- Informed consent is the process by which prospective participants in clinical trials
learn about clinical research in order to decide whether they want to enroll in the
study. It consists of meetings and discussions with the health care team.
- Phase I clinical trials are designed to determine what dose of an investigational agent
is safe to administer to patients.
- To study communication, comprehension and decision-making during the informed consent
- To examine ethical, psychological, social, and educational issues regarding informed
- To help researchers understand how to improve informed consent and education about
- Parents or guardians of children with cancer who are being considered for participation
in phase I clinical trials
- Prospective patients for pediatric phase I clinical trials who are between 14 and 21
years of age.
- Members of the research team who obtain consent from patients and families for pediatric
phase I clinical trials
- Research assistants observe and record the informed consent conference held with the
research team and the parents and children.
- After the conference, the research assistant interviews the parents in a private area
about their experience during the conference and their decision-making process. They are
asked about their thoughts and opinions during the informed consent conference,
including the decision-making process, communication and trust in the medical team.
- With their parent's permission, patients are interviewed privately to discuss their
experience during the informed consent conference.
- After parents and patients have made their decision about participation in the study,
they are interviewed again about how they made the decision, aspects of the
communication during the conference, and how they feel about the doctor. This interview
is also recorded.
- Parents may be contacted 6 months to 2 years from the time of their participation to be
part of a parent advisory group about the informed consent process.