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UM Policies & Procedures - HSRO/IRB
1. Preface
2. Background Topics
3. Authorities and Responsibilities
4. Conflict of Interest
5. Institutional Review Boards
6. IRB Meetings
7. General Principles for IRB Reviews
8. Definition of IRB Review Types
9. IRB Review of Initial Studies
10. IRB Review of Continuing Studies
11. Amendments
12. Closing Studies and Final Reports
13. Suspension, Termination and Administrative Closure of IRB Approved Research
14. Unanticipated Problems and Adverse Events
15. Study Violations
16. Compliance Audits
17. Data Safety Monitoring Boards
18. Ancillary Committees
19. External IRB's
20. Policies Specific to Certain Types of Research
21. Informed Consent
22. Participant Recruitment Methods, Advertising Materials and Recruitment-Relevant Payment Arrangements
23. Vulnerable Populations
24. Privacy, Security, Confidentiality and HIPAA
25. Subcontracts/Agreements for UM-Initiated Studies that Engage or Involve non-UM Institutions or Investigators
26. International Research
27. Emergency Use
28. Record Retention
Other Policies
UChart Forms & Guidance
HSRO Forms & Documents
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Ancillary Committee Information
eProst User Guide
Ethics, Federal Regulations & Guidance
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Western IRB (WIRB)
About the HSRO


Basic Folder Information

27.1 Emergency Use of Unapproved Drugs or Biologics


approval date

Review Responsibility:

IRB Policy and Procedure Committee

Current Approval Date:

August 24, 2008



policy

FDA regulations at 21 CFR 56.102(d), 21 CFR.104(c), 21 CFR 312.36 and this policy pertain to the “emergency use”, without prospective IRB review and approval of an unapproved drug or biological product in a patient with a life-threatening (or severely debilitating) problem under the following conditions:

  1. the condition is life threatening necessitating use of the test article
  2. no standard acceptable treatment is available
  3. there is not sufficient time to obtain prospective IRB approval. 

Note - If IRB review is possible, prospective IRB approval should be sought.  Only if  treatment of a life-threatening condition is necessary before IRB approval is made,  does this “emergency use” policy apply. 

For purposes of this policy, “life threatening” means diseases or conditions where the likelihood of death is high unless the course of the disease is interrupted;  or  diseases or 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. Per the FDA also, “severely debilitating”  means diseases or conditions that cause major irreversible morbidity such as blindness, loss of hearing, paralysis or stroke.

Federal regulations stipulate that research activities may not be started, even in emergency situations, without prior IRB review and approval.  Whenever “emergency use” of an investigational product is initiated without prior IRB  approval, the patient may not be considered a research subject, the emergency treatment may not be claimed as research, and data obtained from this treatment may not be included in any report of a research activity or used for research purposes. 

Federal regulations, guidance documents and this policy are not intended to limit the authority of a physician to provide emergency medical care to the extent permitted under applicable federal, state or local law [c.f. 45 CFR 46.116(f)].  Rather, this policy pertains only to the use of an investigational (i.e. “test”) article [21 CFR 56.102(l)]in emergency situations. 

The emergency use of an unapproved investigational drug or biologic requires an IND unless the intended subject meets the inclusion criteria of an existing study protocol, or an approved study protocol exists.  The IND requirement may be met if the manufacturer makes the drug or biologic available for the emergency use under the manufacturer’s IND.

If the emergency situation does not allow time for submission of an IND or amendment of the manufacturer’s IND, only the FDA may authorize shipment of the test article in advance of the IND submission (or amendment).  Requests for such authorization may be made by telephone or other rapid communication means to the FDA [21 CFR 312.36].

Note – FDA Contacts for Obtaining an Emergency IND:

Product Office/Division to Contact

Drug Products

 

Division of Drug Information
(HFD-240)
301-827-4570

Biological Blood Products

 

Office of Blood Research and Review
(HFM-300)
301-827-3518

Biological Vaccine Products

 

Office of Vaccines Research
(HFM-400)
301-827-3070

On Nights and Weekends

 

Office of Crisis Management & Emergency
Operations Center
(HFC-160)
301-443-1240



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