National Heart, Lung, and Blood Advisory Council October 2020 Meeting Summary

U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES NATIONAL INSTITUTES OF HEALTH NATIONAL HEART, LUNG, AND BLOOD INSTITUTE

NATIONAL HEART, LUNG, AND BLOOD ADVISORY COUNCIL MEETING SUMMARY

October 27, 2020

The 290th meeting of the National Heart, Lung, and Blood Advisory Council (NHLBAC) convened virtually on Tuesday, October 27, 2020. The meeting began in closed session at 10:04 a.m. and was open to the public between 12:42 p.m. until adjournment at 4:02 p.m. Dr. Gary H. Gibbons, Director of the National Heart, Lung, and Blood Institute , presided as chair.

NHLBAC Members Attending

E. Dale Abel, M.D., Ph.D.
Donna K. Arnett, Ph.D., M.S.P.H.
Jennifer Devoe, D.Phil., M.D.
Grace Anne Dorney Koppel, J.D.
Martha U. Gillette, Ph.D.
Karen Glanz, Ph.D., M.P.H.
Garth Graham, M.D., M.P.H.
David H. Ingbar, M.D.
M. Luisa Iruela-Arispe, Ph.D.
Monica Kraft, M.D.
Kiran Musunuru, M.D., Ph.D.
Mohandas Narla, D.Sc.
Julie A. Panepinto, M.D., M.S.P.H.
Richard S. Schofield, M.D. (Ex Officio)
Dean Sheppard, M.D.
Kevin L. Thomas, M.D.
Sally E. Wenzel, M.D.
Andrew S. Weyrich, Ph.D.
Zachariah P. Zachariah, M.D.

NHLBI Employees Attending

A number of NHLBI staff members were in attendance via Zoom.

NIH Employees and Public Attending

The total number watching/participating online was reported by NIH Videocast to be 230.

Closed Session

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.

Review of Applications

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 2,849 applications requesting $6,582,229,040 in total costs. For the record, it is noted that secondary applications were also considered en bloc.

Open Session

I. CALL TO ORDER

After a brief break, Dr. Gibbons reconvened the NHLBAC meeting at 12:42 PM in Open Session. He welcomed Council members, NHLBI staff and public attendees to the Open Session of the meeting.

II. ADMINISTRATIVE ANNOUNCEMENTS

Dr. Laura K. Moen (Director, Division of Extramural Research Activities, NHLBI) recognized the NHLBAC members who are retiring after four years of service on the Council: Dr. Dale Abel, Dr Donna Arnett, Dr. Karen Glanz, Dr. Luisa Iruela-Arispe and Dr. Sally Wenzel.

Dr. Moen reminded Council members of conflict of interest requirements and noted that the meeting would be publicly broadcast and archived on videocast.

III. NICHD AND NHLBI: HIGHLIGHTS FROM A STRONG PARTNERSHIP AND SHARED ACTIVITIES

Dr. Diana Bianchi, Director of the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), described the role of NICHD and provided an overview of the many significant collaborations between NICHD and NHLBI. She noted the following points of interest in her presentation to Council members:

• NICHD devotes 55 percent of its funding to research on children’s health. It also supports research on reproductive health and on intellectual and physical disability. However, NICHD is not the only, or even the primary, Institute at NIH that funds pediatric research.
• Since Dr. Bianchi became director of NICHD in late 2016, the institute has developed a strategic plan to inform future investments and collaborations. The NICHD mission is to lead research and training to understand human development, improve reproductive health, enhance the lives of children and adolescents, and optimize abilities for all.
• In 2018, Dr. Bianchi initiated a trans-NIH consortium (NIH Pediatric Research Consortium, N-PeRC) to harmonize efforts in child health research across NIH. Its most recent meeting focused on an area of major concern: the challenge of transitioning adolescents to adult health care.
• In March, the consortium quickly formed a COVID-19 working group. The NHLBI, NICHD, and the National Institute of Allergy and Infectious Diseases (NIAID) are working together, leveraging existing resources, to harmonize access to clinical data relating to Multisystem Inflammatory Syndrome in Children (MIS-C), a severe complication of COVID-19. There are plans to follow children with MIS-C for 5 years through a longitudinal protocol. NICHD is also using existing infrastructure to study how COVID-19 affects pregnant women and outcomes in their infants.
• NHLBI and NICHD are also collaborating on investigating co-occurring conditions across the lifespan of those with Down syndrome. Dr. Gibbons and Dr. Bianchi chair a committee focusing on conditions that are common in Down syndrome which also affect other people, such as Alzheimer’s disease; and are also considering why certain conditions, like coronary heart disease and certain solid tumors, are rare in people with Down syndrome.
• Maternal health research is another area of shared interest between NHLBI and NICHD. About one-third of maternal deaths occur a week to a year after delivery, with cardiomyopathy being a frequent cause. Black women are at particular risk for maternal death. Age and location, especially living far from medical care, are also important risk factors.
• Dr. Gibbons and Dr. Bianchi co-chair the trans-NIH initiative, Implementing a Maternal health and Pregnancy Outcomes Vision for Everyone(IMPROVE), which addresses disparities in maternal health and pregnancy outcomes based on race and age. This group awarded $7.2 million before the end of the last fiscal year, supporting research on major causes of maternal death like heart disease and hemorrhage, as well as the role of infections, mental health, and structural factors that disrupt care.
• NHLBI and NICHD are also collaborating on nuMoM2b, a prospective cohort study that began in 2010 and enrolled about 10,000 women. When NHLBI picked up the study in 2014, it added an investigation of the relationship between complications during pregnancy and cardiovascular outcomes in women 2 to 7 years later. Investigators have since observed a significantly increased risk for hypertension among women who previously had pregnancy complications.

Dr. Bianchi concluded by saying that she looked forward to exploring possibilities for expanding collaboration with NHLBI.

IV. REPORT OF THE DIRECTOR

Dr. Gibbons provided an update on the fiscal year (FY) 2020 and 2021 budgets. He noted that appropriations from the Coronavirus Aid, Relief, and Economic Security (CARES) Act may be spent until the end of FY 2024.

Throughout FY2020, NHLBI has continued to prioritize investing in investigator-initiated science and maintaining high success rates for R01 applications. Dr. Gibbons noted that NHLBI tracks diversity in sex/gender and race/ethnicity among grant awardees as part of its commitment to inclusive excellence. A focus on high-success rates for early-stage investigators and for career development (K award) applicants has proven to be an effective approach towards enhancing inclusive excellence.

NHLBI has Other Transactions authority that allows it to support projects in a more nimble and strategic way than typical contracts, grants, or cooperative agreements do. This authority has been useful for supporting:

• BioData Catalyst, a cloud-based data platform that has recently come into operation and advances access to the Trans-Omics for Precision Medicine (TOPMed) program, providing data for a very large number of genomes.
• The Cure Sickle Cell Initiative, an NHLBI-led collaborative research effort that is moving forward with the aim of developing genetic therapies for sickle cell disease.
• Rapid response to COVID-19, which affects the heart, lungs, blood, and sleep. NIH is supporting research to understand the short- and long-term trajectories of the disease to enable risk stratification and precision interventions, develop therapies, and help direct treatments to the most severely affected populations.

Dr. Gibbons explained that COVID-19 has had a disproportionate impact on communities of color. Presumably this disparate impact is due to a heightened exposure risk, reduced access to testing and care, and a higher burden of co-occurring conditions. NIH Director, Dr. Francis Collins, called on NHLBI to lead a Community Engagement Alliance (CEAL) against COVID-19 disparities. NHLBI developed a strategy to engage with communities in 11 states with two major objectives: first, to promote education and awareness and combat misinformation and mistrust; and second, to promote and facilitate inclusive participation in research studies such as vaccine trials. The alliance leveraged existing community partnerships and trusted messengers to begin working very quickly.

One of the key areas of NHLBI’s strategic vision is to address the social determinants of health, in particular in heart disease. For example, in women, pregnancy can serve as a “stress test” revealing who is at long-term risk for heart disease. NHLBI encourages researchers to look beyond single risk factors and consider the whole life course in promoting health and equity.

V. UPDATE ON NIH DATA MANAGEMENT AND SHARING POLICY

Dr. Dina Paltoo (Assistant Director, Scientific Strategy and Innovation, NHLBI) discussed the new NIH policy for data management and sharing. She began by noting that a culture of data stewardship and sharing is important to accelerating scientific research and building trust in the research enterprise. NIH and NHLBI have had a longstanding commitment to data and resource sharing.

Dr. Paltoo then explained that the new NIH policy released in October replaces a data sharing policy established in 2003. The new policy requires that all NIH-funded research have plans to manage and share data. The NIH policy has been developed in an iterative way, with drafts released for public comment. The community requested clear expectations, the ability to update data submission plans, that these plans be made public, and for guidance on selecting data repositories. The policy is expected to become effective in 2023.

NIH is working to develop guidance on the new policy, which applies to all NIH-supported research that is intended to generate scientific data. It does not apply to lab notebooks, preliminary analyses, peer reviews, or physical objects. Data should be shared no later than publication, or for unpublished data, no later than the end of the award period. Certain issues, such as human subject protections, need further consideration.

Dr. Paltoo said that she expects many questions on the policies, but emphasized that guidance will be provided. She also noted that NIH will encourage the use of existing repositories and recommend desired repository characteristics. NIH wants to promote consistency across NIH institutes.

VI. NHLBI CONCEPT CLEARANCE

The NHLBI staff presented six concepts for clearance. Members expressed support for these concepts during the discussions. They asked for clarification on certain details and offered recommendations.

Title: T32 Training Program for Institutions That Promote Diversity (T32)

Description: A renewal was sought for this training program, which targets minority and diversity-focused institutions that lack a robust track record of research training. The current program has met its aims.

Title: Renewal of Secondary Participation: Stimulating Hematology Investigation: New Endeavors (SHINE) (RO1)

Description: This concept will renew participation in an investigation initiated by the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) to counteract the decline in hematology research applications and grants at NHLBI. The current program has been well received by hematologic investigators.

Title: Renewal of Secondary Participation: New Directions in Hematology Research (SHINE II) (R01)

Description: This related concept was launched three years after the first SHINE initiative. It provides support for single-aim applications for up to three years for research that aims to go in new directions in hematology. The current program recruits new investigators who are likely to have limited data. For both SHINE and SHINE II, many of the awards made thus far have been to principal investigators (PIs) who are new to NHLBI.

Title: Mentored Career Development Award to Promote Faculty Diversity in Biomedical Research (K01)

Description: This renewal request focuses on increasing the number of highly trained junior faculty from diverse backgrounds. Proposed research may be directed toward a broad range of questions representing NHLBI interests. The proposed program will use the NIH examples of diversity, which include racial/ethnic groups underrepresented in biomedicine, people with disabilities, and those from a disadvantaged background. The renewal proposes to increase the number of awards given, to 20 per year. Previous grantees have been productive and have done well in transitioning to independent research.

Title: Short-Term Research Education Program to Increase Diversity in Health-Related Research (R25 – Clinical Trial Not Allowed)

Description: This concept is meant to renew a program to enhance mentoring opportunities for undergraduate students from diverse backgrounds. The renewal proposes to increase funding and the number of awards from seven to nine per year.

Title: NHLBI R35 Programs – Outstanding Investigator Award (OIA) and Emerging Investigator Award (EIA) (R35)

Description: A renewal was proposed for two R35 funding programs, which are intended to provide long-term support (seven years) and increased flexibility for experienced PIs. Current awardees may apply again for the program. NHLBI expects to have data on the impact of the program as the first award period ends.

NHLBI staff also provided a brief update on the plan to renew the Research Program Project Grant (P01) and early-phase clinical trials FOAs. The renewals propose no additional changes, since data were needed on how changes made previously were fulfilling goals.

Closing Remarks

Dr. Moen adjourned the meeting at 4:02 p.m.