FDA Removes Informed Consent Protections from Some Human Clinical Trials
- by Carolyn Hendler, JD
- Published February 11, 2024
- Informed Consent
The U.S. Food and Drug Administration (FDA) has issued a final rule that authorizes some experimental human clinical trials to operate without first obtaining informed consent from participants. The new rule, which took effect on Jan. 22, 2024, allows clinical investigations that pose no more than a “minimal risk” and have appropriate safeguards to protect the rights, safety and welfare of its human subjects to be exempt from the requirement to obtain prior informed consent from them.1
Informed consent can only be withheld from human participants in clinical trials that pose no more than a minimal risk. The FDA defines minimal risk as…
… means that the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.2
Robert Califf, MD, commissioner of the FDA, wrote:
We anticipate this new rule will enable minimal risk research that would not be practicable to conduct otherwise, This could include studies comparing the effectiveness of approved products to determine which option works best for certain patients.
The rule change was originally proposed in November 2018 and, while the majority of the 50 public comments were in support of the rule change, the new rule was not implemented until December 2023.3
Informed Consent is a Human Right
In 1947, the Doctors’ Trial at Nuremberg in Germany after World War II defined the ethical principle of informed consent as a human right for individuals participating in scientific research. Informed consent guarantees that one has the legal right to be fully informed about the benefits and risks of medical intervention and the right to make a voluntary decision about whether or not to take those risks without being coerced or punished for the decision made.4
Dr. Califf wrote about the new rule:
These efforts will promote additional robust clinical research to generate the evidence needed to inform clinical decision making and ultimately enhance treatment and diagnostic options for patients.
The potential additional clinical research that could lead to enhanced treatment and diagnostic options for patients globally comes at the expense of the basic human right for the individual to exercise informed consent.
Barbara Loe Fisher, co-founder and president of the National Vaccine Information Center, has stated:
Utilitarianism was discredited as a pseudo-ethic in 1947 at the Doctors Trial at Nuremberg after World War II. The horrifying truth about what can happen when utilitarianism is used to create public health law was exposed for the whole world to see and gave birth to the informed consent principle articulated in the historic Nuremberg Code. The next year, basic human rights that include autonomy and freedom of thought, conscience and religious belief were affirmed in the Universal Declaration of Human Rights.5
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