November 2019
The Research and Science Policy Update is a monthly 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 (position statements, letters, white papers) will be highlighted.
For more information contact:
William A. Muller, MD, PhD , RSPC Chair or Jennifer Dreyfus , Science Policy Consultant
Federal Budgeting
As of today, federal agencies are operating under a continuing resolution set to expire November 21. While there has been significant activity on the Hill, progress towards a 2020 federal budget has been slow. The Senate and House have proceeded along separate tracks, and mutually agreeable top line budget numbers for each of the twelve appropriations bills have not been established. Strongly held beliefs regarding the border wall, as well as impeachment activities compound the situation, making it difficult for either side to offer concessions and increasing the likelihood of a second continuing resolution. Reports from Capitol Hill indicate that the second continuing resolution will likely keep the government open through December 20. NIH has issued a notice on operating under a continuing resolution. As has been the past practice, the notice reflects that non-competing grants will be funded at the 90% level. 

The Senate as part of its appropriations process has issued strong guidance regarding Basic Experimental Studies with Humans (BESH) research. The language expresses support for NIH’s continued lack of enforcement of the expanded clinical trials reporting requirements and urges NIH to work with the research community to balance reporting requirements with the interests of study participants, investigators and taxpayers. There remains some potential for this stance to be modified in committee or with reconciliation. 
ASIP speaks up
ASIP continues to advocate around issues important to research pathologists. As in years past, ASIP stands with other scientific research organizations calling for timely and appropriate federal funding. We joined 300 others in urging swift enactment of a Labor-Health & Human Services bill with a meaningful increase in the allocation, to allow for robust growth in biomedical research funding. 

ASIP joined over 60 organizations representing public health, medical, academic and scientific groups in objecting to EPA's "Transparency Rule."
This letter was sent to the House Science Committee. ASIP has been a vocal opponent of the proposed rule originally presented in 2018 and continues to oppose EPAs efforts to restrict the use of the best available science in policymaking.

ASIP has also represented the interests of pathology investigators by joining research organizations in expressing ongoing commitment to the National Science Foundation’s (NSF's) fellowship program. Finally, we joined a coalition requesting changes to recently announced human fetal tissue research restrictions. 
The Promise of FHIR (pronounced ‘FIRE’) in Clinical Research
Patient data in electronic health records is of inestimable value for research. However, utilization of this resource has remained elusive given challenges associated with human subjects protections in combination with data capture, integration and exchange. To address these needs, federal and international standards were developed to enable the exchange of clinical data to enhance clinical decisions and improve patient outcomes. Thus,  Fast Healthcare Interoperability Resources (FHIR)  facilitates the seamless and secure sharing of health data from disparate systems. The FHIR framework offers tremendous promise to accelerate the use of clinical data in biomedical research. NIH encourages investigators to explore the use of FHIR to advance the translation of discoveries to improve human health. Further details are provided by the NIH in  NOT-OD-19-122
Animal Studies  
Environmental Protection Agency (EPA) issues restrictive directive
In September, EPA Administrator Andrew Wheeler signed a directive prioritizing efforts to reduce animal testing by 30 percent by 2025. EPA hopes to eliminate virtually all mammal study requests and funding by 2035 with any mammal studies after 2035 requiring administrator approval on a case-by-case basis. A Federation of American Societies for Experimental Biology (FASEB) statement opposes this directive. At this point, ASIP is unaware of other federal agencies that intend to follow EPA in this area. 

Other information regarding animal studies:
Are you a post doc or Early Stage Investigator?
NIH has issued the following notices that might be of interest to you. 
  • Early Stage Investigators: NIH notice of intent to publish a funding opportunity announcement for NIGMS’s Maximizing Investigators' Research Award (MIRA, R35) likely to be released in 2020 with a first application due date of October 2020.
  • Notice that NHGRI will participate in Maximizing Opportunities for Scientific and Academic Independent Careers (MOSAIC) Postdoctoral Career Transition Award to Promote Diversity (K99/R00).
  • Early-Stage Investigator information from the NIH Databook
Other Items of Information