When a subject begins the study as a minor and then becomes an age of majority, does that subject need to be “re-consented” on the IRB-approved informed consent document as an adult?
From a discussion with the FDA, the response is yes. The minor should be re-consented using the approved informed consent document for an adult providing informed consent.
The FDA goes on to state that while the regulations do not specifically address the issue of what should be done once a minor reaches the age of majority (as defined by that state’s law), it is clear per 21CRF50 that legally effective informed consent is required. Once a minor reaches the age of majority, the informed consent provided by the legal guardian would not be considered “legally effective informed consent” for a research subject who has now reached the age of majority.
As with all elements surrounding the discussion of informed consent, it would be prudent to document the discussion you had with the minor subject (and his or her legal guardian) that the process of “re-consenting” would be the plan when the minor reached the age of majority. Additionally, having a system at the site to track the time when the minor would be of age to need to be re-consented would be very helpful.
You can also try:
- Noting the date on a calendar (paper or electronic);
- Placing a note on the visit date of the source documentation page that corresponds with the subject’s next visit.
Reference: Good Clinical Practice: A question and Answer Reference Guide 2010
Disclaimer: This article and the SCRS website are public resources of general material and do not constitute legal or professional advice.