ABA Family Legal Guide

Health-Care Law

Regulating Health-Care Professionals

Research on Humans

How do I give informed consent?

Your informed consent to be a research subject most likely will be in written form and include eight parts:

1. An explanation of the research, including how long you would be expected to participate, a description of the procedures to be done and which of the procedures are experimental.

2. A description of any risks or discomfort you might be expected to experience.

3. A description of any possible benefits to you or to others that may come out of the research. It is important to remember that any benefit of an experimental procedure or drug is highly speculative. The reason why the researcher is conducting the experiment is because the researcher does not know if it is beneficial, and wants to find out. You should be highly suspicious if the described benefit is any more than merely having an additional medical exam or two. Getting "free" medicine is not a benefit—that is what they are studying.

4. An explanation of any other procedures or treatments that are available to you for your particular medical condition.

5. A description of how your privacy will be protected.

6. If the research involves more than minimal risk to you, a description of any medical treatments that are available if you are injured. In this case, the researcher should tell you whether you would be entitled to financial assistance for your injury. The researcher is not required to pay you, only to tell you whether compensation will be available.

7. The names of persons to contact for answers about the research or your rights as a research subject.

8. A statement that your participation is voluntary and that you can withdraw as a research subject at any time.