Emergency Use Investigational Drug or Device
POLICY
It is the policy of UTHealth that the treating physician may use an investigational drug or device in an emergency, provided that the treating physician justifies to CPHS that an emergency exists.
The emergency use of a test article, other than a medical device, is a clinical investigation, the patient is a participant and the FDA may require data from an emergency use to be reported in a marketing application. DHHS regulations do not permit data obtained from patients to be classified as human subjects research, nor permit the outcome of such care to be included in any report of a research activity subject to DHHS regulations.
Key Terms
Emergency use is defined as the use of an investigational drug or biological product in 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 CPHS approval. Life-threatening for the purposes of this policy includes the scope of both life-threatening and severely debilitating.
Life-threatening means diseases or conditions where the likelihood of death is high unless the course of the disease is interrupted. The condition does not need to be immediately life-threatening or to immediately result in death. Rather, the subjects must be in a life-threatening situation requiring intervention before CPHS has the ability to review the use at a convened meeting.
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.
PROCEDURE
If a situation arises necessitating the use of an investigational drug or device, in an emergency situation (“event”) the treating physician should determine if an active protocol is available at the institution and the patient meets the inclusion criteria. If an approved study protocol does not exist, the treating physician should contact the manufacturer of the investigational drug or device to determine if the test article can be made available for the emergency use under the manufacturer’s IND. If, due to the emergency situation, there is not enough time for submission of an IND application, the treating physician may make a direct request to the FDA to authorize shipment of the test article in advance of the IND submission.
The treating physician should contact the IRB office. The IRB director or designee requests for information regarding the event including but not limited to:
- An explanation of the conditions supporting the determination that the patient is in an immediate serious or life-threatening condition that needs immediate treatment;
- There is no generally acceptable alternative treatment; and
- An informed consent document for review.
The IRB director or designee evaluates whether the situation meets the FDA regulatory requirements. The following may be requested to facilitate the evaluation:
- An authorization from the sponsor or manufacturer to allow the use of the test article by the treating physician;
- An approved IND or IDE or a letter explaining exemption from the FDA;
- An adequate description of the situation regarding the use of the test article with an independent physician’s certification, if applicable; and
- Any other information that may aid in the evaluation.
The IRB director forwards all the information to an IRB panel chair (who must be an MD). If necessary, the IRB panel chair communicates with the treating physician for additional information or clarification. If the panel chair agrees with the treating physicians determination, the IRB office issues a letter with the determination that the situation meets the FDA regulatory requirements for emergency use of investigational drug or device.
Informed Consent- The treating physician must obtain informed consent of the subject or the subject's legally authorized representative, unless waived.
Waiver of Informed Consent – The requirement for informed consent may be waived by the IRB panel chair if it meets the criteria listed below. The treating physician and a physician who is not otherwise participating in the treatment of the subject shall certify in writing the following criteria:
- The patient is confronted by a life-threatening and/ or severely debilitating situation necessitating the use of the investigational drug or device;
- Informed consent cannot be obtained because of an inability to communicate with, or obtain legally effective consent from, the patient;
- Time is not sufficient to obtain consent from the patient’s legal representative; and
- No alternative method of approved or generally recognized therapy is available that provides an equal or greater likelihood of saving the patient’s life.
If, in the treating 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 listed above apply, the treating physician should make the determination and, within five working days after the use, have the determination reviewed and evaluated in writing by a physician who is not otherwise participating in the treatment of the subject.
Reporting: The treating physician must submit a written follow-up report to the CPHS within five (5) working days of the emergency use of an investigational drug or device. This report should include:
- Name of the investigational drug or device;
- Conditions under which the investigational drug or device was administered;
- Date and time administered;
- Any adverse events or unanticipated problems to recipient or others; and
- Outcomes, if known.
Subsequent Use: Any subsequent use of the test article is subject to CPHS review. According to FDA guidelines, it would be inappropriate to deny emergency treatment to a second individual if the only obstacle is that the CPHS has not had sufficient time to convene a meeting to review the issue. The treating physician should evaluate the likelihood of a similar need for the drug, agent, or biologic and if future use is likely, immediately initiate efforts to obtain CPHS approval and an FDA approved IND for the drug, agent or biologic’s subsequent use.
APPLICABLE REGULATIONS
1. 21 CFR 50.104
REFERENCES TO OTHER SOP
1. None.
ATTACHMENTS
1. None.
If you find errors in this document, contact clinicaltrials@uth.tmc.edu
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Document Number: |
101-D04 |
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Document Name: |
Emergency Use Investigational Drug or Device |
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Approved by: |
Executive Director, Research Compliance |
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Effective: |
1 Aug 2008 |
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Revision History: |
1 Aug 2011, 1 Jun 2016 |
CPHS HELPLINE 713-500-7943
iRIS HELPLINE 713-500-7960
UTHealth’s Compliance Hotline (1-888-472-9868)
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Committee for the Protection of Human Subjects IRIS Support 713-500-7960 |
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CLINICAL TRIALS RESOURCE CENTER OFFICE OF RESEARCH ENVIRONMENTAL HEALTH & SAFETY |
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