ASIP
American Society for Investigative Pathology
December 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 A. Muller, MD, PhD , RSPC Chair or Jennifer Dreyfus , Science Policy Consultant
Implementation of the updated Common Rule is right around the corner
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The updated Common Rule goes 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 , HHS, along with a resource page devoted to educational material on this updated regulation.

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 either ClinicalTrials.gov  or a docket folder on  Regulations.gov  (Docket ID: HHS-OPHS-2018-0021). Additional instructions are being developed by HHS and other Common Rule departments and agencies. ASIP will continue to monitor the implementation of this updated regulation. 
ASIP Statement on manipulation of the human genome
In 2015, ASIP developed 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. The Committee reaffirmed ASIP’s 2015 statement . For additional information, researchers may also be interested in the statements from the Society for Developmental Biology and The American Society for Human Genetics . 
Clinical Trials – objecting to the expanded definition
NIH issued a Request for Information (RFI) entitled Registration and Results Reporting Standards for Prospective Basic Science Studies Involving Human Participants, NOT-OD-18-217 . This RFI follows upon the new NIH definition of a clinical trial as 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. For more information and to see if the expanded definition applies to your research, see the NIH website or speak with your IRB office.  

In the past few months, ASIP’s dissatisfaction with NIH’s expanded definition has been expressed in the following ways:
  • In October, ASIP joined a coalition of research organizations reiterating objections to the expanded definition;
  • As a member of the Federation of American Societies for Experimental Biology (FASEB), ASIP’s concerns were communicated in FASEB’s letter to NIH, as well as FASEB’s RFI response; and
  • ASIP continued its partnership with a coalition of biomedical research organizations as a formal RFI response was submitted.

The first funding opportunity announcement (FOA) has been released for what is now being called “basic experimental studies with humans.” An accompanying blog post provides background information. NIH has delayed enforcemen t of the policy as it acknowledges the need for short-term flexibility and additional dialogue with the research community. NIH has developed FAQs for clinical trial specific FOAs, as well as a table comparing  Funding Opportunity Types by Clinical Trial Allowability .
ASIP continues to monitor developments in this area. We are pleased that NIH has responded to ASIP’s request for additional clarification on the types of biospecimen research that fall outside the expanded definition, beyond what was previously available in the general and institute-specific case studies . 
Federal budget update
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At the end of September 2018, President Trump signed a Labor; Health and Human Services and Education; and Defense ‘minibus’ appropriations measure funding NIH for fiscal year 2019. The measure provided NIH with a $2 billion increase over fiscal year 2018, bringing NIH’s total funding level to $39.1 billion. Funding for fiscal year 2019 was also provided for the U.S. Department of Energy Office of Science (total budget of $6.6 billion, a $325 million increase) and the Veterans Affairs Medical and Prosthetic Research Program (funded at $779 million, a $57 million increase).

That legislation also included a continuing resolution funding programs outside of those contained in the ‘minibus,’ including the National Science Foundation. At this point, the revised continuing resolution has been extended through December 21. 
Sexual harassment in science continues as an important focus 
  • Congressional activities:  Legislation was introduced to the House Science Committee in an effort to “… expand research efforts to better understand the causes and consequences of sexual harassment affecting individuals in the scientific, technical, engineering, and mathematics workforce, including students and trainees, and to examine policies to reduce the prevalence and negative impact of such harassment.” It authorizes funding for enhanced research and data collection and a National Academies study assessing the state of research on sexual harassment and progress made on implementing the recommendations included in the National Academies study entitled “Sexual Harassment of Women: Climate, Culture, and Consequences in Academic Sciences, Engineering, and Medicine.” The bill language also directs The White House Office of Science and Technology Policy (OSTP) to establish a working group coordinating federal science agency efforts to reduce the prevalence of sexual harassment involving grant personnel.

  • NIH activities: An NIH Notice on institutional training grants noted that training grant applications must “include a letter on institutional letterhead signed by a key institutional leader that describes the institutional commitment to ensuring that proper policies, procedures, and oversight are in place to prevent discriminatory harassment and other discriminatory practices.” This policy applies to applications submitted on or after January 25, 2019. 


 
Early Stage Investigators
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The National Institute of Allergy and Infectious Diseases (NIAID) issued a  Request for Information  (RFI) seeking input on a proposed NIH Directors New Innovator Award Program (DP2 for short) intended to “fund applications proposing bold new ideas from Early Stage Investigators (ESIs) and those currently in their postdoctoral years.” DP2 awards are designed to support highly innovative research projects by new investigators. The NIAID proposal calls for using this ‘high risk, high reward’ vehicle to fund ESIs or post-docs with new and innovative ideas yet with little preliminary data requirement. This proposed NIAID DP2 program would not replace the current K22 and K99/R00 programs. Comments on the NIAID RFI are due December 31, 2018. As this is one of the first DP2 RFIs, it may serve as a model for future DP2 programs across NIH’s Institutes and Centers.  
Additional NIH activities: 
  • The NIH issued a Notice (NOT-OD-19-020) reminding NIH-funded institutions about the responsibility to report research misconduct to NIH and to "work with NIH to assess the effect on the ability to continue the project" as well as protect the privacy of those involved while investigating and protecting the integrity of the research. The Notice delineates NIH’s requirements and outlines procedures for recipient institutions to communicate with NIH and the Office of Research Integrity. 

  • A recent NIH Notice (NOT-OD-19-023) announced increased access to genomic summary results for most NIH-sponsored research. Unrestricted access to genomic summary results, described as pooled genomic data from multiple individuals yielding a statistical result, will be allowed for most NIH-supported studies for health or research purposes. Where there are privacy concerns, additional protections will be in place. For more information, see an Office of Science Policy posting and a recent “Under the Poliscope” blog.

Additional NSF activities: 

  • NSF has revised its Proposal and Award Policies and Procedure Guide (PAPPG). This updated Guide includes a number of significant changes such as:
  • changes to conference proposal over $50,000;
  • revision of resubmission guidelines for programs that accept proposals at any time (see “no deadline” policy above); and
  • Requiring proposers to have a policy or code-of-conduct that addresses harassment.
The recently announced update to the PAPPG goes into effect on January 28, 2019. 
Other Items of Interest
  • ASIP recently filed formal comments joining other members of the research community asking the Department of Transportation to investigate animal transport complaints. The original complaint was filed by the National Association for Biomedical Research. 

  • The National Academies, FASEB and the Association of American Medical Colleges (AAMC) are co-sponsoring a five part webinar series on each of the following recently released National Academies reports:
  • Graduate STEM Education for the 21st Century (December 17)
  • Open Science by Design (January 14)
  • Next Generation of Biomedical and Behavioral Science Researchers: Breaking Through (February 19)
  • The Integration of the Humanities and Arts with Sciences, Engineering and Medicine in Higher Education: Branches of the Same Tree (March 18)
  • Sexual Harassment of Women: Climate, Culture, and Consequences in Academic Sciences, Engineering, and Medicine (April 15)
You can listen to previously held webinars or attend live through this portal.