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HRPP Primer: Critical Care Research


Waivers for Critical Care Research

The medical status of prospective subjects in a critical care setting may preclude his/her ability to provide informed consent.  However, when the research presents no more than minimal risk and involves no procedures for which written consent is normally required outside the research context, the IRB may waive the requirement for written consent.

See institutional procedure H-30B: Procedures for Waiver or Alteration of Informed Consent.

All attempts must first be made to determine what the subject would do if he/she had decision-making capacity.  The circumstances which preclude the individual providing consent personally should be documented in the medical record.  Diligent effort should be made to obtain informed consent from the subject’s legally authorized representative before beginning the study treatment or procedure, with the patient’s best interest being of priority.  If the subject’s legally authorized representative is not physically present, consent should be obtained by fax, email or telephone (and documented appropriately).

Waivers for Exceptions Outlined in [21 CFR 50.23

Informed consent may be waived in selected cases when use of test article (drug, medical or electronic device) would benefit the subject, providing the investigator and a physician not otherwise participating in the investigation will certify to all the following:

  1. The subject is confronted by a life-threatening situation necessitating its use.
  2. Informed consent cannot be obtained from the subject because of an inability to communicate with or obtain legally effective consent.
  3. Time is not sufficient to obtain consent from the subject’s legal representative.
  4. No alternative method of approved or generally recognized therapy is available that provides an equal or greater likelihood of saving the life of the subject.