November 2018
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 Muller, MD, PhD , RSPC Chair or Jennifer Dreyfus , Science Policy Consultant
Federal budget 
A combined Labor Department and Health & Human Services (Labor/HHS) budget bill has been signed and includes a $2 billion (5.4%) increase for NIH. A continuing resolution was also part of the bill thereby funding other agencies, such as the National Science Foundation (NSF), until December 7. There were two unusual items about this budget approval process. First, the House agreed to proceed directly to conference on the Senate’s Labor/HHS bill, instead of having the House pass their own bill and then reconciling to two bills. It also marks the first time in 22 years that Congress has finalized the NIH budget prior to the end of the fiscal year. ASIP members, through our membership in the Federation of American Societies for Experimental Biology (FASEB) have access to two excellent fact sheets related to federal funding of research – one on the impact of funding delays on research and another on the value of federal research funding
Expanded defi nition of cllinical trials
ASIP has joined others to express a shared concern with NIH’s redefinition of clinical trials such that a broad set of basic research is now classified as a clinical trial. This change was made without sufficient notification and research community consultation. NIH has issued a Request for Information based on the premise that a third category of research would be appropriate – “prospective basic science studies involving human participants,” - which is research that is both basic science and a clinical trial. This third category is not a unique separate category but the intersection of the two types of research. The Research & Science Policy Committee is currently evaluating the best course of action to express ASIP’s ongoing concerns regarding the expanded definition of a clinical trial.

 ASIP continues to seek examples of research that appear to meet NIH’s definition of a clinical trial but where such categorization isn’t logical or appropriate from a researcher’s point of view. Please send these examples to Jennifer Dreyfus , ASIP Science Policy Consultant.  
National Science Foundation (NSF) Bio Directorate no deadline system
The BIO Directorate has officially implemented its   “no deadlines” policy for the submission of grant proposals. Investigators may now submit proposals to a BIO core program at any time with certain limits on the number and type of grant that may be submitted within a fiscal year. For more information about the new grant policies within BIO, please see the full program solicitations:
Transport of Research Animals
The National Association for Biomedical Research (NABR) is asking organizations to submit letters supporting their complaint filed with the Department of Transportation. NABR’s complaint alleges that the airlines’ refusal to transfer animals for one legal and legitimate purpose, while transporting the same animals for another purpose, is in violation of several laws. NABR pointed out that researchers are experiencing increasing difficulty transporting animals needed for research. Some airlines will transport animals for zoos, conservation efforts, or as personal pets, but refuse to ship animals of the same species that are destined for research. NABR named four airlines in its complaint, but it noted that others have similar policies. Joining many other organizations, ASIP has filed comments asking for a Department of Transportation investigation into the NABR complaint. 
Research using fetal tissue 
ASIP joined a coalition letter supporting the appropriate use of fetal tissue in biomedical research. In a related development, HHS told the FDA to cancel its fetal tissue contract with Advanced Bioscience Resources calling for a comprehensive review of all research involving fetal tissue. It is not clear what prompted the HHS announcement. The Research & Science Policy Committee will continue to monitor this issue. 
Other items of interest: