On August 15, 2023, the U.S. Food and Drug Administration (“FDA”) released final guidance on informed consent for clinical investigations (“Final Guidance”). This update follows FDA’s draft guidance, which was issued in July 2014, and supersedes the FDA’s “A Guide to Informed Consent,” which was issued in September 1998. The Final Guidance is intended to assist clinical research stakeholders, such as institutional review boards (“IRBs”), investigators, and sponsors, in complying with FDA’s informed consent regulations for clinical ...
One of the issues with which we often grapple in the telehealth space is the relative lack of availability of studies and data when compared to other areas of the health care sector. Telehealth is relatively young and therefore has not had the time to build a voluminous body of data and evidence. But things are changing. Many stakeholders are doing exemplary work in telehealth research, and stakeholders like the Department of Veterans Affairs have longstanding evidence regarding the efficacy of telehealth. However, it’s a more recent document that has caught my attention.
A ...
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