June 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
Gene patenting
ASIP joined over 170 other organizations in the fight against proposed modifications to Section 101 of the current patent law that prohibits the patenting of abstract ideas, laws of nature, and natural phenomena. In cooperation with the American Civil Liberties Union and the Association of Molecular Pathology, organizations are expressing concern about potential changes to the Patent Act that, if enacted, would allow for patenting of genes that exist "exclusively" in nature. ASIP continues to be active in this area. Should your organization wish to join future iterations of this letter, please be in touch with Tara Burke or Sarah Thibault-Sennett at AMP. The number of signers continues to climb as this effort’s momentum grows.  
Research using human fetal tissue
ASIP has a history of supporting the availability of human fetal tissue for federally funded research. Recently, Health and Human Services (HHS) announced a new policy regarding the use of human fetal tissue from elective abortions. This change in federal policy may result in significant additional restrictions on the use of human fetal tissue in research. Highlights of this new HHS policy are listed below.  
  • NIH intramural research using fetal tissue from elective abortions and requiring new acquisition of fetal tissue will not be supported. Existing projects may continue to use this tissue until the supply is exhausted.
  • Current extramural research projects supported by NIH will not be affected by the new HHS policy during their current approved project period.
  • New extramural research grant applications or current research projects in the competitive renewal process, when proposing to use fetal tissue from elective abortions and after being recommended for funding through today’s peer review process, will be required to undergo an additional review by an Ethics Advisory Board. 
  • NIH’s currently funded extramural research using human fetal tissue will not be required to go through an Ethics Advisory Board review. 
  • The Ethics Advisory Board will be made up of individuals appointed by the Secretary of HHS. Biomedical or behavioral researchers with substantial accomplishments and scientific expertise may serve on the Ethics Advisory Board and may hold a minimum of one third and a maximum of one half of the Board seats. The Board is charged with determining whether the proposed research meets ethical standards.  
ASIP continues to advocate for the use of human fetal tissue without additional restrictions or review beyond those currently in place for federally funded research.  
ASIP leads FDA response effort
A number of organizations joined the ASIP-sponsored letter to the FDA, supporting the FDA’s current policy related to unidentified biospecimens. We were pleased to partner with societies on this effort to ensure the ongoing ability to use unidentified biospecimens in FDA-related research. ASIP also filed an additional letter raising more detailed concerns.  
Federal Budget
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Discussions about budgeting for federal agencies for the upcoming fiscal year is well underway. In general, the House is approving recommendations and offering substantial increases in non-defense funding, including funding for research. The Senate is slower in developing spending bills. So far, the House’s recommendations are for significantly more funding than offered in the President’s budget and higher than fiscal year 2019. This sets the stage for a difficult negotiation between the House, Senate and the Administration. 

Potential increases in funding heighten the pressure to increase the Budget Control Act caps mandated to come back in full force in FY 2020 and 2021. If the caps are not modified by legislative action, it would result in an effective 9 to 10% decrease (approximately $55 billion) in nondefense federal funding for FY 2020. ASIP is on record joining 550 organizations supporting raise the caps efforts and an increase in Health and Human Services funding. There have been talks between Congress and the administration on a two-year budget deal - as was done two years ago - that would include a debt ceiling agreement. Such talks are challenging and there is the potential for another continuing resolution and/or government shutdown.  
HR 1608
The House has passed a bill that would have the unanticipated effect of requiring all peer reviewers to become special government employees, subject to a greatly increased clearance process. The overall goal of the legislation is to increase transparency of federal advisory committees. The bill has now gone to the Senate for their consideration. NIH’s Center for Scientific Review estimates that this change would result in substantial delays in awards funding. The Federation of American Societies for Experimental Biology (FASEB), of which ASIP is a member, is working with the Hill on potential modifications that would allow more timely grant reviews while promoting ongoing interests in a fair scientific review process. 
Plan S
Coalition S responded to feedback and updated the proposed policy. The biggest change is that the compliance deadline has now been extended by a year to January 1, 2021. Additional highlights can be found in articles published in Nature and Science.
NSF updating Policies & Procedures Guide
The National Science Foundation (NSF) has issued proposed revisions to its Policies and Procedures Guide. Readers can review the proposed changes as well as explanations. Comments on the draft are being accepted through July 29, 2019.   
Federal wide Unique Identifier
NIH issued a Notification of an upcoming change in Federal wide Unique Entity Identifier Requirement. The DUN and Bradstreet Data Universal Number System (DUNS) will be replaced by a new government-owned identifier, SAM Managed Identifier or SAMMI. This change will be fully implemented by December 2020. ASIP will provide more information as it becomes available. 
Posting informed consent forms for NIH Funded clinical trials
NIH announced additional information regarding the federal websites where informed consents may be posted. Posting of NIH-funded clinical trials must be done after the end of study enrollment and within 60 days of the last study visit. The Protocol Registration and Results System offers information on how to upload these documents, with step by step instructions available the Office of Human Research Protections website.  
Other items of information
  • Biospecimen collections: NIH issued a Notice of Intent regarding an upcoming Funding Opportunity Announcement (FOA) on maximizing the value of existing biospecimen collections.  
  • Sexual Harassment: NIH announces new webform for anyone in the biomedical research community to report a potential case of sexual harassment directly to NIH. This reporting may be done anonymously.  
  • Germline editing: The National Academies announced an international commission charged with developing a framework for researchers, clinicians, and regulators to use when evaluating the clinical applications of human germline genome editing. Representatives from 10 countries are included with a final recommendation expected next spring. 
  • Physician scientists: The National Institute of Diabetes, Digestive and Kidney Diseases (NIDDK) is looking to expand its physician scientist pilot program. Keep an eye out for a FOA regarding this as the effort may now include basic research.  
  • White House announces Joint Committee to Invigorate US Research. The White House National Science and Technology Council announced a joint committee to be co-chaired by White House Office of Science and Technology Policy director Kevin Droegemeier, PhD, NIH Director Francis Collins, MD, PhD, and other directors. The press release states that the joint committee will “examine: administrative burdens on federally-funded research; rigor and integrity in research; safe, inclusive, and equitable research settings; and protecting American research assets.”
  • Re-Imagine HHS Accelerate Clinical Innovation Initiative – Public Hearing. HHS will be holding a public meeting on June 20 and 21 “to seek public input and comment on opportunities to leverage departmental resources, increase collaboration, and to partner with private stakeholders in the service of accelerating the process for clinical innovation in the U.S. HHS is specifically interested in how to decrease the overall time for a new medical product (drug, medical device, biologic) to go from discovery to widespread patient access and use while maintaining the critical public health standards of the Department.” Additional details here.
  • Now available: FASEB new fact sheet Humanized mouse models: using human cells to conquer disease
  • Now available: FASEB updated state and local federal funding fact sheets 
  • Now available: The National Academies report entitled “Reproducibility and Replicability in Science.”