Expanded Access Submissions

For Emergency Use, Compassionate Use, Expanded Access, and Humanitarian Use Device (HUDs), please contact irb-orp@psu.edu 

Use the following format for a proposed emergency use submission of an FDA-regulated drug or device and email it as instructed below. Resources for Emergency Use of Investigational Test Articles are available in CATS IRB, including:

  • HRP-582 – HRPP Consent Form for Emergency Use
  • HRP-023 – SOP Emergency Use
  • HRP-322 Worksheet – Emergency Use
  1. Confirm in the email that the circumstances meet the following criteria for emergency use:

    • The patient is confronted by a disease or condition that is life-threatening or severely debilitating, or the patient is confronted by a life-threatening disease or a serious condition requiring immediate use of an unapproved device.
    • The situation necessitates the use of the test article (drug, biologic, device).
    • No generally acceptable alternative for treating the patient is available.
    • There is insufficient time to obtain IRB approval. (Or if there is time for review at the next IRB meeting, indicate this and the information will be added to the agenda.)
    • Note: The above findings for emergency use must also be noted in the medical record.
  2. Attach the following materials to the email as supporting documentation:

    • Document or email that describes the patient’s medical condition and the reason for the use of the test article. (Do not include any identifiers in documents.)
    • Correspondence to and from the FDA with the investigational new drug (IND) number or investigational device exemption (IDE) number, if available. (For a single-patient IND or compassionate IDE, submit the number when it is available).
    • Correspondence to and from the sponsor regarding use of the test article.
    • Protocol or detailed treatment plan for this patient.
    • Investigator’s brochure or drug package insert, or device information.
    • Emergency use consent form to be used. (Use “HRP-582 – HSPO Consent Form” in CATS IRB.)
  3. Send the email and all subsequent communications about the emergency use to irb-orp@psu.edu or to staff member contacted; also copy other persons involved in coordinating the use.
  4. Keep the HRPP informed about the status of a proposed use to proceed or if circumstances change.
  5. By close of business within five days after the use of the device or first administration of the drug/biologic, submit to the IRB written notification of the emergency use of a test article in a life-threatening situation, and include a copy of the signed consent document used (or provide certification by the treating physician and an uninvolved physician that the criteria for the exception from informed consent were met).