Participation in Studies
Why You Should Participate
Participation in clinical trials is completely voluntary – it is up to the discretion of each patient to determine if participation is a viable option for his or her unique situation. Learn more about the benefits and risks of participation:
- Gain access to potentially new research treatments
- Receive expert medical care for the condition being studies, since investigators (physicians) are often specialists in the disease being studied
- Help others by contributing to medical research and treatment advances
- There may be unpleasant, serious, or even life-threatening side effects resulting from treatment
- The treatment may not be effective
- Participation in the trial may be demanding and time consuming
Many safeguards are in place to make clinical trials as safe as possible and protect patients. Therapies are carefully studied in the lab long before a human being ever receives a new therapy. Any clinical trial involving people must be approved by the Institutional Review Board (IRB). The IRB is made up of doctors from different specialties, ethicists, administrators, and members of the public. An IRB is required by the U.S. Food and Drug Administration (FDA) to ensure the protection of the rights and welfare of patients who are enrolled in clinical trials.
Choosing to Participate
It is always your choice to participate without affecting your standard care. In turn, you may change your mind at any time for any reason, once you area in a study.
Informed consent is a process of learning the important facts about the clinical trial to help people decide whether to participate. After learning about the study, participants will be able to ask the researcher or his/her research staff questions. People should only agree to take part in a study if they clearly understand the study and feel comfortable. If they agree to take part in the study, they will be asked to read and sign an "informed consent form". Signing the form does not require patients to stay in the study.
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