Related Experiment Videos
Informed consent in the Childrens Cancer Group: results of preliminary research
E D Kodish1, R D Pentz, R B Noll
1Department of Pediatrics, Rainbow Babies and Childrens Hospital of University Hospitals of Cleveland, Ohio 44106, USA.
Insights
Pediatric cancer research consent is vital. Parents found the process helpful but confusing, while clinicians expressed dissatisfaction, highlighting a need for improved communication strategies.
Area of Science:
- Pediatric Oncology
- Clinical Research Ethics
- Informed Consent
Background:
- Informed consent is essential for ethical pediatric cancer clinical research.
- Limited research has explored the nuances of this process in pediatric oncology.
Purpose of the Study:
- To evaluate parental and clinician experiences with the informed consent process in pediatric cancer clinical trials.
- To identify areas for improvement in communication and understanding during consent.
Main Methods:
- A survey of principal investigators (PIs) at 113 Children's Cancer Group (CCG) centers.
- Detailed interviews with 23 parents and 23 clinician-investigators at 5 CCG institutions regarding informed consent for pediatric cancer trials.
Main Results:
- Parents found the informed consent process helpful but somewhat confusing, with discussions with staff being more valuable than documents.
- While most parents felt the amount of information was appropriate, nearly 50% of clinicians believed too much information is usually provided.
- Clinician-investigators cited parental "state of shock" as a major obstacle to effective informed consent.
Conclusions:
- Parents generally reported satisfaction with the informed consent process, contrasting with clinician dissatisfaction.
- Future research should expand to more centers, include diverse participants (enrolled and declined), examine minority subgroups, and further investigate clinician-parent interactions during consent.
Background:
Informed consent is critical to the ethical conduct of pediatric cancer clinical research. Research regarding such consent has been limited.
Methods:
After conducting a background survey of institutional practice from principal investigators (PIs) at 113 Childrens Cancer Group (CCG) centers, the authors obtained more detailed data regarding informed consent from 23 parents of children recently enrolled in CCG research trials and from 23 clinician-investigators at 5 CCG institutions.
Results:
Approximately 73% of PIs responded to the background survey, providing context in which to interpret the more detailed information. Parents reported that they found the informed consent process helpful, although somewhat confusing. Satisfaction with informed consent was not related to ethnicity or education level. Parents found discussion with staff more helpful than the consent document, and the majority reported that the amount of information conveyed was appropriate. Although only 3 parents (13%) reported that too much information was given, nearly 50% of the investigators believed too much information usually is provided. All investigators believed that patients benefit from participation in CCG studies; the majority recommend that the child be enrolled on study, and the majority believe the major obstacle to good informed consent is parents' "state of shock."
Conclusions:
Parents expressed general satisfaction with the consent process. By contrast, clinician responses indicate dissatisfaction with the informed consent process. Future research must include more centers and larger numbers of parents of children who we enrolled as well as those who declined to participate in CCG studies, examine consent in minority subgroups, and further investigate the role of clinician-investigators and their interaction with parents and children during the informed consent process.