September 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
Budget Update
With an overall funding level for the federal budget agreed to, the hard work of allocating dollars begins. How funds flow down to biomedical research remains to be seen and allocations may not be completed by the end of the federal fiscal year (September 30th). If allocations are not done by this deadline, there will likely be one or more short term continuing resolutions. The potential for a shut-down remains a possibility given the limited number of working days in September for the Hill to consider budget allocations. The new budget deal has come with the likely demise of the Budget Control Act, which had the potential for causing dramatic cuts in research funding. The elimination of this Act was welcomed by most on both sides of the aisle.  
Foreign influence
The House and Senate are in the early stages of discussing potential legislation on the issue of foreign influence over scientific research. Efforts to date are fairly partisan with substantial differences in approaches. Topics of discussion include the creation of a nonpublic database about scientists, as well as the potential for additional cybersecurity requirements for universities. Kelvin Droegemeier, the Director of the White House Office of Science and Technology Policy recently issued a letter regarding foreign influence. Dr. Droegemeier called for the recently appointed Joint Committee on the Research Environment to play a critical role in protecting “… our research assets in a manner balanced with the openness and collaboration that has been so critical to our success.” 

The Federation for American Societies of Experimental Biology (FASEB), of which ASIP is a member, has issued the following statement on the importance of foreign collaborations. 

“Federation of American Societies for Experimental Biology (FASEB) reaffirms the importance of and its support for international scholars to furthering discovery and innovation in the life sciences. Nearly 20 percent of the 130,000 individual scientists represented by our 29 member societies are of non-U.S. origin. As a result of continued federal investments in science and technology, the U.S. is recognized as the leading nation in these fields, attracting scientists from around the world to train and work in a broad range of research environments. International collaborations have played critical roles in numerous biological research endeavors, ranging from deciphering the human genome to stemming the spread of infectious diseases such as Ebola and Zika virus.

FASEB also recognizes the delicate balance between fostering an environment of open scientific collaboration and protecting U.S. investments and discoveries. Therefore, we welcome the opportunity to work with the leadership of federal agencies, including the National Institutes of Health, the National Science Foundation, and the Department of Energy, as well as interested stakeholders in the research community, to develop and communicate policies that confirm appropriate utilization of critical resources and outputs and discoveries gained from those resources to ensure continued engagement of international scholars in research endeavors.”
Approved by FASEB Board of Directors, August 6, 2019
Early Stage Investigators
A recent NIH Notice describes policies and procedures for requesting an extension of early stage investigator status. Now, researchers may request an extension directly through eRA Commons using the ESI Extension request button (located in the Education section of your personal profile). A video on this new feature, including step-by-step instructions, is available. 
Fetal Tissue
NIH’s recent Guide Notice announced that applications submitted on or after September 25, 2019 that plan to use human fetal tissue must now, among other requirements,
  • include justification for the use of fetal tissue in the application, including a literature review;
  • explain why other approaches are not feasible;
  • include IRB review of the informed consent used to gather the tissue; and
  • present how the tissue will be obtained.
There are a number of concerns regarding this Guide Notice including the NIH decision not to increase the page limitations in the Approach section. Also, there is a need for further clarification around the order of reviews, including delineating when in the process Ethics Advisory Board review will occur.  ASIP has joined a number of prominent organizations outlining these concerns to NIH and the Department of Health and Human Services. Additional information on the Administration’s policy on research using human fetal tissue may be found in FASEB’s summary of these recommendations; FASEB’s letter to key leaders regarding NIH’s recent policy changes and a recent article in Science .
House Passes Sexual Harassment Legislation
The House of Representatives passed the Combating Sexual Harassment in Science Act of 2019 (H.R. 36), which would establish an interagency working group led by the director of the White House Office of Science and Technology Policy. The working group would be tasked with developing a uniform set of policy guidelines to address sexual harassment in science. The bill also directs the National Science Foundation (NSF) to commission a National Academies report on the influence of sexual harassment at higher education institutions on career advancement and authorizes NSF to award grants for the study of the causes and implications of sexual harassment for individuals. Whether the Senate will take up similar legislation is unclear at this point in time. 
Other items of information
Meetings of interest