Summary Minutes – December 6-7, 2021

National Advisory Board on Medical Rehabilitation Research (NABMRR)
National Center for Medical Rehabilitation Research (NCMRR)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Members Present:

Members Absent:

Ex-Officio Members Present:

Ex-Officio Members Absent:

NICHD Staff and Visitors:

Day 1: December 6, 2021

Welcome, Approval of Minutes, and Future Meetings

Ralph Nitkin, Ph.D., Deputy Director, NCMRR
Eric Perrault, Ph.D., NABMRR Chair

NCMRR Deputy Director Ralph Nitkin, Ph.D., opened the virtual meeting at 10:00 a.m. Chair Eric Perrault, Ph.D., asked the following six new NABMRR members to introduce themselves during roll call:

• Barbara S. Bregman, P.T., Ph.D., Professor of Neuroscience and Rehabilitation Medicine, Georgetown University
• Jose Luis Contreras-Vidal, Ph.D., Hugh Roy and Lillie Cranz Cullen Distinguished Professor and Director of Building Reliable Advances and Innovation in Neurotechnology Center, University of Houston
• Dawn M. Ehde, Ph.D., Professor of Rehabilitation Medicine, University of Washington
• Michelle J. Johnson, Ph.D., Associate Professor of Physical Medicine and Rehabilitation and of Bioengineering, University of Pennsylvania
• Robert L. Sainburg, Ph.D., Dorothy Foehr Huck and J. Lloyd Huck Distinguished Chair in Kinesiology and Neurology, Pennsylvania State University
• Francisco Valero-Cuevas, Ph.D., Professor of Biomedical Engineering and of Biokinesiology and Physical Therapy, University of Southern California

A motion to approve the minutes of NABMRR’s May 2021 meeting carried.

Future NABMRR meeting dates are as follows:

• May 2–3, 2022
• December 5–6, 2022
• May 1–2, 2023

NICHD Update from the Director

Diana W. Bianchi, M.D., Director, NICHD

Dr. Bianchi opened her presentation with a new video featuring NICHD’s COVID-19–related accomplishments each month since March 2020.

National Institutes of Health (NIH) Budget and Appropriations

Congress recently passed a second continuing resolution, which funds the federal government in fiscal year (FY) 2022 at the FY 2021 level. Both the House of Representatives and the Senate have passed FY 2022 funding bills. These bills would provide $48 billion to $49 billion for NIH, including approximately $1.7 billion for NICHD.

The House also passed the Build Back Better Act in November, and the Senate is currently working on its version. The bill has the following three components that are relevant to NICHD:

• $15 million for NICHD to support research on the effects of COVID-19 on pregnant, lactating, and postpartum people, with a focus on racial and ethnic minority groups
• $10 million for NIH (probably NICHD and the National Institute on Deafness and Other Communication Disorders [NIDCD]) to support research related to developmental delays, including speech and language delays in infants and toddlers
• $75 million to NIH for programs that increase research capacity at minority-serving institutions (MSIs), enhance efforts to diversify the national scientific workforce, and support and expand the activities of the Scientific Workforce Diversity Office

Francis Collins, M.D., Ph.D., is stepping down from his position of NIH director at the end of 2021, and no transition plan has been announced yet.

COVID-19 Research

The NIH Rapid Acceleration of Diagnostics (RADx^®) program has four components, including RADx–Underserved Populations (RADx-UP), which funds community-engaged projects to assess and expand COVID-19 testing for underserved and vulnerable populations. With a RADx-UP supplement, the Washington University in St. Louis’s Eunice Kennedy Shriver Intellectual and Developmental Disabilities Research Center provided 50,000 SARS-CoV-2 tests to students, teachers, and staff in six special education schools through its Safe Return to School for All project. This project also assessed the perspectives of parents of children with intellectual and developmental disabilities and school staff on COVID-19’s impact and identified strategies to maximize the use of diagnostic testing for vulnerable children with disabilities in school settings. More information on this research and a fact sheet with tips for schools to keep students and staff safe during the COVID-19 pandemic are available on the Safe Return to School for All website .

NICHD used its Other Transaction Authority (OTA) to fund research on vaccine hesitancy, uptake, and implementation among populations that experience health disparities (NOT-OD-21-101). NICHD awarded $58 million for this research in the spring and summer of 2021. This program gathered evidence on the effectiveness, sustainability, and scalability of COVID-19 testing and mitigation strategies in schools, including special education schools, in 13 states. The results have already been used to develop evidence-based strategies for preventing infection, containing outbreaks, reducing quarantine time, and tracking viral variants in schools. A commentary in Pediatrics, “Building the Evidence for Safe Return to School During the COVID-19 Pandemic,” (PMID: 34737174) summarizes lessons learned from the first phase of this program, and the results were presented in a workshop in August 2021.

The NIH Researching COVID to Enhance Recovery (RECOVER) program is an effort to understand, prevent, and treat long COVID. This program will support adult, pregnancy, pediatric, and autopsy clinical cohorts, including patients with multisystem inflammatory syndrome in children.

Details on these and other NICHD COVID-19 activities are available on the COVID-19 Research and NICHD website.

Reproductive Health for People with Disabilities

Adolescent and young adult women with disabilities are less likely to have accurate knowledge about or use contraception, receive appropriate reproductive health education, or have access to timely cervical cancer screening. They are also more likely to experience an unintended pregnancy. Recent activities related to this topic include the following:

• An NICHD workshop on October 27, 2021, on Reproductive Health for Persons with Disabilities in the Transition from Adolescence to Adulthood
• A workshop on November 1-3, 2021, co-sponsored by NICHD and the Administration for Community Living’s National Institute on Disability, Independent Living, and Rehabilitation Researchon The Accessibility of Motherhood: A Virtual Workshop on Disability and Pregnancy
• An NICHD Notice of Special Interest (NOSI) on Reproductive Health, Pregnancy, and Parenting among Women with Disabilities (NOT-HD-21_025)
• An NICHD Request for Applications (RFA) for research on Promoting Reproductive Health for Adolescents and Adults with Disabilities (RFA-HD-23-005)

Research has recently shown that maternal responses to COVID-19 vaccination in the first and third trimester of pregnancy are better than in the second trimester. In addition, SARS-CoV-2 antibody levels are higher in pregnant people after vaccination than after natural infection.

NIH Efforts to Support Equity, Diversity, Inclusion, and Accessibility

NIH has published several RFAs to support transformative research to address health disparities and advance health equity through the NIH UNITE initiative. UNITE has also established an antiracism steering committee and is developing expectations for ensuring equity among different racial and ethnic groups in each institute or center’s FY 2022 performance plan. At NICHD, a Eunice Kennedy Shriver Intellectual and Developmental Disabilities Research Center working group meets monthly to discuss efforts to enhance the diversity of trainees and participants in research projects.

Discussion

Dr. Perrault asked how NICHD is disseminating the findings of its research on keeping students and staff safe in schools. Dr. Bianchi reported that the investigators work with community boards to publicize their findings, and NICHD issues publications and press releases with research findings.

A Board member asked whether RECOVER will study long COVID in people with disabilities. Dr. Bianchi explained that RECOVER does not have a separate effort for this population, but people who develop disabilities as a result of long COVID are a focus area.

Another Board member commented that the NICHD STrategies to enRich Inclusion and achieVe Equity (STRIVE) workshops were very helpful (STRIVE was presented in more detail later in the Board meeting).

NCMRR Director’s Report

Theresa Cruz, Ph.D., Director, NCMRR

Staff Updates

The following two staff members recently joined NCMRR:

• Maria Nurminskaya, Ph.D., a program officer in devices and rehabilitation interventions
• Dave Gutekunst, Ph.D., an American Association for the Advancement of Science policy fellow

Activities and Collaborations

The NIH Pathways to Prevention program resulted in two recent publications: a systematic review by an Agency for Healthcare Research and Quality evidence-based practice center (PMID: 34653376) and a summary of an NCMRR workshop on physical activity and health for wheelchair users (PMID: 34977545). NCMRR has published a new RFA, Home and Community-Based Physical Activity Interventions to Improve the Health of Wheelchair Users (RFA-HD-22-017).

NCMRR is supporting the development of common data elements (CDEs) for neurorehabilitation. Twelve working groups with more than 130 members spent approximately a year developing the CDEs. The first version of the CDEs will be published on the National Institute of Neurological Disorders and Stroke (NINDS) CDE website in January 2022, and NCMRR will discuss how to address the need for new neurorehabilitation CDEs.

Recent NIH-sponsored workshops and meetings have included:

• Presentations on motor rehabilitation in May and on sensory rehabilitation in November as part of the NCMRR speaker series
• An NIH Wednesday Afternoon Lecture Series presentation by an NICHD grantee
• A workshop for the National Heart, Lung, and Blood Institute (NHLBI) on pulmonary rehabilitation in the telehealth era on December 9–10

NCMRR plans to continue its speaker series in 2022 and welcomes suggestions of speakers and topics.

Recent NIH-wide opportunities for rehabilitation research have included the following:

• Brain Research Through Advancing Innovative Neurotechnologies (BRAIN): neural interfaces and invasive device clinical trials
• Blueprint for Neuroscience Research: funding opportunity announcements for development of breakout neural devices
• Helping End Addiction Long-term^® (HEAL) Initiative: interdisciplinary teams to elucidate the mechanisms of device-based pain relief
• Stimulating Peripheral Activity to Relieve Conditions (SPARC) program: the SPARC Human Open Research Neural Engineering Technologies (HORNET) initiative aims to advance the clinical translation of neuromodulation therapies in humans by supporting an ecosystem of accessible technology and tools

Several NCMRR grantees gave a presentation about urological disorders after spinal cord injury at an National Institute of Diabetes and Digestive and Kidney Diseases Urology Coordinating Committee meeting in June (PDF 168 KB). NCMRR plans to support the  Design by Biomedical Undergraduate Teams (DEBUT) Challenge, led by the National Institute of Biomedical Imaging and Bioengineering (NIBIB), in 2022.

Outreach

In the fall of 2021, NCMRR participated in a 5-week training series on NIH funding strategies for Tribal colleges and universities, historically Black colleges and universities, and other MSIs. This program, run by Langston University’s Rehabilitation Research and Training Center, provided practical information on navigating the NIH funding process, including how to identify NIH funding opportunities and prepare successful grant applications.

NCMRR representatives continue to participate in national professional society meetings and meet with stakeholder groups, including the Spina Bifida Association and the American Urological Association.

COVID-19

NCMRR continues to call for research on rehabilitation needs associated with COVID-19 (NOT-HD-20-031). The center also funded a study on remotely monitored, high-intensity interval training supported by mobile health after COVID-19 critical illness.

Discussion

A Board member said that NCMRR’s collaboration with the BRAIN Initiative’s neural interface and invasive device clinical trials program provides a good opportunity to bring more of these technologies to pediatric populations. In addition to helping pediatric patients, these devices can be used to understand the developing brain. Very little research has been done in this area. Dr. Cruz said that NCMRR accepts applications for pediatric indications through the UG3 and UH mechanisms, but so far it has only funded one such grant, for a device to support patients with epilepsy.

Dr. Perrault asked whether NCMRR could leverage its experience training MSIs to connect these institutions to the Medical Rehabilitation Research Resource (P2C). Dr. Cruz offered to ask the P2C coordinating center to contact MSI training program participants. Experience with pilot grants, which are supported through the P2C centers, could help these investigators apply successfully for larger NIH research grants.

Another Board member asked whether NCMRR helps investigators at MSIs identify collaborators at other institutions. Dr. Cruz said that some programs, including the BRAIN Initiative, have funding opportunities for MSIs, but NCMRR does not provide small grants for team building. NCMRR should determine how to support the formation of equitable partnerships between more- and less-experienced investigators and give them time to demonstrate that they have a true partnership.

Another Board member asked whether NCMRR could fund nonprofit organizations to help MSI researchers learn how to submit successful grant applications. Dr. Cruz said that NCMRR provides this training itself, but an impartial arbitrator might be useful. The R25 mechanism might be able to support this type of mentorship.

Back on Track: Behavioral Science and Technology for Promoting Motor Learning in Infants at Risk of Cerebral Palsy (CP)

Thubi H. A. Kolobe, Ph.D., Professor and Director of Research, College of Allied Health, University of Oklahoma

The most disabling condition for children with CP is impaired mobility. The earliest form of functional mobility in typically developing infants in the first year is prone locomotion, used by almost 90% of children who eventually walk. Dr. Kolobe discussed her research on using the self-initiated prone progression crawler to promote early and independent mobility and locomotion in infants with or at risk of CP. This system integrates robotics and sensor technologies that capture and influence movement effort as infants with CP learn prone locomotion.

NABMRR Liaison to the NICHD Advisory Council

Arthur English, Ph.D., Professor, Department of Cell Biology, Emory University

Dr. English has been serving as the NABMRR liaison to the National Advisory Child Health and Human Development (NACHHD) Council, which advises the NICHD director on NICHD research and other activities. In addition, Catherine Lang, P.T., Ph.D., of Washington University in St. Louis and Patricia Dorn, Ph.D., who represents the Department of Veterans Affairs with NABMRR, also have a strong background in medical rehabilitation research.  

Council meetings typically include a session that is open to the public and is used for discussions of broad scientific and policy issues. This is generally followed by another session, which is closed to the public, that is focused on second-level review of grant and cooperative agreement applications to be funded by NICHD. Recent NACHHD Council meetings have featured presentations on topics such as policies to prevent COVID-19 transmission in schools and a mother’s perspective on the NTrainer somatosensory training device’s benefits for her premature infant who could not suckle.

Concept Clearance

Maria Nurminskaya, Ph.D., Health Scientist Administrator, NCMRR

Dr. Nurminskaya asked NABMRR for feedback on a program announcement with review to renew the NCMRR Early Career Research Award (PAR-20-042), which supports collection of preliminary data for an initial R01 grant application by researchers within 7 years of their final degree. Because of this 7-year limit, awardees can still qualify for early-stage investigator (ESI) status if/when they go on to submit R01 applications. The Early Career Researcher program began in 2017 and has been active for 5 years; its final receipt date is in March 2022. NCMRR proposes renewing this program for another 3 years, and because many awardees are proposing clinical studies, NCMRR plans to keep the large budget (up to $100,000 per year for each of 2 years) in the next phase. As before, Early Career applications would be reviewed by the NICHD Scientific Review Branch.

Discussion

Dr. Perrault said that this initiative has been very helpful for junior investigators. Dr. Kolobe added that increasing the funding amount is a good idea, because obtaining good pilot data with only $50,000 per year was challenging. Two years of funding is also helpful.

A Board member suggested that the study sections that review these applications be informed that requirements for preliminary data are lower for ESIs. Dr. Nurminskaya explained that NIH policy allows ESIs to provide less preliminary data than established investigators, although these data must still be rigorously collected, and study sections always review applications from ESIs separately. The Board member suggested that the funding announcement indicate that awardees can use the funds to develop research ideas or teams and not just pilot data.

A motion carried to approve the renewal of the NCMRR Early Career Research Award program for another 3 years.

Providing Support for Care Partners Through Family-Integrated Care

Barbara Lutz, Ph.D., R.N., McNeill Distinguished Professor, School of Nursing, University of North Carolina Wilmington

Dr. Lutz distinguished between caregivers and care partners. Caregivers provide support to care recipients that these recipients cannot provide on their own, and the relationship between caregivers and care recipients is not reciprocal. In contrast, care partners work together to address the impact of the person’s illness or condition. Dr. Lutz described the positive and negative effects of providing care for care partners and the needs of individuals with chronic illness or disability during the transition from facility-based care to the home setting. She also discussed ways to assess the needs of people providing informal care to patients in the home and interventions to address these care-giving needs.

Day 1 of the meeting closed at ### p.m. EST.

Day 2: December 7, 2021

NIH Research Plan on Rehabilitation

Theresa Cruz, Ph.D., Director, NCMRR

Dr. Cruz began by acknowledging the death earlier in the week of Senator Bob Dole, who sustained injuries to his right arm during World War II and was a longtime supporter of people with disabilities. He was instrumental in passing the Rehabilitation Act of 1973 and worked with Senator Ted Kennedy—brother of NICHD’s namesake, Eunice Kennedy Shriver—to pass the Americans with Disabilities Act, which ultimately led to NCMRR’s creation.

2021 Research Plan on Rehabilitation

The 21st Century Cures Act of 2016 mandated the development of a medical rehabilitation research plan every 5 years and annual presentations by the NCMRR director to NABMRR on progress in achieving the report’s objectives.

NCMRR produced the first Research Plan on Rehabilitation (PDF 443 KB) in 2016. To start developing the next research plan, NCMRR issued a request for information in 2019 (NOT-HD-19-006) and incorporated the responses into its development process. With assistance from NABMRR, NCMRR decided to build on the major themes from the 2016 plan but to update some of the research objectives. The center published the draft objectives (PDF 178 KB) in the fall of 2020 along with a request for information to collect feedback (NOT-HD-20-033). The 2021 rehabilitation research conference included a presentation on the updated objectives and the feedback received. After the objectives were presented to NABMRR, they were sent to the NIH institute and center (IC) directors for their review and then underwent clearance at NIH and the Department of Health and Human Services (HHS).

Dr. Cruz presented all of the objectives for each of the plan’s six themes. She highlighted the revisions to the objectives and provided some examples, in the following list, of activities under each objective:

1. Rehabilitation Across the Lifespan: NCMRR and others at HHS are working to add more disability-related questions to large surveys and datasets.
2. Community and Family: NCMRR called out the need to include consumers with disabilities in the research enterprise and is pilot testing ways to expand the participation of persons with lived experience.
3. Technology Use and Development: NCMRR is well positioned to address these objectives in the next few years, including through the Bridge to Artificial Intelligence (Bridge2AI) program (Bridge2AI was presented in more detail later in the Board meeting).
4. Research Design and Methodology: Many activities are underway outside NCMRR, including at the NIH Collaboratory, which conducts many rehabilitation pragmatic trials. The NIH data-sharing policy, which will go into effect in January 2023, will require all applicants to submit a data-sharing plan. Dr. Cruz plans to ask Rebecca Rosen, Ph.D., director of NICHD’s new Office of Data Science and Sharing, to give a presentation to NABMRR at its May 2022 meeting on tools in development to help investigators comply with this policy.
5. Translational Research: This remains a very active area of research with a great deal of room for further growth.
6. Building Research Capacity and Infrastructure: NABMRR’s approval of the NCMRR Early Career Research Award concept is an important step in addressing the objectives for this theme. More needs to be done to increase the diversity of rehabilitation researchers. Dr. Cruz and several former NABMRR members are part of a subgroup of an Advisory Committee to the Director working group that is developing recommendations for the NIH director on how to best support individuals with disabilities in the scientific workforce.

The 2021 NIH Research Plan on Rehabilitation (PDF 1.51. MB) calls for action instead of observation and for inclusion of more people with disabilities in research. The plan takes an expansive lifespan approach, especially for early intervention opportunities, and it recommends more data sharing and individual training awards. Dr. Cruz hopes that the research community will respond to the plan with investigator-initiated research applications that address its themes and objectives.

Progress Since the 2016 Research Plan

Dr. Cruz explained that some of the recent data she would be presenting on progress since 2016 are in draft form because they have not yet received Office of Management and Budget clearance. In addition, NCMRR typically presents data from the previous fiscal year to NABMRR during its December meeting, but these data are not yet available for FY 2021.

Although the NCMRR budget declined between 2012 and 2013 because of mandatory sequestration, it has since increased steadily, as has funding for rehabilitation research throughout NIH. Of the 241 grants that NCMRR funded in 2021, 48% were research program grants, 39% were training grants (a much higher rate than the typical 10% at NIH), and 7% were small business grants. NCMRR funds a larger proportion of small business grants than the NIH target of 3.5% because assistive and rehabilitation technologies are so important to the NCMRR target population. The large number of training grants is based on numbers of trainees.

NINDS funds the largest number of NIH grants for rehabilitation research, followed by NIDCD and the National Institute on Aging (NIA). NINDS also awards the largest amount of funding for this research, followed by NIA and NIDCD.

Dr. Cruz hopes to provide an update on numbers of awards that address the primary and secondary themes of the 2021 research plan at the May 2022 NABMRR meeting. Data from 2019 show that NIH had a robust portfolio for many of the themes, but with less activity  occurring with a focus on community and family. At the May 2022 meeting, Dr. Cruz also plans to discuss meaningful measures of progress in addressing the research plan.

Initiatives and Programs by Research Theme

Dr. Cruz listed initiatives and programs that address each theme in the research plan:

• Rehabilitation Across the Lifespan
  • NIA RFA: Tailoring Cardiac Rehabilitation to Enhance Participation of Older Adults (RFA-AG-18-016)
  • NICHD RFA: Research Project Grants in Pediatric Rehabilitation (RFA-HD-20-005)
• Community and Family
  • NHLBI RFA: Increasing Use of Cardiovascular and Pulmonary Rehabilitation in Traditional and Community Settings (RFA-HL-18-019)
  • NICHD RFA: Home and Community-Based Physical Activity Interventions to Improve the Health of Wheelchair Users (RFA-HD-22-017)
• Technology Use and Development
  • Blueprint MedTech: accelerates development of cutting-edge medical devices to diagnose or treat disorders of the nervous system
  • NIH Small Business Education and Entrepreneurial Development: leads initiatives that develop relationships among universities, research institutions, small businesses, trade associations, and others to build opportunities for NIH innovators to advance their product development efforts
• Research Design and Methodology
  • NIH Collaboratory’s Rethinking Clinical Trials: A Living Textbook of Pragmatic Clinical Trials
• Translational Research
  • Workshop: Opportunities for Rapid Advancement of Limb Regeneration: From Animal Models to Humans, in February 2021
• Building Research Capacity and Infrastructure
  • Medical Rehabilitation Research Resource (RFA-HD-20-004): provides consultations, didactic opportunities, pilot funds, and sabbaticals related to rehabilitation research
  • NCMRR Early Career Research Award program: COVID-19–related extensions for trainees, child care supplements, and life event supplements
  • Equity, diversity, inclusion, and accessibility programs: programs that include NIH UNITE and NICHD STRIVE

NIH Research Matters, a weekly newsletter that highlights recent NIH-sponsored research findings, included summaries of several recent publications on rehabilitation research in 2021.

Discussion

Dr. Perrault asked about initiatives under development to respond to the 2021 research plan. Dr. Cruz noted that NABMRR is the first group to see new NCMRR concepts and will continue to review new initiatives as they are developed. NCMRR is planning several workshops, and Dr. Cruz will have more to say about new activities in response to the plan at the May 2022 meeting.

Dr. Perrault suggested that NCMRR create initiatives to bridge research plan themes that have robust activity with themes that have much less activity. Such a strategy could encourage investigators to enter different fields. In addition, Dr. Perrault asked how NCMRR plans to measure the effectiveness of its new initiatives. Dr. Cruz said that measuring the effectiveness of these initiatives is challenging. Dr. Nitkin added that NCMRR needs to determine whether the field is ready for each new initiative and which collaborations need incentives to reach a critical mass of activity. For example, NCMRR must determine whether to provide training to encourage researchers to address certain rehabilitation research questions.

A Board member asked about NCMRR support for art therapy initiatives. Dr. Cruz explained that NICHD supports the recently-issued NIH Music and Health program (PAR-21-100), which NINDS leads. Some applications submitted in response to this RFA were assigned to NICHD for review. Before the COVID-19 pandemic, NCMRR had discussed a joint conference on art therapy with the National Endowment for the Arts and the Kennedy Center, but those plans did not come to fruition because of the pandemic.

Another Board member emphasized the importance of longitudinal studies, including studies that start in infancy, and asked about longitudinal rehabilitation research support. Dr. Cruz explained that investigators can extend their (5-year) R01 awards by submitting competitive renewal applications. NCMRR does not have set-aside funds for longitudinal studies, but other federal partners, such as NIDILRR, can support such research. In addition, NCMRR is working to ensure that ongoing longitudinal studies gather data on its populations. For example, NCMRR worked with the Centers for Disease Control and Prevention to add questions about disability to the Pregnancy Risk Assessment Monitoring System questionnaires.

Another Board member noted that when she served on a committee that evaluated NIDILRR’s grant activities, it found that many of the same investigators and types of projects tended to receive funding. She asked about efforts to analyze NCMRR funding for new investigators and new research topics. In addition, the Board member suggested that NCMRR analyze the effectiveness of training programs by determining, for example, whether trainees in these programs ultimately submit grant applications to NIH. Dr. Cruz said that Dr. Gutekunst can analyze the outcomes of NCMRR’s T32 awards over the past 30 years. NCMRR funds many ESIs and does not tend to give grants to the same set of investigators, but it can review rehabilitation funding by other NIH ICs.

Overview of NICHD STRIVE Initiative

Charisee Lamar, Ph.D., M.P.H., Director, Office of Health Equity, NICHD

In the 2020 NICHD Strategic Plan, health disparities is a cross-cutting theme, and related research themes are promoting an inclusive workforce and promoting workforce development and balance. Events that set the stage for the development of STRIVE include racial and ethnic disparities in the impact of COVID-19, demonstrations in response to the death of George Floyd, media reports on systemic racism, anti-Asian sentiment, and a report showing that NIH was not funding enough African American scientists. NIH launched UNITE and asked the Office of Health Equity at NICHD to develop STRIVE.

STRIVE is an NICHD-wide program that has three components:

• Equity, diversity, and inclusion (EDI) in the NICHD workforce: will develop NICHD’s EDI efforts for the internal workforce 
• Diversity of the extramural workforce and training programs: will promote the diversity of extramural trainees and investigators who are underrepresented in NICHD-supported biomedical and biobehavioral research
• Health disparities and systemic racism in scientific research: will examine opportunities to address the social determinants of health, including structural racism, in NICHD’s health disparities research portfolio

STRIVE committees include more than 50 staff members from throughout NICHD. STRIVE coordinates its activities with UNITE and consults with external stakeholders. The STRIVE website provides details on STRIVE’s goals and activities.

STRIVE charged its EDI Committee with developing a charter and preparing a Management Directive 715 report in 2020, as required by the Equal Employment Opportunity Commission to ensure a diverse and inclusive workforce. The EDI Committee has also analyzed demographic, employment, and personnel action data; fielded an NICHD pulse survey; and established staff training and brown bag lunch programs. The pulse survey measured the NICHD climate for EDI. The results have been analyzed, and a report with the findings will be finalized soon.

NIH is requiring each IC to submit a racial and ethnic equity plan by April 1, 2022. The EDI Committee will coordinate the development and submission of these plans. In addition, all federal agencies are required to develop a plan for diversity, equity, inclusion, and accessibility, and agency heads must report annually on progress made in achieving the goals of these plans. The EDI Committee and NICHD leaders will coordinate development of this plan.

The STRIVE Scientific Workforce Diversity Committee is analyzing data on the more than 44,000 investigators and trainees supported by NICHD. This committee is hosting workshops to gain insights from stakeholders and is forming intramural and extramural collaborations. The committee determined that NICHD funding for Black and Hispanic principal investigators (PIs) has not increased substantially in the last 25 years.

The STRIVE Health Disparities Research Committee has analyzed NICHD’s health disparities research portfolio and hosted five virtual workshops that engaged more than 1,500 internal and external stakeholders. The committee also launched an IdeaScale campaign to expand engagement in the discussions initiated during the workshop series.

Most NICHD health disparities research focuses on underserved racial and ethnic groups. Other NICHD studies include people with low income or low socioeconomic status, sexual and gender minority groups, and rural populations. Many NICHD health disparities projects address HIV/AIDS, maternal health, and preterm birth.

Discussion

A Board member asked whether NICHD asks employees and grant applicants about their disability status, which is relevant to the institute’s target populations. Dr. Lamar said that the pulse survey asked employees about their disability status, and the STRIVE portfolio analysis is examining the disability status of NICHD-funded investigators and trainees. Dr. Cruz reported that only approximately 1% of all NIH-funded PIs report a disability, and program staff do not have access to PIs’ demographic data. When investigators register for eRA Commons, they are asked whether they have vision, hearing, or other impairments, but some investigators with a disability might be reluctant to disclose it. The Board member said that if a culture of inclusion is created, the fear of reporting a disability will diminish.

Another Board member asked about STRIVE’s benchmarks. Dr. Lamar explained that STRIVE is developing metrics that will go beyond quotas.

Another Board member asked about efforts to ensure that the NICHD peer review process is equitable. Dr. Lamar said that the Scientific Workforce Diversity Committee is reviewing the entire grant process. Opportunities to enhance equity are probably available at all stages of the process, not only at the peer review stage. Dr. Cruz added that the NIH Center for Scientific Review often conducts studies on how to make the review process fairer. In one study, study section members were asked to review grant applications without receiving information on the race or ethnicity of the PIs. The study found that White PIs received lower scores, but African American PIs did not receive higher scores. Dr. Lamar said that culture change is a major undertaking, and STRIVE will identify opportunities for change in many areas, including the peer review process. The problems have existed for centuries, so making change will take time.

Another Board member said that efforts to promote equity and inclusion must begin at the precollege level, when students are forming their views of science and technology. Dr. Lamar said that STRIVE is considering when in the training pipeline to start its programs, and STRIVE might leverage some National Science Foundation (NSF) programs. Inviting high school students into a system that does not serve them well will not achieve STRIVE’s goals. STRIVE is also considering the entire research ecosystem, because not everyone in the biomedical research enterprise is or will become a PI.

NIH Common Fund Activities

Stimulating Peripheral Activity to Relieve Conditions (SPARC)

Felicia Qashu, Ph.D., Program Officer, NIH

The NIH Common Fund supports bold scientific programs that catalyze discovery across areas of biomedical and behavioral research that are important to the missions of several ICs. SPARC is a Common Fund program that capitalizes on recent advances in technology to deliver detailed, integrated, functional, and anatomical neural circuit maps for organs. SPARC aims to provide the scientific foundation to pilot test new and improved neuromodulation devices and stimulation protocols.

NIH launched the first phase of SPARC in 2015. The initial set of awards mapped the anatomical and functional innervation of the visceral organs, with a focus on the heart, stomach, colon, lung, and bladder. These studies assessed innervation of the healthy condition to provide a baseline map, and most initial studies were in rodents. SPARC subsequently supported studies in large animals and in humans, as well as in disease states, to inform translational neuromodulation studies. SPARC also invested in the development of new tools to modulate the peripheral nervous system, as well as sensors to detect neural and organ activity and provide information on how and when to use stimulation to normalize a condition.

For example, SPARC supported the development of wireless pressure and volume systems that can be used in animal studies—and potentially in humans to monitor bladder and colon activity. These devices are not affected by anesthesia or catheters that typically impede natural function. SPARC clinical studies included a human and complementary rat study to determine how epidural lumbar sacral spinal cord stimulation could help remediate bladder activity in motor complete spinal cord injury.

Data on the SPARC Portal must be FAIR: findable, accessible, interoperable, and reusable. The portal provides access to curated datasets, maps of nerve–organ interactions, experimental protocols, and tools and resources to help users create visualizations and run simulations.

SPARC Phase 2, which starts in FY 2022, has three components:

• SPARC-V: construction of high-resolution connectivity profiles of human vagus nerves and a large multisite study of the multiorgan effects of vagus nerve stimulation in humans
• SPARC-O: the HORNET initiative, which will fund centers to create interoperable open-source modules that can be combined for neuromodulation studies in the peripheral nervous system and potentially the central nervous system
• SPARC-X: a competition offering prizes for demonstration of independent modulation of multiple endpoints

Bridge2AI

Grace Peng, Ph.D., Program Director, Division of Discovery Science & Technology (Bioengineering), Mathematical Modeling, Simulation, and Analysis, NIBIB

Bridge2AI is a new Common Fund program to support widespread adoption of AI that tackles complex biomedical challenges in ways that are not possible with human intuition alone. This program is led by several NIH ICs and collaborates with several federal agencies, including the Department of Energy, the Food and Drug Administration, and the National Institute of Standards and Technology.

Bridge2AI promotes a culture shift toward the generation of AI- and machine learning (ML)–friendly data that have clear provenance and are well described, accessible, large, multimodal, and longitudinal. The data descriptors will be novel (describe new biomedical or behavioral phenomena), complete (with information on the context of the phenomena), trustworthy (FAIR), and ethically sourced.

Bridge2AI issued the following funding opportunity announcements:

• Data Generation Projects for the NIH Bridge2AI Program (OT2) (PDF 602 KB): will create flagship datasets based on ethical principles, associated standards and tools, and skills and workforce development activities to address biomedical and behavioral research grand challenges that require AI and ML analysis
• Integration, Dissemination, and Evaluation (BRIDGE) Center for the NIH Bridge2AI Program (RFA-RM-21-023): will integrate activities and knowledge from the data generation projects, disseminate products and best practices, create skills development materials and activities, and evaluate Bridge2AI with input from external stakeholders

All data generation projects must include plans for addressing all six Bridge2AI modules of team science, ethics, standards, software, tools, relevant methods of data acquisition, and skills and workforce development. Once the data are produced, they will be shared in public repositories.

NIH is reviewing applications for both funding opportunities and will issue awards in the spring of 2022. A kickoff meeting and community jamboree will take place in the fall of 2022.

Discussion

Dr. Perrault said that collecting hypothesis-agnostic data is important, but these data must be complemented by hypothesis-driven research. He asked how Bridge2AI will bring together these two components of science. Dr. Peng explained that Bridge2AI will collect flagship sets of ethically sourced data that will be mined using modern AI and ML tools for hypothesis-driven research. NIH hopes that researchers with hypothesis-driven projects will join the Bridge2AI consortium once it is established.

A Board member asked whether researchers who are collecting data for ongoing NIH-funded studies can leverage the resources that Bridge2AI will build. Dr. Peng replied that the first priority for Bridge2AI is to form a community. Collecting ethically sourced data from diverse sources is challenging, and Bridge2AI will offer skills and workforce development opportunities. In addition, all of the tools and resources Bridge2AI develops will be available to investigators collecting data. The Bridge2AI concept is encouraging researchers to submit applications to other NIH programs to collect ethically sourced data.

The Board member asked whether NIH is collaborating with NSF to ensure that engineers processing biomedical data are using appropriate tools and ethically sourced data. Dr. Peng replied that NSF has a representative on the Bridge2AI working group.

Another Board member asked whether Bridge2AI will issue more funding opportunities. Dr. Peng replied that NIH launched Bridge2AI very recently, and the program has funding for 7 years. The initial projects will receive 4 years of funding. Bridge2AI uses the OTA, which provides flexibility to add awardees and fund nontraditional partners. Bridge2AI will support a substantial amount of activity as its programs move forward.

Dr. Perrault asked about the types of competitions in SPARC-X. Dr. Qashu replied that SPARC has not yet launched this competition, but the hope is that it will spur interest in improving the selectivity of neuromodulation. In the past, SPARC has focused on visceral function, and studies related to rehabilitation research would be in scope.

Advances in Wearable Technologies and Their Impact on Rehabilitation

Overview

Eric Perrault, Ph.D., NABMRR Chair; Professor of Biomedical Engineering, Northwestern University

In recent decades, wearable sensors have become ubiquitous, including in consumer products (e.g., Fitbit™, Apple Watch™); these sensors can monitor health in ways that were never thought possible before. Verbal sensors are also beginning to transform medical inquiry and medical practice. Wearable sensors can be used for various areas of epidemiology and have many applications in rehabilitation. This mini-symposium would feature advances in wearable technologies and their impact on rehabilitation.

Skin-Interfaced, Wireless Wearable Devices for Clinical-Grade Health Monitoring

John Rogers, Ph.D., Professor, Departments of Materials Science and Engineering, Electrical and Computer Engineering, Chemistry, Biomedical Engineering, and Mechanical Engineering, Northwestern University

Dr. Rogers described his studies to make wearable devices more relevant to rehabilitation through innovations in hardware and material sciences. The physical formats of conventional wearable devices constrain their use for measurement, because the bulk and planar construction of the electronic components prevent persistent scans of the body, especially at anatomical locations that are relevant to rehabilitation and other areas of medicine. Dr. Rogers has developed wireless, silicon-based electronic devices that can adopt the mechanical properties of skin and be used for continuous monitoring of vital signs, vocal biomarkers, body orientation, and other clinical markers in a variety of applications and populations.

Digital Health Technology and the Design of Precision Rehabilitation Interventions

Paolo Bonato, Ph.D., Assistant Professor of Physical Medicine and Rehabilitation, Harvard Medical School

This presentation focused on the collection of proxies of clinical scores in clinical, home, and community settings from wearable devices to capture severity of impairment, functional limitations, and patient recovery longitudinally and adjust interventions accordingly. Dr. Bonato focused on applications for people with hemiparesis after stroke, but the devices he described have many other applications.

Planning for Next Meeting

Dr. Perrault asked for topics to address at the next NABMRR meeting. Board members provided the following suggestions:

• Updates on STRIVE and the other diversity programs presented at this meeting
• Development of more appropriate outcome measures, especially those that go beyond academic research to clinically actionable information, translation improvement, and functional independence support
• Impact of COVID-19 on people who did and did not previously have a disability
• Use of telehealth to improve access to care for people with disabilities
• Use of technology to make rehabilitation interventions affordable and usable in developing and under-resourced countries, especially in the context of health disparities
• A broader discussion of  support for people with disabilities dealing with infectious diseases
• New patient-focused self-management paradigms that enable patients to continue treatment at home and support caregivers
• Role of social media in rehabilitation, especially to motivate therapy
• Telerehabilitation at the macro-level and from an analytical perspective
• Support for faculty development and senior administrator support for academic rehabilitation research programs
• Genetics and epigenetics of treatment responsiveness to rehabilitation interventions

A Board member commented that splitting this virtual meeting into 2 days was helpful.

Adjournment

Dr. Cruz said that she would book a conference room for the May 2022 NABMRR meeting, in the hope that it can be held in person. Future virtual NABMRR meetings will continue in the 2-day format.

Dr. Perreault adjourned the meeting at 2:54 p.m. EST.