Consent expectations

No investigator may involve a human subject in covered research without legally effective informed consent from the subject or legally authorized representative.

Consent must be sought under circumstances that give the prospective subject enough opportunity to consider participation and minimize coercion or undue influence. Information must be understandable to the subject or representative and translated when needed.

  • Do not include exculpatory language that waives, or appears to waive, legal rights or releases the investigator, sponsor, institution, or agents from liability for negligence.
  • State that the study involves research, explain the research purpose and expected duration, and describe experimental procedures.
  • Describe reasonably foreseeable risks or discomforts.
  • Describe reasonably expected benefits to the subject or others.
  • Disclose appropriate alternative procedures or treatment courses.
  • Describe confidentiality of records and note that FDA and the ICMS IRB may inspect records.
  • For more-than-minimal-risk research, explain compensation, available medical treatment for injury, who pays for study-related problems, and where to obtain more information.
  • Explain whom to contact for research questions, subject rights questions, and research-related medical problems or injury.
  • State that participation is voluntary, refusal involves no penalty or loss of benefits, and participation may be discontinued at any time without penalty or loss of benefits.
  • Include pregnancy and reproductive-risk language when appropriate.

Additional consent elements when appropriate

Additional elements may be required depending on the study, risk profile, and applicable law.

  • Statement that risks may be unforeseeable.
  • Anticipated circumstances under which participation may be terminated by the investigator.
  • Any additional costs resulting from participation.
  • Consequences of withdrawing from research and procedures for orderly termination.
  • Approximate number of subjects involved in the study.
  • Any additional federal, state, or local disclosures required for legally effective informed consent.