Required Elements of Consent

  1. A statement that the study involves research
  2. An explanation of the purpose of the research
  3. A description of the procedures to be followed
  4. The expected duration of the study
  5. Identification of any procedures that are experimental
  6. A description of any foreseeable risks or discomforts
  7. A description of the benefits to the subjects or others that may result from the research
  8. A statement describing the extent, if any, to which confidentiality of records identifying the subject will be maintained
  9. A explanation that participation is voluntary and that the subject may discontinue at any time
  10. Terms of payment and conditions under which subjects will receive partial or no payment
  11. An explanation of whom to contact with questions about the research
  12. A explanation of whom to contact with questions about subjects’ rights
  13. A description of appropriate alternative procedures or courses of treatment that might be advantageous to the subject
  14. For research involving more than minimal risk, an explanation about whether any compensation is offered and/or whether medical treatments are available if injury occurs, and where further information may be obtained
  15. For research involving more than minimal risk, an explanation of whom to contact in the event of research-related injury