EmergencyUseReportForm-SeattleChildrensHospital.doc

Please refer to IRB Policy 29 for more detailed information about emergency uses: /pdf/29.pdf. Sections A B of this form should be emailed to the IRB representative (per IRB Policy 29) and discussed before the use, whenever possible. The fully completed form must be submitted to IRB@ within 5 working days after initiation of the emergency use. A. Physician Information Treating Physician’s Name: Date: Department, Division: Phone/Pager: Email address: Preferred method of contact: B. Confirm that Emergency Use is Appropriate (all boxes must be checked) 1. Patient has a life-threatening or serious disease or condition (see IRB Policy 29 for the definitions of these terms, which differ for drugs/biologics vs. devices) Describe the patient’s condition (noting why it is life-threatening/serious): 2. No generally acceptable alternative for treating the patient is available Explain why available alternatives are not acceptable (e.g., standard therapies have been exhausted; patient does not qualify for research study; research study is not approved at SCH): Explain the proposed therapy (also attach any available materials, protocols, investigator’s brochures provided from the manufacturer): 3. Patient’s condition requires immediate treatment, such that there is not sufficient time to obtain IRB review and approval at a convened meeting. Explain timing considerations: 4. Depending on whether the test article is a drug/biologic or device, the treating physician has made the additional determinations specified in IRB Policy 29. For Drugs/Biologics, determine that the probable risk to the person from the investigational test article is not greater than the probable risk from the disease or condition. See Policy 29 for the additional determinations to be made by FDA. For Devices, assess the potential for benefit from the use of the unapproved device, and to have substantial reason to believe that benefits will exist. ( (1) Email: After completing