Proposed Revisions to the Common Rule: Perspectives of Social and Behavioral Scientists: Workshop Summary by Robert Pool

Author:Robert Pool
Language: eng
Format: epub
ISBN: ISBN0309288266
Publisher: The National Academies Press

Waiver of Guardian Permission

An issue specific to minors is the waiver of guardian participation, Fisher noted. Emancipated minors are adolescents who are supporting themselves and who are, under the laws of their state, considered adults; they may themselves be parents. Mature minors are those adolescents who by state law can independently and without parental permission gain access to health or mental health services. Under federal regulations, both emancipated and mature minors are considered to be adults. However, Fisher said, most states do not include language specific to research participants in their emancipated and mature minor laws, and “this has been incredibly confusing to IRBs because they don’t know whether or not they should require parental permission.”

As a result, she said, IRBs often needlessly require guardian permission for minors’ involvement in research related to treatment and procedures for which they’ve already obtained a legal right to adult status. For example, an adolescent who can go to a clinic and get sexual health treatment or prescriptions independently under the mature minor rule may still be required by an IRB to get parental permission to participate in a survey that asks about his or her experiences. This requirement could deprive adolescents of their rights and of the potential benefits of research participation, Fisher said.

Waiver of guardian permission is also relevant to Section 46.116 of the Common Rule, which discusses procedures to ensure that “waiver or alteration will not adversely affect the rights and welfare of the subjects.” When studies involve children and adolescents—and some other vulnerable populations—IRBs often overreact when considering what the participants actually understand, Fisher said. However, there is a considerable body of developmental research that can be used to determine whether subjects can give an independent consent, so IRBs should use “evidence-based literature to evaluate whether or not an age group has an understanding of their rights and research procedures.”

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