National Heart, Lung, and Blood Advisory Council February 2022 Meeting Summary

Bethesda, MD


The 296th meeting of the National Heart, Lung, and Blood Advisory Council (NHLBAC) convened virtually on Tuesday, February 8, 2022. The Council meeting began with a closed session that started at 10:02 a.m. and ended at 11:15 a.m. The open session convened at 11:31 a.m. and ended at to 1:28 p.m. Dr. Gary H. Gibbons, Director of NHLBI, presided as chair.




February 8, 2022

The 296th meeting of the National Heart, Lung, and Blood Advisory Council (NHLBAC) convened virtually on Tuesday, February 8, 2022. The Council meeting began with a closed session that started at 10:02 a.m. and ended at 11:15 a.m. The open session convened at 11:31 a.m. and ended at to 1:28 p.m. Dr. Gary H. Gibbons, Director of NHLBI, presided as chair.


NHLBAC Members Attending
Victoria L. Bautch, Ph.D.
Kirsten Bibbins-Domingo, M.D., Ph.D.
Mercedes R. Carnethon, Ph.D.
Jennifer E. DeVoe, D.Phil., M.D.
Grace Anne Dorney Koppel, J.D.
Martha U. Gillette, Ph.D.
Garth Graham, M.D., M.P.H.
Tina V. Hartert, M.D., Ph.D.
David H. Ingbar, M.D.
Monica Kraft, M.D.
Edward E. Morrisey, Ph.D.
Kiran Musunuru, M.D., Ph.D.
Mohandas Narla, D.Sc.
Richard S Schofield, M.D. (Ex Officio)
Dean Sheppard, M.D.
Kevin L. Thomas, M.D.
Andrew S. Weyrich, Ph.D.
Zachariah P. Zachariah, M.D.

Members of the Public Attending
The total number watching online was reported by NIH Videocast to 252.

NHLBI Employees Attending
Several NHLBI staff members were in attendance via Zoom.


This portion of the meeting was closed to the public in accordance with the determination that it concerned matters exempt from mandatory disclosures 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.


The session included a discussion of procedures and policies regarding voting and confidentiality of application materials, committee discussions and recommendations. 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. The Council considered and recommended 3,489 applications requesting $8,315,941,244 in total costs. For the record, it is noted that secondary applications were also considered en bloc.



Dr. Gary H. Gibbons, Director of the National Heart, Lung, and Blood Institute (NHLBI), called the meeting to order at 11:31 A.M. He welcomed Council members, NHLBI staff, and public attendees to the Open Session of the meeting.


Dr. Laura K. Moen (Director, Division of Extramural Research Activities, NHLBI) noted that the meeting will be publicly broadcast and archived on videocast. She reviewed the agenda.


Dr. Gibbons began by updating the Council on leadership transitions within NHLBI. Drs. Robert

S. Balaban (Scientific Director, NHLBI Division of Intramural Research) and Catherine Stoney (Deputy Director, NHLBI Center for Translation Research and Implementation Science ) are stepping down from their positions. Dr. Gibbons expressed his deep appreciation for the contributions to the Institute and its mission. He noted that searches for both positions are open. Dr. Gibbons also bid farewell to Dr. W. Keith Hoots (Division Director, NHLBI Division of Blood Diseases and Resources) and thanked him for his superb service. Dr. Julie Panepinto has been recruited by Dr. Hoots to step in as a highly qualified Acting Director.

Dr. Gibbons observed that this month is American Heart Month, the theme of which is “Taking the Stress Out of Heart Health.” He invited all members to participate in the spirit of the initiative and join in the social media campaign to raise awareness of America’s number-one killer and to trigger action to move toward healthier lifestyles.

Accountable Stewardship: Dr. Gibbons updated the NHLBAC on NHLBI’s funding prospects for fiscal year (FY) 2022. Under the current continuing resolution, NHLBI’s appropriations are aligned with those of FY 2021. In preliminary budget negotiations, indications are that NHLBI’s budget in FY 2022 will increase relative to FY 2021. Future budget models project that NHLBI will be able to optimize its clinical research enterprise by increasing investment as appropriations allow. This trend recognizes the great opportunities and importance of NHLBI’s clinical trial portfolio to impact patient care, provide mechanistic insights, and develop treatments.

NHLBI is actively promoting diversity and inclusive excellence in biomedicine. From FY 2018 to FY 2021, the proportion of female investigators receiving awards under R01, R01 ESI, K, and F award mechanisms have increased. Awards to members of underrepresented minorities also give an indication of NHLBI’s support of diversity and inclusion.

Advancing Scientific Priorities: Dr. Gibbons highlighted the relevance to the NHLBI mission of addressing the impact of climate change on health disparities. Rising temperatures, extreme weather, rising sea levels, and increasing drought affect populations made vulnerable by increased sensitivity, increased exposure, and impaired adaptive capacity. Climate change affects acute and chronic cardiovascular and respiratory illnesses by altering exposure pathways. Communities of color and low-income communities are disproportionately affected. For example, climate impacts surface heat from urban heat islands. The NIH Climate Change and Health Initiative, led by the National Institute of Environmental Health Sciences (NIEHS), supports research to decrease health threats from, and increase resilience to, climate change.

Asthma provides an example of the need to address health disparities in climate change impacts. Racial disparities in the burden of asthma persist and are exacerbated by climate drivers such as wildfires. Children in communities of color have higher exposures to air pollution, affecting lung development. Exposure to wildfire smoke has had health implications across the U.S. However, improving air quality has been shown to improve lung health in children.

Health conditions that fall within NHLBI’s mission cause many heat-related deaths. Urban heat islands are an example of how the built environment drives health inequities. Historic redlining has contributed to health inequities. For example, in Washington, D.C., Blacks disproportionately live in disinvested urban areas with greater urban heat island effects.

However, climate change creates an opportunity to measure the mitigating effects of interventions on public health in underserved communities. Leveraging community-engaged research will promote participation in, and adherence to, these interventions.

Expanding data resources will better inform public interventions. Leveraging partnerships will facilitate data integration, harmonization, and the sharing of a variety of data sources and types. Harnessing big data, and using resources such as NHLBI’s BioData Catalyst, will foster connecting data types and cohorts and promote cross-disciplinary teams. An all-hands approach will engage diverse communities, foster diverse partnerships, expand cohort study indicators, leverage existing data, and develop a multidisciplinary workforce.

In responding to new initiatives like NIH’s Climate Change and Health, NHLBAC has played a critical role in its strategic guidance of NHLBI.


Dr. Richard Woychik (Director, NIEHS and the National Toxicology Program) reported on NIH’s strategic framework on climate change and health equity. The federal government has renewed federal actions on climate change, impelled by Executive Orders 13990, Protecting Public Health and the Environment and Restoring Science to Tackle the Climate Crisis; and 14008, Tackling the Climate Crisis at Home and Abroad; and allocating $100 million in funding to NIH for climate change and health (CCH) research. The U.N. Secretary General has declared a Code Red for humanity because of climate change. From a global view, the impacts of climate change are felt most by under resourced and marginalized communities. The United States has experienced increases in weather-related disasters that need to be understood.

Climate change’s effects on health include both direct and indirect impacts, and their complexity requires a transdisciplinary approach. Accordingly, the governance structure for NIH’s Climate Change and Health Initiative, led by NIEHS, includes the heads of six NIH Institutes and Centers (ICs). Governance is provided by the Executive Committee, Steering Committee, and CCH Working Group. The working group conducted a portfolio analysis of current CCH research across NIH, finding that a strong majority of the more than 350 unique CCH awards are administered by NIEHS. The analysis also described the research focus of NIH’s portfolio across a range of weather-related effects and health outcomes. The working group then issued a request for information about priority areas for CCH research, the top three responses being innovative research, translation and dissemination, and scientific infrastructure.

Climate change affects people unequally. The most vulnerable populations are those with health disparities, disabilities, and chronic medical conditions, as well as those in vulnerable life stages, exposed workers, and populations in low- and middle-income countries. The CCH Working Group brainstormed research project examples, ranging from predictive exposures of extreme weather events to laboratory studies of how heat exposure affects cellular systems.

NIH’s CCH initiative goals are to reduce health threats, especially among those at highest risk. Its objectives are to identify risks and optimize health benefits, develop the needed infrastructure and workforce, leverage partnerships, and translate findings. NIH’s strategic framework on climate change and health equity calls for transformative, transdisciplinary efforts in health equity research, training and capacity building, intervention science, and health effects research. The proposed appropriation would serve as a catalyst to implement this NIH-wide initiative.

Dr. Woychik concluded by acknowledging the Executive Committee and Steering Committee members, as well as other critical contributors, cochairs, and advisors.


Dr. Gail Pearson (Associate Director, Division of Cardiovascular Sciences; and Director, Office of Clinical Research, NHLBI) and Ms. Katie Kavounis (Office of Clinical Research, NHLBI) presented an overview of the Triennial Inclusion Report, the NIH inclusion policy, NHLBI inclusion data, and NIH and NHLBI inclusion initiatives. The Council’s awareness and discussion of the report constitute certification that NHLBI complies with the NIH policy.

Under the NIH Revitalization Act of 1993, women and minorities must be included in all clinical research studies unless a reason for their exclusion exists; Phase III clinical trials must analyze data by sex/gender, race, and ethnicity; and advisory councils must discuss inclusion efforts.

NIH policy is to include women, minorities, children, and older adults in research unless there is a reason not to. NIH policy on inclusion across the lifespan was revised in 2019 to expand reporting, clarify reasons for exclusion, and require annual reporting of trial participants’ ages at enrollment.

NHLBI’s approach to inclusion is multifaceted, including investigating factors that account for differences in health among populations. To evaluate whether a study meets inclusion standards, NHLBI examines the study’s enrollment plan, the match between proposed enrollment and prevalence, and annual progress toward inclusion. These data are included in the Triennial Report to Congress.

This report’s data were collected in FY 2019, FY 2020, and FY 2021. Total enrollment has been consistent across all 3 years. Phase III trial enrollment also has been consistent, except for a large all-woman trial that ended in FY 2019. Total female enrollment was somewhat lower in FY 2021 relative to the 2 earlier years because of the all-woman trial ending and the COVID-19 pandemic. The proportion of female enrollment in Phase III trials also was highest in FY 2019 because of the all-woman trial. Total enrollment by race increased for Blacks and Asians from FY 2019 to FY 2021 as underrepresented populations were targeted. In Phase III trials, Black and Asian enrollment almost doubled from FY 2019 to FY 2021. By ethnicity, total enrollment of Hispanic/Latinos was greatest in FY 2020. In Phase III trials, Hispanic/Latino representation increased from FY 2019 to FY 2021, reflecting trial topics and dissemination efforts. NHLBI’s investments in diverse trial participation have fostered inclusivity by sex/gender, race, and ethnicity.

Enrollment data by age group is only available for FY 2021. Enrollment was greatest in those over 65, as is consistent with NHLBI’s focus on chronic conditions. A majority of enrolled children were school age. Most enrolled older adults were in the 75 to 79 and 80 to 84 age groups. NIH’s interest in diversity extends to institutions’ student and faculty populations.

NIH policy is that studying sex as a biological variable strengthens science. NIH developed a strategic plan to advance research on sexual and gender minorities and to foster a diverse workforce in such research. One approach taken is that of NIH’s Brain Research Through Advancing Innovative Neurotechnologies® (BRAIN) Initiative, which requires and scores workforce diversity plans in all of its grant proposals. NIH established a grass-roots strategy to share best practices and review innovative recruitment methods for increasing inclusion in NIH research.

NHLBI is actively carrying out NIH’s policy. NHLBI’s Women’s Health Working Group has sponsored workshops and other activities on maternal and sex/gender-specific health. In addition, the NHLBAC/Board of External Experts Working Group on Trials met in 2021 with a charge that included considering ways to optimize inclusion in NHLBI clinical trials, and developed sets of recommendations for investigators and participants.


Delegated authorities allow NHLBI staff to perform specific functions without Council involvement, adding flexibility and decreasing the burden on the Council. NHLBAC members approved the delegated authorities presented, with no changes.


Dr. Gibbons asked Council members whether they had any issues or matters of concern to raise. Retiring members voiced their appreciation for their time on Council.


Dr. Gibbons adjourned the meeting at 1:28 p.m.