A few days ago, I was alerted to a notice on reginfo.gov; an Office of Management and Budget website that gives the public access to administration agendas and governmental regulatory information.
11 days after Trump took office, he signed Executive Order 14192: Unleashing Prosperity Through Deregulation. In that vein, the Department of Health and Human Services and the Office of the Assistant Secretary for Health have begun work on deregulating the strict rules surrounding research using human subjects.
The administration argues that “the current regulatory framework no longer reflects the realities of modern research.” So are they planning on increasing protections of human research subjects based on the recent integration of Artificial Intelligence, or shoring up the privacy concerns of medical research participants given updated technology in electronic health records?
Nope.
They have decided that regulations protecting human research subjects are too burdensome for the folks running the experiments, so now they’re targeting the “Common Rule.” The Common Rule, also known as the Federal Policy for the Protection of Human Subjects, was adopted by 17 federal agencies codified as 45 CFR 46 at HHS in 1991.
From the American Medical Association Journal of Ethics:
The history of human subjects research in the United States is checkered with horrifying examples of exploitation that demonstrate the need for overarching protections for research participants. From the US Public Health Service Syphilis Study at Tuskegee, in which poor African American men in rural Alabama were denied treatment for their syphilis so that federal researchers could study its natural progression, to Willowbrook, where institutionalized mentally disabled children were deliberately infected with hepatitis in order to develop treatments for the disease, researchers have time and again trampled upon the legal and ethical rights of vulnerable populations in the name of science. To address these egregious violations, scientists, ethicists, academics, and politicians in the 1970s and 1980s developed a body of regulations to oversee biomedical and behavioral research involving human subjects in the US, known today as the Common Rule.
According to Trump’s HHS, The Department anticipates that [their new] proposed rule would generate significant quantifiable and unquantifiable deregulatory benefits by improving efficiency and enabling a more risk-based application of human subjects protections requirements.
They claim the current regulations are hindering the kinds of human subject research they’d like to do, specifically taking aim at informed consent requirements. They want to change the definition of “undue influence” so they can “reduce administrative burden on investigators, institutions, and institutional review boards.” The HHS says that “Without additional changes intended to clarify ambiguities, expand flexibilities, and redirect protective measures toward high-risk activities, the rights and safety of research participants as well as scientific breakthroughs can be impeded.”
In other words, private industry’s ability to make money is hampered by pesky regulations that protect vulnerable human research subjects from undue influence.
Currently, the Common Rule says that Institutional Review Boards “should be particularly cognizant of the special problems of research that involves a category of subjects who are vulnerable to coercion or undue influence, such as children, prisoners, individuals with impaired decision-making capacity, or economically or educationally disadvantaged persons.”
Coercion is defined as an overt or implicit threat of harm, whereas undue influence “is the broader category: any excessive, unwarranted, or inappropriate overture offered to obtain compliance, whether or not it rises to a threat. It can be monetary or non-monetary — for example, a supervisor recruiting subordinates, or a physician recruiting their own patients, where the relationship itself creates pressure to say yes regardless of any payment involved.” (CASRAI)
According to the government’s regulatory information website, the government is currently working on their proposed rule. I will let you know once it is published on the Federal Register so we can see just how the government intends to redefine undue influence, and what other parts of the Common Rule they plan to roll back.
Thanks again for reading The Breakdown. For further discussion, check out the Daily Beans Podcast wherever you get your podcasts. Support us by becoming a sustaining member here.
~AG
Federal Tuskegee syphilis study. Photo credit: The National Archives
This is nauseating.
WTAF?!?