April 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 efforts
Bi-partisan federal budgeting efforts for 2020 and beyond are gearing up with the primary focus being the need to increase the Budget Control Act caps mandated to come back in full force in 2020 and 2021. If the caps are not modified by legislative action, it would result in an effective 9-10% decrease (approximately $55 billion) in non-defense federal funding for 2020. While the need to support biomedical research continues to be an area of general bipartisan agreement, the most likely political scenario would be a modification of the caps to maintain or only slightly increase funding at the 2019 level. ASIP is on record joining 550 organizations to support raising the caps as well as increasing Health and Human Services funding. The Federation of Societies for Experimental Biology (FASEB), of which ASIP is a member, has also issued a recent statement calling for an increase in the caps. 

In the mean time, President Trump released his FY 2020 budget request adhering to the Budget Control Act spending caps described above. If the Administration’s budget were enacted, scientific research organizations would be significantly impacted.

  • The NIH budget would fall by nearly $5 billion, slightly more than a 12% cut. Budget details indicate that this would mean a one third reduction in the number of funded research project grants, translating to a 14% success rate.
  • The NSF would be cut by approximately $1 billion to $7.1 billion, a cut of about 10%.
  • At this point in time, the Administration’s proposal does not appear to be gaining traction. 
Research concerns – security & foreign influence
A number of stakeholders are focused on the potential for foreign influence on research, as well as security concerns. These efforts, summarized below by organization, focus principally on addressing how foreign entities may seek advantages by improperly accessing or replicating federally funded or proposed research. At this point, the only clear conclusion is that this is an important issue and the scientific research community can expect modifications to current policies over the coming year or two. 
NIH activities: 
In December 2018, the Advisory Committee of the Director received a summary of recommendations . As a result, NIH is developing guidance that should address required disclosures, as well as how NIH intends to work with researchers having one or more affiliations with foreign entities or research efforts. One sticky point will be addressing the fine line between collaboration with foreign researchers and influence. The NIH Office of the Inspector General is investigating twelve allegations of foreign influence (articles from ScienceMag and STAT news ). 
National Science Foundation activities:  
NSF also has been addressing security concerns, commissioning a study by the JASON group on data misappropriation and diversion of intellectual property to look at “…how the ecosystem has changed and whether there are additional safeguards that should be put in place…” 
Congressional actions:   
  • The Protect Our Universities Act (HR 1678) calling for the establishment of a task force within the Department of Education focused on espionage threats to institutions of higher learning. Though this bill may not get much traction, it is possible that components of the bill may be incorporated into future legislation.
  • A bi-partisan bill was introduced to establish the Office of Critical Technologies and Security in the Executive Office of the President. The Office would coordinate a government wide effort to prevent the transfer of “critical emerging, foundational, and dual-use technologies” to countries of concern.
  • Senator John Kennedy (R-LA) introduced the Protecting American Technology Act of 2019 requiring universities to file for a deemed export license when a foreign national conducts research requiring access to technology controlled under the Export Administration Regulations.
  • Senator John Kennedy (R-LA) also introduced the Concerns Over Nations Funding University Campus Institutes in the United States (CONFUCIUS Act). This bill would restrict the ability for universities to receive Department of Education funding if the university did not include provisions to protect academic freedom and full managerial authority to the university when contracting with China’s Confucius Institutes.

Related congressional activities include Senate hearings in March. The permanent Subcommittee on Investigations staff has released its report  China’s Impact on The U.S. Education System and the Government Accountability Office has begun to study university adherence to export control regulations, including a review of select universities’ policies and security procedures.
Health and Human Services activities
HHS has released its audit work plans including four planned audits focused on foreign influences. These audits are different from the NIH audits described above where potential allegations of foreign influence are being investigated. The HHS audits instead look at adherence to practices. In February 2019, the Office of the Inspector General published the audit report Opportunities Exist for the NIH to Strengthen Controls in Place to Permit and Monitor Access to its Sensitive Data . The report concluded that “NIH has not assessed the risks to national security when permitting data access to foreign PIs” and NIH has failed to confirm that such principal investigators have completed security training. These audits exert substantial pressure on NIH to strictly adhere to existing policies, as well as to develop tighter future procedures. 
Other related activities:  
According to Council on Government Relations (COGR), the National Academies are planning workshops to engage research institutions on how to protect the U.S. research system while continuing collaborations with foreign scientists and institutions. The Department of Energy has updated requirements , tightening the use of foreign research collaborations. The Department of Defense has been making regular updates to its policies over the past nine months or so.
Impact of increased attention on foreign influences :  
The focus of NIH, Congress and others is having negative consequences as reported in various sources. In Science, letter  from three Chinese-American scientific societies expressed concern about political rhetoric and policies that identify students and scholars of Chinese descent working in the U.S. as threats to U.S. National Interests calling for efforts to avoid casting an ethnic group as spies for China. The NIH response  was published in the same issue, expressing NIH’s concern for potentially prejudicial actions. Concerns about efforts to address foreign influences and the potential effect on graduate students was also expressed in a recent genomeweb article . Finally, NIH has had a rocky start to its increased efforts to inquire about citizenship before visitors may gain access to the NIH campus. 
Integrity in the peer review process
FASEB recently released a summary article on recent efforts to address integrity in the peer review process. Other efforts include a recent presentation by the Center for Scientific Review on integrity in the peer review process . NIH has also released a podcast on confidentiality in peer review ( MP3 and transcript ). As with the security and foreign influences topic, modifications to current policies will likely be forthcoming. 
NIH funding trends
NIH’s report on FY 2018 funding was released with some interesting findings summarized below.
  • 83% of NIH’s funding supports extramural research. 
  • Overall RPG success rates increased from 18.7% in 2017 to 20.2% in 2018. With the average size of RPG awards increasing by 2.8%. 
  •  Success rates increased for R01 equivalent awards going from 19.3% in 2017 to 21.7% in 2018. The percentage change in R01 equivalent awards is harder to calculate as the definition of R01 equivalent changed between the two years, but overall the funding level of R01 equivalent awards also trended upwards.
For more information, see a recent Open Mike blog or NIH’s Data Resource book .

Looking forward, NIH has updated the Funding Strategies page with links to information about funding at each Institute or Center (ICs) including the strategic direction for R01s and early stage investigators.  This information is likely worth reviewing to better understand the strategic direction and priorities of the ICs you work with.  
Sexual Harassment
NIH released a  statement  in March updating the research community on plans to increase efforts to address sexual harassment in science. The statement acknowledged NIH’s slow response to the problem of sexual harassment and offered an apology. NIH has launched an email reporting system for those reporting sexual harassment concerns. On behalf of member societies including ASIP, FASEB issued a letter from President, James Musser, M.D., PhD,   applauding this step forward, raising concern regarding lack of confidentiality and the need for consultation with the community. A recent piece in ScienceMag noted NIH’s ability to bar scientists accused of sexual harassment from serving as peer reviewers. 

New resources relating the issue of sexual harassment.
  • The Societies Consortium on Sexual Harassment in STEMM was officially introduced with 49 members.
  • FASEB released anti-harassment and diversity positions.
  • FASEB endorsed the “Combatting Sexual Harassment in Science Act of 2019” (H.R. 36), building upon the 2018 policy implemented by the National Science Foundation (NSF) requiring awardee organizations to report findings and determinations of harassment or assault involving an NSF-funded principal or co-principal investigator.
  •   FASEB co-signed a letter from 75 scientific societies expressing concern about the U.S. Department of Education’s proposed amendments to Title IX implementing regulations. The signatories were apprehensive about possible unintended consequences associated with the proposed changes, specifically the narrowing of the harassment definition, the circumstances under which Title IX would require a response, and notice requirements. 
Germline editing in the news again
In the March 13 issue of Nature , NIH Director Francis Collins, MD, PhD, and Associate Director for Science Policy Carrie Wolinetz, PhD, co-authored correspondence to  express support  for a proposed moratorium on clinical uses of germline editing. This commentary was offered in response to a commentary  in the journal  Nature  by an international group of scientists and ethicists calling for a "global moratorium on all clinical uses of human germline editing." 
Other items of information