February 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 Funding – 2019 National Science Foundation budget approved
With the recent bipartisan agreement to avoid another government shutdown, the budgets for various agencies have been finalized. The FY 2019 budget for the National Science Foundation is now $8.075 billion ($308 million, or 4%, above FY18). Funding for other agencies was finalized last September, including:
  • NIH at $39.1 billion ($2 billion, or 5%, above FY18);
  • VA Research at $779 million ($57 million, or 8%, above FY18); and
  • Department of Energy Office of Science: $6.585 billion ($325 million, or 5%, above FY18).
Reminder of key changes beginning January 2019 - updated Common Rule implemented & changes to applications & progress reports
The updated Common Rule went into effect January 21, 2019, after two 6-month delay periods. The updated rules for cooperative research (known as single IRB regulations) are effective January 20, 2020. ASIP has prepared a summary of key provisions contained in the updated Common Rule.  Additional resources on the updated Common Rule are available through the Office of Human Research Protections (OHRP), along with a resource page devoted to educational material on this updated regulation and has a set of Q and A’s. OHRP has also provided resources, including more information on the revised Common Rule requirement to post one consent form on a publicly available federal website. NIH has issued a Notice implementing the updated Common Rule, and as part of its Grants Policy resources, NIH updated its human subjects research website . 

For NIH grant applications with a due date of January 25 or later, there are c hanges to applications and progress reports . Applications now must address age-appropriate inclusion or exclusion of individuals in the research project proposal. Progress reports for awards from applications due January 25 th or later must submit de-identified participant data on sex/gender, ethnicity, race and age as of the date of enrollment. NIH has expanded its Inclusion of Children Policy to individuals of all ages and the expanded policy applies to competing applications submitted for due dates January 25, 2019 or later, contract solicitations issued on or after this date, and intramural studies initiated after this date. See NIH’s guide notice and recent Open Mike blog for more information.  
ASIP reaffirms its opposition to fetal tissue research restrictions 
ASIP joined a coalition of over sixty research advocacy organizations and universities in opposing restrictions on research conducted with fetal tissue. In the comprehensive letters to Secretary Azar and to the House Oversight and Government Reform Subcommittee on Healthcare, Benefits, and Administrative Rules, the coalition addressed the importance of this research and the lack of other alternatives which might replace the use of fetal tissue.   On a related note, NIH has announced a Notice of Intent to Publish Funding Opportunity Announcements for Research to Develop, Demonstrate, and Validate Experimental Human Tissue Models that Do Not Rely on Human Fetal Tissue.
ASIP Statement on manipulation of the human genome
Since 2015, ASIP has had a position statement on manipulation of the human genome. In December, the Research & Science Policy Committee reviewed this statement given recent developments with the possible application of CRISPR technology on human embryos, reaffirming ASIP’s call for a voluntary moratorium on all manipulation of pre-implantation human embryos by genomic editing. ASIP’s statement is also referenced in the Federation of American Societies for Experimental Biology’s (FASEB’s) recent Statement on Claim of Gene-Edited Human Embryos
FASEB expands 2020 Excellence in Science Award
FASEB is now accepting nominations for the  2020 FASEB Excellence in Science Award. This is the first year FASEB is offering two new awards ($5,000 each) for Mid-Career and Early Career Women Scientists. To be eligible, Nominators and Nominees must be current members of a FASEB member society – if both a Nominator and a Nominee are members of ASIP, then you qualify. See FASEB’s archived webinars, including one on the Award, HERE .  
Office of Science & Technology Policy Director appointed
As one of the last acts of the 115 th Congress, Kelvin Droegemeier was confirmed as the new Director of the Office of Science and Technology Policy (OSTP). Droegemeier is a meteorologist specializing in weather events with a doctorate and master’s degree in atmospheric scirences. His credentials include serving as the Vice President for Research at the University of Oklahoma, and appointment to the National Science Board. Last summer’s announcement of Dr. Droegenmeier’s nomination was received positively by the scientific community. During his confirmation, Dr. Droegenmeier expressed his ongoing commitment to scientific integrity.     
ASIP responds to HIPAA RFI
ASIP continues to highlight the current conflict between HIPAA regulations and CLIA requirements. In the latest correspondence on this issue, ASIP noted concerns in our response to a Request for Information from the Office of Civil Rights, U.S. Department of Health and Human Services. ASIP calls upon the federal government to clarify HIPAA regulations so that research results may be released to research participants in any of the following scenarios.
  • When testing becomes part of a research participant’s clinical record and may be used in prevention, diagnosis or treatment.
  •  When the research protocol approved by the IRB and consented to by the research participant includes provisions for either: (a) the release of individual study results to research participants; or (b) return of incidental findings to participants.
  •  When the researcher believes that a finding should be further corroborated by a CLIA-certified laboratory.

Spotlight on: Next Gen researchers; rigor & reproducibility; and clinical trials
Next Gen Researchers:  Center for Scientific Review (CSR) has issued an update  to the policy for review and resubmission of New Investigator R01 applications. This update brings the RO1 application process in line with the Next Generation Researchers Initiative policy.

Rigor & Reproducibility:  NIH has enhanced its online resources supporting rigor and reproducibility efforts. The new website includes information for applicants so that they can better understand what rigor and reproducibility concerns reviewers are evaluating during application review. 

Expanded Definition of Clinical Trials:  The recently expanded NIH definition of a clinical trial is any project that prospectively assigns a human subject to an “intervention,” which is broadly defined such that many basic research studies are now considered clinical trials and subject to additional reporting and regulatory requirements. Expect to see more use of the term BESH which stands for Basic Experimental Study with Humans. As NIH moves forward with the expanded definition of clinical trials, NIH is providing new FAQs , a table comparing funding opportunity types by clinical trial allowability and guidance for determining if a study falls within a basic experimental study of humans Funding Opportunity Announcement .  NIH has also significantly expanded and updated clinical trial case studies . For more information and to see if the expanded definition applies to your research, see the NIH website or speak with your IRB office.
Other informational items
  • New York Times article on foreign threats to U.S. biomedical research.
  • On March 11, the National Academies Committee on Women in Science in Science, Engineering, and Medicine will sponsor a “Symposium Highlighting Evidence-Based Interventions to Address the Underrepresentation of Women in Science, Engineering, and Medicine.” As of today, the only option for attendance is in person at the National Academy of Sciences, 2101 Constitution Ave., NW, Washington DC. Register HERE 
  • Register for the upcoming FASEB webinar on research on non-human primates will be held February 26 at 11 am EST. If you missed the webinar, an archived copy should be available HERE