Any civil case about whether lack of disclosure of ApoE4 status and risks was a violation of medical ethical standards would likely hinge on whether the CLARITY trial was conducted consistent with the global ethical standards that they stated they used. This is from a 2023 article on Lecanemab Clarity AD: Quality-of-Life Results from a Randomized, Double-Blind Phase 3 Trial in Early Alzheimer’s DiseaseTheresaB wrote: ↑Sun Nov 10, 2024 7:31 am... But since no laws were violated with the drug trials I was pondering if legal action could be taken for violating medical ethics.... Since the ethical violation led to emotional and physical consequences by participating in the trial, families may be eligible for compensation, that’s the legal basis.
The Declaration of Helsinki was first adopted by the World Medical Association's 1964 meeting in Helsinki, Finland, and updated several times since, most recently in October 2024. Below is an excerpt from the current version, which is very similar to what was in effect before 2024:Ethical standards: The trial was conducted in accordance with International Conference on Harmonisation guidelines and ethical principles of the Declaration of Helsinki. Clarity AD was approved by the institutional review board or independent ethics committee at each center, and all participants provided written informed consent.
The FDA held a virtual public webinar on Friday, November 8th on “Informed Consent – More than Just Another Document to Sign?”. Speakers included trial participants who had been in gene therapy and other trials for non-Alzheimer's diseases. The FDA staff stated that "informed consent" is not as a one-time signature, and may need to be revisited as new information arises and/or participants have additional questions and/or needs. Here is part of the info prior to the webinar; the webinar recording should soon be available on the link below.5. Medical progress is based on research that ultimately must include participants.
Even well-proven interventions should be evaluated continually through research for their safety, effectiveness, efficiency, accessibility, and quality.
6. Medical research involving human participants is subject to ethical standards that promote and ensure respect for all participants and protect their health and rights.
Since medical research takes place in the context of various structural inequities, researchers should carefully consider how the benefits, risks, and burdens are distributed. Meaningful engagement with potential and enrolled participants and their communities should occur before, during, and following medical research.
7. The primary purpose of medical research involving human participants is to generate knowledge to understand the causes, development and effects of diseases; improve preventive, diagnostic and therapeutic interventions; and ultimately to advance individual and public health.
These purposes can never take precedence over the rights and interests of individual research participants.
https://www.fda.gov/news-events/fda-mee ... n-11082024Individuals who volunteer to participate in clinical research perform a critical role in advancing scientific knowledge. They also support the development of potentially life-saving therapies for patients who need better treatments. The research community has an ethical obligation to ensure that people understand the purpose and the potential risks and benefits of the research before they agree to join a trial.
In addition, the FDA published draft guidance in April 2024, which I hope will be finalized before the end of this year, with the section on Risks excepted below, with emphasis added: Key Information and Facilitating Understanding in Informed Consent: Guidance for Sponsors, Investigators, and Institutional Review Boards: DRAFT GUIDANCE
Reasonably Foreseeable Risks and Discomforts
To help prospective subjects assess risks, interested parties should consider prioritizing key risks from any investigational medical products, research procedures, or other aspects of the study, at the beginning of the information about risks. It may be appropriate in the key information section to present only the most important risks or discomforts based on frequency or magnitude, rather than listing all reasonably foreseeable risks. In clinical studies involving investigational medical products, the possibility that the product may present unknown risks to prospective subjects should generally be included as key information. Information about any potential risks should be explained in detail when possible, including, as applicable, the possibility that participation may not improve or could exacerbate a prospective subject’s condition.
