Researchers are required by law to obtain informed consent from patients or their legal representative before giving treatment within a clinical trial.
You will be asked to sign a Clinical Trial Informed Consent Document, which is written in lay language and has been vetted and approved by the local research ethics committee.
This document describes the study’s purpose, duration, required tests, treatment and follow-up protocol, potential risks and benefits, and investigator contact details.
You have a right to see and keep a copy of the complete clinical trial protocol document before consenting to your child’s recruitment to the trial.
The Informed Consent Process
Before consenting to your child’s enrolment in a clinical trial, the researchers must give you sufficient information that you can make an informed decision. The informed consent process aims to ensure you feel comfortable with your decisions, and can comply with treatment.
The doctor will first explain all appropriate treatment options for your child. They will clearly identify any options considered experimental, and discuss them with you, comparing side effects, risks and benefits of each option.
The research assistant (usually a nurse) will go over the study with you again. You will also be given a copy of the Informed Consent Document to review. Translations can be provided if your native language is different from the study protocol. Accessible formats should also be offered.
Carefully review all the information before deciding which treatment to pursue. Take the document home to read and think about it before you give consent.
If you don’t understand part of it, ask questions until you feel confident that you understand and agree with the consent form. Your questions should be answered in plain language. If they are not, ask for clarification.
You have the right to ask for a copy of the complete clinical trial protocol, and you should not feel pressured to enrol your child in the research study.
Second Opinions
You are the expert on your child and their care, but retinoblastoma is complex. No matter how much you read medical
A second opinion can help you assess your child’s options, especially if you are unsure about which to pursue. Even if you have total confidence in your child’s doctor, don’t hesitate to seek a second opinion. Explain your concerns to the doctor, and ask for their support. A conscientious doctor will embrace your request, and give recommendations.
Be careful not to delay treatment when seeking second opinions. Your child’s cancer may be threatening her life. Do not keep asking for second opinions in the hope that you will be offered an alternative treatment, especially if your child’s doctor has recommended that the eye be removed.
The longer you put off treatment, the greater the risk becomes to your child. Retinoblastoma that has spread beyond the eye has a very poor chance of cure, even in developed countries.
For more information on seeking a second opinion, click here.
Withholding and Withdrawing Consent
Participation in clinical trials is voluntary. You have the right to withhold consent, and the doctors must respect your wishes. Your child will still be given the best possible care.
You have the right to remove your child from the trial at any time during or after treatment, without fear of reprisals. Your child will still receive the best possible care. If you have questions or concerns after you have given consent, discuss them with the doctors as soon as possible so they don’t become stressful burdens.
However, explaining your reasons can help the doctors understand your concerns so they can give the best advice to protect your child. Your concerns can also give them valuable insight that may help them improve clinical trial research.
Further Resources
These resources are available on our website:
