The U.S. Food and Drug Administration (FDA) has finalized a rule that removes the requirement to obtain informed consent for medical research.
“This final rule allows an exception from the requirement to obtain informed consent when a clinical investigation poses no more than minimal risk to the human subject,” the rule reads.
The rule went into effect on January 22, 2024.
A closer look:
From the Federal Register:
The Food and Drug Administration (FDA, the Agency, or we) is issuing a final rule to amend its regulations to implement a provision of the 21st Century Cures Act (Cures Act). This final rule allows an exception from the requirement to obtain informed consent when a clinical investigation poses no more than minimal risk to the human subject and includes appropriate safeguards to protect the rights, safety, and welfare of human subjects. The final rule permits an institutional review board (IRB) to waive or alter certain informed consent elements or to waive the requirement to obtain informed consent, under limited conditions, for certain FDA-regulated minimal risk clinical investigations.
The FDA received critical comments opposing the rule, stating that “waiving consent conflicts with existing ethical and international standards, such as the Belmont Report, the Nuremberg Code, the Declaration of Helsinki, and the International Covenant on Civil and Political Rights (ICCPR).”
The agency ‘disagreed’ with the comments opposing the rule, saying “there are some situations in which important research cannot practicably be conducted if informed consent is required.”
Cont. from the Federal Register:
(Comment 2) Of the comments that oppose the proposed rule, two oppose it because they assert that waiving consent conflicts with existing ethical and international standards, such as the Belmont Report, the Nuremberg Code, the Declaration of Helsinki, and the International Covenant on Civil and Political Rights (ICCPR). Two other comments suggest that FDA withdraw the proposal because the underlying law and revised Common Rule are defective and “against the spirit” of human subject protection.
(Response 2) FDA disagrees with the comments opposing the rule. We believe that the rule upholds the principles underlying existing ethical standards, while accounting for advances in the conduct of FDA-regulated clinical investigations. It is also consistent with the obligations of the ICCPR and the U.S.’ reservations, declarations, and understandings to the Covenant (see, e.g., Ref. 1). The standards referenced in the comments emphasize the importance of voluntary informed consent for research participants. As stated in the proposed rule, obtaining informed consent from those who volunteer to participate in research is a fundamentally important principle of human subject protection. However, there are some situations in which important research cannot practicably be conducted if informed consent is required. This rule permits a waiver of consent in limited circumstances, consistent with the statutory amendments Congress made in section 3024 of the Cures Act. The waiver is only permitted in circumstances where the risks posed to subjects by the research are minimal and where an IRB has reviewed the research and determined, among other things, that the waiver or alteration will not adversely affect the rights and welfare of subjects. If research can be practicably carried out without a waiver of informed consent, investigators cannot obtain a waiver under this rule.
Additionally, the ethical principles identified in many of the national and international guidelines for research conduct, such as the three ethical principles described in the Belmont Report (respect for persons, beneficence, and justice), should be considered and weighed within the context of a particular clinical investigation, as the consideration of each principle depends on multiple factors associated with the investigation, such as research methodologies or participant populations. This rule permits a waiver or alteration of consent only in limited circumstances where the risks posed to subjects by the research are very low. We believe that with the protections in place under this rule (including the requirement for an IRB to find and document that the waiver or alteration will not adversely affect the rights and welfare of subjects), the balance between respect for persons and beneficence should come out in favor of facilitating research that satisfies the criteria in § 50.22 by permitting waiver or alteration of informed consent requirements to advance the public health. Additionally, although informed consent is a critical element of FDA’s regulations that reflects the principle of respect for persons through the exercise of autonomy, we believe that the criteria provided in this rule also reflect the principle of respect for persons. For example, in a minimal risk clinical investigation for which an IRB waives consent, ensuring that the rights and welfare of subjects are not adversely affected by the waiver demonstrates respect for persons, as does providing additional pertinent information about the investigation to subjects whenever appropriate (Ref. 2).
Finally, FDA declines to withdraw the proposed rule in response to the comments that disagree with section 3024 of the Cures Act and the revised Common Rule. The Common Rule’s provisions for waiver or alteration of informed consent for minimal risk research have been in effect for over 30 years and have provided appropriate safeguards to protect the rights and welfare of human subjects. As noted above, FDA believes that this rule provides an important mechanism for conducting clinical investigations that will both appropriately safeguard human subjects and potentially lead to medical advances that serve the public health.
“Will this waiver of informed consent for ‘minimal risk’ clinical trials allow hospitals & other medical facilities to enroll patients in clinical trials without their knowledge?” one X user questioned.
Chief Nerd writes:
“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.
‘This could include studies comparing the effectiveness of approved products to determine which option works best for certain patients.’”
The Epoch Times reports:
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.