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Obtaining Informed Consent from Adults Who Were Children When Enrolled in a Human Subjects Research Study
As described in Organization Policy D403.1, individuals enrolled as children with parental or guardian consent must be re-consented when they become adults unless a JHM IRB determines that a waiver of consent can be granted.
A waiver of consent will be considered in those cases in which the subject's continuing participation constitutes no more than minimal risk and meets the other requirements for waiver under 45 CFR 46.116(d), including the requirement that the "research could not practicably be carried out without the waiver." Generally speaking, the JHM IRBs will deem it impracticable to re-consent an adult who was enrolled as a child if there are no additional research interventions or interactions. For example:
- Subjects whose parents gave informed consent for their samples to be entered into a biorepository where those samples remain identifiable (either directly or by linking codes).
- Subjects whose parents gave informed consent for their information to be entered into a database where that information remains identifiable (either directly or by linking codes).
- Subjects enrolled as children in interventional trials with parental consent in which all intervention or interaction prescribed by the protocol, including follow-up visits, has concluded prior to subjects' reaching adulthood.
- All subjects' information has been de-identified pursuant to HIPAA such that their data or any samples collected cannot be linked to their identities.
It is the obligation of Principal Investigators to report to the JHM IRBs at the time of continuing review whether:
- Any pediatric subjects have reached the age of majority during the approval period; and
- Whether those individuals have been re-consented or will be re-consented at their next scheduled interaction with the study team; or
- Whether the Principal Investigator wishes to request a waiver of consent for their continued participation pursuant to the standards outlined in this guidance and the related policy.
The JHM IRBs will document waivers of consent in the convened minutes (when applicable) and in the official correspondence with investigators notifying them of the study's approval for continuation.
Where re-consent is required, investigators may use the abbreviated informed consent document, "Consent for Continued Participation in a Research Study by a Participant Who Has Reached Age 18". When using this form, the participant must be presented with a signed copy of the most recent version of the full informed consent document signed by his or her parent(s). In the alternative, investigators may choose to use the full informed consent document most recently approved by the IRB rather than the abbreviated form.