May 2021
The Research and Science Policy Update is a periodic digest of news items related to important developments that impact biomedical researchers, including issues such as research funding, government oversight, and regulatory burden. In addition, reports related to research endeavors around the world and from research advisory groups are presented. The information contained in the Research and Science Policy Update is assembled by the ASIP Research and Science Policy Committee (RSPC), and products of this Committee’s work will be highlighted.

For more information, contact Kelsey Dillehay McKillip, PhD, Chair, ASIP Research and Science Policy Committee
FASEB Responds to NIH RFI on Racial Equity, Diversity, and Inclusion
In Early April, FASEB responded to the recent National Institutes of Health (NIH) Request for Information (RFI) on advancing and strengthening racial equity, diversity, and inclusion in the biomedical research workforce. In its comments, FASEB highlighted the importance of (i) culturally aware mentoring, (ii) sponsorship in addition to mentorship, (iii) promising practices for equitable recruitment, retention, and promotion of diverse scientists, and (iv) professional societies acting to create inclusive spaces and combat harassment. Read more here.
 Eligibility Extended for NIH K99/R00 Awards
On April 15th, the National Institutes of Health (NIH) issued a Notice (NOT-OD-21-106) extending eligibility for postdoctoral scientists applying to the K99/R00 award. Usually, individuals can have no more than four years of postdoctoral research experience when applying. However, recognizing the disruption of research due to the COVID-19 pandemic, the NIH is automatically extending eligibility by two cycles. Individuals whose final window of eligibility would have been during the June/July 2021 or October/November 2021 application cycles will now have until February/March 2022 or June/July 2022, respectively. New applicants and resubmissions do not need to submit additional documentation to receive the eligibility extension. Only one extension is permitted. If the previously announced extension was utilized, this new extension does not apply. Similarly, multiple extensions for events occurring during the same time period, such as childbirth during the COVID-19 pandemic, are not permitted.
Fiscal Year 2022 Budget Includes Increased Research Spending
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The Biden Administration’s much anticipated outline of the budget for fiscal year (FY) 2022 was released on April 9th. The proposed budget includes $1.5 trillion in discretionary funding – an increase of more than 8% or $118 billion from the FY2021 base discretionary funding. In the current budget outline, the National Institutes of Health (NIH) is provided $51 billion, including $6.5 billion for the President’s new health research initiative, the Advanced Research Projects Agency – Health (ARPA-H). ARPA-H will focus on cancer, diabetes, and Alzheimer’s disease to drive transformational innovation in health research and speed application and implementation of health breakthroughs. NIH falls under the larger umbrella of the President’s request for $131.7 billion for Health and Human Services, a 23.5% increase over FY2021. This budget also provides an investment in Minority-Serving Institutions to create and enhance research funding opportunities and invest in infrastructure such as laboratory facilities and information technology upgrades for Historically Black Colleges and Universities (HBCUs) and Minority-Serving Institutions (MSIs). New grant awards will expand research capacity and create new opportunities at HBCUs and other MSIs.
Senate Confirmation Hearing for OSTP Nominee Emphasizes Diversity and Cures for Disease
On April 29th, the U.S. Senate Committee on Commerce, Science, and Transportation held a confirmation hearing for Eric Lander, PhD. Dr. Lander is President Biden’s nominee for Director of the White House Office of Science and Technology Policy (OSTP). The hearing covered a wide range of topics affecting the U.S. research enterprise, including diversity in science, technology, engineering, and mathematics (STEM) and strategies to accelerate treatments for diseases that afflict millions of Americans. In his opening remarks, Dr. Lander emphasized that one of his goals as OSTP Director would be to create the most diverse President’s Council of Advisors on Science and Technology in history. Committed to prioritizing inclusive and equitable outcomes at OSTP, Dr. Lander pledged to make the OSTP staff “look like America” by increasing the participation of women and underrepresented people in STEM professions by 50 percent. Dr. Lander noted that the first step to increasing STEM diversity is providing women, people of color, and advocacy groups the opportunity to provide input and highlight specific solutions. Recognizing that efforts to increase diversity in STEM begins at a young age, Dr. Lander stressed the importance of having mentors and role models that look like the young people across America. More broadly, Dr. Lander emphasized the role of OSTP in facilitating increased diversity across different agencies by setting goals, developing best practices, and measuring agency accountability. Regarding the proposed Advanced Research Projects Agency – Health (ARPA-H), Dr. Lander stated that ARPA-H is modeled off of the military’s Defense Advanced Research Projects Agency (DARPA) to fund high-risk innovation projects. He further explained that the proposed ARPA-H agency could fall within NIH’s research purview, but funding will focus on projects beyond the scope of NIH’s basic research grants, bridging the gap between basic science and market-ready innovations.
NIH Reverses 2019 Restrictions on Human Fetal Tissue Research
On April 16th, the National Institutes of Health (NIH) issued a Guide Notice reversing restrictions on human fetal tissue research put in place by the Trump Administration in 2019. A key change was the elimination of the requirement for extramural research grants and contracts proposing use of human fetal tissue to be reviewed by an Ethics Advisory Board. In addition to eliminating the Ethics Advisory Board for extramural research, the NIH confirmed that the policy update removes restrictions that prevented intramural researchers from acquiring new fetal tissue upon exhaustion of existing resources.
CSR Advisory Council Discusses Future Directions for Peer Review
On March 29th, the Advisory Council of the National Institutes of Health’s (NIH) Center for Scientific Review (CSR) convened to discuss the impact of the COVID-19 pandemic on peer review process and procedures. CSR Director Dr. Noni Byrnes presented findings from reviewer surveys designed to assess the impact of the virtual environment on the peer review process. Reviewers reported that their personal experience (ability to contribute to discussion and voice opinions) and overall impressions of the meeting were similar to in-person meetings. Key benefits of virtual meetings included the ability to recruit individuals previously unable to serve as reviewers and an overall cost savings for the NIH. Post-pandemic, CSR will likely pursue a hybrid approach for peer review meetings, with study sections meeting in-person one or two times per year to build rapport and remaining meetings to be held virtually. Council members also heard an update from the workgroup charged with simplifying review criteria for clinical trials. To ensure peer review achieves its goal of identifying high-quality research proposals free from bias, the workgroup recommended streamlining review criteria to address three key factors: (i) scientific importance, (ii) feasibility and rigor, and (iii) investigators and environment. “Importance of the Science” will replace the current criterion of significance and address the question of whether the research should be done. “Feasibility and Rigor” will address approach and innovation to assess the ability of the science to be done well. “Investigators and Environment” will take a holistic approach to assessing the resources associated with a proposal. In addition to these factors, each application will receive a score for “Overall Impact.” These recommendations will undergo additional review within NIH and the U.S. Department of Health and Human Services before the proposed changes are implemented.
NIH Director Speaks at National Academies of Science Annual Meeting
At the recent meeting of the National Academies of Science, Dr. Francis S. Collins, Director of the National Institutes of Health (NIH), indicated that 52% of NIH’s budget goes to basic science and the remainder is disease-oriented or applied research. In the area of diagnostics, Dr. Collins mentioned the need early in the pandemic for point-of-care diagnostics resulting in RADX being developed. Dr. Collins also expressed support for the proposed Advanced Research Projects Agency-Health which will be a $6.5 billion organization in its first year to focus on infectious diseases, cancer, diabetes, ad other important diseases. Additional items discussed by Dr. Collins include the need to support the scientific workforce with both no cost and cost extensions where appropriate, providing $2,500 per year per fellow for childcare, extending eligibility for researchers who need to stay in the early-stage investigator category, and addressing health disparities and structural racism.
NASEM Workshop Explores Culture of Data Management and Sharing
On April 28-29, the National Academies of Science, Engineering, and Medicine (NASEM) hosted a workshop to explore the opportunities and challenges for researchers, institutions, and funders in establishing strategies to promote effective data management and sharing. Sponsored by the National Institutes of Health (NIH), the workshop also sought to assess stakeholder preparedness for implementation of the agency’s final policy for data management and sharing beginning in January 2023. A key challenge cited throughout the two-day workshop is balancing the perception of data management and sharing as compliance versus a way to expand scientific reach. This will require culture change across the scientific enterprise. It will also require resources – financial, physical, and technical. Various barriers to data sharing were identified, including data type, format, and accessibility. There was also extensive discussion regarding the need to balance mandates, such as the NIH policy, with incentives to foster the desired data sharing ecosystem. Workshop materials, including background materials and presenter slides are posted here.
Protecting U.S Biomedical Research from Undue Foreign Influence
On April 22nd, the Senate Committee on Health, Education, Labor, and Pensions (HELP) held a hearing titled, “Protecting U.S. Biomedical Research: Efforts to Prevent Undue Foreign Influence.” The hearing focused on identifying federal strategies to prevent and address unjustifiable foreign influence, specifically in the federal grant process. Committee Chair Patty Murray (D-WA) emphasized the importance of biomedical research in the U.S. and of scientific collaborations with researchers around the globe. Senator Murray acknowledged that while there are only a few researchers who fail to properly disclose conflicts of interest, these individuals put the entire U.S. biomedical research enterprise at-risk. Three key areas of concern related to foreign influence were identified: (i) failure to disclose substantial resources from other organizations, (ii) diverting proprietary information to other entities, and (iii) difficulty in maintaining grant application confidentiality during peer review. A major challenge for NIH in addressing the threat of foreign influence is the personnel time and workload required to investigate claims. Strengthening research and staff training reflects ongoing efforts between federal agencies to develop a national strategy for identifying possible threats and improve reporting of potential areas in which foreign interference can occur. For more information about proposed actions to protect scientific research from undue foreign influence, view the Senate HELP Committee’s webcast and the recent GAO report.
Impact of COVID-19 on the Careers of Women in Academic Sciences, Engineering, and Medicine
The spring of 2020 marked a change in how almost everyone conducted their personal and professional lives, both within science, technology, engineering, mathematics, and medicine (STEMM), and beyond. The COVID-19 pandemic disrupted global scientific conferences and individual laboratories and required people to find space in their homes from which to work. It blurred the boundaries between work and non-work, infusing ambiguity into everyday activities. While adaptations that allowed people to connect became more common, the evidence available at the end of 2020 suggests that the disruptions caused by the COVID-19 pandemic endangered the engagement, experience, and retention of women in academic STEMM, and may roll back some of the achievement gains made by women in the academy to date. Impact of COVID-19 on the Careers of Women in Academic STEMM identifies, names, and documents how the COVID-19 pandemic disrupted the careers of women in academic STEMM during the initial 9-month period since March 2020 and considers how these disruptions - both positive and negative - might shape future progress for women. This publication will inform the academic community as it emerges from the pandemic to mitigate any long-term negative consequences for the continued advancement of women in the academic STEMM workforce and build on the adaptations and opportunities that have emerged.
STEM Restart Act
The STEM Restoring Employment Skills through Targeted Assistance, Re-entry, and Training (RESTART) Act (S.1297) has been reintroduced in Congress. This bipartisan legislation would authorize funding to support small and medium-sized STEM businesses that offer paid, mid-career internships (“returnships”) for mid-career workers seeking to return or transition into the STEM workforce. Key elements from the Act include: (i) providing direct funding ($50 million per year) for organizations within needed STEM fields, (ii) prioritizing funding for those who are unemployed and part of historically underrepresented groups in STEM, to close the hiring gap, (iii) allowing small and medium-sized STEM businesses to apply for grant funds, and (iv) protecting returning workers from exploitation. STEM businesses to apply for grant funds, and (iv) protecting returning workers from exploitation.
 
Other Items of Interest
  • The NIH announced the delayed implementation of the requirement for updated Biographical Sketch and Other Support Format Page for submissions on or after January 25, 2022. However, the NIH does encourage applicants to use the updated biosketch format for earlier grant deadlines.
  •  NASEM’s Committee on Women in Science, Engineering, and Medicine is hosting a virtual workshop on Overcoming Structural Barriers for Women in Entrepreneurship, June 21-22, 11:00 AM – 4:00 PM EST. Click here for more information and here to register.
  •  NASEM is hosting a National Summit on Addressing Diversity, Equity, Inclusion, and Anti-Racism in 21st Century STEMM Organizations on June 29-30. The agenda can be found on the project website and registration is free.
  • Notice of Special Interest (NOSI): Availability of Urgent Award for Competitive Revisions to IDeA-CTR Awards to Address the Continued Need for Documenting COVID-19-Related Patient Outcomes.
  • Request for Information (RFI): Seeking Stakeholder Input on Enhancing Diversity and Inclusion in the Cancer Research Workforce. Comments are due on July 15.
  • Notice of Special Interest (NOSI): NIH Research Project Grant (R01) Applications from Individuals from Diverse Backgrounds, Including Under-Represented Minorities.
  • Notice of Special Interest: Public Policy Effects on Alcohol-, Cannabis-, Tobacco-, and Other Drug-Related Behaviors and Outcomes.
  • Notice of Special Interest (NOSI): Early-life Factors and Cancer Development Later in Life.
  • Notice of Special Interest (NOSI): Biology of Lung and Head and Neck Preneoplasia.
  • Notice: NIAID Funded Extensions for Career Award Recipients Whose Career Trajectories Have Been Significantly Impacted by COVID-19.
  • Notice of Special Interest (NOSI): Expanding Cancer Control Research in Persistent Poverty Areas.
  • Notice of Information: Change in NCATS Prior Approval Process for New CTSA Program Pilot Projects and KL2 Projects that Involve Human Subjects Research.
  • Notice of Special Interest (NOSI): Leveraging Longitudinal Studies in Animal Models to Identify Neural Mechanisms of Vulnerability and Resilience to Substance Use Disorder.