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A Uniquely Vulnerable Group in Need of Oversight and Protection
Children Enrolled in Parents' Research

When investigators propose to enroll their minor children in their own research, a number of ethical concerns arise. Children enrolled in their parents’ research may be entering a situation in which they incur particular vulnerabilities beyond those incurred by other children in the same studies. Unique challenges arise when the role of parent and investigator, and child and research participant, are combined. The investigator-parent’s ability to optimally perform the roles of both investigator and parent is potentially diminished. Specific review by the IRB or another designated unit on a case-by-case basis is warranted in these circumstances. Modification of the permission/assent processes and some research procedures may be necessary. We offer advice both to investigators who consider enrolling their children in their own research and to IRBs asked to consider this possibility.

Key words or concepts: Human subjects research, human research ethics, research with children, vulnerable populations, risks and benefits to research participants

When investigators propose to enroll their minor children in their own research, a number of ethical concerns arise. Children enrolled in their parents’ research may be entering a situation in which they incur particular vulnerabilities beyond those incurred by other children in the same studies. Unique challenges arise when the role of parent and investigator, and child and research participant, are combined. The investigator-parent’s ability to optimally perform the roles of both investigator and parent is potentially diminished. Specific review by the IRB or another designated unit on a case-by-case basis is warranted in these circumstances. Modification of the permission/assent processes and some research procedures may be necessary. We offer advice both to investigators who consider enrolling their children in their own research and to IRBs asked to consider this possibility.

Key words or concepts: Human subjects research, human research ethics, research with children, vulnerable populations, risks and benefits to research participants

Lois L. Shepherd, Katherine Read, and Donna T. Chen, "Children Enrolled in Parents' Research: A Uniquely Vulnerable Group in Need of Oversight and Protection," IRB: Ethics & Human Research 35, no. 3 (2013): 1-8.