Emergency uses of investigational (unapproved) drugs, biologics and devices are done for the purpose of providing clinical treatment to a patient, and are not considered to be research under federal regulations. This means that any qualified physician at Seattle Children's can utilize the emergency use process to treat a patient; research experience is not necessary. If you have any questions about these materials, contact the IRB.
Emergency Use Documents
IRB Policy for Emergency Use
Appendix A-9 of the Investigator Manual, found in the Click IRB Library under the General tab, provides relevant definitions and regulatory requirements, and lists the steps required to complete an emergency use at Seattle Children's.
Emergency Use Report Form
The Emergency Use Report Form (HRP-2141 in the Click Library) is used by the treating physician as follows:
- Form and contact: Complete parts A and B of the form to confirm that an emergency use is appropriate.
- Email the form to the IRB chair or designee (per the Investigator Manual), if possible, so the IRB representative can reference the form.
- Call the paging operator at 206-987-2131 and request the IRB chair or designee to discuss the emergency use.
- Follow-up: Within five working days of initiating the emergency use, complete the remainder of the form and submit it to the IRB for review.
Emergency Use Consent Form Template
Seattle Children's Emergency Use Consent Form template (HRP-506 in the Click Library) may be used to obtain consent from the patient (or their legally authorized representative), or the treating physician may use a form supplied by the manufacturer.
The IRB does not need to review or approve an emergency use consent form prior to using it with a patient or their representative.