IV.04

Emergency Exemption from IRB Approval for Use of Investigational Drug, Agent or Biologic or Unapproved Medical Device

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PURPOSE

1. The purpose of this policy and procedure is to describe the process for emergency use of Investigational Drug, Agent or Biologic or Unapproved Medical Device (investigational drug or device).

SCOPE

2. This policy and procedure is applicable to physicians, Executive Chairperson, CPHS Members and ORSC Staff.

DEFINITIONS

3. Definitions:

3.1. 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.

3.2. 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.

3.3. 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.

POLICY

4. 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.

PROCEDURE

5. 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.

5.1. The treating physician should contact the Executive Chairperson, or designee, who must be an MD, and provide him/her information regarding the event including but not limited to:

1. An explanation of the conditions supporting the determination that the patient is in an immediate serious or life-threatening condition that needs immediate treatment;
2. There is no generally acceptable alternative treatment; and
3. An informed consent document for review.

5.2. The Executive Chairperson will evaluate whether the situation meets the FDA regulatory requirements that allow exemption from CPHS review of the Event. The following may be requested to facilitate the evaluation:

1. An authorization from the sponsor or manufacturer to allow the use by the treating physician of the test article;
2. An approved IND or IDE or a letter explaining exemption from the FDA;
3. An adequate description of the situation regarding the use of the test article with an independent physician’s certification, if applicable; and
4. Any other information that may aid in the evaluation.

6. Informed Consent- The treating physician must obtain informed consent of the subject or the subject's legally authorized representative, unless waived.

6.1. Waiver of Informed Consent – The requirement for informed consent may be waived by the Executive Chairperson 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:

1. The patient is confronted by a life-threatening and/ or severely debilitating situation necessitating the use of the investigational drug or device;
2. Informed consent cannot be obtained because of an inability to communicate with, or obtain legally effective consent from, the patient;
3. Time is not sufficient to obtain consent from the patient’s legal representative; and
4. No alternative method of approved or generally recognized therapy is available that provides an equal or greater likelihood of saving the patient’s life.

7. 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.

8. Reporting: The Executive Chairperson will notify the ORSC Director of receiving the request and granting permission for emergency use of an investigational drug or device.

8.1. 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:

1. Name of the investigational drug or device;
2. Conditions under which the investigational drug or device was administered;
3. Date and time administered;
4. Any adverse events or unanticipated problems to recipient or others; and
5. Outcomes, if known.

9. 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.

RESPONSIBILITY

10. The Investigator is responsible for notifying the Executive Chairperson of an impending emergency use of an investigational drug or device. The Executive Chairperson is responsible for timely review and notifying the ORSC Director of such use.

Applicable Regulations and Guidelines

1. 21 CFR 50.104

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Updated 2/2009, Report broken links