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D403.1 Organization Policy on Informed Consent and Pediatric Subjects Who Reach Adulthood While Enrolled in a Human Subjects Research Study

March 2015

It is the policy of the Organization that when a subject enrolled as a child in a research study with parental or guardian consent (as defined in Organization Policy D403) reaches the age of majority during the course of study participation, the subject's participation is no longer governed by 45 CFR 46.408.  The consent of that individual is required unless a JHM IRB determines that the subject's continued participation meets the requirements for a waiver of informed consent.  (See the Office for Human Research Protections (OHRP) statement and JHM IRB guidance for additional information). ).  Investigators may use either the full informed consent document or the abbreviated informed consent document developed by the JHM IRBs specifically for this purpose.

Note that a waiver of consent granted by a JHM IRB for the purposes of this policy does not affect any future right of the subject to withdraw consent as provided in the consent form signed by the parents(s) or guardian(s).  This policy does not apply to subjects whose initial enrollment in the study was pursuant to a waiver of informed consent granted by a JHM IRB.