Joining a clinical trial is an important decision. Most participants come to the clinic with questions about clinical trials and what joining one could mean.
This is why every study involves an informed consent process. Informed consent is the process of ensuring a potential participant fully understands the details of a clinical trial — and their role in a study — before they join. Throughout a study, participants will also be notified of any changes to the study that may affect them.
To help someone decide whether or not to participate, the clinical staff involved in a trial explain the details of the study to the potential participant. The staff member will explain what could happen during a clinical trial and what is required of participants. This includes the time commitment, length of the study, required study-related exams, and the number of clinic visits, phone calls, and/or diary entries required.
During this process, potential participants also learn about the product being studied and potential side effects and/or benefits. In some studies, participants may receive an inactive placebo. Velocity even conducts interview-only studies that do not involve medications. After the participant fully understands their role in the study, they must sign the consent form before they can join a study.
There is no pressure to join a clinical trial. Participants always join voluntarily. Informed consent is not a contract, and the participant may leave a study at any time and for any reason.
Participants should have the capacity and ability to make decisions for themselves, or for those dependent on them for directing their care. In some cases, such as pediatric clinical trials, a parent or guardian is required to give informed consent for their child’s participation in a clinical trial.
What Happens After the Informed Consent Form is Signed?
After the informed consent form is signed, participants can begin their clinical trial journey. Throughout the clinical trial, the clinical staff will continue to give updates as information about the study — or the product being studied — becomes available. Again, participation is voluntary and patients may leave a study at any time.
For further reading about clinical trials and the informed consent process, visit:
- https://velocityclinicaltrials.com/what-is-a-clinical-trial/
- https://velocityclinicaltrials.com/checklist-questions-to-ask-before-joining-a-clinical-trial/
- https://www.fda.gov/patients/clinical-trials-what-patients-need-know/informed-consent-clinical-trials
