong></p><p>Dr. Alonso commented on the joy of meeting with colleagues, the hardworking NEI team, the Program Officers who helped him with his applications, and especially acknowledged Dr. Shefa Gordon for his efforts in developing the NEI Strategic Plan.</p><p>Dr. Mary Ann Stepp stated that she was honored to be part of a group of talented professionals. She expressed excitement about Dr. Chiang’s energy and leadership and her expectation of positive change for the future.</p><p>Dr. Chiang thanked Drs. Alonso and Stepp for their contributions to the institute and expressed appreciation for their comments, advice, and input. He looks forward to meeting in person again and for their continued contributions to communicating with the extramural community.</p>
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<div class="c-section" id="section-id-18967">
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<h3 class="c-section__heading">
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General Council Discussion
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<p>Dr. Anderson opened the floor for general discussion by Council members. Council comments focused on the importance of connecting science to practice and related communications challenges. She acknowledged that NEI has initiated several new avenues of communications (blogs, newsletters, press releases). Another member raised the issue of increasing clinician awareness of clinical trials and studies relevant to their patients perhaps through some sort of portal; building awareness of funding opportunities; and encouraging members of the research community—particularly new investigators—to connect with Program Officers.</p><p>Dr. Chiang asked members to NEI know when they have new publications coming out so that NEI can highlight them. He also acknowledged that connecting science with clinical practice is an important problem and asked whether it would be useful to form a workgroup to develop recommendations on how to translate research to the real word. One member noted that clinicians often have limited bandwidth to follow the science but that there are some platforms that offer this service. They suggested linking NEI-sponsored research to these platforms.</p><p>It was generally agreed that a working group should be formed to consider ways to address these communications and awareness challenges. It was suggested that the group could start with how to communicate the clinical trials findings to clinicians and provide some type of referral service. Another member suggested it would be helpful to connect researchers with businesses to develop their product. Dr. Chiang asked how NEI could better communicate funding opportunities supported by NEI and encourage new investigators to contact program officers with their ideas. Council members reiterated the importance of new investigators reaching out to program officers.</p><p><strong>Review of NAEC Operating Procedures—Dr. Kathleen Anderson</strong></p><p>Dr. Anderson noted that revised NEI Advisory Council Operating Procedures were provided in the Electronic Council Book. She noted that revisions include minor changes to clarify policy language and streamline text. One substantive change is proposed: to include an option for Council members to provide expedited application review electronically. This option would be implemented for applications that involve time limits or unique resources, such as applications received in response to RFAs, applications deferred for some reason, or applications reviewed due to a successful appeal. Council members have the option to request that these applications be discussed at a meeting if they are not comfortable providing concurrence electronically.</p><p>There was a motion and a second to approve the revised Operating Procedures; the motion carried.</p>
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<h3 class="c-section__heading">
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Open Session Adjournment
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<p>Dr. Anderson adjourned the open session of the Council meeting at 1:40 PM.</p>
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Closed Session
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<p>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.</p>
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<h3 class="c-section__heading">
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Review of Applications
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<p>NAEC members considered 562 research and training grant applications on which NEI was the primary Institute; these applications requested a total of $171,698,381 (direct costs year 01). The Council also considered 405 applications on which another Institute/Center was primary and NEI was secondary. These applications requested a total of $238,217,604 (direct costs year 01). The Council concurred with the Institutional Review Group recommendations on these 967 applications.</p>
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<h3 class="c-section__heading">
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Adjournment
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<p>The 160th meeting of the National Advisory Eye Council was adjourned at 4:00 p.m. on February 11, 2022.</p>
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Closed Session Attendees
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<p><strong>Council Members Present:</strong></p><p>Dr. Michael Chiang, Chair<br>Dr. Kathleen Anderson, Executive Secretary<br>Dr. Jose-Manuel Alonso<br>Dr. Terete Borras<br>Dr. James Coughlan<br>Dr. Reza Dana<br>Dr. Katia Del Rio-Tsonis<br>Dr. Thomas Gardner<br>Dr. Mary Elizabeth Hartnett<br>Dr. Renu Kowluru<br>Dr. Maureen Maguire<br>Dr. Tirin Moore<br>Dr. Mary Ann Stepp<br>Dr. Benjamin Teller</p><p><strong>NIH Staff Members Present</strong></p><p>Dr. Neeraj Agarwal<br>Dr. Houmam Araj<br>Dr. Sangeeta Bhargava<br>Ms. Holly Blake<br>Mr. Nathan Brown<br>Mr. Roland Colbert<br>Mr. Samuel Edwards<br>Dr. Martha Flanders<br>Dr. Ashley Fortress<br>Dr. James Gao<br>Ms. Alexandra Gavrilovic<br>Dr. Nataliya Gordiyenko<br>Dr. Shefa Gordon<br>Dr. Tony Gover<br>Dr. Tom Greenwell<br>Ms. Lateefah Hill<br>Dr. Brian Hoshaw<br>Ms. Alicia Kerr<br>Dr. Jimmy Le<br>Dr. Paek Lee<br>Dr. Ellen Liberman<br>Dr. Barbara Mallon<br>Dr. George McKie<br>Ms. Barbara Payne<br>Dr. Maryann Redford<br>Ms. Carissa Reilly-Weedon<br>Dr. Jennifer Schiltz<br>Dr. Grace Shen<br>Ms. Karen Smith<br>Dr. Hongman Song<br>Dr. Michael Steinmetz<br>Dr. Afia Sultana<br>Dr. Santa Tumminia<br>Ms. Leslie West-Bushby<br>Dr. Cheri Wiggs<br>Ms. Keturah Williams<br>Ms. Nora Wong<br>Dr. Charles Wright</p>
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Certification
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<p>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.</p><p><strong>Michael Chiang, MD</strong><br>Chair<br>National Advisory Eye Council</p><p><strong>Kathleen C. Anderson, PhD</strong><br>Executive Secretary<br>National Advisory Eye Council</p>
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<p class="views-element-container c-last-updated" id="block-views-block-nei-last-updated-block-1"><strong>Last updated:</strong> January 7, 2025</p>
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