Informed Consent means you fully understand the tests, therapy, follow-up, risks and benefits before allowing your child to receive the treatment.
When your child is receiving treatment as part of clinical research, you have a right to see and keep a copy of the complete protocol document before signing the informed consent form.
To fully understand the clinical trial treatment proposed for your child, here are some valuable questions to ask the investigating doctor or research assistant.
Study Design
- What is your question or hypothesis?
- What is the phase and purpose of this study?
- What are the eligibility criteria?
- Does my child qualify?
- Are you comparing several different treatments?
- If there is only one treatment, how will you measure success?
- Will my child be removed from the trial if the treatment fails?
- How many children do you plan to recruit onto the trial?
- How long will the study last?
Tests, Treatment and Follow Up
- Who will be in charge of my child’s care?
- Is this an experimental or standard therapy?
- What tests and treatments will be done?
- How do these differ from other treatments?
- What are the possible benefits?
- What are the possible side effects and risks?
- What are the possible long-term side effects?
- How do these perceived benefits, side effects and risks compare with other recommended therapies my child could receive?
- What will happen if my child has side effects?
- How long has this protocol been used for retinoblastoma? On how many children with what stage of cancer? With what results so far?
- How will this treatment affect my child’s quality of life, during and after treatment?
- Will the study require more hospital visits and tests than other treatments?
- How long will treatment last?
- How does this schedule compare with other options?
- What is the follow-up protocol?
- Is long term follow-up part of the study?
Administration
- Who is the sponsor?
- Who is the lead investigator?
- Is the investigator being paid to lead this research?
- Who monitors patient safety?
- Who reviews the research and how often?
- If my child fails treatment, how will that be recorded in the data?
- Will results of the study be made public, and if so, when?
- Have insurers been reimbursing costs of this treatment?
- Can I have a copy of the full clinical trial protocol?
