October 2020
The Research and Science Policy Update is a periodic 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 will be highlighted.

For more information:
Interim Chair, Research and Science Policy Committee
Change in Research and Science Policy Committee Chair
Dr. Bill Muller was elected into the position of Vice President of ASIP during the 2020 election. He assumed that position on July 1, 2020 and at that time relinquished the RSPC Chair position. The ASIP Council appointed Dr. Kelsey Dillahay McKillip (university of Cincinnati) to take over as Interim Chair for the period of July 1, 2020 to June 30, 2021. The complete roster of Research and Science Policy Committee members can be found here:
Research and Science Policy Committee – Updates 
Regular readers of this newsletter have probably noticed the unusually long gap since the last installment (November, 2019). That is partially due to the disruption caused by COVID-19, but mostly due to the departure of Jennifer Dreyfus, our extraordinary scientific affairs consultant. Back when the Research and Science Policy Committee (RSPC) was the Science Policy Working Group and Mark Sobel was the ASIP Executive Officer, Mark realized that in order to keep up with the rapidly changing science policy scene, we would need a professional consultant with experience in the field and time to devote to it. Jennifer was an outstanding choice. Over the ensuing years the productivity of the RSPC increased tremendously, in large part because of the background information and government policy news that Jennifer provided. Former RSPC Chairs, Dr. Dan Remick and Dr. Bill Muller, agree that Jennifer performed over 90% of the work for the Committee, which included the preparation of the basic information included in this Newsletter.

When the financial realities of the real world caught up to the ASIP budget planning process, it became obvious that we could no longer afford to keep Ms. Dreyfus on the payroll. She was gracious in the months leading up to her departure, providing the Committee with detailed lists of resources she used to keep up with relevant events and government policies. The RSPC has spent much of the time since January reinventing itself in the “Post-Jennifer Era.” It was obvious that there was no one person to replace her. Hence, members of the Committee have now assumed responsibility to monitor various topics (research funding, training issues, and others) and groups (including the FASEB Science Policy Committee, among others) on behalf of the RSPC. In this way, the members of the Committee share in the efforts required and are more engaged in the work of the Committee. 
The Research and Science Policy Committee Publishes a ‘White Paper’ on Return of Individual Research Results
Biomedical research studies as well as clinical trials have long published anonymized results of their findings. However, the recent movement toward returning individual research results to study subjects/participants generates ethical and legal challenges for laboratories performing research on human biospecimens. The RSPC felt that this was an issue affecting many of its members involved in human subjects research and particularly those of us in clinical pathology engaged in running the clinical laboratories. Over the past two years, a subset of RSPC members researched the various laws, guidelines, and best practices, and condensed them into a relatively short practical guide for those involved. This white paper was published in the May, 2020 issue of The American Journal of Pathology. The full citation is: Sobel ME, Dreyfus JC, Dillehay McKillip K, Kolarcik C, Muller WA, Scott MJ, Siegal GP, Wadosky K, O'Leary TJ. Return of Individual Research Results: A Guide for Biomedical Researchers Utilizing Human Biospecimens. Am J Pathol. 2020 May;190(5):918-933. doi: 10.1016/j.ajpath.2020.01.014. Epub 2020 Mar 19. PMID: 32201265.

The following description of the article is taken from the PubMed abstract: The concept of an individual's interest in knowing the results of testing on their tissue is pitted against individual and systemic risks and an established legal framework regulating the performance of laboratory testing for medical care purposes. This article discusses the rationale for returning individual research results to subjects, the potential risks associated with returning these results, and the legal framework in the United States that governs testing of identifiable human biospecimens. On the basis of these considerations, this article provides recommendations for investigators to consider when planning and executing human biospecimen research, with the objective of appropriately balancing the interests of research subjects, the need for ensuring integrity of the research process, and compliance with US laws and regulations. 
Research Funding During the Pandemic  
As a result of the COVID-19 pandemic and resulting shutdown, many of our members could not work due to the closing of their laboratories. Fortunately, unlike many of our friends, families, and colleagues who are not full-time scientists, our paychecks continued since the NIH and other funding agencies allowed people to work from home as much as possible. However, during this time most of the funded research was not being performed and laboratories at many institutions had to significantly cull their animal colonies. The NIH was very generous about allowing extensions for deadlines. Nonetheless, without additional money to fund research projects, many grants would run out before preliminary data for resubmissions could be generated or, if submitted, before the new funding would start. The RSPC felt that this was an issue that affected most of our members. When FASEB mounted a campaign to push for additional funding to compensate for lost research time, the RSPC decided to support their campaign. ASIP members were encouraged to contact their local Representative in Congress to ask for additional financial support for the NIH as part of the HEROS act (H.R. 6800). This passed the House. Now members are asked to contact their Senators to ask them to support similar funding for NIH (a total of $15.5 billion) in the HEALS Act, the Senate version of the same bill (S. 4320).
Simplifying Research Review
An advisory group to NIH was formed last winter to make suggestions for simplifying the peer review process. Public comments were invited. The RSPC investigated this, making contact with members of the advisory panel to determine the scope of recommendations that were being considered. It turned out that no changes to the peer review grading system or evaluation criteria were being considered. Instead, the NIH wanted to hear suggestions such as which review criteria should be evaluated by the scientists of the study section, which could be evaluated by NIH Program staff, and whether changes to the study section review process or evaluation template would reduce the workload on the study section. The NIH Policy subgroup of RSPC drafted a response, which was discussed by the entire RSPC and suggestions were sent to the ASIP membership for comment. The final list of suggestions containing relevant comments from ASIP membership will be forwarded to the NIH advisory group during October.
Sign-on Letters
The Research and Science Policy Committee has evaluated the following recent sign-on letters and recommended that ASIP sign on as an organization:  
  • USCIS/ICE International Student Letter (On 7/14/2020 the Trump administration rescinded the rule that would have forced international students to leave the country if their colleges held online classes in the fall)
  • Letter of Support for Science and Public Health Experts During the COVID-19 Pandemic (7/14/2020)
  • NIH Human Fetal Tissue Research Ethics Advisory Board Letter (7/28/2020)
  • NIH HEALS Act Supplemental Funding Letter (8/4/2020)
  • APS sign-on letter supporting the call for NASEM to undertake a study of systemic racism in academia (9/2/2020)
Other Items of Interest