Higher-hazard, no benefit research involving children: parental perspectives

Objectives: US regulations allow local institutional review boards to approve greater than minimal risk, no-benefit research when the research enrolls children with the condition under study but not when it enrolls healthy children. We aim to describe the opinions of parents regarding higher-hazard, no-benefit research

Methods: Quantitative and qualitative interviews with parents of children without heart disease or chronic medical conditions (no heart disease [noHD], n = 30), children with fully correctable heart disease (FCHD, n = 30), and children with life-altering heart disease (LAHD, n = 30).

Results: Parents of children with heart disease endorse higher-hazard, no-benefit heart disease research more strongly than noHD parents. Eight of 30 noHD parents, 19 of 30 FCHD parents, and 26 of 30 LAHD parents reported willingness to enroll their children in a heart disease research study involving an otherwise unnecessary chest radiograph (P < .01). There was no difference among groups in willingness to enroll their children in a similar study focused on childhood cancer. Twenty-two of 30 FCHD and 30 of 30 LAHD parents reported that parents have a responsibility to enroll their children in medical research to help future children with heart disease. Twenty-one of 30 noHD parents, 29 of 30 FCHD parents, and 30 of 30 LAHD parents feel able to evaluate the risks of medical research (P = .01).

Conclusions: Parental opinions regarding higher-hazard, no-benefit research align with federal regulations. Parental willingness to enroll their children in higher-hazard, no-benefit research is driven in part by a sense of obligation to a community of families affected by childhood heart disease.