Studies cannot pose more than minimal risk to humans and must include appropriate safeguards to protect the rights, safety, and welfare of those involved.
In an effort to encourage the discovery of more treatment and diagnostic options in the medical field, the U.S. Food and Drug Administration (FDA) has finalized a rule allowing certain clinical trials to operate without obtaining informed consent from participants.
The hitch? The study cannot pose more than minimal risk to humans and must include appropriate safeguards to protect the rights, safety, and welfare of those involved.
The rule was issued in late December 2023 and went into effect on Jan. 22, 2024.
“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. The agency received fewer than 50 comment letters on the proposed rule from academia, institutional review boards (IRBs), public advocacy groups, industry, trade organizations, public health organizations, and citizens.
Most of the comments favored the agency’s efforts, supporting the rule because it reduced administrative burdens on both IRBs and researchers while encouraging valuable research on important health issues affecting the public without putting trial participants at risk, according to the FDA.
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.
However, many researchers noted in their support that certain minimal-risk trials are nearly impossible to conduct if consent is required. 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. By being able to dig into such information, these researchers and the FDA argue they may be able to make medical advancements without sacrificing patient safety or rights.
By Amie Dahnke
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