Informed Consent Form

The informed consent form is a document that provides the details of the study.

The form should be approved by an IRB/IEC and includes:

  • That the trial involved research
  • Purpose and duration of participation
  • Approximate number of subjects involved in the trial
  • Trial procedures and treatments
  • Potential risks and discomforts
  • Feasible alternative procedures or treatments
  • Possible benefits to the subject
  • Measures to preserve the confidentiality of records
  • Information regarding compensation for injuries
  • Point of contact to answer questions the subject or family may have and to report any injuries
  • Volunteer’s rights regarding withdrawal from the clinical trial, without losing treatment benefits
  • Subject’s diagnosis, probability of success if known, and prognosis

Source: FDA Protection of Human Subjects, 21 C.F.R. § 50.25 (2021).