There are several safeguards for volunteer protection built into the clinical trial process. The protocol provides the physician with information on how the product must be used, what safety tests will be performed, and how often the volunteer must come to the clinic during the trial. A volunteer has the right to know as much information about the trial as is necessary to make a decision to participate. Therefore, volunteers are encouraged to ask the doctor and the research staff questions or to provide more details. The IRB, which is composed of physicians, scientists and lay people, helps determine that the study poses no unnecessary risks to the volunteer.
People participate in clinical trials for many reasons.
Volunteers can gain access to promising drugs and medical devices long before they are approved for the marketplace. Also, in drug trials, the product is typically supplied to the volunteer at no charge. And, as stated above, there is usually no charge for study-related exams, tests and procedures. Some people volunteer because they enjoy being at the forefront of new technologies. Others participate for humanitarian reasons - helping to gather information on diseases, drugs and medical devices that could potentially impact the lives of millions of people.