CLINICAL TRIALS OF MEDICAL TREATMENTS: HOW AM I PROTECTED?

Informed Consent
To help you decide if you want to be in a study, FDA requires that you be given complete information about the study before you agree to take part. This is known as informed consent. FDA requires that people be told:
* that the study involves research of an unproven drug or device
* the purpose of the research
* how long the study will take
* what will happen in the study and which parts of the study are experimental
* possible risks or discomforts
* possible benefits
* other procedures or treatments that you might want to consider instead of the treatment being studied
* that FDA may look at study records, but the records will be kept secret
* whether any medical treatments are available if you are hurt, what those treatments are, where they can be found, and who will pay for the treatment
* the person to contact with questions about the study, your rights, or if you get hurt
* you can quit at any time.

Informed consents must be written so you can understand it. If you don't, be sure to ask the doctor or other medical person to explain it. Make sure you understand all of it before you agree to be in the study.
Before you can be in the study, you must sign the informed consent form, showing that you have been given this information and understand it. The informed consent form is NOT a contract and you can leave the study at any time, for any reason.

Other Ways Volunteers Are Protected

Institutional Review Boards (IRBs)
Scientists, doctors and other people from the local community serve on IRBs to review and monitor their hospital's or research institution's medical research involving people. They monitor studies to help make sure that there is the least possible risk to volunteers and that the risks are reasonable in relation to the expected benefits. IRBs make sure volunteer selection is fair and that informed consent is done correctly.

Data Monitoring Committees
These committees are used mainly when one treatment is being compared with another. These committees are particularly important in tests of treatments for serious or life-threatening disease. These experts review information from studies to make sure they are being done in a way that is safest for the volunteers. During a study, if the committee finds that the treatment is harmful or of no benefit, it will stop the study. If a study shows that one treatment works better than another, the committee stops the study and all volunteers are offered the better treatment.

FDA Inspections
FDA inspects records and various scientists, clinics, and other research sites involved in a study. The agency does this to make sure volunteers are being protected and studies are being done correctly. From time to time such inspections are done in response to complaints.