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Policy on Informed Consent and Pediatric Subjects Reaching Adulthood
March 31, 2015
The Office for Human Research Protections (OHRP) in DHHS has long noted that informed consent should be viewed as an ongoing process during the conduct of a human research study. Consistent with that view, and with OHRP’s recommendations on subjects reaching the legal age of consent, we are implementing a policy governing obtaining informed consent from individuals enrolled in studies as children who reach adulthood while their participation is ongoing. This policy and an accompanying guidance set forth that informed consent must be obtained from these individuals unless the IRBs are able to waive consent for their continued participation as permitted by the applicable regulations. Investigators will be prompted as part of their continuing review submissions to detail whether any subjects reached adulthood during the study’s last approval period, and whether they will be seeking consent from them or requesting a waiver of consent be granted by the IRB.
I recognize that many investigators already obtain consent from such individuals where intervention continues into their adulthood, as is consistent with good practice. In order to simplify the process, we are also posting for use a new abbreviated informed consent template to be used specifically in these instances. Investigators may choose to use this form, to be presented in tandem with a copy of the consent form signed when the individual was a child, or they may use the most recent IRB-approved version of the consent form in order to obtain consent.
Additionally, for investigators whose studies use CRMS, the system will be sending reminder emails alerting study teams that an individual on-study will soon be reaching the age of 18.
Daniel E. Ford, M.D., M.P.H.
Vice Dean for Clinical Investigation