Research Subject's Bill of Rights

As someone being asked to volunteer as a subject in a clinical research study, I have the following rights:

• to be told what the study is trying to determine;
• to be told what will happen to me, including the procedures, drugs and devices that will be used, and whether any of these are different from what would be used in standard practice;
• to be told about the risks, side effects, or discomforts that may be expected from the research;
• to be told if I can expect any benefit from being in the study, and if so, what the benefit might be;
• to be told about the other alternatives I have and how they may be better or worse than taking part in the study;
• to be told what kind of medical treatment is available if any medical problems arise;
• to ask any questions about the study before I agree to take part and during the course of the study;
• to choose not to take part at all or to change my mind and withdraw from the study after it is started. My decision will not affect my right to receive the care I would receive if I were not in the study;
• to receive a copy of the signed and dated consent form; and
• to be free of any pressure when deciding whether I wish to participate in the study.

If you have any questions about the research, feel free to talk with your doctor or one of the researchers or research nurse coordinators. If you have any questions or comments about your rights as a research subject, the hospital has a department that you should call. This department, called the IRB Office, exists to protect your rights.

Washington Adventist Hospital IRB Office – (301) 891-6624

The Center for Cardiac & Vascular Research Washington Adventist Hospital 7600 Carroll Avenue, 6th Floor Takoma Park, MD 20912 (301) 891-6226 / 1-866-894-CCVR