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NAEC Meeting Minutes - June 17, 2022

National Institutes of Health

National Eye Institute
Minutes of the National Advisory Eye Council
One Hundred Sixty-first Meeting
June 17, 2022

The National Advisory Eye Council (NAEC) convened for its 161st meeting at 10:00 a.m. on Friday, June 17, 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 2:07 p.m. The meeting was closed to the public from 2:35 p.m. until 4:34 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 Borras
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. Tirin Moore
Dr. Benjamin Teller

NIH Staff Members Present:

Mr. Shawn Adolphus
Dr. Neeraj Agarwal
Dr. Houmam Araj
Dr. John Ball
Dr. Sangeeta Bhargava
Ms. Stephanie Blackford
Ms. Holly Blake
Mr. Nathan Brown
Mr. Juan Castillo
Ms. Alysia Champagne
Dr. Emily Chew
Ms. Monique Clark
Mr. Jay Colbert
Ms. Claudia Costabile
Dr. Mary Frances Cotch
Ms. Ashley Dash
Mr. Walter Davis
Ms. Kyla Delaine
Mr. Britt Dennis
Dr. Chairlie Drinnan
Mr. Donald Everett
Ms. Diana Fisher
Dr. Martha Flanders
Dr. Ashley Fortress
Dr. James Gao
Dr. Mohita Gaur
Ms. Alexandra Gavrilovic
Ms. Kerry Goetz
Dr. Nataliya Gordiyenko
Dr. Shefa Gordon
Dr. Tony Gover 
Dr. Tom Greenwell
Dr. Bin Guan
Mr. Syed Haqqani
Ms. Natalie Haynes
Ms. Lateefah Hill
Dr. Brian Hoshaw
Dr. Jeanette Hosseini
Dr. Koray Dogan Kaya
Dr. Michael Lauer
Dr. Jimmy Le
Dr. Paek Lee
Dr. Ellen Liberman
Ms. Renee Livshin
Mr. Alex Manuel
Dr. George McKie
Dr. Sheldon Miller
Ms. Archana Mohale
Mr. Daniel Molina
Dr. Lisa Neuhold
Mr. Russ O'Donnell
Ms. Scarleth Perez
Mr. Trevor Peterson
Dr. Zepeng Qu
Dr. Maryann Redford
Ms. Melissa Reeves
Ms. Carissa Reilly-Weedon
Ms. Holly Russo
Ms. Jessica Ryan
Dr. Jennifer Schiltz
Dr. David Schneeweis
Dr. Trupti Shetty
Ms. Rugie Sillah
Ms. Karen Smith
Dr. Hongman Song
Dr. Michael Steinmetz
Dr. Xun Sun
Dr. Anand Swaroop
Dr. Santa Tumminia
Dr. Chenyue Wang
Ms. Leslie West-Bushby
Dr. Cheri Wiggs
Dr. Angelina Williams
Mr. Michael Wright
Ms. Maria Zacharias

Others Present Virtually:

Ms. Kim Cook, NIH Events Management
Ms. Kathy Sedgwick, Science Writer

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 161st 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.

Council Procedures and Related Matters

—Dr. Kathleen Anderson, Executive Secretary, NAEC

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 NIH videocast website. Dates for future Council meetings are listed on the NEI website. An additional closed Council meeting will be held on August 9, 2022, to review applications submitted to two NEI-issued Requests for Applications (RFAs) to be considered for funding in Fiscal Year 2022. The next open Council meeting is planned to be held in person on Friday, October 14, 2022. Minutes of the February 2022 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.

Director's Report

—Dr. Michael Chiang

NIH and NEI Leadership Updates

In December 2021, Dr. Francis Collins stepped down as NIH Director. Dr. Lawrence Tabak has been appointed by the White House to serve as Acting Director. Dr. Tara Schwetz is Acting NIH Principal Deputy Director.

NEI is currently conducting two major recruitments: Scientific Director and Clinical Director. Dr. David Schneeweis has served as Acting Scientific Director since the retirement of Dr. Sheldon Miller in 2019. Applications for this position closed on January 31, 2022, and second-round interviews are underway. After seven years as NEI Clinical Director, Dr. Brian Brooks stepped down in January 2022 Dr. Brooks will continue to lead the Ophthalmic Genetics and Visual Function Branch. The Clinical Director search committee has been formed and an announcement of the position is pending.

Advanced Research Project Agency for Health (ARPA-H)

On May 25, 2022, Department of Health and Human Services’ Secretary Xavier Becerra announced the formal establishment of ARPA-H as an independent entity within HHS, complementary to but not duplicative of NIH programs, and focused on supporting transformative, high-risk/high-reward biomedical and health research. Adam H. Russell, D.Phil., has been appointed Acting Deputy Director and will report directly to Secretary Becerra.

Awards and Recognition

Dr. Chiang congratulated longtime NEI grantee Dr. Sheila Nirenberg who was awarded the Lighthouse Guild’s 2022 Bressler Prize for “revolutionizing the field of computational neuroscience and biomedicine to help people regain their sight.” Dr. Nirenberg is the Nanette Laitman Professor in Neurology and Neuroscience and Professor of Computational Neuroscience at the Institute for Computation Biomedicine, Weill Cornell Medical College. In addition, two members of the NEI staff recently received awards. Dr. Emily Chew, Chief of the Clinical Trials Branch and Director of the Division of Epidemiology and Clinical Applications, received the American Ophthalmological Society 2022 Medal. Dr. Mitra Farnoodian-Tedrick, a research scientist in the Ocular and Stem Cell Translational Section, received an award from the Knights Templar Eye Foundation for her work on developing a stem cell-based drug discovery platform to target lipid defects in Stargardt disease. Seven NEI-supported investigators have been named members of the National Academy of Sciences in 2022: Drs. Jean Bennett, Hollis Cline, Charles Kimmel, Roberta Klatzky, Alex Kolodkin, Stephen Lisberger, and Krzystof Palczewski.

NEI-funded Research Highlights

NEI intramural researchers Drs. Davide Ortolan and Kapil Bharti used artificial intelligence-based software to generate the first single-cell-resolution map of human retinal pigment epithelium (RPE). Results will enable study of molecular and functional RPE differences responsible for regional retinal disease and help develop precise therapies for specific degenerative eye diseases.

NEI grantees Drs. Fatima Abbas and Frans Vinberg at the University of Utah Moran Eye Center successfully revived light-sensing neuron cells in organ donor eyes and restored communication between them. These first electrophysiological recordings made from the central retina of postmortem human eyes demonstrate the value of the retina as a model for investigating neuronal death and methods for regeneration, with implications for disease treatment and reversibility of cell death.

Finally, a pair of NEI intramural researchers, Drs. John Ball and Wei Li, used a ground squirrel model to explore the optical properties of the retina. They demonstrated that light passing through bundles of mitochondria focus into a beam rather than blocking, absorbing, or scattering light. This explanation for the Stiles-Crawford effect may inform earlier detection of retinal disease that often damages mitochondria.

NEI Strategic Plan Implementation Update

Dr. Chiang provided an update on current and planned activities related to the areas of emphasis (AoE) in the NEI Strategic Plan.

  • Immune System and Eye Health. NEI issued an RFA (RFA-EY-22-001) inviting applications from multidisciplinary research teams to develop A Community Research Resource: Characterization of the Resident Ocular Microbiome aimed at delineating and characterizing the core ocular surface microbiome.
     
  • Regenerative Medicine. Projects in this AoE included publication of an Audacious Goals Initiative (AGI) road-mapping paper in Nature Medicine; The Association for Research in Vision and Ophthalmology (ARVO) Regenerative Medicine Town Hall, “Characterization and Standardization of Cell Sources,” that emphasized the need for harmonized regulation of validated material testing; and review of 3-D Retina Organoid Challenge (3-D ROC) entries. In addition, plans are underway for the AGI Transplant Immunology Workshop on July 29, 2022.
     
  • 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 toward widespread adoption of standards for interoperability. Approximately 350 researchers, clinicians, vendors, and representatives from government and professional societies participated. Several papers to promote adherence to the standard include an editorial, white paper, and workshop proceedings. Additional data science opportunities include the $500,000 DataWorks! Prize, a collaboration between NIH and the Federation of American Societies for Experimental Biology (FASEB). This annual challenge showcases the benefits of research data management, sharing, and re-use for advancement of knowledge, discovery, and human health. In February 2022, NEI signed on to the Biological Knowledgebase funding opportunity announcement (FOA) (PAR-20-097) that supports data curation that scales to the needs of the community.
     
  • Public Health and Disparities Research. NEI issued a Notice of Special Interest (NOSI): Research Addressing Eye and Vision Health Equity/Health Disparities to encourage applications that target reduction of health disparities experienced by visually impaired or blind persons. NEI collaborations with the National Institute of Minority Health and Health Disparities (NIMHD) are in the works, including a series of workshops. NEI also signed onto the trans-NIH funding opportunity, Global Brain and Nervous System Disorders Research Across the Lifespan (PAR-22-097) that encourages applications for innovative, collaborative research projects with scientists and institutions in low and middle income countries (LMIC) focused on brain and nervous system function and disorders.

NEI Training Program Updates

This year, 12 of NEI’s 20 summer interns are participating in person and 11 individuals from traditionally underrepresented groups in vision research became interns through the Diversity in Vision Research and Ophthalmology (DIVRO) program. Recruitment is ongoing for the NEI Clinician Scientist Reviewer Program to increase the pool of clinician scientists—particularly those from groups underrepresented in science and medicine—to serve as reviewers on NEI special emphasis panels.

Peer Review Bias Training

In September 2021, the NIH Center for Scientific Review (CSR) began piloting a 30-minute online training module to raise reviewer awareness of potential sources of bias in peer review and develop practical skills to mitigate them. During the January 2022 Council round of review, over 6,000 reviewers completed the training. Of those who completed an evaluation, 87 percent reported that NIH has a moderate, big, or very big problem with bias in peer review, 90 percent were extremely satisfied with the training, and 82 percent indicated they would probably or definitely take specific actions to combat bias.

Diversity, Equity, Inclusion, and Accessibility (DEIA)

The NEI Eye on the Future Campaign video contest aims to inspire teenagers to pursue careers in science, eye health, and vision research, with an emphasis on underrepresented groups in science and medicine.

The NIH Chief Officer for Scientific Workforce Diversity (COSWD) issued a notice inviting comments on the development of a prize competition for institutional excellence in DEIA (NOT-OD-22-109) that will recognize institutions that model innovative interventions for enhancing faculty and student diversity.

The 2022 Consolidated Appropriations Act (P.L. 117-103) included a provision requiring NIH grantee institutions to report cases of sexual harassment to NIH within 30 days of removal or disciplinary action. The provision aims to make NIH-funded projects welcoming for all grantees, staff, and trainees, and goes into effect on July 8, 2022.

On March 24, 2022, the Rapid Acceleration of Diagnostics (RADx®) Tech program held a listening session to solicit input on the accessibility challenges of current at-home COVID-19 tests and potential improvements for these products. Takeaways from the listening session are available in the executive summary. This effort will inform future product accessibility standards for broader groups.

The NIH Artificial Intelligence/Machine Learning (AI/ML) Consortium to Advance Health Equity and Researcher Diversity (AIM-AHEAD) is hosting a series of events (a 2-day conference, startup competition, 4-week workshop series, and monthly webinars) in support of AIM-AHEAD goals to enhance the participation and representation of researchers and communities currently underrepresented in the development of AI/ML models and improve the capabilities of this emerging technology to address health disparities and inequities.

NEI Budget Update

NEI Budget Officer, Karen Colbert, reported that the FY 2022 appropriation for NEI represented a 3.4 percent increase over FY 2021. Estimated shares of the total NEI budget are as follows: extramural research, 83.8 percent; intramural research, 11.8 percent; and research support, 4.4 percent. Another Continuing Resolution is likely for FY 2023. She presented a comparison of NEI operating levels versus buying power for FY 1999 through FY 2022. Despite regular budget increases, buying power has not increased proportionately.

Dr. Dana asked Ms. Colbert how the proportion of the 11 percent for intramural research compares to other NIH Institutes and what is the dollar density at the NEI compared to some of the laboratories and institutions that NEI supports extramurally. Ms. Colbert replied that generally 10-11 percent is the NIH benchmark for Intramural Research Programs. However, depending on the Institutes’ research focus that amount can vary. For the latter question, Ms. Colbert did not have that data available. Dr. Dana explained the reason for his questions is based on data presented by his institutions, Massachusetts General Hospital and Brigham and Women’s Hospital, that showed the purchasing power of a typical $250,000 modular grant has decreased by 46 percent in 20 years. Dr. Dana stated that the decrease in purchasing power of this grant amount creates significant difficulties in providing salaries that will permit institutions to retain investigators, postdoctoral fellows, and other staff.

Real-World Adoption of Findings from Clinical Trials

During the February 2022 NAEC meeting, Council members called for strong efforts to connect science to clinical practice and specifically for increasing clinician awareness of clinical trials and studies relevant to their patients. According to a National Academies of Science report, it takes approximately 17 years for significant findings to become incorporated into clinical practice. Dr. Chiang asked for volunteers to serve on a Council Workgroup to develop priorities and recommendations on how to communicate, disseminate, and translate NEI-funded clinical research findings into real-world practice.

NEI Leadership

In September 2022, Dr. Michael Steinmetz will step down from his position as Director of the NEI Division of Extramural Science Programs (DESP). He joined NEI in 2003 and has served as Director of DESP since 2014. Dr. Chiang thanked Dr. Steinmetz for his exceptional leadership overseeing the NEI extramural grant portfolios and representing NEI on many trans-NIH and government-wide committees, including the BRAIN and Blueprint initiatives. Dr. Steinmetz made remarks on his work at NEI and the Institute’s successes, which include maintaining a high investigator-initiated award success rate, strong support for vulnerable groups of investigators (early-stage and at-risk), the development of initiatives for targeted research areas (e.g., AGI and ASI) to address knowledge gaps and barriers to progress and implementing a requirement that consortia be formed under these initiatives to promote collaboration. He attributed these successes to his outstanding mentors, NEI Program Officers, Scientific Review Officers, and Grants Management Specialists, and especially recognized the NEI Chief Grants Management Officer, Karen Robinson Smith.

Discussion

Dr. Maguire asked how the scope and operation ARPA-H projects will differ from NIH initiatives. Dr. Chiang noted that ARPA-H will emphasize nontraditional high risk/high reward projects to speed the development of deliverables that directly benefit the public, citing the development of the COVID vaccines as one example.

Dr. Hartnett inquired if the new vision for NEI will cause a change to the funding of investigator-initiated applications. She believes these grants are valuable for their creativity and ability to move science forward. Dr. Chiang indicated that the bulk of projects that NEI supports will continue to be investigator-initiated with an emphasis on at-risk and young investigators. The NEI mission includes a statement to recruit, inspire, and train a diverse workforce so it remains important to focus on young investigators and interest them in NEI research. For targeted initiatives, NEI will focus on identifying the important unanswered questions, anticipate future directions of science, and increase collaboration to push science and advance translation to the clinic. The number of targeted initiatives published each year will be relatively small and will not significantly impact the success rates of investigator-initiated grant applications.

Dr. Del Rio-Tsonis wondered if NEI has collaborations with other agencies on initiatives to remediate disparities in eye health. In response, Dr. Chiang pointed to ongoing trans-agency efforts with the Centers for Disease Control and Prevention (CDC), NIMHD, and other institutes. Future efforts will consider the impact of vision loss on education, quality of life, and how individuals interact in the real world. Dr. Kowluru mentioned that a recent meeting included a session on health disparities and eye health, with an emphasis on artificial intelligence. Dr. Chiang pointed out the strong expertise of NEI-supported investigators in clinical vision science, vision care, and technological methods. However, he noted that there are gaps in sociological expertise relevant to investigation of health disparities. The challenge will be to collaborate with researchers who bring this type of expertise to the investigative team. Translating clinical trial results to the community will provide opportunities to identify disparities and determine how best to communicate findings. It will be important to go beyond traditional methods (e.g., published papers, presentations) to effectively disseminate findings to the community.

Dr. Teller asked if NEI has internships for high-school students or medical school students. Dr. Chiang confirmed NEI and NIH training programs include students from high school through postdoctoral training. He encouraged everyone to contact Dr. Cesar Perez Gonzalez cesarp@nei.nih.gov for questions about these programs.

PORTFOLIO OVERVIEW: Structure, Function, and Diseases of the Cornea

—Dr. George McKie, Program Director, DESP, NEI

Dr. McKie presented an overview of the NEI corneal structure, function, and disease portfolio, which includes preclinical and clinical studies.

Studies of corneal structure and function look at differentiation, contractility, and patterning of corneal keratocytes; homeostasis of the cornea; and maintenance of corneal transparency. Techniques include culture models that mimic the three-dimensional tissue environment, models of corneal nerve damage and transgenic mouse models; multidimensional imaging approaches (in vitro, in situ, and in vivo); single-cell, real-time polymerase chain reaction (qRT-PCR); and flow cytometry. Preclinical studies of corneal disease focus on wound healing, infection (bacterial, fungal, viral), and limbal stem cells; structural conditions such as keratoconus, Fuchs endothelial dystrophy, lysosomal storage disease dystrophy, and Down syndrome; lacrimal gland concerns; treatments; and biomarkers (e.g., ASI NOSI NOT-EY-21-007).

Dr. McKie highlighted several ongoing clinical studies. Seasonal Conjunctivitis Outbreak Reporting and Improved Outcomes (SCORPIO) is an international collaboration that aims to identify pathogens, pathogen evolution, global trends, and immune responses involved in the epidemiology of conjunctivitis. The Mesenchymal Stromal Cell Secretome for Promoting Corneal Regeneration trial aims to accelerate corneal wound healing while limiting unnecessary inflammation and secondary scarring. The Cultivated Autologous Limbal Epithelial Cell (CALEC) project aims to rebuild a healthy surface for the damaged eye using cells from the healthy eye.

In 2021, NEI hosted two workshops relevant to this portfolio: Immunity and Inflammation in the Anterior Segment of the Eye and Investigating the Ocular Surface Microbiome for Low-Biomass Microbial Research. Recently, an NEI-funded investigator published mass spectrometry workflows for proteomic analysis of tear fluid collected via Schimer strips.

NEI is partnering with the National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) Accelerating Medicines Partnership (AMP) – Autoimmune and Immune-Mediated Diseases (AIM). Sjögren’s is one of four autoimmune diseases included in AMP-AIM partnership. Dr. McKie anticipates that this effort will obtain biomarkers from the skin and gut microbiome of Sjögren patients and normal subjects to contribute to the Ocular Microbiome initiative.

Discussion>

Dr. Del Rio Tsonis asked Dr. Mckie to explain how secretomes, used in one of the studies she highlighted, are collected for use in patients. Dr. Steinmetz explained that stem cell populations are grown in cultures and the secretomes collected from those cells are used to treat corneal injuries. Dr. Steinmetz noted that the Department of Defense is funding a companion project using stem cells to treat corneal injuries. Dr. Dana elaborated on cells being cultured and applied to injured eyes and while there are some concerns about immunogenicity and scalability of the secretome protein products, the approach is very promising.

PORTFOLIO OVERVIEW: Small Business Innovation Research and Technology Transfer Programs (SBIR/STTR)

—Dr. Paek Lee, Program Director, DESP, NEI

Dr. Lee described the NEI small business research program. The congressionally mandated SBIR is one of the largest sources of early-stage capital supporting small U.S. businesses with commercial promise for private research and development. The goals of the program are to (1) create innovative, high-risk technologies designed to improve health and save lives, and (2) translate these technologies from bench to bedside. In the case of NEI, the goal is to save sight-debilitating conditions and improve quality of life of the blind and visually impaired.

The mandated budget set-aside for SBIR is 3.2 percent. The STTR set-aside is .45 percent of the Institute budget. The STTR program requires a partnership with U.S. research or nonprofit institutions.

Both the SBIR and STTR are three-phase programs. Phase I (R41, R43) is the feasibility and proof-of-concept testing stage. Phase II (R42, R44) focuses on full research and development (R&D) over a 2-year period. Phase III is for commercialization is supported by non-SBIR/STTR funds (e.g., investors, FDA, the marketplace).

Technical and Business Assistance (TABA) awards are available to SBIR and STTR grantees. Small business may request up to $6,500 per year for Phase I and up to $50,000 per year for Phase II projects to support subcontracts or consultants. Details are provided in NOT-OD-21-062. Alternatively, applicants can take advantage of centralized TABA services, such as a needs assessment during Phase I and more specialized consulting services from the NIH Entrepreneur-in-Residence during Phase II. Additional entrepreneurial training is available through the NIH I-Corps™ (Phase I), National Institute on Biomedical Imaging and Bioengineering Concept to Clinic Program and investor coaching.

NEI SBIR/STTR is a cross-cutting program relevant to all areas of the NEI strategic plan. Key areas of interest include preclinical development and validation of therapeutics; clinical and rehabilitation tools; diagnostics and research tools; and assistive technology and telehealth applications. During 2012–2022, funded projects focused on devices (55%) and therapeutics (45%).

Dr. Lee described several current projects, including an aptamer technology that shows promise as an alternative to antibodies and aims for more effective, less frequent treatments with fewer side effects; PhotoBioModulation that uses specific light wavelengths to activate protective and disease-delaying processes in the retina, offering a less-invasive treatment and prevention for dry age-related macular degeneration (AMD) and diabetic retinopathy; devices that measure high-resolution ocular blood flow or oxygenation; adaptive optics-based devices; and artificial intelligence/machine learning-based disease screening technologies.

Dr. Lee also highlighted two initiatives: Translation of BRAIN® Initiative Technologies to the Marketplace (NOT-MH-21-125) for development of imaging and functional tools to revolutionize our understanding of the human brain; and Administrative Supplements to Promote Diversity in Research and Development for Small Businesses (PA-21-345) to attract a healthy influx of new entrepreneurs to engage in this field.

Discussion

Dr. Dana noted that the ultimate success of the program is reflected in the proportion of technologies that become licensed. He wanted to know what proportion of the technologies supported by NEI has made it through advanced rounds of price financing series B and series C or has made it through FDA approval in the past 10 years. Dr. Lee reported that approximately 20 clinical trials were started via the SBIR/STTR programs and that NEI is developing metrics to determine which of these have received FDA approvals.

Dr. Moore asked for clarification about patents, royalties, and license rights and whether there are differences in how SBIRs are handled from grants. Dr. Lee explained that the federal government does not claim any royalties or license rights for SBIR grants.

Dr. Coughlan inquired why the SBIR’s budget is seven times more than the STTR budget and are there major differences in the application success rates between the two portfolios. Dr. Lee reiterated that these budgets are congressionally mandated: 3.2 percent of each IC’s budget is set aside for SBIR and .45 percent for STTR. Dr. Lee noted that there are fewer STTR applications submitted but there are no major between in application success rates between STTRs and SBIRs.

BRAIN® MULTI-COUNCIL WORKGROUP REPORT

Dr. Tirin Moore, NAEC council member and NEI representative to the BRAIN Multi-Council Workgroup.

Dr. Moore is the NEI representative on the Brain Research Through Advancing Innovative Neurotechnologies® (BRAIN) Initiative Multi-Council Workgroup (MCWG). He highlighted key information from the MCWG’s May meeting, noting that no new concepts were presented for clearance.  He encouraged everyone to view the meeting to hear about the scientific highlights that were presented.

BRAIN® Director Dr. John Ngai provided a brief overview of the budget, summarized demographics of BRAIN® investigators and their institutions, described efforts to enhance diverse perspectives among grantees, and outlined some recent scientific advancements.

Recent events include the Brain Behavior Quantification and Synchronization Workshop (March 1–2, 2022); The Brain Across the Lifespan: Tools and Technologies for Measuring the Changing Brain (April 18–19, 2022); and The Neuroethics Working Group (NEWG) Workshop on Continuing Trial Responsibilities (May 24 and May 25, 2022). The 8th Annual Brain Initiative Meeting on June 21 and 22 will serve as a forum to discuss BRAIN-supported projects and bring the BRAIN community together.

Dr. Ngai then discussed the demographics of BRAIN investigators and their institutions.  Engineering is the most frequently listed discipline. Although women and minorities are still underrepresented compared to NIH overall, there is no discernable difference in success rate among women and minorities compared to other majority groups. Early and mid-career applicants are more successful than those from advanced career applicants. Applicant institutions are distributed across most states and Puerto Rico but are still concentrated on the East and West coasts. To increase the diversity of perspectives in research, a Plan for Enhancing Diverse Perspectives is required for applications to BRAIN initiatives.  Finally, he noted that for research participants in BRAIN awards, the ethnic, racial, and gender representation is fairly well distributed.

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.

IMPLEMENTATION UPDATE: NIH POLICY FOR DATA MANAGEMENT AND SHARING

—Dr. Mike Lauer, Deputy Director for Extramural Research, NIH 

Dr. Lauer provided an update on the implementation of the NIH Data Management and Sharing Policy. The 21st Century Cures Act, passed in 2016, authorized the NIH Director to require data sharing from all NIH awards that generate data. The current policy implements this element of the law. Data sharing policies are not new and have evolved and expanded from the 2003 NIH policy to include sharing policies for specific data types (e.g., 2014 Genomic Data Sharing Policy), research activities (2016 NIH Policy on Dissemination of NIH-Funded Clinical Trial Information), disorders (e.g., Autism Data Sharing Policy), institutes (e.g., National Institute of Mental Health), and programs (e.g., BRAIN®). The updated policy and guidance were released in October 2020 and replace the 2003 data sharing policy. The new policy will be effective for competing applications received on or after January 25, 2023. This policy is not new but raises the level and depth of data sharing required.

The policy includes two requirements: applications must (1) submit a Data Management and Sharing Plan for all NIH-funded research and (2) compliance with the plan approved by the Institute, Center, or Office (ICO). Data sharing should be the default practice and maximized. The plan should be responsibly implemented in a way that protects privacy, rights, and confidentiality and abides by existing laws, regulations, and policies.  Plans should be prospective and include all stages of the research process. Plans may be amended over time with approval by the agency.

The extramural plan submission and review process includes submission, assessment, and compliance. Plans must be submitted with the application and include a brief description of the plan in the budget justification section and a full plan as a separate attachment. Peer-reviewers comment on but do not score the budget for the plans. The plans are then assessed and approved by NIH program staff and incorporated into the Terms and Conditions of the Notice of Award. Plans can be revised at any time but need to be approved by agency staff.  Compliance with the plan will be monitored at regular reporting intervals and may factor into future funding decisions.

All data should be managed, but not all data need to be shared. Scientific data refers to published or unpublished “factual material…of sufficient quality to validate and replicate research findings.” Data should be accessible as soon as possible but typically not later than publication of results or the end of the award.

Currently available information and tools for understanding the policy include webinars and FAQs. Additional supplemental information, sample plans, and harmonization with the Genomic Data Sharing Policy are planned for the summer and fall. Following implementation, the policy will be assessed for short and long-term goals. The goal is for data sharing to become something that scientists want to do rather than a burden. Dr. Lauer acknowledged Dr. Chiang as a key thought leader in this area and commended his work on thinking about ways to embed this into professional culture.

Dr. Lauer encouraged attendees to visit the NIH Data Sharing website (sharing.nih.gov), which includes the NIH sharing policies for scientific data, genomic data, research tools, model organisms, and clinical trials. The site includes policy overview infographics, decision tools, and step-by-step instructions. Detailed information is provided on planning and budgeting for data management and sharing, proper data management, and methods for sharing scientific data.  Information on available repositories is also included.

Dr. Lauer acknowledged that there are additional costs associated for data sharing and that they should be requested in grant application budgets. The Data Management and Sharing Plans will be made public, possibly by posting on NIH RePORTER.

Dr. Chiang thanked Dr. Lauer and his team for their efforts in shepherding this big cultural change in the way science is done.

Discussion

Council members commented on the value of plan templates as well as having sample plans for a variety of experimental designs (e.g., a small mouse study versus a longitudinal study of a 4,000-person cohort including a large battery of tests). Dr. Lauer noted that a simple template will be available soon as well as a series of questions to assist investigators in developing their plans. Eventually there will be a web form to use. The goal is to have sample plans for different scientific fields. Once the policy is implemented, additional examples from the community will be made available.

In response to questions about how to budget for data sharing, Dr. Lauer noted that the policy guidance spells out costs that can be requested, such as fees for data deposition, curation, and maintenance in a repository. Some universities have developed their own framework for calculating the costs of data sharing. A National Academies study provided detail about an appropriate budgetary framework for data management and sharing. It is recognized that grants will become more expensive to comply with the policy.

One council member asked about available repositories for smaller studies (e.g., laboratory-based animal studies). Dr. Lauer pointed out that PubMed Central (PMC) accepts small datasets accompanying author manuscripts for inclusion on PMC. Guidance for authors is available in the NIHMS FAQ. Guidance on repository selection and a searchable database of different types of repositories are available on the sharing.nih.gov site.

Dr. Chiang asked for advice on specific ways to help everyday real-world investigators navigate the data sharing plan. He views this kind of communication as an NEI responsibility. For a long time, within the culture of biomedical research, the published paper has been viewed as the output of a project, and the data are subsidiary to the publication. There is a shift toward thinking about data more broadly as a second output and as something that others can use for the benefit of the community at large. How can NEI share this message and gain community buy-in?

Dr. Lauer noted that data sharing has been the norm in some academic fields (e.g., economics, physics, astronomy) for a long time. As a junior investigator at Cleveland Clinic in the 1990s, Dr. Lauer learned that the National Heart, Lung, and Blood Institute (NHLBI) had a repository for data from clinical trials and epidemiology studies. He obtained access to these data and was able published several important papers that included credit to the original investigators who collected the data.

Several years ago, NHLBI published a paper reporting on the use of their data repository, which highlighted the increasing demand for trial data for secondary analysis that led to high-quality publications that were not necessarily related to the original goals of the project. The world of science is enriched by data sharing. Nature’s Scientific Data journal publishes papers describing datasets and research that advances sharing and reuse of data.

A Council member raised some potential unintended consequences of this policy, for example peer-review judgements on the value, integrity and validity of the data that have not been published. How would this be handed by the peer review community? Dr. Lauer responded that it seems likely peer reviewers have used data from repositories and know their quality, which might lend credence to their use in an application.  He acknowledged that this is an open question and that the experience of other areas of science that have a culture of data sharing can be informative. Another member asked about what types of restrictions would be imposed on creative commons licenses, for example. They requested guidance from NIH on these types of questions.  Dr. Lauer noted that this was a reasonable request, and that NIH would follow-up on this issue.

 

GENERAL DISCUSSION 

Council members highlighted the following concerns about the Data management and Sharing Policy: budgetary implications of implementing the policy, especially for investigators requesting modular budgets; the lack of data sharing and management expertise within their community, which might be addressed through NIH-wide training; institutions unprepared for the policy and/or lacking repositories; and the need to ensure that data are findable and useable.

A Council member pointed to the policy as an opportunity to upgrade the way research is done. To make reproducibility possible, shared data must be well-documented. Dr. Chiang described the policy as a mechanism for doing better research and increasing the value derived from the public’s investment in research. He hopes that vision science will be a leader in this effort.

OPEN SESSION ADJOURNMENT

Dr. Anderson adjourned the open session of the Council meeting at 2:07 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 518 research and training grant applications on which NEI was the primary Institute; these applications requested a total of $166,021,213 (direct costs year 01). The Council also considered 434 applications on which another Institute/Center was primary and NEI was secondary. These applications requested a total of $685,466,891 (direct costs year 01). The Council concurred with the Institutional Review Group recommendations on these 952 applications.

ADJOURNMENT

The 161st meeting of the National Advisory Eye Council was adjourned at 4:34 p.m. on June 17, 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. Thomas Gardner
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. Mary Frances Cotch
Ms. Ashley Dash
Mr. Donald Everett
Dr. Martha Flanders
Dr. Ashley Fortress
Dr. James Gao
Ms. Kerry Goetz
Dr. Nataliya Gordiyenko
Dr. Shefa Gordon
Dr. Tony Gover
Dr. Tom Greenwell
Ms. Lateefah Hill
Dr. Brian Hoshaw
Dr. Barbara Mallon
Dr. Lisa Neuhold
Dr. Maryann Redford
Dr. Jennifer Schiltz
Dr. Grace Shen
Ms. Karen Smith
Dr. Hongman Song
Dr. Michael Steinmetz
Dr. Afia Sultana
Ms. Leslie West-Bushby
Dr. Cheri Wiggs
Ms. Keturah Williams

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: October 6, 2022