ASIP SCIENCE POLICY

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 
(click here for quick and easy tools)

• 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

Administrative Burden

• 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 
  (March 2014)

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 jdreyfus@asip.org. Thank you!