Language Creep and Informed Consent: When Did ‘Human Experiments’ Become ‘Clinical Trials?’
Surprisingly, not in immediate aftermath of Nuremberg Trials
There was a time when research involving human subjects was not couched in the relatively innocuous terms like “clinical trials” or “research,” but labeled baldly as an “experiment.”
While on the one hand a seeming innocuous matter of semantics, there is also the concern that the development of more euphemistic phrasing for human research is a subtle erosion of informed consent.
“‘The point of using the term ‘study’ or ‘clinical trial’ is to put a positive spin on the whole enterprise,” says Carl Elliott, MD, a professor in the Center for Bioethics at the University of Minnesota. “People are afraid if they hear the phrase ‘human experimentation.’ It has become so associated with the abuses of the past it could scare people off. If it’s a question of informed consent, maybe they should be scared off.”
Elliott gave this matter some thought and penned a recently published essay on the subject, recalling the time an attorney speaking to an audience involved in various aspects of human research said, “Don’t call it a study. Don’t call it a clinical trial. Call it what it is. It’s an experiment.”1
The common perception may be that the notion of “human experiments” was convicted and exiled from research language at Nuremberg during the Nazi war trials.
“No, it wasn’t Nuremberg,” he says. “In fact, it wasn’t even the big scandals of the 60s and 70s here like Tuskegee and Willowbrook [State School in Staten Island, NY]. It took a while after the American scandals for the bad connotations of the word ‘experiment’ to spread. But it was definitely the case by the mid-1990s.”
Specifically, a 1995 survey by federal Advisory Committee on Human Radiation Experiments found that “medical study” was perceived by patients as a much less risky endeavor than participating in a “medical experiment.”2 Some people viewed the term as the final option of terminally ill patients, Elliott notes.
“The shift from the term ‘experiment’ to ‘clinical trial’ and ‘research study’ is really just a small part of the whole change of language in research,” he tells IRB Advisor. “It is all about keeping information away from patients. Ironically, if you look at informed consent documents, the language is so clinical and so bureaucratic that you can’t imagine a research subject reading that and getting the full emotional impact of what they are signing up for. The documents read like indemnification clauses or the fine print in a rental car agreement.”
As part of this shift in nomenclature, controversial and unethical research began to be described as the Tuskegee syphilis “experiment” or the Stanford prison “experiment.”
“If you are a researcher, recruitment is a huge problem, so surely you are not going to use any language that is going to possibly scare people off,” Elliott says. “So it doesn’t surprise me at all the researchers would shy away from using words like ‘experiment.’ But it is a little more striking that supposed neutral fields like bioethics or federal guidelines have all gone along completely with this shift. Even codes of research like the Declaration of Helsinki have gradually cleansed themselves of the word ‘experiment.’”
Of course, there is no shortage of examples about of using cloaked language in other areas of medicine, few more brazen than the CDC’s original use of the arcane word “nosocomial” to describe infections acquired by patients in a hospital. The CDC was concerned that hospitals wouldn’t report what are now called healthcare-associated infections if they more directly described an adverse event that has implications for liability.
“‘Clinical trial’ is a term that the general public does not understand at all,” Elliott says. “For you and me it becomes completely normal to use that term, but in the real world nobody knows what a clinical trial is. When you use that phrase instead of the word ‘experiment’ — a word which people do understand — it does seem like an intentional effort to confuse people.”
REFERENCES
- Elliott C. “Whatever Happened to Human Experimentation?” Hastings Center Report 46 (2016): 1-4. DOI: 10.1002/hast.531.
- Advisory Committee on Human Radiation Experiments, Final Report of the Advisory Committee on Human Radiation Experiments (Washington, D.C.: U.S. Government Printing Office, 1995), 734.
There was a time when research involving human subjects was not couched in the relatively innocuous terms like “clinical trials” or “research,” but labeled baldly as an “experiment.”
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