Before you take part
Before you take part in a clinical trial
Before you decide to participate in a clinical trial, it’s important to understand what’s involved. Clinical trials, also known as medical studies, are research studies conducted to test new treatments, diets, or medical devices. As a participant, you play a crucial role in advancing medical knowledge.
Understanding the clinical trial
Researchers and clinical trial teams are legally and ethically obligated to provide you with comprehensive information about the trial before you consent to participate. This includes details about:
- Objective of the Trial: What the researchers hope to study and the expected results.
- Treatment Groups: An explanation of different treatment options or groups within the trial.
- Risks and Side Effects: Potential risks and side effects you might experience during the trial and how these are going to be monitored and managed.
- Potential Benefits: Any possible benefits of participating, which might include access to new treatments.
- Testing and Check-ups: Information about any tests, check-ups, or procedures you will undergo.
- Follow-up Schedule: The frequency and duration of follow-up appointments.
- Sample Collection: If researchers plan to retain any blood, tissue, or other samples for future research.
- Treatment Location: Where the treatment will be administered, and whether hospital stays are required.
- Your right to withdraw from the clinical trial at any time: Remember, you have the right to withdraw from the trial at any time, without needing to provide a reason. This decision will not affect your ongoing care or access to standard treatments.
Patient Information Leaflet (PIL)
A detailed guide, known as the Patient Information Leaflet (PIL), is provided to all potential participants. This document includes all the information mentioned above and should be reviewed thoroughly.
A member of the research team will discuss the contents with you and provide a copy for you to take home.
It’s a valuable resource for making an informed decision and can be shared with your friends, family, GP, specialists, or nurses for further discussion.
Consenting to the Clinical Trial
Before entering the clinical trial, you must sign a statement to say you have been told, and understand, what taking part in the trial means. This is called informed consent. Consent is a cornerstone of participating in a medical trial. You will be asked to sign an informed consent form, which is a formal agreement indicating that you understand the trial and its implications. This process involves:
You can’t enter a trial without signing your agreement. You will have a chance to ask any questions you like if there is anything you don’t understand. You may want to bring someone along with you to help make sure all your concerns are addressed. Please remember that you can say no to joining the trial if you don’t want to. It is entirely voluntary.
Informed consent is an ongoing process throughout the trial. So you should always be able to ask questions, and get answers to them, while you are in the trial.
Connect to Clinical Trial teams and request information
Participation in a medical trial is a decision that should be made with full understanding of the trial’s purpose, procedures, risks, and benefits. Connect to the clinical trial teams to request all the information. Then take your time to review all the information, discuss with trusted individuals, and feel comfortable with your decision, whether it’s to participate or not. Your involvement could contribute to vital medical advancements and potentially benefit many others in the future.