Required Elements of Informed Consent

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A written consent form must include the following items. Additional elements of informed consent may be required when appropriate or applicable. Special provisions are required when subjects are from special populations.

  • A statement that the study involves research.
  • An explanation of the purposes of the research.
  • A description of the procedures to be followed.
  • The expected duration of the subjects' participation.
  • A description of any reasonably foreseeable risks or discomforts to the subject.
  • A description of any benefits to the subject or to others which may reasonably be expected from the research.
  • A statement describing how confidentiality of records identifying the subject will be maintained.
  • An explanation of whom to contact:
    1. for answers to pertinent questions about the research (researcher's name and phone/address, and that of faculty advisor if investigator is a student);
    2. regarding research subjects' rights (Research Compliance Services); and
    3. in the event of a research-related injury to the subject (Research Compliance Services).
  • A statement that:
    1. participation is voluntary;
    2. refusal to participate will involve no penalty or loss of benefits to which the subject is otherwise entitled, and
    3. the subject may discontinue participation at any time without penalty or loss of benefits to which the subject is otherwise entitled.
  • An indication that the subject may keep a copy of the consent form.