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ASIP.org > BLOG > August 2018

ASIP Pathogenesis Blog, August 2018

ASIP is actively involved in science policy and has been discussing the recent EPA Notice of Proposed Rulemaking (NPRM) that would limit the use of data in regulatory decision-making to only data that is publicly available. We have many concerns about this proposed regulation and two of our Research & Science Policy Committee (RSPC) members have stepped forward to share their reasons for concern about this proposed regulation. We thought we'd share their thoughts with you as ASIP generally does not comment on EPA regulations. We believe this is a special case that merits our attention. Should you have questions or comments, feel free to reach out to either of the authors;
to William A, Muller, MD, PhD, Research and Science Committee Chair; or our science policy consultant, Jennifer Dreyfus.


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Kristine Wadosky, PhD
Research Affiliate, Postdoctoral 
Department of Pharmacology and Therapeutics
President, Association of Postdoctoral Scientists (APoDs)
Roswell Park Comprehensive Cancer Center
Lab Ph: (716) 845-1563
Kristine.Wadosky@RoswellPark.org
Twitter @KristineWadosky
Instagram @kristinewadosky


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 HERE .  

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 website.  

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 HERE.  

About Me
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.

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Adeola O. Adebayo Michael, Ph.D.
EBICS Distinguished Postdoctoral Fellow
Coulter Dept. of Biomedical Engineering
at GeorgiaTech and Emory University
Ph: (646) 256-0813
adeola.michael@bme.gatech.edu
www.linkedin.com/in/AdebayoAdeola
Twitter: @adeolaoadebayo


Ignoring Science: EPA and the need for adequate transparency with regulations that affect the public. (OR Why I think it is important that the ASIP comment on the EPA NPRM).
Strengthening Transparency in Regulatory Science is a proposed regulation by the EPA that, simply put, states that EPA regulations will be made based on publicly available scientific data. This rule was proposed in April and has been met with impressive, well-informed opposition and a successful extension of the initial public comments deadline. 

Does this mean the scientific community is opposed to science transparency or access to data? 
No! quite the contrary. As a postdoctoral fellow, science transparency and data communication are a pivotal part of my career development. First, dissemination of data and transparency of science are key aspects of scientific conferences, both regional and national. Second, the majority of data are already publicly available through journals and other scientific agencies that actively review and publish novel discoveries. 

Why is there such an opposition to the current proposed rule? 
The crux of the matter is that EPA has proposed to make regulations based ONLY on studies in which ALL data are publicly available. That means that instead of relying on compiled data from a sample population, the EPA could insist on only using studies in which the data are listed separately for each individual. For many studies, complying with this would risk potentially identifying personal health information and other statistics from the individuals participating in the study. This would be a serious deterrent to participation in these scientific studies. Another danger in this language is that some of the best scientific discoveries will fall through the cracks in the new rule. Discoveries that have potential to shape or advance current regulations will essentially be ignored. Yet another concerning aspect is that some previously well-implemented regulations may be rescinded based on this proposed rule. 

Why not make all raw scientific data publicly available? 
This approach might disrupt ongoing groundbreaking discoveries. Studies that are ongoing and not yet "fact-conclusive" should not be considered in EPA regulation making strategies. 

What do I think? 
The EPA proposed regulation may have some merits if the purpose is truly to increase transparency in decision-making. By using publicly available scientific data as a basis for new regulations, the EPA may provide more credibility to science. This in turn may improve reproducibility and confidence in scientific results. However, if the intention of this rule is to allow the EPA to ignore well-grounded and reproducible scientific studies simply because all of the primary data are not publicly available, this is a perversion of transparency in science. Clearer policy language, justification of the impacts, and cost-effectiveness of the proposed change are needed to clarify how sensitive data will be used and protected. A better understanding of whether certain information, such as confidential patient data, is needed to make such regulations also must be clarified. Addressing these concerns is the core of scientific evidence and transparency, without political judgement, bias or interference.

About Me
My name is Adeola (Adebayo) Michael. I am a member of the ASIP and a member of the Research Science Policy Committee. I received my PhD in Pathobiology from Brown University in Providence, Rhode Island. My first postdoctoral position was with the Monga lab at University of Pittsburgh, where I studied signaling pathways interaction in hepatocellular carcinoma models. I am currently training as a Postdoctoral Fellow at Georgia Tech in Atlanta, Georgia studying protein degradation inhibition in biological robots (bio-bots).