The FY22 appropriations process is underway, with Members of Congress weighing in with appropriators on funding levels. Senators Bob Casey (D-PA) and Richard Burr (R-NC) are circulating a “Dear Colleague” asking their fellow Senators to sign onto a letter supporting strong funding for NIH in FY22. Take action by using this editable email and/or Tweet asking your Senators to sign on (or thanking them if they already have). The more Senators who sign onto the Casey/Burr letter, the greater the chances of robust funding for NIH in FY22. As always, thank you for your partnership and your advocacy.
On Capitol Hill: Regrettably, there are no dollars to fill COVID-19 engendered research gaps — meaning all the many research programs put on hold or even shelved as the pandemic consumes attention — in the $1.9T relief package the House will vote on next week. That’s why we must all advocate for inclusion in the next supplemental, which is in the works. So much is at stake — answers for patients and the ability of researchers to generate those answers. The American taxpayer has invested a great deal in research and researchers; it is penny wise and pound foolish to leave so many of them high and dry at this point. Your Members of Congress can urge Congressional leadership to include research relief in the next supplemental spending bill. Use this editable email or tweet to make the case.
Dennis Jones, PhD, Assistant Professor of Pathology and Laboratory Medicine at Boston University has been selected as the inaugural early career representative to the Federation of American Societies for Experimental Biology (FASEB) Board of Directors. Dr. Jones was nominated for this position by the American Society for Investigative Pathology (ASIP), and will begin his three year term in July 2020. FASEB represents 28 constituent Societies and more than 130,000 researchers from across the world. FASEB is recognized as the research and science policy voice for biomedical investigators. Dr. Jones’s selection to serve on the FASEB board recognizes his status as early investigator who will contribute to the direction of scientific studies.
Dr. Jones was recruited to ASIP membership when he became a faculty member at Boston University by ASIP Past President Dr. Dan Remick who served as Chair of the Department of Pathology and Laboratory Medicine at the time. Dr. Jones immediately engaged in our Society’s functions and activities, and his immense potential was quickly recognized when he was chosen to receive a prestigious George Michalopoulos Junior Faculty Research Award in 2019. Dr. Jones’ laboratory was selected to host a summer research student through the ASIP Summer Research Opportunity in Pathology Program (SROPP) during the summer of 2019. He has also taken on a leadership role with the ASIP Breast Cancer Scientific Interest Group, collaborating with others to organize scientific sessions for the ASIP Annual Meeting. In all of these Society pursuits, Dr. Jones brings a clear understanding of the challenges faced by young academic faculty members that run an academic research program. Dr. Jones has experience with NIH and other grant funding sources, the need to publish, the importance of teaching and training students, and the frequent burden of regulation faced by research scientists.
It is clear that Dr. Jones is the model of an early career academic researcher that recognizes the importance of membership in scientific societies like the ASIP and the important role that FASEB plays in representing working scientists across the United States. He will provide an informed voice for young investigators who face tremendous challenges as they pursue basic and translational research in the current funding and regulatory environment.
Available for FREE to all readers as an Editor’s Choice article for May.
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 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.
Mark E. Sobel, MD, PhD, Jennifer C. Dreyfus, MBA, Kelsey Dillehay McKillip, PhD, Christi Kolarcik, PhD, William A. Muller, MD, PhD, Gene P. Siegal, MD, PhD, Melanie Scott, MD, PhD, , Kristine Wadosky, PhD, Timothy J. O’Leary, MD, PhD
The Research and Science Policy Committee, currently chaired by William Muller of Northwestern University, supports ASIP by ensuring that the public affairs concerns of ASIP members are heard within ASIP, in cooperation with FASEB and in the wider biomedical and research communities. Areas of active interest to the ASIP Research and Science Policy Committee are listed below with links to current information.
Advocating on behalf of funding for Pathology Research
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- Communicating Science FASEB resources
- Advocacy resources for scientists
- State and district information fact sheets
- NIH research funding overview
- FASEB Fact Sheet: The Value of Federally Funded Biomedical and Biological Research
Human Subjects Research Protection and Biomedical Ethics
- ASIP joins over 170 organizations objecting to changes to patent law that would allow patenting of naturally occurring genes (June 2019)
- ASIP leads scientific organizations in commenting on FDA guidance (May 2019)
- ASIP comments to FDA on use of de-identified biospecimens (May 2019)
- ASIP outlines ongoing conflicts between HIPAA & CLIA to HHS Office for Civil Rights (January 2019)
- Common Rule 2019 – updated summary and rule (November 2018).
- National Academies report Returning Individual Research Results to Participants: Guidance for a New Research Paradigm (July 2018)
- Dreyfus and Sobel add ASIP’s voice to return of results discussion: Response to Evans Commentary; Evans original Commentary; Evans rebuttal (July 2018)
- ASIP files additional comments with National Academies Committee on Return of Individual Research Results (October 2017)
- ASIP files comments with National Academies Committee on Return of Individual Results by Research Laboratories (August 2017)
- Recommendations from MRTC Center Return of Individual Results to Participants (October 2018)
- Sobel and Dreyfus stress transformative nature of proposed changes to Common Rule and rules governing return of results (December 2016)
- ASIP statement on Human Genome Manipulation (November 2015)
Research Funding, Submission and Related Concerns
- ASIP joins over 500 organizations in calling for boost to 2020 Labor-HHS funding (April 2019)
- ASIP signs on to Plan S letter (February 2019)
- ASIP reaffirms opposition to fetal tissue research restrictions in letters to Secr. Azar and House Committee(December 2018)
- ASIP joins others in opposition to fetal tissue research prohibitions (September 2018)
- ASIP comments on EPA Notice of Proposed Rulemaking (August 2018)
- ASIP joins 69 organizations in opposing proposed EPA transparency rule (July 2018)
- ASIP joins Ad Hoc Group for Medical Research in seeking appropriate FY 2019 funding (May 2018)
- ASIP requests extension to EPA Strengthening Transparency NPRM (May 2018)
- Instrumentation: federal grants & programs for the life sciences, FASEB resource (April 2018)
- Perceptions of Science in America report from AAAS (March 2018)
- ASIP as FASEB member society objects to President’s 2019 budget proposal (February 2018)
- ASIP joins others in opposition to cuts to facilities & administration expenses (August 2017)
- Report on strengthening canadian research funding (April 2017)
- National Academies Report – Fostering Integrity in Research (2017)
- FASEB Sustaining Discovery discussion framework (January 2015)
Laboratory Developed Tests
- FDA discussion paper on LDTs (January 2017)
- ASIP comments on draft FDA’s draft laboratory developed test guidances (January 2015)
- Timothy O’Leary authors Editorial on Regulating Laboratory Developed Tests (November 2014)
Clinical trials – Expanded definition
- ASIP signs on to response to NIH RFI on clinical trials (November 2018)
- ASIP joins others reaffirming opposition to expanded clinical trial definition (October 2018)
- Clarification from NIH on biospecimen research not considered a clinical trial (August 2018)
- ASIP joins coalition opposing expansion of clinical trials definition (April 2018)
- Final FABBS Letter to appropriators re clinical trials (April 2018)
Clinician Scientist Workforce
- NIGMS summary of MSTP comments (February 2018)
- NIH Update from Physician Scientist Work Group (June 2017)
- ASIP joins key organizations highlighting importance of implimenting physician scientist support recommendations (September 2016)
- American Board of Medical Specialties 2016 report on physician-scientists (June 2016)
- NIH report: Physician Scientist Workforce Working Group Report (June 2014)
Animals in Research
- ASIP supports National Association for Biomedical Research complaint regarding animal transport (October 2018)
- ILAR webinar on animal regulations (January 2018)
- FASEB-AAMC-COGR report on reforming animal regulations to reduce regulatory burden (October 2017)
- FASEB database on research organism providers (November 2016)
- White paper: critical role of nonhuman primates in medical research (September 2016)
- FASEB fact sheets (November 2015)
- FASEB statement supporting air transport of animals (September 2014)
- FASEB report: The Threat of Extremism to Medical Research: Best Practices to Mitigate Risk through Preparation and Communication
- FASEB releases shared resources report (October 2017)
- ASIP Letters to NIH and National Science Foundation supporting the recommendations of the National Science Board Report on reducing administrative workload (June 2014)
- National Science Board Report: Reducing Investigators Administrative Workload for Federally Funded Research
Resources for Next-Generation Scientists
- National Academies report on next generation scientists (May 2018)
- Next-Generation Research Initiative website (June 2017)
- NIH presentation on Next Generation Research Initiative (June 2017)
Other areas of interest to the ASIP Research and Science Policy Committee include translational research, gene patent law; health information technology as it applies to the research enterprise; creating a physician-scientist track for Pathology Board certification; reduction in NIH’s graduate education funding; open access and open government initiatives; HIPPA policy impact on research; and issues related to biorepository and biosecurity regulation.
To contribute your point of view on any issue, please contact the ASIP Research and Science Policy Committee through Jennifer Dreyfus at email@example.com. Thank you!