What does the ASIP Research and Science Policy Committee do?
Our committee is made up of researchers at all career levels who, with the help of policy experts, ensure that public and governmental affairs that affect our mission to “promote the discovery, advancement, and dissemination of basic and translational knowledge in experimental pathology and related disciplines” are shared amongst the ASIP membership as well as the wider biomedical community through our society partners in the Federation of American Societies for Experimental Biology (FASEB). We also craft responses on behalf of ASIP to policies, requests for information, publications, and other public documents that relate to our mission.
Currently, our attention is focused on human subjects research protection, return of research results, regulations regarding the use of biospecimens,
laboratory-developed tests, maintenance of adequate research funding, and supporting the next generation of biomedical scientists.
What is the Environmental Protection Agency (EPA)’s “Strengthening Transparency in Regulatory Science” rule?
The EPA has released a
Notice of Proposed Rulemaking
in Docket No. EPA-HQ-OA-2018-0259 stating that “action should be taken” only when “data underlying those (actions) are publicly available in a manner sufficient for independent validation.” You can read about the rule
Why is ASIP talking about opposition to this rule?
When a researcher performs studies with human subjects, these people are protected under an Institutional Review Board agreement. If this document did not ask for permission to make de-identified data publicly available at the beginning of the study, then the researchers cannot legally release that data. These legal regulations would prevent data from environmental studies that include human subjects from being publicly shared by the EPA. In addition, several environmental studies without human subjects contain data that would be difficult to make publicly available.
Wait, isn’t it part of your mission to promote “dissemination of basic and translational knowledge in experimental pathology”? Why would you oppose this rule?
Yes, ASIP follows the general principles that the merit and contribution of scientific studies should be judged on the strength of the research design, execution, data analysis, and peer review of the research study. Indeed, making data available for validation by other researchers is part of scientific rigor.
BUT, we think this rule would allow the government to disregard validated scientific research proving that various pollutants, such particulate matter, pharmaceutical toxins, and volatile compounds, to name a few, cause disease in humans. It is also possible that the true purpose of this “Transparency Rule” is to ignore these key findings in order to reduce disposal costs for industries that produce toxic waste.
Do other professional societies in biomedical disciplines also oppose this rule?
Yes, nearly 70 other biomedical research societies agree with ASIP in opposing this rule; see
our joint statement.
If this rule was put into effect, what do you think would happen?
ASIP and our society partners believe that if the EPA put the “Transparency Rule” into effect, there would be a negative impact on human health and increased rate of disease caused by pollutants. These negative health effects would be the result of the government rescinding current policies that prevent companies from releasing pollutants. Additionally, our national and international environmental pollution goals would be suspended, leading to accelerated climate change and loss of vital habitats for animals.
What is ASIP going to do next?
The ASIP RSPC is crafting a letter to the EPA’s Acting Administrator, Andrew Wheeler, expressing our concerns about the proposed “Transparency Rule” and requesting that further information be provided regarding data from environmental studies with human subjects. When this letter is filed, it will be available on the Science Policy page of the ASIP
What can I do?
The comment period for this Notice of Proposed Rulemaking is open until August 16th. Please make your voice heard by leaving an individual comment
My name is Kristine Wadosky and I have been a member of the ASIP since 2010 and part of the Research Science Policy Committee since 2017. I received my PhD in Pathology from the University of North Carolina at Chapel Hill and am currently a postdoctoral researcher at Roswell Park Comprehensive Cancer Center in Buffalo, NY, studying prostate cancer.