1. A statement that the study involves research and an explanation of the purposes, procedures, and expected duration of the study.
2. A description of any reasonably foreseeable risks or discomforts to the subject.
3. A description of any benefits to the subject or others that may reasonably be expected from the research.
4. A disclosure of appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the subject.
5. A statement describing the extent to which confidentiality of records identifying the subject will be maintained.
6. For research involving more than minimal risk, an explanation as to whether any compensation or medical treatments are available if injury occurs and, if so, what they consist of, or where further information may be obtained.
7. An explanation of whom to contact for answers to pertinent questions about the research and research subjects' rights and who to contact in the event of a research-related injury to the subject.
8. A statement that participation is voluntary, refusal to participate will involve no penalty or loss of benefits to which the subject is otherwise entitled, and the subject may discontinue participation at any time without penalty or loss of benefits to which the subject is otherwise entitled.
List the 8 basic requirements of informed consent delineated in
21 CFR 50.25 (FDA's regulation)
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