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.
You can leave the study at any time. It is your right to withdraw your consent to participate in the trial. Should you decide to leave the trial, you are not required to explain your reasons for leaving.
Federal rules help ensure that clinical trials are run in an ethical manner. A participant’s rights and safety are protected through scientific panels, informed consent and ongoing monitoring throughout the trial.
All trials must be reviewed and approved by an Intuitional Review Board (IRB). An IRB is an independent committee of physicians, statisticians, community advocates and others who ensure the clinical trial is ethical and the rights of the participants will be protected. Federal rules require that each IRB be made up of at least five people with one from outside the institution running the trial.
Phase III trials are monitored by Data and Safety Monitoring Boars (DSMBs). DSMBs monitor the trial to help ensure your safety. This is also an independent committee made up of statisticians, physicians and other experts. The Board must ensure:
- Any risk that comes from being in the study is reduced as much as possible
- The data is sound
- A trial is stopped is safety concerns come up or as soon as objectives have been met