by Craig Klugman, Ph.D.
Transparency is a good thing. In ethics courses, we teach that doctors should be transparent to their patients, being truthful and disclosing information. In research, we teach that researchers should be transparent, sharing their methods, analysis, results and increasingly their data, for peer review. Transparency builds trust and is an important backbone to science and medicine. However, like all prima facie values, there are also limits to transparency. Under ethical notions of confidentiality, legal notions of privacy, and HIPAA, the names and identifying details about patients and subjects must be kept secret to protect them. Their private health information could be used against them in employment, housing, and relationships. Often companies want to preserve their intellectual property to maintain a competitive advantage. In fact, much of our research would not be possible if we did not offer confidentiality. If the name of every subject or every study had to be made public, then the risk -benefit ratio of participating in research would lead to most research not being viable.
In a new move, the Environmental Protection Agency has announced a planto prohibit “secret science”, that is studies that keep any information private. As Scott Pruitt, EPA Administrator said in a press release, ““The ability to test, authenticate, and reproduce scientific findings is vital for the integrity of rulemaking process. Americans deserve to assess the legitimacy of the science underpinning EPA decisions that may impact their lives.” While this sentiment is a good one, it is in the details that we find undermining of ethical science.
Under this proposal, the EPA will only be able to consider scientific studies that can be independently validated and replicated. For the agency, this means that all information will have to be made available, including data that ethically and legally must be kept confidential such as identifiable information. Scientists would need to submit identifiers linked to their information. The result is that no study that includes confidential or anonymous human subjects, human health information, or medical information will be considered in environmental rulemaking. This is a significant problem because in much of this research, the confidential information is the data. Without that, there is nothing available to be verified.
What can be considered? Publicized , non-scientific, case studies and papers by companies that have an interest in preventing environmental regulation. Large, multiyear studies will no longer be admissible unless researchers violate human subjects law, ethics, and IRB approval by revealing the identities of their subjects.
Such a rule makes no inherent sense unless the goal is to eliminate the factual evidence that supports the need for environmental regulations. Essentially, this approach gives preference to unsubstantiated claims. In a way, this proposal uses science against itself: As my opening paragraph shows, there is an inherent tension between the desire for transparency in science and the need to preserve confidentiality of research subjects and their private health information. If we eliminate privacy protection, however, then one could not do a study that met federal human subject requirements. This balance is a nuanced one that IRBs are trained to weigh. By taking a blunt approach and saying that protecting people is “secret science” then one has a catchy phrase and essentially dismisses all research on human health. The result is that the EPA will only rely on industry funded research, non-human subjects research, and the words of “trusted people.” Ironically, the industry research would likely not be peer-reviewed by other researchers (I’m assuming that other corporations would not offer an unbiased peer review). The only “science” that could be looked at, would not fit the definition of science at all. In other words, only the voice of industry will be heard; not that of medicine, public health, or unaffiliated science.
Consider some of the more famous environmental cases that led to rules and regulations. Love Canal was a toxicwaste dump built next to a large housing development, over which a school was built in upstate New York. The medical data of the community that showed higher than normal levels of cancers was instrumental in making some progress toward protecting people. Other regulations come about when data shows the effects of pollutants on health over a period of years. With the new proposal, such studies could be done, but their results could never be used to support environmental regulations.
While much of the commentary on this proposal focuses on how horrible this rule would be for the environment and science, I wonder why there is a desire to know who is a subject? Is the wish to disprove the subjects and throw out their data, one person at a time? Is the goal to intimidate people to stop participating in research? Is the goal to find people who are suffering from environmental harm and bully them into silence? I suspect the hope is that their voices can be silenced and regulations to protect health can be ignored and rolled back.
All of this leads to a few choices: (A) Eliminate the use of human subjects research in setting environmental rules, as proposed; (B) Eliminate privacy and confidentiality in human subjects research (both in-person and using records); (C) Only recruit people into studies who are willing to have their private information made public; (D) Simply make the EPA a branch of industry and get the government out of rule-making; or (E)Make sure this rule is shut down.
I vote for E because tossing aside studies that meet the highest scientific criteria under the guise of doublespeak is unethical and only hurts the public. Transparency of methods, selection criteria, and analysis are essential to good science. Serious and rigorous peer-review is essential to science. Protecting the well-being of human research subjects is essential to science. This proposal would ban health research based on actual people and records from being considered in environmental rule setting. And yet, these rules are how we ensure a clean environment to protect the public’s health. The EPA is trying to have its pie and eat it too. Confidentiality is not a means to suppress data or put forth a liberal stamp to conclusions. Confidentiality is how we protect people who are courageous enough to be part of these research studies, who are scared enough by their damaged health to want to stop polluters, and who are concerned enough that they want to leave a healthy world to future generations.