Federal rules help ensure that clinical trials are run in an ethical manner. Your rights and safety are protected through:
- Informed consent
- Careful review and approval of the clinical trial protocol by two review panels. These panels include:
- A scientific review panel
- An institutional review board (IRB)
- Ongoing monitoring provided during the trial by:
- The IRB
- Data and Safety Monitoring Boards (DSMBs)
- Your research team
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:
- Tests and procedures
- Risks and benefits
They will also discuss your rights, including your right to:
- Make a decision about participating
- Leave the study at any time
Before agreeing to take part in a trial, you have the right to:
- Learn about all your treatment options
- Learn all that is involved in the trial - including all details about treatment, tests, and possible risks and benefits
- Discuss the trial with the principal investigator and other members of the research team
- Both hear and read the information in language you can understand
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:
- Ensure that any risks that come from being in the study are reduced as much as possible
- Ensure that the data are sound
- Stop a trial if safety concerns come up or as soon as its objectives have been met