Once you decide to participate, you will be provided with a written document called an informed consent. It will explain the study in detail. After you have reviewed the consent and have had a chance to have your questions answered, you can decide whether you would like to see if you qualify to be in the study.
If you and the study physician decide this study might be right for you, you will be scheduled for a screening visit to see if you qualify. Whether or not you participate is entirely up to you, and you can withdraw from the study at any time.
Participants must give consent to participate in a clinical research study and be willing to comply with all study requirements.
An Institutional Review Board (IRB), which is an independent group of experts, must supervise and monitor each clinical trial to ensure that a patient’s rights are protected and that the study does not pose any undue or unnecessary risk to the patient’s safety. Any and all volunteers who wish to participate in a clinical trial must also be provided with an informed consent statement that presents the details of the research study. These include the length of the study, what medical procedures may be performed, the possible medicine used, the number and frequency of visits, what will happen at those visits, the potential benefits of the treatment, and possible side effects. The informed consent also advises that the patient has the right to withdraw from the study at any time and for any reason. Prior to being included in a study, the volunteer must sign the informed consent.