HRPP Policy - Emergency use

The clinician must obtain prospective, written informed consent from the patient or the patient's legally authorized representative (LAR) in accordance with IU HRPP Policy on Informed Consent.

An exception to the informed consent requirement may apply if both the treating clinician and a physician who is not otherwise associated with the use of the test article certify in writing all of the following:

• The patient is confronted by a life-threatening situation necessitating the use of the test article.
• Informed consent cannot be obtained because of an inability to communicate with or obtain legally effective consent from the patient.
• Time is not sufficient to obtain consent from the patient's LAR.
• No alternative method of approved or generally recognized therapy is available that provides equal or greater likelihood of saving the life of the patient.

If, in the clinician's opinion, immediate use of the test article is required to preserve the life of the patient and time is not sufficient to obtain the independent determination regarding exception to the informed consent requirement in advance, the determination shall be made by the clinician and, within five (5) business days after the use of the article, be reviewed and evaluated in writing by a physician who is not participating in the use of the test article.

During regular business hours, the clinician must contact the IU Human Research Protection Program (HRPP) and consult with staff regarding whether an existing IRB-approved protocol would allow use of the test article, whether an Investigational New Drug application (IND) or Investigational Device Exemption application (IDE) from the FDA is needed, and whether the situation allows for sufficient time to obtain IRB approval.

Outside of regular business hours, or if IU HRPP is not available, the clinician may use the test article under this policy, carefully documenting the following:

• The conditions for emergency use specified in 2.0 are met.
• Consent was obtained and documented in accordance with the IU HRPP Policy on Informed Consent, unless the exception from informed consent requirements described in 2.1 above applies.

Use of a test article under this policy must be reported to the IRB within five (5) business days. The clinician must submit notification via a Kuali Protocols Emergency Use submission and provide the following information:

• A full description of the situation, including justification for the emergency use;
• A full description of the test article, including the trade name, generic name, chemical name, and/or device name, the IND or IDE number, and name of sponsor/manufacturer;
• A full description of the procedure(s) employed; and
• A description of the consent process used, including an unsigned copy of the informed consent document.

When the HRPP receives notification of an emergency use that has taken place, an IU HRPP Assistant or Associate Director or the University Director, HRPP, review the report to determine if the use complied with FDA and institutional requirements.  If requirements were met, an acknowledgement letter is sent to the clinician.  If it is determined that requirements were not met, the matter is handled according to the noncompliance procedures delineated in the IU HRPP Policy on Reportable Events.

Use of the exception from informed consent requirements described in 2.1 above must be reported to the IRB within five (5) business days. The clinician must submit notification via Kuali Protocols and provide the documentation from both the clinician and the physician who is not participating in the clinical investigation.