- IRB: ETHICS & HUMAN RESEARCH
Children Enrolled in Parents’ Research: A Uniquely Vulnerable Group in Need of Oversight and Protection
We could find no formal guidance that addresses these questions. The federal regulations governing federally funded research or research on investigational drugs, while containing somewhat detailed rules about the permissibility of research on children generally, do not address the situation of an investigator’s own child participating in his or her parent’s research. The Office for Human Research Protections (OHRP) does not appear to have issued any formal guidance on the matter. Nor do any of the OHRP determination letters from 2004 to 2011 mention the recruitment or enrollment of children in their parents’ research.4Further, a review of institutional Web sites for the top 10 National Institutes of Health–funded institutions of 2009 revealed no guidance or even notice of this practice.5Finally, a comprehensive literature search indicates that, when theNew York Timesarticle appeared, this practice had received little, if any, academic or professional attention.6
The lack of serious attention given to this issue to date might indicate that the practice is either exceedingly rare or only occurs in the most innocuous of circumstances. More likely it has simply escaped scrutiny. History reveals a long practice of researchers conducting research on their own children, from Jonas Salk, who injected his children with his polio vaccine, to Jean Piaget, who developed theories of childhood development based in part on systematic observations of his own children.7The recentNew York Timesarticle indicates that this tradition of conducting research on one’s own children continues today, as does anecdotal evidence gathered by asking colleagues at various institutions. The anticipated pressures of tomorrow’s research environment will continue to make the child of a researcher8an especially attractive recruit—he or she is easily accessible, may be predisposed to participate, is apt to show up for appointments, and does not require costly, formal recruiting tactics. The issue then is unlikely to go away.