If you are interested in and accepted to a study, you will be asked to sign an informed consent, which outlines everything you need to know about the trial and the rules and regulations that protect you. Laws and regulations regarding informed consent differ across states and research institutions, but most are modeled after the informed consent policies of the federal government.

Informed Consent

Federal law requires that the following information be provided to each subject:

• A statement that the study involves research, an explanation of the purposes of the research, how long you are expected to participate, and what procedures are to be followed. Any experimental procedures must be identified.

• A description of any reasonably foreseeable risks or discomforts you might experience.

• A description of any benefits to you or to others that might reasonably be expected from the research.

• A disclosure of appropriate alternative procedures or courses of treatment, if any, that might be advantageous to you.

• A statement describing the extent to which records identifying you will be kept confidential, and a note that the FDA may inspect the records.

• If the research involves more than minimal risk, the consent form should provide details about whether patients will be compensated and whether any medical treatments are available should injury occur. Those details should describe what compensations and treatments consist of, or where further information may be obtained.

• Names and numbers of authorities the patients can call with questions about the research study and research subjects' rights, and in the event of a research-related injury.

• A statement that participation is voluntary, that refusal to participate will involve no penalty or loss of benefits to which you are otherwise entitled, and that you may discontinue participation at any time without penalty or loss of benefits to which you are otherwise entitled.

Depending on the study protocol, the informed consent may also include warnings that a particular treatment or procedure may pose unforeseeable risks and provide details of additional costs you may incur while participating in research. For more details on informed consent, visit the FDA's website at www.fda.gov.