Informed Consent and Patient Protection
There are many patient protections in place ensure a clinical trials participant’s safety. Every trial must be reviewed and monitored by scientific panels to make sure the risks are as low as possible and are worth the potential benefits. Study participants are also provided with an informed consent form that provides facts and details about the trial.Informed consent is a patient’s bill of rights. This is the process through which you learn the purpose, risks, and benefits of a clinical trial before deciding whether to join. It is a critical part of ensuring patient safety in research. During the informed consent process you learn important information about a clinical trial. This information can help you decide whether to join.
You will be provided with an informed consent document that will give you detailed facts about the clinical trial. The informed consent will explain the purpose of the trial, tests and procedures, schedule, treatments, risks and benefits. It should be written in everyday, non-technical language. If you do not understand something or have questions, be sure to ask the study doctor or nurse to explain it to you.
If you decide to participate in the study, you will sign the informed consent document to acknowledge you understand and agree to all aspects of the study. You are also agreeing that you understand the potential risks and benefits that are involved.
