In an effort to encourage the discovery of more treatment and diagnostic options in the medical field, the U.S. Food and Drug Administration has finalized a rule allowing certain clinical trials to operate without obtaining informed consent from participants.
"We anticipate this new rule will enable minimal risk research that would not be practicable to conduct otherwise," Dr. Robert M. Califf, serving commissioner of Food and Drugs for the FDA, wrote on his FDA blog, "Catching Up With Califf." "This could include studies comparing the effectiveness of approved products to determine which option works best for certain patients."
The FDA initially proposed the rule in November 2018, permitting an institutional review board to waive the requirement for informed consent under certain conditions.
Not all comments were supportive, with some warning that "a waiver of consent may be necessary and ethically justifiable for certain types of clinical investigations that are critical for medical advancement, patient care, and safety." Two commenters believed the rule simply goes "Against the spirit" of protecting humans in medicine.
One example includes the analysis of a retrospective records review; before the new rule, such a study required informed consent from the patients whose data were being studied.
Much of the pushback against the new rule suggested the changes would allow IRBs to compromise on standards more and more, adding that the term "Minimal risk" is too vague and could be misinterpreted or abused.
In his blog post, Dr. Califf says the new rule is a start.
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