Upcoming Calls For Public Consultation      

INSERM – Public consultation of the Global Ethics Charter for the Protection of Healthy Volunteers in Clinical Trials
   The draft Charter is open for public comments up to March 30, 2024. 
Download the draft Charter (pdf, 201 Ko)  [Attached with response template]
The « Global Ethics Charter for the Protection of Healthy Volunteers in Clinical Trials » is a key deliverable of the VolREthics initiative that was set up to promote ethical guidelines to protect healthy volunteers in biomedical research.
…The central ethical question raised by the involvement of healthy volunteers in biomedical research is that of respect for the person’s free will to decide to participate in the research, without any direct or indirect pressure. Another ethical imperative is to ensure the safety and well-being of the healthy volunteers both during and after the research. This is because all biomedical research involves a certain number of risks that, even if kept to a minimum by the researchers and authorities, can never be ruled out entirely. The two main risks to which healthy volunteers are exposed are:
:: That of being exploited in a context of vulnerability, for example economic, educational, cultural or related to age…
:: That of experiencing adverse events during or after the study in which they are taking part.. 

Key Information and Facilitating Understanding in Informed Consent; Draft Guidance for Sponsors, Investigators, and Institutional Review Boards
21 CFR Part 50  [Docket No. FDA-2022-D-2997] Comments due: May 1, 2024
SUMMARY:
   The Office for Human Research Protections, Office of the Assistant Secretary for Health (OHRP), and the Food and Drug Administration (FDA) are announcing the availability of a draft guidance entitled “Key Information and Facilitating Understanding in Informed Consent.”
This draft guidance provides recommendations related to two provisions of the revised Federal Policy for the Protection of Human Subjects (the revised Common Rule) by the U.S. Department of Health and Human Services (HHS) and identical provisions in FDA’s proposed rule “Protection of Human Subjects and Institutional Review Boards.” FDA’s proposed rule, if finalized, would harmonize certain sections of FDA’s regulations on human subject protections and institutional review boards (IRBs), to the extent practicable and consistent with other statutory provisions, with the revised Common Rule, in accordance with the 21st Century Cures Act (Cures Act). The guidance addresses the provisions of the revised Common Rule that require informed consent to begin with key information about the research and to present information in a way that facilitates understanding and identical provisions in FDA’s proposed rule.