<p> Instructions for Compassionate Use Approvals at the University of Michigan</p><p>INTRODUCTION</p><p>“Compassionate Use” is the use of an investigational drug or device outside of a clinical trial to treat a patient with a serious or immediately life-threatening disease or condition who has no comparable or satisfactory alternative treatment options. Compassionate use exists under a larger program of Expanded Access to investigational agents in order to provide patients with opportunities to be treated with unapproved drugs or devices when certain criteria are met.</p><p>FDA regulations allow access to investigational drugs/devices for treatment purposes on a case-by-case basis.</p><p>GENERAL REQUIREMENTS</p><p> Compassionate use is not research but requires prospective review and approval by the IRB.</p><p> IRBMED approval is required via completion and submission of a Standard Application in eResearch. The IRBMED must be notified of each patient intended to be enrolled on the protocol by submission of an ORIO report in eResearch. </p><p> Informed consent is required from the patient. Either the sponsor’s template containing all elements of informed consent or the IRBMED Compassionate Use template must be used. The informed consent template must be uploaded in section 10-1 of the eResearch application. </p><p>INVESTIGATIONAL DRUGS</p><p>As part of the eResearch application process, answer all applicable questions in section 15.2. </p><p>In order for a patient to gain access to an investigational drug outside of a clinical trial, the patient must have a serious or immediately life-threatening disease or condition and no comparable or satisfactory therapeutic alternatives. Additionally, the drug manufacturer and the patient’s doctor must make special arrangements to obtain the drug for the patient. These arrangements must be authorized by the FDA. The IRB must approve this at a convened board meeting.</p><p>Page 1 of 2 Specific information from FDA and additional links are available at:</p><p> http://www.fda.gov/aboutfda/centersoffices/officeofmedicalproductsandtobacco/cder/uc m163982.htm</p><p>INVESTIGATIONAL DEVICES</p><p>As part of the eResearch application process, answer all applicable questions in section 16.2.</p><p>Prior FDA approval is needed before expanded access use of a device occurs. In order to obtain FDA approval, the sponsor should submit an IDE supplement requesting approval for a protocol deviation. The physician should not treat the patient (or patients) identified in the supplement until FDA and the appropriate IRB both approve the use of the device under the proposed circumstances. The IRB may approve the use by either a convened board or an expedited review procedure per IRB operating procedures.</p><p>Specific information from FDA and additional links are available at: http://www.fda.gov/medicaldevices/deviceregulationandguidance/howtomarketyourdevice/in vestigationaldeviceexemptionide/ucm051345.htm#compassionateuse</p><p>Page 2 of 2</p>