Federal rules help ensure that clinical trials are run in an ethical manner. Your rights and safety are protected through:
Informed consent is a 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.
The research team, which is made up of doctors and nurses, first explains the trial to you. The team explains the trial's:
They will also discuss your rights, including your right to:
Before agreeing to take part in a trial, you have the right to:
After discussing all aspects of the study with you, the team gives you an informed consent form to read. The form includes written details about the information that was discussed and also describes the privacy of your records. If you agree to take part in the study, you sign the form. But even after you sign the consent form, you can leave the study at any time.
Most clinical trials have to go through different types of review that are designed to protect all people who take part. These reviews are conducted by scientific review panels, Institutional Review Boards (IRBs), and Data and Safety Monitoring Boards (DSMBs).
Scientific Review Panels
This panel is made up of experts who review a clinical trial protocol before it starts accepting patients to make sure it is based on sound science. All clinical trials that are funded by the Government must go through this review.Many other clinical trial sponsors, such as drug companies, also seek expert advice on the scientific merit of their trial protocols.
Institutional Review Boards
This board also reviews a clinical trial protocol before it starts accepting patients. The board members make sure the risks involved in the trial are reasonable when compared to the possible benefits. They also closely watch the ongoing progress of the trial from beginning to end.
Federal rules require that each IRB be made up of at least 5 people. One member must be from outside the institution running the trial. IRBs are usually made up of a mix of medical specialists and members of the community. Many include members from diverse careers and backgrounds. In most cases IRBs are located where the trial is to take place. Many institutions that carry out clinical trials have their own IRBs.
Data and Safety Monitoring Boards (DSMBs)
For phase III trials, DSMBs monitor the trial to help ensure your safety. They may also be appropriate and necessary for certain phase I and II clinical trials. A DSMB is an independent committee made up of statisticians, physicians, and other experts.
The Board must:
Source: The Web site of the National Cancer Institute (http://www.cancer.gov)