Rockville, August, 2023. FDA revised and issued “Informed Consent: Guidance for IRBs, Clinical Investigators, and Sponsors”.
The document represents finalized guidance, superseding the first guidance issued in September 1998, and updating draft guidance from July 2014. The document first provides general guidance information on FDA’s regulatory requirements for informed consent, then includes a review of the roles of IRBs, clinical investigators, sponsors, and FDA related to informed consent, and ends with a series of frequently asked questions. In addition to the general informed consent guidance information, it also covers specifics and exceptions not covered in the earlier 2014 draft, such as on avoiding coercion and exerting undue influence on subjects, making consent language more understandable to the subject or the legally authorized representative, avoiding the use of exculpatory language, and also additional IRB financial arrangement responsibilities. The frequently asked questions section covers a myriad of enrollment issues facing many medical device clinical studies today including enrollment of children, non-English speaking, low literacy, and those with disabilities, and or impaired consent abilities. For a complimentary copy of the guidance, click here.
If you’re interested in discussing your upcoming medical device clinical study plans with a CRO Group consultant and would like to review how CRO Group may be of assistance in meeting the new FDA guidance, click here.