Informed consent is more than just a form; it is a process that actively involves the participant. It is an "ongoing exchange of information between the investigator and [participant]" per the OHRP.

Conversations about clinical trial diversity have finally gone mainstream, but the numbers haven’t quite caught up. Improvement may rely on homing in on one key aspect: informed consent. “Informed ...

Thank you for reminding the research and scholarly community of the fundamental importance of striving to obtain each subject’s true informed consent prior to her or his participation in research ...

Informed consent remains critical in healthcare, and over the last several years, there have been multiple updates from agencies and commissions providing clarifications. Most recently in April 2024, ...

The FDA issued “Informed Consent Guidance for IRBs, Clinical Investigators, and Sponsors” that supersedes its 1998 guidance and finalizes its 2014 guidance. The guidance outlines the primary ...

Potential research subjects must be accurately informed of what a project involves, and given the opportunity to decide of their own free will whether or not to participate. This process may be brief ...

Failure to obtain informed consent can result in significant consequences Exceptions to informed consent apply only in limited circumstances Elements of valid informed consent include patient capacity ...

In a cross-sectional study, ChatGPT demonstrated variable effectiveness in generating informed consent forms for treatment with energy-based dermatologic devices, highlighting the need for expert ...