Controversial E.P.A. Proposal Could Spell Trouble for Medical Researchers

Over the past several years, multiple organizations within multiple industries have become more transparent with their consumer base. Many food businesses are now revealing the ingredients in their products, manufacturers are revealing where their products are made, and even the US government is attempting to become more transparent with the public, especially in relation to scientific data stemming from the medical field. Multiple governments in Europe as well as Canada have already set systems in place to make scientific data for new drugs, biological treatments, and medical devices available for public scrutiny. US universities were supposed to take a leap in this direction by reporting their raw data to the government site ClinicalTrials.gov, but according to an article released early in 2019, more than 30% of the studies have yet to deposit their data to the website. While we can commend the government for trying to become more like our Northern neighbors, a plan to expose the raw data of scientific and medical research to the public before accepting the conclusions (which includes confidential medical records), we all can agree, is highly debatable at best.

First reported by the New York Times, the new Environmental Protection Agency (E.P.A.) Strengthening Transparency in Regulatory Science proposal will, according to officials, “plan a step toward transparency and… allow conclusions to be verified independently.” Though the E.P.A., in response to the New York Times article, reports the article is, “completely false,” and, “not true,” journal editors from Science, Nature, PLOS, Cell Press, and the Proceedings of the National Academy of Sciences also responded to the proposal with a combined statement: “We urge the E.P.A. to continue to adopt an approach that ensures the data used in decision-making are the best available, which will at times require consideration of peer-reviewed scientific data, not all of which may be open to all members of the public.”

Indeed, asking researchers to expose the medical records of the individuals they are currently studying undoubtedly can be chalked up as an ethical debate, it also goes against the government HIPAA Privacy Rule that regulates the disclosure of medical information “without patient authorization.” Subjecting researcher’s work as null simply because they refuse to hand over sensitive information hardly seems appropriate or fair. In an opinion piece from STAT, several Ph.Ds.’ (including Elsevier’s Director of Scholarly Communications, William Gunn) report that research journals are already using data availability rules that allow medical data to be shared, but without breeching any privacy laws in the process.

If the research community has already found a way to successfully protect private data while still producing accurate science, surely there can be a way for the government to come to a similar understanding. Time will tell, as the E.P.A looks to formally decide on this rule early in 2020.

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