July 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 news
The Senate, House of Representatives and the President have announced a budget deal that would achieve three important aims: 
  • raising the Budget Control Act spending caps for fiscal years (FYs) 2020 and 2021; 
  • suspending the debt ceiling until July 2021, avoiding a default on U.S. government debt; and
  • establishing overall discretionary spending for the upcoming two fiscal years - FY 2020 and FY 2021.

The  Bipartisan Budget Act of 2019 would result in the following changes to defense and non-defense discretionary spending in FY 2020 and 2021 
The new budget Act results in non-defense discretionary spending increases of $24.5 billion in FY 2020 compared to FY 2019. The bill will be voted on shortly, and if the overall Act is approved, Congress must still allocate actual appropriations to fund the government by October 1 when FY 2020 begins. After completion of those allocations, ASIP will have more information about the funding levels available for biomedical research. All-in-all, it’s a positive step forward. 
Restrictions on research using fetal tissue
ASIP has joined other organizations expressing opposition to HHS Secretary Azar about the recently proposed fetal tissue research restrictions. It is unclear at this point how the proposed Ethics Advisory Boards will be rolled out and there is some discussion that each project would have its own Ethics Advisory Board. 

In an earlier approved House appropriations resolution, the Pocan amendment was added, partially blocking the new restrictions by preventing funding of the Ethics Advisory Boards that would be used to review extramural research (it did not address intramural research). While the adoption of this amendment was positively received by the research community, the ultimate fate of this amendment is tied to the budget allocation process and it may not move forward.
Changes to the patent law
ASIP continues to watch developments with the 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, ASIP and 170 other organizations expressed concerns 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 and will review proposed legislation. 
Foreign influence on scientific research remains in the news
The Hill: The House passed its National Defense Authorization Act, including HR 3038 - Securing American Science and Technology Act. This Act empowers the Director of the Office of Science and Technology Policy to establish an interagency working group to coordinate across federal agencies to protect research from foreign interference. 
 
NSF: The National Science Foundation has released a “ Dear Colleague Letter” reconfirming NSF’s disclosure requirement and ethics standards. It states that positions at NSF are limited to U.S. citizens or those applying for citizenship. A policy is expected in the near future that will clarify “… that NSF personnel and IPAs detailed to NSF cannot participate in foreign government talent recruitment programs.”

NIH: NIH issued a  Guide Notice on receiving other support and financial conflicts of interest. This Notice clarifies NIH’s current policy about reporting requirements, including reporting standards around additional appointments and financial support.

The NIH Advisory Committee to the Director received an update from the Working Group on Foreign Influences. NIH is recommending a broad awareness campaign in cooperation with many outside groups; ongoing evaluation of existing policies and forms; and continued work with recipient institutions. NIH is also exploring improved systems controls/cybersecurity; specialized training; and potential changes to grant terms and conditions. The presentation emphasized the need to work closely with stakeholders and reinforcing “… the importance of the contribution of foreign scientists to biomedical research; we must not create a climate that is unwelcoming to them.”  

Additional items related to foreign influence:
  • FASEB on Senate’s discussion of foreign influence on scientific research.
  • Science on ramifications of NIH’s probe of foreign ties.
  • MITNews on immigration as oxygen.
  •  KPBS article on UCSD scientists and foreign influence.
  • AAMC’s community forum Key Issues in Science and Research Policy: Data Sharing and Foreign Government Influence. Live event was July 24, at 2 pm EST. 
  • Open Mike blog on NIH policies for disclosing other support (highlighting the Guide Notice mentioned above).
  • White House launches Joint Committee on Research Environments.
  • Nature editorial on collaboration and foreign influence
Updates on NIH efforts regarding diversity & sexual harassment
At the June Advisory Committee to the Director (ACD) meeting, Hannah Valantine, M.D., Chief Officer for Scientific Workforce Diversity, presented a report on scientific workforce diversity actions and progress (2014-2019). In addition, draft recommendations were released from the ACD working group on diversity and harassment in high risk high reward research. Dr. Collins, NIH Director, announced his intent to no longer participate in “manels.” NIGMS has carried forward this same policy announcing that all NIGMS staff will attend conferences and events only where sponsors show a strong commitment to diversity and inclusion. 

An Open Mike blog posting addressed how to notify NIH of a sexual harassment concern, including the announcement of a new web platform for reporting, moving NIH away from the email reporting system that existed previously. In addition, the ACD received a report from the ACD Work Group focused on changing the culture to end sexual harassment. This report included the following 4 interim recommendations:
  1. Treat professional misconduct, including sexual harassment, as seriously as research misconduct.
  2. Require all PIs to attest, when submitting NIH grant applications and progress reports, that they have not violated and will not violate their institutional code of conduct. (This recommendation includes a proposed seven year look back period).
  3. Establish mechanisms for restorative justice for survivors and to recapture lost talent.
  4. Develop novel approaches to address investigator independence from their mentors

The ACD received a briefing on the interim results from NIH workplace climate survey
Animals in research getting increased attention
monkey-sm.jpg
Rigor & reproducibility in animal studies:  NIH is establishing an ACD working group on rigor and reproducibility in animal studies. The proposed charge will include identify gaps and opportunities to improve rigor, reproducibility, translational validity and transparency; evaluate how animal models are currently developed, validated, and accepted into routine use, and how this process could be improved; model the financial implication of potential changes; and consider how rigor in animal research is incorporated into training. 
 
Use of nonhuman primates in research FASEB released a statement on the importance of research using nonhuman primates. On September 16-17, 2019, NIH is sponsoring a workshop entitled Optimizing Reproducibility in Non-Human Primate Research Studies by Enhancing Rigor and Transparency . The workshop will further explore reproducibility efforts by highlighting best practices for enhancing rigor and transparency. NIH has stated its particular interest in exploring the role of ethical factors that may influence study design given that these models are important to numerous research fields. More information about this webinar, including an online registration portal, will be available in August. NIH is offering limited space for in-person attendance and registration will be required. This event will also be webcast.  

FASEB and AAMC webinar on animal research Animal Research: Still Necessary for Understanding Human Disease is available for review. The recording is available online.
Basic experimental studies involving humans (BESH)
Last year NIH expanded the definition of a clinical trial to include any project that prospectively assigns a human subject to an “intervention,” which was broadly defined such that many basic research studies are now considered clinical trials and subject to additional reporting and regulatory requirements. Such studies are now called Basic Experimental Study with Humans (BESH). 

A recent Open Mike blog discussed ongoing challenges that researchers have faced in using ClinicalTrials.gov as required under the new policy. In addition to the 2018 request for comments on the new policy, the National Library of Medicine conducted a review that demonstrated that the principle challenges to BESH registration and reporting were:
  • reporting for multiple, interrelated small studies;
  • the absence of prespecified primary outcome measures;
  • results reported for a small number of research subjects in a non-aggregated fashion; and
  • the use of iterative preliminary studies to develop or optimize research procedures.

NIH has determined that additional time is needed to address these concerns, announcing in a Guide Notice ( NOT-OD-19-126) the extension of delayed enforcement of registering and results reporting of BESH on ClinicalTrials.gov through September 24, 2021. NIH states that “(i)nvestigators conducting BESH are still expected to register and report results on alternative, publicly available platforms during this interim period, but are not required to do so on ClinicalTrials.gov at this time.” NIH remains committed to ongoing “stewardship and transparency of the research we support” and will be working with the basic research community to explore solutions that are meaningful and useful to other researchers and the wider community. 

Additional resources regarding BESH:
NSF adopts SciENcv as approved Biosketch format
NSF has designated the National Institutes of Health’s SciENcv (Science Experts Network Curriculum Vitae) as an NSF-approved format for submission of biographical sketches and will be encouraging the use of SciENcv for proposals. There are several resources available to learn more about SciENcv including:
Other items of interest