To examine how neonatologists determine which risks require inclusion for informed consent per the ‘Common Rule’ and ‘Draft Guidance’ regulations in comparative effectiveness research (CER).STUDY DESIGN:
Neonatologists active in research were invited to complete an online survey. Questions focused on clinical practices for treating hyperbilirubinemia in premature infants and about risk disclosure related to a hypothetical randomized trial.RESULTS:
Response rate was 57%. 43% were primarily researchers; 31% primarily clinicians. 69% had conducted CER. 81% thought hypothetical study enrollment was not riskier than receiving routine care. 76% labeled the study ‘minimal risk’ by comparing study risks to clinical care risks. Respondents would not currently disclose many of the treatment risks but would disclose more if the Draft Guidance were enacted into law.CONCLUSION:
Findings suggest the Draft Guidance requires disclosure of more risks than does the Common Rule; applying either rule results in disclosure of more risks than in standard clinical care.