Informed consent is the process by which a potential study participant agrees to participate in a trial after being provided with information about the study and treatment. It includes an explanation of what’s involved in the trial, the duration of the study, the frequency and length of the required visits, as well as the known risks and benefits associated with the study treatment.
Participation in a clinical trial is completely voluntary. All questions about the study should be answered to the participant’s satisfaction before an informed consent form (ICF) is signed. Participants have the right to refuse participation or to withdraw their consent at any time during the study without penalty.
The wishes and best interest of the participant are considered at all times. Throughout the trial, participants will be provided with any new information that may affect their decision to continue their involvement in the study. In addition, the study physician may withdraw a participant at any time, without consent, if it becomes evident that it’s not in their best interest to continue.
Before you and your child decide whether to participate in research, you must be fully “informed.” It is important for you to understand:
- Your participation is voluntary
- Why the research is being done
- What the researchers want to accomplish
- What will be done and for how long
- What risks are involved
- What possible benefits can be expected
- What other treatments are available
- You have the right to leave the study at any time without interfering with you regular care.