NAEC Meeting Minutes - June 11, 2021

National Institutes of Health
National Eye Institute
Minutes of the National Advisory Eye Council
One Hundred Fifty-Eighth
Meeting June 11, 2021

• Videocast

The National Advisory Eye Council (NAEC) convened for its 158^th meeting at 9:30 a.m. on Friday, June 11, 2021. 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 the Executive Secretary. The meeting was open to the public from 9:30 a.m. until 1:30 p.m. The meeting was closed to the public from 2:00 p.m. until 4:00 p.m. for the review of grant and cooperative agreement applications.

Dr. Michael Chiang, Chair
Dr. Kathleen Anderson, Executive Secretary
Dr. Jose-Manuel Alonso
Dr. Teresa Borras
Dr. James Coughlan
Dr. Katia Del Rio-Tsonis
Dr. Thomas Gardner
Dr. Mary Elizabeth Hartnett
Dr. Renu Kowluru
Dr. Mary Ann Stepp
Dr. Benjamin Teller

Dr. Neeraj Agarwal
Ms. Lisa Applewhite
Dr. Houmam Araj
Dr. Steven Becker
Dr. Thomas Beres
Dr. Sangeeta Bhargava
Mr. Nathan Brown
Dr. Emily Chew
Ms. Karen Colbert
Ms. Monique Clark
Dr. Mary Frances Cotch
Dr. Donald Everett
Dr. Martha Flanders
Dr. Ashley Fortress
Dr. James Gao
Dr. Susan Gillmor
Ms. Kerry Goetz
Dr. Nataliya Gordiyenko
Dr. Shefa Gordon
Dr. Tony Gover
Ms. Alexandra Gavrilovic
Dr. Tom Greenwell
Mr. Peter Guthrie
Ms. Lateefah Hill
Dr. Brian Hoshaw
Dr. Jeanette Hosseini
Dr. Jimmy Le
Dr. Paek Lee
Dr. Ellen Liberman
Ms. Barbara Mallon
Dr. George McKie
Dr. Sheldon Miller
Dr. Lisa Neuhold
Ms. Barbara Payne
Dr. Maryann Redford
Ms. Amber Reed
Dr. Jennifer Schiltz
Dr. Mohor Biplab Sengupta
Dr. Grace Shen
Ms. Karen Smith
Dr. Hongman Song
Dr. Michael Steinmetz
Dr. Afia Sultana
Mr. Brian Trent
Dr. Santa Tumminia
Dr. Cheri Wiggs
Ms. Keturah Williams
Ms. Nora Wong
Dr. Charles Wright
Mr. Michael Wright

Mr. Jonathan Bennett
Mr. Abraham Hanson
Mr. David Higgins
Mr. Daniel Marmorstein
Mr. Rick Marquez
Mr. Alexander Papadopoulos
Dr. Fernanda Ruiz
Ms. Natalie Van Eman
Mr. Edward Woodhouse

Members of the Public Present:

Dr. Paul P. Lee, University of Michigan
Dr. Scott E. Page, University of Michigan
Dr. Fernanda Ruiz, Nova Research
Ms. Natalie Van Eman, Access Interpreting Services
Mr. Abraham Hanson, Access Interpreting Services

NOTE: Due to the open videocast format of this meeting necessitated by the COVID-19 pandemic, 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.

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

Dr. Chiang called the 158^th NAEC meeting to order and welcomed attendees.

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

Dr. Anderson welcomed attendees and thanked Council members for their service. She expressed her appreciation for their advice and feedback and noted that the approval of the new members is still pending. She also welcomed the NEI research and advocacy community, NIH and NEI staff, and members of the public. Dr. Anderson extended special thanks to guest speakers Drs. Paul Lee and Scott Page.

Dr. Anderson indicated all fall Council meetings will be held virtually. She reviewed the procedures and etiquette for this Zoom meeting and noted that the open session of the meeting was being videocast and will be available on the NIH videocast website.

Dr. Chiang noted NEI is hoping to use social media to enhance the dissemination of information to the research community, especially during the pandemic. He encouraged members to follow him on twitter and share relevant information with their colleagues. He provided a brief outline of the day’s agenda and highlighted the themes for this meeting—diversity, equity, and inclusion (DEI)—and the NEI strategic plan and revised mission statement. For this meeting, one of the goals is for Council members to suggest themes and topics for future council meetings that would be most relevant for the community to hear about.

Dr. Chiang introduced and welcomed new NEI extramural staff. Ms. Lisa Applewhite is Operations Coordinator; Mr. Nathan Brown is Lead Program Analyst and Committee Management Specialist; and Ms. Alexandra Gavrilovic, Ms. Holly Blake, and Ms. Stephanie Blackford are Grants Management Specialists. New NEI intramural staff include Ms. Devina Fan, Director of the National Eye Health Education Program in the Office of Science Communications, Public Liaison and Education, and Ms. Dorian Oliveira, Senior Program Analyst in the Intramural Administrative Management Branch.

Dr. Chiang congratulated NEI grantees Drs. Denise Montell, Tirin Moore, Rachel Wong, Marisa Carrasco, Arturo Alvarez-Buylla, John Maunsell, and Rachel Klevit for being elected to the National Academy of Sciences.

NAEC Budget Update—Ms. Karen Colbert, NEI Budget Officer, provided a brief overview of the NIH and NEI budget for Fiscal Year (FY) 2021. She noted that budget estimation for FY 2021 was challenging because there were many competing priorities, including the need to address funding for coronavirus relief.

The NIH budget of $42.7 billion is a 3 percent increase over the final FY 2020 allocation and includes an appropriation of $404 million authorized in the 21st Century Cures Act, which is an expected decrease of $88 million (18%) from FY 2020. Total Cures funding includes $195 million to the National Cancer Institute (NCI) for the Cancer Moonshot Project, $100 million to the National Institute of Neurological Disorders and Stroke (NINDS) and the National Institute of Mental Health (NIMH) for the Cures Brain Research Through Advancing Innovative Neurotechnologies^® BRAIN Initiative, and $109 million to the NIH Innovation for the All-of-Us Program. NIH also received $1.25 billion in supplemental funding for coronavirus activities.

For FY 2021, NEI received a 1.5 percent increase over 2020. NEI anticipates funding over $700 million in extramural research. Of the total budget, extramural research accounts for 84 percent, intramural research accounts for 12 percent, and research support accounts for 4 percent. Ms. Colbert presented an estimate of competing and noncompeting awards that will be funded in FY 2021. Due to infrastructure costs, the number of competing research project grants (RPGs) that will be funded this year was reduced.

The President’s budget (FY 2022) requests include a $23 million (2.8%) increase for NEI. The transition to a new administration caused a delay to the budget release and it is unclear how this delay will impact the timing of the congressional appropriations process. The new fiscal year may begin under a continuing resolution, which would restrict available funds until NIH receives a final appropriation.

The proposed NIH increase in the FY 2022 President’s budget is $9 billion (21%), which includes $6.5 billion to establish the Advanced Research Projects Agency for Health (ARPA-H). The estimated NEI funding for FY 2022 represents a 2.8 % increase over 2021 and includes $718.7 million (84%) to extramural research, $104 million (12%) to intramural research, and 35.8 million (4%) to research support. This plan provides an additional $17 million for extramural research which would cover existing commitments, mandatory increases, and new awards.

The NIH-specific research priorities identified in the President’s budget include: Combatting the Opioid and Methamphetamine Crisis; Health Disparities and Inequities Research; Impacts of Climate Change on Human Health; Ending the HIV Epidemic in the U.S.; Improving Maternal Health; Addressing Gun Violence in America; Research of the Effects of COVID-19; Creating a Diverse Biomedical Workforce; Protecting Biomedical Research; and Research Infrastructure.

NEI Audacious Goals Initiative—Dr. Steven Becker, Office of Regenerative Medicine (ORM), presented an update on the NEI Audacious Goals Initiative (AGI) and regenerative medicine activities. The Functional Imaging Consortium Symposium (held in February 2021) videos and a summary of accomplishments stemming from the meeting are available online (Audacious projects develop imaging technology to aid eye tissue regeneration.).

A new notice of special interest (NOSI) for AGI-relevant R13 scientific meetings was released in March (NOT-EY-21-009). During the Association for Research in Vision and Ophthalmology (ARVO) special session, six AGI projects describing new factors in regenerative medicine for vision research were presented. An AGI perspective piece summarizing initiative activities and future plans will be featured in July’s Translational Vision Science & Technology (TVST) special edition.

Dr. Becker highlighted a new collaboration with the New York Stem Cell Foundation Research Institute (NYSCF) and Columbia University–NY Presbyterian Hospital to develop a therapy for age-related macular degeneration (AMD) using retinal pigment epithelium (RPE) patches developed by Dr. Kapil Bharti.

NEI hosted a webinar showcasing the new AMD Integrative Biology Initiative with NYSCF as a resource providing induced pluripotent stem cell (IPSC) lines from AMD patients with known risk alleles. Email respository@nyscf.org to request the lines.

The NEI 3-D Retina Organoid Challenge (3-D ROC) has three new company sponsors that are providing resources (e.g., technology) to participants. The 3-D ROC team deadline to register for the final phase of the challenge is October 1, 2021.

ORM is providing new trainee resources and sponsoring activities focused on targeting support for training. (K awardees are eligible.) A Careers Pathway Forum featuring a biotech career coach and speakers from academia, industry, and nonprofits was held recently. The ORM Trainee Committee has been established to advocate on behalf of trainees in regenerative medicine and serve as liaison to the extramural community. ORM plans to find liaisons to propagate this information and generate an information hub for trainees—including those seeking to obtain funding. Dr. Becker encouraged Council members to disseminate information about these resources to their trainees.

Anterior Segment Initiative—Dr. Chiang provided an update on the Anterior Segment Initiative (ASI). A prior request for information (RFI) identified dry eye as one pressing topic in anterior segments. Since the last NAEC meeting, a workshop was held in April that focused on immunity and inflammation in the anterior segment of the eye to identify knowledge gaps in immune homeostasis and regulation; aging, microbiome, and environment; neuroinflammation; and resolution of inflammation. Results from this workshop will be analyzed to define next steps. A workshop on Investigating the Ocular Microbiome: Best Practices for Low Biomass Microbial Research will be held on August 2, 2021.

Extramural Response to COVID—Dr. Chiang reported that many of the questions NEI is receiving regarding COVID are about productivity in the COVID era. The NEI Division of Extramural Science Programs (DESP) is advising researchers to apply for no-cost extensions. NEI is accepting administrative supplement (PA-18-591) requests on a case-by-case basis for active NEI-sponsored projects affected by COVID-19 and focusing resources on cases of extreme need.

NIH Council of Councils: Concept Clearances—Dr. Chiang reported on three concepts by the NIH Council of Councils (COC). An Office of Data Science Strategy concept that aims to address the workforce gap in data governance for Artificial Intelligence (AI) and Biomedicine, was referred for refinement due to potential overlap with the Bridge to AI (Bridge 2AI) Common Fund Program. Phase 2 of the Human BioMolecular Atlas Program, which aims to extend integration, visualization, and collaboration, was approved, and includes a project on 3D mapping of eye tissue. The Somatic Mosaicism Across Human Tissues (SMaHT) program was also approved. In the first phase, a 5-year program will create a census of somatic gene variation in the human body, but it does not currently include eye tissue. Dr. Van Gelder proposed that NEI join the SMaHT working group because retinal blastoma is possibly the best-understood example of how somatic mosaicism can cause fatal human disease. NEI plans to follow this effort and determine whether there are areas for NEI involvement.

Ophthalmic Imaging Standards— NEI recently endorsed the American Academy of Ophthalmology (AAO) call for standardization of ophthalmic imaging devices. Despite past efforts to improve interoperability between imaging devices, the lack of the adoption of standards remains a challenge for ophthalmology and clinical care. To produce a significant change, Dr. Chiang proposed sponsoring an Imaging Standards Workshop in fall 2021 to gather perspectives from key stakeholders (e.g., clinicians, researchers, government representatives, industry, patients) and identify opportunities and barriers for adopting standards for interoperability in ophthalmic imaging for clinical care and research. An RFI will be published this summer to get input and comments from these communities to inform the workshop.

The NIH Data Management and Sharing Policy (DMSP) becomes effective in January 2023 and applies to all NIH-funded research generating data regardless of type, size, or funding amount. Applicants will need to include data sharing and management plans in their applications which if funded, will be included in the terms and conditions of awards. NEI will begin piloting a DMSP policy in the Intramural Research Program. Dr. Chiang thanked Dr. David Schneeweis and Kerry Goetz for their efforts to implement this in the intramural program.

NIH Common Fund Programs—Dr. Chiang is working with various Common Fund programs including Bridge 2AI, which is chaired by five Institutes, including NEI, and aims to generate data to address the limited availability of robust datasets to train algorithms and use artificial intelligence (AI)/machine learning (ML) approaches. There is a need for standards for data collection, representation, and exchange. In total, $96 million will be awarded over a 4-year period for data generation centers and integration sites.

Dr. Chiang was a member of the Advisory Committee to the Director (ACD) working group on how to use AI and Electronic Health Records (EHRs) for research purposes, which worked to identify unique research opportunities for NIH to apply resources to EHR data, determine barriers to the widespread use of AI, and identify useful partnerships. The ACD focused on supporting AI/ML work to address challenges of health disparities and minority health and address errors, gaps, and racial and gender inequities/biases in EHR data. A consortium and coordinating center will be created to address data sharing, use AI approaches to detect bias, and generate data representation standards. Dr. James Gao is NEI’s representative for this effort.

Discussion

A question was raised on whether the AGI training committee included NEI mentored K-awardees. Dr. Becker noted that when the committee was created, they reached out to all NEI K-awardees and asked council members to help spread the word and encourage all trainees to use the resources on the AGI website. Another member emphasized the importance of communicating with all trainees not just those with current funding.

Council members discussed barriers to standardization of ophthalmic imaging devices and possible stakeholders. Dr. Chiang noted that vendors must implement standards and customers must want those standards. There may be specific cultural barriers (e.g., investigators and clinicians may not see the need to share data so there is not a push for standards). He noted that other fields, including radiology, have adopted imaging standards.

Another council member noted the importance of data standards and sharing and asked whether the workshop would address cultural issues that may be barriers? Dr. Chiang responded that there may be incentives that could promote data sharing. He also stated that the tenure system often values individual accomplishments over data sharing and suggested that a future Council meeting focus on data sharing as one way to disseminate this message to the community. He also invited members to become involved with the workshop on imaging standards and encouraged them to contact Drs. Chiang or Anderson if they are interested in participating.

Dr. Michael Chiang; Dr. Paul Lee, University of Michigan; Dr. Scott Page, University of Michigan; Mr. Brian Trent, Executive Officer, Executive Officer, NEI; Dr. Michael Steinmetz, Director, Division of Extramural Science Programs, NEI

Dr. Chiang summarized NEI activities aimed at addressing DEI. An ARVO-NEI Diversity Symposium was conducted to raise awareness of this issue and identify activities to perform as a community. Dr. Chiang also had discussions with leadership of the AAO, ARVO, and other organizations to determine how best to work together to enhance diversity in vision-related research. Stressing that the vision community thrives when the most talented next generation from a wide range of backgrounds are involved, Dr. Chiang noted the goal of this session was to present evidence showing that the scientific workforce benefits with diversity and the roadmap for NEI collaboration with other organizations.

Diversity in Ophthalmology and Vision Research—Dr. Lee described the state of the vision workforce and the research opportunities presented by demographic changes in the U.S. Although the percentage of women faculty members at ophthalmology training institutions has been increasing, the proportion of investigators from underrepresented backgrounds in medicine have remained flat or in some cases, decreased. Underrepresented women have a higher interest in pursuing non-research careers than research-intensive careers, suggesting that efforts are needed for recruitment and retention. Multiple institutions are focused on increasing diversity.

Assuming current trends continue, the prevalence of visual impairment in the U.S. will grow significantly by 2050. Hispanics have the highest rates of visual impairment or blindness and other minority groups having higher rates than the national average. Different diseases cause vision loss in different ethnic groups. For example, in African Americans, glaucoma is one of the main causes of irreversible blindness, which may be due to African American Medicaid recipients receiving fewer glaucoma tests than White or Latino Medicaid recipients. Social determinants of health impact the ability to take advantage of NEI research and apply it to all individuals to prevent vision loss and restore vision. The AAO has commissioned two task forces: one to study DEI within the AAO and the second to generate a white paper on the state of visual disparities in the United States using data from population-based studies.

Benefits of Diversity in the Workforce—Dr. Page described how diversity makes people better able to perform their tasks. According to Cultural Logics theory, individuals apply different weights to criteria and view the world through different lenses based on the diversity of lived experiences. Dr. Page proposed looking at diversity through a different cultural lens rather than just in terms of normative and/or demographic terms. He suggested using a logic based on producing better outcomes within individual disciplines. He argued that diversity improves performance on complex tasks and can be defined as both identity – who we are - (e.g., gender, race, age) and cognitive – how we think - (e.g., education, information, heuristics) diversity.

He presented a case for how cognitive diversity makes us better at what we do. Interdisciplinary research across the sciences is on the rise. Since 1960, the number of authors on academic scientific papers has increased from one to two authors to more than five currently. Research papers authored by teams are 4.5 times more likely to be cited over 100 times than those written by an individual author. The NIH study on the Science of Team Science showed that teams are more innovative, but teams with too much diversity do not work as well (there is an inverted U for the benefits of diversity). One study showed that large, diverse teams develop whereas small, diverse teams disrupt (e.g., have breakthrough ideas). Cognitive diversity (e.g., members from different universities) also enhances the innovation of a team.

To explain why cognitive diversity enhances innovation, he described the science behind how cognitive diversity using the Diversity Prediction Theorem. Diversity is beneficial for prediction, problem solving, and creativity. For a prediction, crowd error equals average error minus diversity. The complexity of the task is also important—in a complex task, the average error is large, thus more diversity is needed for the crowd error to be small. Including individuals on a team who are really smart but use different approaches to the problem. He used an example that showed that individual teams from different schools (MIT, Michigan, and CalTech) vary in the amount of prediction errors they make but when combined provide the best prediction. He showed other examples of how teams/crowds with varying degrees of competence make better predictions than individuals, even very smart (high IQ) individuals. The examples all demonstrated that the more complex the problem, the more you need teams and diversity to solve. He similarly demonstrated that creativity benefits from more group into individuals through increased cognitive diversity.

He also showed how identity-diverse groups are more innovative than homogeneous groups because individuals’ identities and characteristics affect their experiences and the lens through which they see the world. Individuals also think differently and harder when around identity-diverse people. For example, there is a 5-10% increase in the mean number of citations if the authors are ethnically diverse. The cultures in which individuals operate also affect them as identity drives one’s purpose. He then described how identity matters more in problem searches (e.g., use of AI) and less in solution searches (e.g., curing macular degeneration).

Dr. Page advised thinking of diversity as useful in improving the profession (not just in terms of being the right thing to do). Work must be done on building pipelines by engaging, listening, attracting, encouraging, and creating spaces where it is permissible to differ. Diverse groups are more effective than homogenous groups. Cultures must support cognitive and identity diversity to realize the bonus that both provide for solving complex problems.

NEI Workforce Diversity Efforts—Mr. Trent described NEI efforts related to DEI. NEI’s commitment to DEI and the creation of environments where all are seen, heard, and valued will be integrated into leadership and strategy, culture, talent, and systems and structures of NEI. Leadership will connect DEI to NEI’s mission, vision, and strategy. DEI also informs NEI’s culture development efforts. NEI recognizes that DEI enables great vision research, translation, policy making, and administration, and, in the strategic planning process, allows for evaluation of talent processes and practices at each phase of the talent development life cycle. Systems, structures, and mechanisms are studied to normalize equity and inclusion at NEI.

Mr. Trent is working with consultants and the newly formed DEI Employee Council to find the balance between relationship building and delivering on planned activities. Members of the DEI Employee Council represent different Divisions and levels across NEI. The NEI three-phase project approach to DEI work during 2021 focuses on developing a strong project framework supported by the DEI Employee Council, conducting a DEI and culture assessment, and creating a strategic plan for future investments in diversity, equity, and inclusion. Employee engagement activities include DEI leadership messages, DEI coffee circles, a DEI Staff Pulse Survey, and a Leadership DEI Strategy Lab. NEI Leadership is committed to DEI efforts and the first Strategy Lab will be conducted in July 2021.

NEI Extramural Programs to Promote Diversity—Dr. Michael Steinmetz described the funding opportunities that are available to NIH and NEI to expand diversity across the full range of the workforce including underrepresented minorities, sex, disability, and economic status. Individual institutions are responsible for certifying the eligibility of applications. The list of funding opportunities he described include:

• Research supplements (1–2 years) to promote diversity in health-related research, which are administrative supplements
• Ruth L. Kirchstein National Research Service Award (NRSA) Individual Predoctoral Fellowship to Promote Diversity in Health-related Research [F31]
• National Research Service Award (NRSA) F32 Postdoctoral Fellowship applications from individuals from diverse backgrounds, including underrepresented minorities
• NIH Blueprint and BRAIN (Brain Research Through Advancing Innovative Neurotechnologies^®) Initiative Diversity Specialized Predoctoral to Postdoctoral Advancement in Neuroscience (D-SPAN) Award [F99/K00]
• BRAIN Initiative Advanced Postdoctoral Career Transition Award to Promote Diversity [K99/R00]
• Maximizing Opportunities for Scientific and Academic Independent Careers (MOSAIC) Postdoctoral Career Transition Award to Promote Diversity [K99/R00]
• Support for Research Excellence – First Independent Research (SuRE-First) Award [R16]
• NIH Blueprint Program for Enhancing Neuroscience Diversity through Undergraduate Research Education Experiences (BP-ENDURE) [R25]
• NIH Faculty Institutions Recruitment for Sustainable Transformation (FIRST) Program: FIRST Cohort [U54].

A new funding announcement for BP-ENDURE will be published in the NIH guide soon. Those interested in diversity supplements should contact Dr. Houmam Araj, and those interested in training and career development awards should contact Dr. Neeraj Agarwal.

Dr. Santa Tumminia

Dr. Tumminia asked how to overcome feeling challenged by diversity (those who are different than us). Dr. Page commented that having a specific mindset is important—integrating diversity because it increases effectiveness, not for normative reasons. The type of conflict involved is also important; task conflict is good whereas personal conflict is bad. Thus, leadership must recognize and reward task conflict and confront personal conflict. In response to a related question, he noted that too many diverse individuals on a team may cause conflict; however, as leadership skills improve, the number of diverse individuals on a team may grow without causing conflict.

A council member asked whether there is a list of schools eligible to apply to the SUrE First program. Dr. Steinmetz replied that there is no set list of schools that can apply to the program, but institutions must satisfy requirement of having a large percentage of underrepresented minorities enrolled.

A council member asked how large the pool of available underrepresented minorities at the postdoctoral level. Dr. Steinmetz replied that there is a shortage of underrepresented minorities in ophthalmology and in other disciplines throughout the career pipeline and especially at the top. One Council member suggested that emphasis be placed on programs targeting undergraduate students at the beginning of the pipeline. Dr. Steinmetz responded that evidence shows that investments in investigators at higher career levels are far more likely to stay in the field than at earlier levels who are more likely to leave. Investments need to be made throughout the pipeline.

Another member asked about the success rate of the BRAIN K99/R00 Mosaic program. Dr. Steinmetz noted that there the program is still in its early stages so not a lot of data is available. However, the early data suggest that the K99/R00 grantees do successfully transition from the postdoctoral level to faculty positions. The pool of applicants is small but expected to grow. The same question was asked about the D/SPAN F99/K00 program. Dr. Anderson responded that the data she has seen for this mechanism indicates that the majority of trainees do transition to the postdoctoral level. One council member noted that success for these funding mechanisms should also include trainees who transition to other careers, not just faculty positions.

Dr. Chiang noted that diversity has become a polarizing topic in society and asked for advice on ways to communicate diversity efforts in ways that do not lead to increased polarization. Dr. Page responded that listening matters the most and that broader life experiences will inform how people respond. He emphasized the need to have talented, diverse people who share a common mission. Focusing on a shared mission and purpose can minimize polarization. Dr. Lee added that setting guiding principles on how we behave around others is important for minimizing conflict and moving forward with a shared purpose.

Dr. Chiang asked whether data or anecdotes are more effective at communicating the importance of and need for diversity. Dr. Page responded by noting the importance of three factors in persuasive communication: a compelling narrative or anecdote that elucidates the main concept; the concept needs to line up with logic; and the data supporting the concept needs to be used in situations only where it is useful (conditional).

One Council member asked how the success of the NEI DEI initiative will be defined and over what time-frame. Dr. Chiang expressed his opinion that meaningful change will take time and will require getting more people in the pipeline, especially for vision research. He suggested taking a broader definition of success beyond number of grantees from underrepresented backgrounds. Dr. Gardner suggested using both hard (e.g., numbers) and soft (e.g., satisfaction) metrics to evaluate success.

A council member noted the utility of the anecdotes and how to combine quantitative and qualitative data in communications around diversity. Dr. Chiang agreed and stressed the importance of working together with organizations and communities to enhance diversity rather than as an individual institute.

One Council member noted that while increasing overall diversity will take time, embracing cognitive diversity is one action that research programs can undertake now.

Dr. Michael Chiang and Dr. Shefa Gordon, Director, Office of Program Planning and Analysis

NEI Mission Statement—Dr. Chiang thanked Council members for their contributions in the evolution of the NEI mission statement and reviewed the rationale for the new revised version, which states that the mission of the National Eye Institute is to eliminate vision loss and improve quality of life through vision research. The revised version was developed by a Council work group with input from NEI staff and the public and aims to be inspirational and to consider the impact of NEI’s work holistically. To achieve this, NEI will drive innovative research to understand the eye and visual system, prevent and treat vision diseases, and expand opportunities for affected people; foster collaboration to develop new ideas and share knowledge across other fields; recruit, inspire, and train a talented new generation to strengthen the vision workforce; and educate about advances in vision research and their impact on health and quality of life.

This statement has been released for public comment. Dr. Chiang asked Council members to share comments and concerns about the revised NEI mission statement. Council members commended the revised NEI mission statement, including inclusion of the themes of research and collaboration across many fields, comprehensiveness, and broadness of the message—it explicitly considers quality-of-life impact and emphasizes contributors and diverse stakeholders. The Council members also compared the current mission statement to the revised mission statement.

A motion to accept the council workgroup recommendation for the revised NEI mission statement was made, seconded, and approved unanimously.

NEI Strategic Plan: Vision for the Future—Dr. Chiang thanked Drs. Gordon and Tumminia and all who contributed to the NEI strategic planning process. He described the review process for the draft chapters for the strategic plan and noted that these drafts were provided to Council members in advance of the last Council meeting for comment. A new version was provided to Council members and released to the public for comment prior to this Council meeting. The goal is to publicly release the final version in October 2021.

Dr. Gordon thanked Council members and noted that Dr. Chiang has carefully considered how this strategic plan will guide the priorities of NEI and how recommendations will be implemented. Dr. Gordon described the content, structure, and focus of the NEI Strategic Plan: Vision for the Future, which focuses on the science and programs, includes plans that involve the community, contains substantial external input, and greatly emphasizes public health. Focusing on the seven areas of emphasis allowed the team to work across NEI core extramural programs, identify new synergies, and recognize areas in need of attention. These seven areas are: From Genes to Disease Mechanism; Biology and Neuroscience of Vision; Immune System and Eye Health; Regenerative Medicine; Research Needs, Gaps, and Opportunities; Individual Quality of Life; and Public Health and Disparities Research. Dr. Gordon stressed that the plan covers the scope of core programs, and areas of emphasis are layered on top of core extramural programs. A funding initiative from one area of emphasis may cut across various programs.

A recent RFI asking for input on the strategic plan draft generated responses (46 unique respondents inside and outside the vision community) with ideas, suggestions, and concerns that are being reviewed carefully. Once suggestions are incorporated, a draft of the plan will be provided to Council members for review. Implementation plans include establishment of NEI internal working groups to determine priorities and strategies, which will be implemented through workshops, initiatives, personnel hires, and strategic partnerships.

Discussion

Dr. Jose-Manuel Alonso summarized comments from a group of prominent scientists in the NEI portfolio about three important vision research areas they believe are not properly emphasized in the current draft, including nonhuman primate research, theory in visual processing, and amblyopia. Dr. Gordon thanked Dr. Alonso for coordinating the group’s response and noted that the comments will be considered, and an additional red line draft will be sent. Dr. Gordon also discussed the significant edits that have had to be made to keep the document manageable but still have proper emphasis. Dr. Gordon also mentioned that the National Academy of Sciences will be starting a study on nonhuman primate research that NEI will be co-sponsoring. Dr. Chiang added that one barrier to research is that clinicians and researchers are not connected. Thus, NEI could link theory and practice as teams are built. He commended Dr. Gordon and his staff for their efforts in reviewing the strategic plan. Unlike prior strategic plans, this plan includes cerebral visual impairment (CVI), which is a challenge that will require a community with a wide range of expertise (e.g., theoreticians and researchers using nonhuman primate models).

Dr. Del Rio-Tsonis expressed appreciation for the executive summary and Director’s message, which will make this document more accessible. She suggested creating a more simplified document for the general public and proposed that a planned collaboration with the Centers for Disease Control and Prevention’s (CDC’s) Vision Health Initiative be included in the strategic plan. Dr. Gordon noted that one of NEI’s goal is to establish more trans-agency collaborations and pointed out that NEI works closely with CDC on the Healthy People 2030 initiative.

One member asked how NEI plans to balance the strategic plan with the decreasing budget. Dr. Chiang responded that this will be done through prioritization—NEI staff will be organized to determine areas where an impact, even a short-term impact, can be made. He hopes NEI can stimulate connections between scientists and clinicians in different fields. Dr. Gordon added that the goal of the strategic plan is to understand NEI’s priorities and opportunities so that available resources can be allocated. Strategic planning may position NEI to capitalize on funds as they become available.

REGENERATIVE MEDICINE CLINICAL TRIAL PLANNING GRANT – Dr. Jimmy Le, Collaborative Clinical Research

The proposed clinical trial planning funding opportunity focused on regenerative medicine would support efforts to conduct clinical trials aiming to evaluate interventions that restore vision in humans by regenerating cellular function using strategies such as stem cells, stem cell-derived precursors, and progenitor cells or products from progenitor cells. NEI does not currently have a mechanism to support planning of clinical trials that evaluate regenerative strategies. This concept would facilitate creation of a clinical trial manual procedure for a trial that assesses regenerative strategies; preparation and establishment of agreements with GPC manufacturers and production facilities or data coordinating centers; and obtaining of regulatory approvals. This funding mechanism also could be used to support preliminary activities (e.g., studies that evaluate feasibility and collect safety and toxicity information).

Drs. Harnett, Gardner, and Stepp served as concept reviewers. During the discussion, Dr. Le clarified that this opportunity would be available to investigators who are working in any area of the regenerative medicine field. A Council member noted that the goals statement mentions the use of cell-based therapies rather than exosomes or products derived from stem cells. Dr. Le stated that this feedback will be taken into consideration.

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

SINGLE-SITE CLINICAL TRIALS – Mr. Donald Everett, Division of Extramural Science Programs

The proposed initiative to support single-site clinical trials where the intervention represents greater than minimal risk to the participant. Minimal risk means that the probability and magnitude of harm or discomfort anticipated in the research are not greater than ordinarily encountered in daily life or during performance of routine physical or psychological examinations. This initiative would support investigator-initiated single-site clinical trials that are less complex and resource-intensive than those currently supported by other NEI clinical research funding opportunities.

Drs. Gardner, Hartnett, and Teller were the designated reviewers. Council members indicated this initiative would fill a niche that is not available in the current repertoire of NEI funding mechanisms.

A motion to approve moving forward with the single-site clinical trials concept was made, seconded, and approved unanimously.

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

Dr. Chiang commented that considering the day’s discussions, a pertinent topic to discuss in the next Council meeting is data sharing. Members who would like to communicate other possible topics for the next meeting should contact Dr. Chiang and Dr. Anderson.

Dr. Anderson adjourned the open session of the Council meeting at 1:40 PM.

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 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.

NAEC members considered 330 research and training grant applications on which NEI was the primary Institute; these applications requested a total of $109,297,133 (direct costs year 01). The Council also considered 424 applications on which another Institute/Center was primary and NEI was secondary. These applications requested a total of $302,290,527 (direct costs year 01). The Council concurred with the Institutional Review Group recommendations on these 754 applications.

The 158^th meeting of the National Advisory Eye Council was adjourned at 4:00 p.m. on June 11, 2021.

Council Members Present:

Dr. Michael F. Chiang, Chair
Dr. Kathleen Anderson, Executive Secretary
Dr. Jose-Manuel Alonso
Dr. Teresa Borras
Dr. James Coughlan
Dr. Katia Del Rio-Tsonis
Dr. Thomas Gardner
Dr. Mary Elizabeth Hartnett
Dr. Renu Kowluru
Dr. Mary Ann Stepp
Dr. Benjamin Teller

NIH Staff Members Present:

Dr. Neeraj Agarwal
Ms. Lisa Applewhite
Dr. Houmam Araj
Dr. Steven Becker
Dr. Thomas Beres
Dr. Sangeeta Bhargava
Mr. Nathan Brown
Ms. Monique Clark
Dr. Mary Frances Cotch
Dr. Martha Flanders
Dr. Ashley Fortress
Dr. James Gao
Ms. Alexandra Gavrilovic
Ms. Kerry Goetz
Dr. Nataliya Gordiyenko
Dr. Shefa Gordon
Dr. Tony Gover
Dr. Tom Greenwell
Mr. Peter Guthrie
Ms. Lateefah Hill
Dr. Brian Hoshaw
Dr. Paek Lee
Dr. Ellen Liberman
Ms. Barbara Mallon
Dr. Lisa Neuhold
Ms. Barbara Payne
Dr. Maryann Redford
Ms. Amber Reed
Dr. Jennifer Schiltz
Dr. Mohor Biplab Sengupta
Dr. Grace Shen
Ms. Karen Smith
Dr. Hongman Song
Dr. Michael Steinmetz
Dr. Afia Sultana
Dr. Santa Tumminia
Dr. Cheri Wiggs
Ms. Keturah Williams
Ms. Nora Wong
Dr. Charles Wright

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 are accurate and complete.

Michael Chiang, MD
Chair,
National Advisory Eye Council

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