September 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
Peer Review & Foreign Entity Influence 
Francis S. Collins, MD., PhD, Director of the National Institutes of Health (NIH), recently released a public statement regarding efforts of foreign entities to systematically influence NIH researchers and peer reviewers. Dr. Collins has identified the following three areas of concern:
  • diversion of intellectual property to other entities, including other countries;
  • sharing confidential information on grant applications by NIH peer reviewers with others, including foreign entities; and
  • failure of some researchers to disclose substantial resources from other organizations, including foreign governments, which threatens to distort decisions about the appropriate use of NIH funds. 

NIH is working with NIH-funded institutions and university professional organizations to identify steps to mitigate “…these unacceptable breaches of trust and confidentiality that undermine the integrity of U.S. biomedical research.” NIH is also forming a working group to address:
  • reporting of all sources of research support, financial interest and relevant affiliations;
  • mitigating the risk to intellectual property security while continuing international collaborative efforts; and
  • exploring additional steps to protect peer review integrity. 

At this initial phase, NIH is working primarily with the individual institutions where breaches have occurred. The Research and Science Policy Committee (RSPC) will continue to monitor activities in this area and provide updates as appropriate.
Clinical Trials & Biospecimen Case Study
Following the August Research & Science Policy meeting, the Committee requested that NIH determine that the following case study is NOT a clinical trial .

A research study is being conducted comparing fluorescence in situ hybridization probe (FISH probe) type A with FISH probe type B to determine which probe is better able to detect mutations associated with a specific gene. Identifiable biospecimens will be used (for purposes of this example it does not matter whether the sample is from previously consented archived biospecimens or whether the sample is gathered under the appropriate consent with the specific intent to use it in this research study). The identifiable biospecimens are randomly assigned to be either type A or type B. For comparison, the same gene region is analyzed using direct DNA sequencing. Conclusions are drawn as to the accuracy of each type of FISH probe.
ASIP has received NIH’s concurrence that this example is NOT a clinical trial and this is now available on ASIP’s Science Policy webpage . The clarification is important as the NIH definition of a clinical trial appeared to require a study, such as the one described above, to meet the regulatory requirements of a clinical trial. We have offered to collaborate with NIH on the development of a case study for the NIH web site. Please share other 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. Send these examples to Jennifer Dreyfus , ASIP Science Policy Consultant.
Federal Budgeting
In August, a combined Labor Department and Health & Human Services (Labor/HHS) budget bill passed the Senate, including a $2 billion increase for NIH. Several amendments were included addressing foreign influence in U.S. research (see lead article above). Recently, a joint House-Senate Conference Committee released an appropriations package bringing together funding for Labor/HHS and the Department of Defense. This package includes the same $2 billion (5.4%) in additional NIH funding and adds a continuing resolution that would fund those governmental agencies not addressed specifically in this Labor/HHS/Defense package. The continuing resolution would fund the other agencies at their existing FY 2018 level until December 7. Also, the House and Senate have passed a measure that includes Military Construction /Veterans Administration and Energy and Water appropriations. It is expected that the President will sign this into law shortly. The bill provides $325 million in additional funding for the Department of Energy Office of Science beyond current funding and $57 million additional for the VA research program. For more information, the Federation of American Societies for Experimental Biology (FASEB) has provided an excellent summary of 2019 congressional budgeting activities to date. FASEB has also analyzed the impact that two decades of federal budget appropriations delays has had on scientific research. 
Nominee put forth to head the White House Office of Science and Technology Policy (OSTP)
The Trump administration has put forth Dr. Kelvin Droegemeier to be the new Director of OSTP . Dr. Droegemeier has received strong support from the scientific community and a quick confirmation is being urged. 
Privacy Rule Rewrite
The Secretary of Health & Human Services (HHS) announced the intent to rewrite health care privacy rules. HHS has stated it will “release requests for comment on three laws, including the anti-kickback statute and Health Insurance Portability and Accountability Act, better known as HIPPA…” To date, further information about the potential timing and content of the RFI(s) has not been provided.  
Sexual Harassment
Top Democrats on Senate and House appropriations committees criticized NIH's current sexual harassment policy, sending a letter stating that NIH should be doing more to address sexual harassment concerns. On September 17, Dr. Collins published a statement entitled “Changing the culture of science to end sexual harassment,” noting NIH’s need to increase its transparency on this issue and highlighting NIH’s anti-sexual harassment website . Michael Lauer, MD, NIH Deputy Director for Extramural Research, released his September 17 blog post sharing an update on how NIH handles incidents of sexual harassment when reported at NIH-funded institutions. He notes that “if a grantee takes administrative or disciplinary action against its employee(s) … that impacts the ability of the employee(s) to continue as ‘senior/key personnel’ on an NIH award, NIH requires the grantee to notify NIH and seek NIH’s advance approval for replacement(s) of PD/PIs and senior/key personnel.” 
The National Academies released its report on sexual harassment in academia, entitled “ Sexual Harassment of Women: Climate, Culture, and Consequences in Academic Sciences, Engineering, and Medicine .” The recording and slides are now available from the August webinar entitled “Preventing Sexual Harassment and Beyond sponsored by the National Academies’ Government-University-Industry Research Roundtable. Other future events related to the National Academies report can be found  here

In a related development, the National Institute of General Medical Sciences (NIGMS) issued a  Notice  modifying its T32 application instructions and requiring that documents now include “information about institutional policies and procedures to prevent discriminatory harassment and appropriately respond to such allegations.” This requirement may be added to other training grants in the future, beyond the NIGMS T32s. 
Common Rule update on posting consents
Effective January 19, 2019, researchers must publicly post sample clinical trial consent forms as required under the revised Common Rule. The consent form must have been used in enrolling participants and may be posted to eithe r   or a docket folder on   (Docket ID: HHS-OPHS-2018-0021). Additional instructions are being developed by HHS and other Common Rule departments and agencies.
NSF Idea Machine
The National Science Foundation has launched the NSF Idea Machine . This prize competition is intended to identify ambitious and creative ideas to inform NSF’s agenda for basic research through 2026 and beyond. The grand prize is a $26,000 cash prize with additional finalists receiving a $1000 cash prize. Proposals will be accepted through October 26, 2018 .
ASIP’s recent science policy activities
  • Submitted comment letter on EPA Notice of Proposed Rulemaking (NPRM)
  •  Joined 69 other organizations opposing EPA NPRM
  • Released blog postings by two RSPC members on EPA NPRM
  • Continued participation in coalition concerned with expanded definition of clinical trials, which will likely increase its activities given the recent release of the RFI on Registration and Results Reporting Standards for Prospective Basic Science Studies Involving Human Participants
  •  Joined coalition letter on fetal tissue