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Advisory Committee to the Director – Updates from the NIH

June 18, 2021

The Advisory Committee to the Director of the National Institutes of Health (NIH) held its 122nd meeting on June 10th and 11th to provide expert guidance on a range of timely topics.

See the June 10th agenda and video.

See the June 11th agenda and video.

NIH Director, Francis S. Collins, opened the meeting with a report on endeavors in different areas and disciplines of science across the NIH that continue to progress despite restrictions of convening in person. He mentioned advances from NIH HEAL initiative to address methamphetamine use disorder and from NIA to prevent Alzheimer’s disease. NIH is contributing to an international cohort consortium to share how data is collected and how to best learn from comparisons, while leveraging diversity in heritage and environments to better understand health and illness.

Adrienne Hallett, Associate Director of the Office of Legislative Policy and Analysis, provided a brief legislative update explaining thar more information about the budget will come later this summer. House appropriations bills are currently working their way through the committee process, and Senate appropriators will likely begin committee consideration of appropriations bills in July. Meanwhile, the Endless Frontier Act (EFA), now the United States Innovation and Competition Act (USICA), an enormous authorizing package to expand science and technology investment, passed the Senate with some implications for the NIH. (See FABBS coverage here.)

Neil Shapiro, NIH Associate Director of Budget, provided a budget update for FY 21 and 22. (See FABBS coverage here). Increases for the current fiscal year are targeted towards Alzheimer’s disease, the BRAIN initiative, and chronic diseases and health disparities. FABBS previously commented on findings of the NIH working group addressing diversity within the BRAIN Initiative and advocated for inclusion of cognitive and behavioral sciences, found here.

As for the 2022 budget, $6.5 billion of the proposed NIH budget is allocated to the new Advanced Research Projects Agency—Health (ARPA-H, or HARPA). Director of the Office of Science and Technology Policy (OSTP) Dr. Eric S. Lander and Assistant Director for Biomedical Science Initiatives at OSTP Dr. Tara Schwetz provided coverage on the vision of the agency. Dr. Lander noted that President Biden aims for ARPA-H “to make pivotal investments in breakthrough technologies and broadly applicable platforms, capabilities, and resources that have the potential to transform important areas of medicine and health that cannot readily be accomplished through traditional research or commercial activity.”

FABBS recognizes that such pivotal breakthroughs rely on the foundation laid by basic scientific research as we continue to advocate for the cognitive, brain, and behavioral sciences to be included in the ARPA-H vision.

Other increases to the NIH budget for FY 22 are targeted toward opioid and pain research, the  HEAL initiative, health disparities, mental health, pediatric research on the effects of COVID-19, the BRAIN initiative, the IMPROVE program, the ECHO program, and the INCLUDE project.

Dr. Anthony Fauci, Director of the National Institute of Allergy and Infectious Diseases, delivered an update on the state of the COVID-19 pandemic and pandemic research, citing efficacy rates for some of the vaccines, and other data collected from real-world cases as Covid-19 vaccine uptake increases.

Deputy Director of the National Heart, Lung, and Blood Institute Dr. Amy Patterson spoke about the new initiative Post-Acute Sequelae of SARS-CoV-2 (PASC), also known as “Long Covid” or “RECOVER: Researching COVID to Enhance Recovery.” Congress provided $1.15 billion in support for this trans-NIH initiative, a collaboration across 20 institutes, to investigate ongoing pandemic effects using a public health impact lens. The initiative aims for a multidisciplinary assessment of incidence, prevalence, risk factors, epidemiology, and outcomes, using a comprehensive collection of cases from electronic health records and real-world data, ongoing and new clinical cohorts, and autopsy studies, to encompass a diverse representation of participants. Updates will be posted on the recently launched RECOVER website.

Other presentations on day one included Accelerating COVID-19 Therapeutic Interventions, Community Engagement Research Alliance (CEAL), Rapid Acceleration of Diagnostics (RADx), and an update on NIH efforts to redress harassment.

NIH Chief Officer for Scientific Workforce Diversity Marie A. Bernard, the NIH Deputy Director for Management Alfred C. Johnson, and the NIH Principal Deputy Director Lawrence A. Tabak kicked off the second day with a presentation about the UNITE initiative. (See FABBS submitted comments.) Dr. Collins and the UNITE Committees reflected on the robust feedback from public and stakeholder organizations and recently released in-depth commentary of UNITE activities in the journal Cell. Opportunities are underway for the NIH to gather more feedback from both the extramural community and the internal NIH workforce.

Dr. Bernard covered progress and accomplishments, next steps, and metrics of success of the NIH to address the initial recommendations for the UNITE program. See the highlights below:

NIH outlined actions and priorities for the next six months, including various changes in research, institutional culture, and interactions with other organizations, among others. The full presentation can be found here.

Dr. Gene Civillico, Program Manager at the Office of Strategic Coordination, and Dr. James Anderson, Deputy Director for Program Coordination, Planning, and Strategic Initiatives, presented on the NIH Bridge to Artificial Intelligence (Bridge2AI) Program, a short-term investment which aims to “bridge the biomedical and behavioral research communities with the rapidly growing community of experts developing artificial intelligence (AI) and machine learning (ML) models by producing flagship datasets that adhere to the FAIR principles (Findable, Accessible, Interoperable, Reproducible) and critically integrate ethical considerations in preparing data for computation,” using funding support by the NIH Common Fund and the U.S. Department of Energy Office of Science.

The final report of the ACD Working Group on Enhancing Rigor, Transparency, and Translatability in Animal Research was presented by Dr. Barbara Wold, professor at the California Institute of Technology, and Dr. Lawrence A. Tabak, NIH Principal Deputy Director. As part of the ACD mission to assure that funding dollars granted into research are used to produce reliable data, the ACD Working Group suggested recommendations following a long-standing recognition of the need to elevate the standards of rigor and reproducibility, as well as a re-examination into the appropriateness in using the animal model to understand human disease and how to use the smallest number of animals while maintaining statistical validity, as well as re-analyzing the ethics of animal husbandry. See the NIH statement about animal research and the full working group charge.

Dr. Wold emphasized the need to stop using long-ingrained processes that no longer work. She also noted to researchers, science journalists, and writers that the oft-noted “statistically significant” (p < 0.05) is not enough to judge reproducibility, citing findings of the low chances of the replication of the initial study “succeeding.”

The working group made recommendations on five themes:

  • Improve study design and analytic rigor
  • Address bias, incomplete reporting, and questionable research practice
  • Improve relevance of use of animal models
  • Improve methodology and results reporting (i.e., extrinsic factors, use of ARRIVE Essential 10 checklist for publication
  • Cross-cutting: need for NIH and community as participants to measure and evaluate effectiveness and results of the implemented recommendations and cost (opportunity cost within animal research world and from ACD)

See the final full report with the working group recommendations.

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