Conducting research studies with children requires that stringent federal and state regulations are met. In the case presented here, the biological father of a baby disclosed to a researcher that he was 9 years older than the adolescent mother. The research was conducted in a state where statutory rape is defined as sexual contact between a minor and someone 4 or more years older. What obligations do the researchers have to meet, and what are the roles of the various oversight and regulatory bodies charged with ensuring that research is conducted responsibly and ethically?
Commentators Erin Talati Paquette, MD, JD, MBe, and Lainie Friedman Ross, MD, PhD, from the Lurie Children’s Hospital of Chicago and the University of Chicago, respectively, discuss the implications of certificates of confidentiality on the approach to disclosure. Stacy Hodgkinson, PhD, and colleagues from Children’s National Health System consider the implications of this case for the approach to informed consent. Stuart Finder, PhD, from Cedars-Sinai Medical Center, and Stanley Korenman, MD, from the University of California Los Angeles Medical School, discuss the role of the community context and the roles of researchers compared to clinicians.