Research
Informed Consent in Pediatric Phase I Cancer Trials
Protocol Description
This multi-center project focuses on informed consent, the process by which a person learns about a clinical trial to help make a decision about participation. Through this project, researchers will observe how a clinical trial is explained to parents/guardians and the patient being considered for participation. A multi-disciplinary research team will then examine the ethical, psychological, social and educational issues regarding informed consent with a goal of improving informed consent and education about clinical research.
Eligibility Criteria
This study will be available to children, ages 14 to 21, who are being considered for a Phase I cancer study and their parents/guardians. While this age range is reflected below, participation is also open to parents/guardians of all pediatric patients being considered for a Phase I cancer study, regardless of the child’s age.
Boys: Age 14 to 21
Girls: Age 14 to 21
Requirements
Research assistants will observe and record the Phase I cancer study informed consent conference held with parents/guardians and children. Afterwards the assistant will interview parents/guardians and patients about the consent conference experience. When families have decided whether to participate in the cancer study, they will be interviewed, again, about how they arrived at their decision. Parents may be contacted 6 months to 2 years from the time of their participation to be part of a parent advisory group about informed consent.
Visits: Only the initial cancer study informed consent discussion
Duration: Not applicable
Status: Open for Enrollment
Sources of Support
National Cancer Institute
Additional Resources
Study description at National Institutes of Health
Primary Investigator(s)
Robert Noll, PhD
Contact Information
Amy Hamilton, BS
Monica Vanderslice
412-864-8732
