FDA, HHS Cut 'Informed Consent' Rule That Gives Patients Full Understanding of Risks, Benefits, and Alternatives of Medical Procedures and Drugs Before Agreeing to It in Some Clinical Tests
COVID-19 vaccines involved clinical testing—critics cite violations of Nuremberg Code, Declaration of Helsinki, the International Covenant on Civil and Political Rights (ICCPR), U.S. Constitution.
A December publication in the U.S. Federal Register, part of the National Archives and Records Administration, reveals the Food and Drug Administration (FDA) and Department of Health and Human Services (HHS) have issued a final rule that “allows an exception from the requirement to obtain informed consent” in certain clinical investigations.
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Informed consent is a fundamental ethical and legal principle in medicine, ensuring patients are fully informed about the risks, benefits, and alternatives of a procedure before agreeing to it. This involves effective communication between patients and healthcare providers, facilitating voluntary and informed decision-making. The process is crucial for respecting patients' autonomy, allowing them to receive comprehensive information and make decisions about their care, with the understanding that in emergency situations, treatment may be initiated without prior consent but should be obtained at the earliest opportunity.
The new rule nullifying informed consent in certain clinical trials is effective as of January 22, 2024.
COVID-19 vaccines represent a drug that would have fallen under this rule. However, it was recently reported that scientists representing the Canada-based nonprofit ‘CORRELATION Research in the Public Interest’ found that COVID vaccines have killed about 17 million people worldwide. This raises concerns about the safety of future drugs not being disclosed to patients under the new FDA/HHS rule.
The new rule will allow an institutional review board (IRB) to “waive or alter” certain informed consent components or to outright waive the requirement to obtain informed consent. IRBs are groups designated to review and monitor biomedical research involving human subjects and are responsible for protecting the rights, welfare, and privacy of the participants.
The FDA/HHS publication reads:
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.
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FDA/HHS Reject Nuremberg Code, U.S. Constitutional Rights Violations Concerns
The publication cited many comments arguing against the FDA/HSS’s new rule.
These comments raised concerns suggesting the rule would violate the Nuremberg Code, the Declaration of Helsinki, the International Covenant on Civil and Political Rights (ICCPR), and guaranteed rights under the U.S. Constitution.
The following is a list of five of these comments cited in the FDA/HHS publication:
“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.”
“Some comments suggest that conducting research without informed consent would violate the U.S. Constitution or weaken constitutionally guaranteed rights. One comment argues that “invasive procedures, interventions or intrusions” into a person's “body, cognition, or otherwise” without consent is a violation or a potential violation of the Fourth, Fifth, Eighth, and Fourteenth Amendments. A second comment asserts that waiving consent for research involving physical interventions would violate the Fourth and Fifth Amendments and requested clarification that Constitutional rights are among the rights at issue when considering whether the proposed criteria for waiver of consent are satisfied. Another comment indicates that a waiver of informed consent would constitute an unwanted bodily invasion and that individuals have a constitutional right to privacy that protects them against such invasions. Other comments make general statements questioning the constitutionality of a waiver of informed consent.”
“Several comments argue that waivers of informed consent weaken human subject protections and would allow IRBs to retreat from their human subject protection responsibilities. These comments also express concern that the proposal might decrease public trust in both research and healthcare providers. One comment states that no third parties, including IRBs, should be allowed to make decisions for study subjects as to what constitutes ‘minimal risk.’”
“Several comments criticize the proposal as too vague and subjective. These comments recommend adding definitions or providing further description of the criteria in § 50.22. They also recommend clarifying or providing examples of research for which a waiver or alteration would be allowed under the proposal in order to reduce the potential for inconsistency and variability in IRBs' decision making.”
“Two comments suggest tracking the cumulative effects of minimal risk studies on subjects who have participated in more than one such study and suggest establishing a centralized registry containing the names of all human subjects who are involved in research or clinical investigations, the names of the sponsor and researcher, whether the research is classified, and whether informed consent was waived or altered.”
FDA/HHS apparently rejected all of these concerns raised by objectors to the new rule, and “decline[ed] to adopt” suggested requirement additions that would have protected against these implied violations.
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How Is This Legal?
The final rule allowing for a waiver or alteration of informed consent is legal because of statutory changes made to the Federal Food, Drug, and Cosmetic Act (FD&C Act) by the ‘21st Century Cures Act.’
Sections 505(i)(4) and 520(g)(3) of the FD&C Act, as amended by the Cures Act, in conjunction with FDA's general rulemaking authority in section 701(a) of the FD&C Act, serve as FDA's principal legal authority for this rule. In addition, the Cures Act directs the Secretary of the Department of Health and Human Services (HHS) to “harmonize differences between the HHS Human Subject Regulations and the FDA Human Subject Regulations,” to the extent practicable and consistent with other statutory provisions.
The Cures Act was signed into law on December 13, 2016.
The FDA/HHS publication reads:
On December 13, 2016, the Cures Act (Pub. L. 114–255) was signed into law. Section 3024 of the Cures Act amended sections 505(i)(4) and 520(g)(3) of the FD&C Act (21 U.S.C. 355(i)(4) and 360j(g)(3)) to provide FDA with the authority to permit an exception from informed consent requirements when the proposed clinical testing poses no more than minimal risk to the human subject and includes appropriate safeguards to protect the rights, safety, and welfare of the human subject. This rule implements the statutory change by allowing an additional exception from the general requirements of informed consent for certain FDA-regulated clinical investigations.
Both Democrats and Republicans in the U.S. House of Representatives resoundingly voted in favor of the Cures Act in July 2015.
Senate Democrats and Republicans also teamed up to pass the bill in December 2016.
You can download the full FDA/HHS publication below:
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