Emergency Use of an Investigational Article (Drug or Device)



Emergency Use of an Investigational Article (Drug or Device)This form must be completed and received by the Office of Research Administration (ORA) no later than 5 days after the Emergency Use. Please do not include any patient identifiers on this form (i.e., no protected health information (PHI)). If the sponsor/manufacturer will not ship the test article immediately for an emergency use situation, without an IRB acknowledgment letter from the IRB Chair, then this form must be completed and submitted to ORA before the use. The IRB Chair will review this form and any attachments and will provide a written statement that the IRB is aware of the proposed use and considers the use to meet the requirements of the FDA at 21 CFR 56.104(c). The Chair’s concurrence should NOT be construed as IRB approval. ?Definitions:Emergency use means the use of a test article on a human subject in a life-threatening situation in which no standard acceptable treatment is available, and in which there is not sufficient time to obtain IRB approval [21 CFR 56.102(d)].Test article means any drug for human use, biological product for human use, medical device for human use, human food additive, color additive, electronic product, or any other article subject to regulation under the act or under sections 351 or 354-360F of the Public Health Service Act [21 CFR 55.102(l)].Life-threatening, for the purposes of this policy and in conformity with FDA guidance, includes the scope of both life-threatening and d severely debilitating, as defined below.Life-threatening means diseases or conditions where the likelihood of death is high unless the course of the disease is interrupted and diseases of conditions with potentially fatal outcomes where the end point of clinical trial analysis is survival. The criteria for life-threatening do not require the condition to be immediately life-threatening or to immediately result in death. Rather, the subjects must be in a life-threatening situation requiring intervention before review at a convened meeting of the IRB is feasible.Severely debilitating means diseases or conditions that cause major irreversible morbidity. Examples of severely debilitating conditions include blindness, loss of arm, leg, hand, or foot, loss of hearing, paralysis, or stroke. [FDA IRB Information Sheet 9/98].Federal regulations do not permit research activities to be started, even in an emergency, without prior IRB review and approval. When emergency medical care is initiated without prior IRB review and approval, the patient may NOT be considered a research subject. Such emergency care may not be claimed as research, nor may any data regarding such care be included in any report of a research activity. Please complete the following information:Physician name: Phone Number: Department:Fax Number: Sponsor’s/Manufacture’s name: Sponsor’s/Manufacture’s number: Address: Emergency Use Exemption from Prior IRB Review and Approval Criteria: The exemption, allows for one emergency use of a test article without prospective IRB review. FDA regulations require that any subsequent use of the investigational product at the institution have prospective IRB review and approval. (ALL 3 criteria below must apply):The patient is in a life-threatening situation as defined above: Yes FORMCHECKBOX No FORMCHECKBOX No standard acceptable alternative for treating the patient is available: Yes FORMCHECKBOX No FORMCHECKBOX There is not sufficient time to obtain IRB approval for the use:Yes FORMCHECKBOX No FORMCHECKBOX Agent: Dose: Duration: Emergency IND, IDE, or HUD number: Date of emergency use of test article: Date of notification of use to IRB: Provide a summary of this emergency use, including the patient’s age, diagnosis, condition, when and where the investigational drug was/will be administered, duration of treatment, and evaluate the likelihood of a similar need for the test article occurring again:0666750Informed consent: Even for an emergency use, the physician is required to obtain informed consent from the patient or the patient’s legally authorized representative A copy of the informed consent form provided to the patient (written in a language that is understandable to the patient) must be attached to this form. A HIPAA Authorization form (if any protected health information will be released to the sponsor/manufacturer) may be required and must be attached to this form. This form is located on the College’s website. Exception From Informed Consent Requirement: If informed consent cannot be obtained by the patient, then both the treating physician and an independent physician who is not otherwise participating in the clinical investigation of the patient must certify in writing ALL of the following [21 CFR 50.23(a)]: The subject is confronted by a life-threatening situation necessitating the use of the test article. Yes FORMCHECKBOX No FORMCHECKBOX Informed consent cannot be obtained because of an inability to communicate with, or obtain legally effective consent from, the subject. Yes FORMCHECKBOX No FORMCHECKBOX Time is not sufficient to obtain consent from the subject's legal representative.Yes FORMCHECKBOX No FORMCHECKBOX No alternative method of approved or generally recognized therapy is available that provides an equal or greater likelihood of saving the subject's life. Yes FORMCHECKBOX No FORMCHECKBOX If, in the physician’s opinion, immediate use of the test article is required to preserve the patient's life, and if time is not sufficient to obtain an independent physician's determination that the four conditions above apply, the clinical investigator should make the determination and, within 5 working days after the use of the article, have the determination reviewed and evaluated in writing by a physician who is not participating in the clinical investigation. The investigator must notify the IRB within 5 working days after the use of the test article [21 CFR 50.23(c)]. An Independent Physician’s certification that ALL of the above waiver criteria (a, b, c, and d) apply is required. Please attach the independent physician’s written evaluation, including his/her signature and date. . I, as the treating physician, certify that the information submitted herein and within the accompanying form is true, complete and accurate to the best of my knowledge.Signature: Date: Print Name: ................
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