How do I submit a request for emergency use of an investigational agent?
Emergency treatment of a patient with an investigational agent may not need prospective IRB review and approval if the patients condition is life threatening and there is no standard treatment available. However, many sponsors and our pharmacy may not release the agent without receipt of an authorization letter from the IRB. Call the IRB office and request to speak with a Team Manager or the Associate Director, or the Executive Director regarding the emergency and she/he will assist you with the process and regulatory requirements. Submit a letter or e-mail to one of the above listed IRB professionals providing the name of the investigational product, the indication, the IND or IDE number, the patient’s initials, the patient’s diagnosis and an explanation of the life-threatening condition. The letter should also specifically state that there is no standard treatment or therapy available and another physician not involved in the case should provide specific documentation concurring with
