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------------------------------------------------- Top of Form Bottom of Form Text size: A A * Theodore Lange ID: 1113086 * Log Out * Help CITI Program Collaborative Institutional Training Initiative at the University of Miami ------------------------------------------------- Top of Form Bottom of Form * Main Menu * My Profiles * My CEUs * My Reports * Support * Main Menu › VA Human Subjects Protection › Informed Consent Informed Consent Content Author * Diane Paul, M.S., RN National Comprehensive Cancer Network Introduction It is important to understand that informed consent is a process that begins with the recruitment and screening of a subject and the signing of the…show more content…
6. For research involving more than minimal risk, an explanation as to whether any compensation and an explanation as to whether any 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 whom to contact in the event of a research-related injury to the subject. 8. A statement that participation is voluntary, that refusal to participate will involve no penalty or loss of benefits to which the subject is otherwise entitled, and that the subject may discontinue participation at any time without penalty or loss of benefits to which the subject is otherwise entitled. Additional Requirements In addition, if relevant to the research, legally effective informed consent will also include the following elements, outlined in The Code of Federal Regulations 45 CFR 46.116(b) and 21 CFR 50.25(b): 1. A statement that the particular treatment or procedure may involve risks to the subject (or to the embryo or fetus, if the subject is or may become pregnant) which are currently unforeseeable. 2. Anticipated circumstances under which the subject's participation may be terminated by the investigator without regard to the subject's consent. 3. Any
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