What is ‘informed consent’ and why is it so vitally important?
This is arguably one of the most critical parts of any clinical trial.
It is the process by which a subject voluntarily confirms his or her willingness to participate in a particular trial, after having been informed of all aspects of the trial that are relevant to the subject’s decision to participate.
What does this mean for me as a patient? Simply put, it means that you have a discussion about the design of the trial with someone at the facility who is conducting the research. This involves all information about the trial: how many other patients will be enrolled, what medication is being tested and why, the outcome of any previous trials for the same medication, how long the trial is expected to last, how often you will need to come for check-ups, what will be expected of you (e.g. diary entries about your condition, etc), what procedures are involved and what risks these may pose to you (e.g. blood tests, x-rays, etc), all of the potential risks involved in participation, known side effects to the medications and how they can be treated if they occur, all of the potential benefits to you if you choose to participate, what chance you have of being given a placebo and what chance you have of being given an active substance, what your treatment options are for your condition should you choose not to participate in the trial, and what happens if you get ill or develop a side effect on the trial. You have the chance to ask as many questions as you need to, and have the right to receive answers and explanations as needed until you are satisfied that you understand.
The purpose of this discussion is NOT to convince you to be on the trial, but to give you the necessary information to make your own decision. There is no obligation to make an immediate decision, and no obligation to agree to be on the trial after this discussion.
You are invited to take a copy of the written informed consent document with all the details of the discussion home with you, and to discuss this with whomever you choose, whether it be your doctor, family member or a friend. If you have more questions, you can contact the study team to make an arrangement to have them answered.
Once you are satisfied that you have all the information you need to make an informed decision, you can choose whether you would like to be on the trial or not. You sign the informed consent form to confirm that you understand the contents and are choosing voluntarily to participate in the trial. But this is not a binding contract; you are free to leave the trial at any time and with no repercussions if you change your mind.
This document is important, but informed consent is not just a piece of paper and a single decision. It is a dynamic, evolving and ongoing process. During a clinical trial a patient has the right to be continually informed about any changes to trial design, any new side effects or benefits or risks that have been found along the way, to have the opportunity to ask questions at any time during the trial, and to choose to withdraw from the trial if they so choose. This is a complicated subject with many moral, legal and ethical facets. We hope that this brief explanation has helped to simplify and summarize it for you. It is also well explained in this video: https://www.youtube.com/watch?v=YXrfW8a3k7E