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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
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eProst User Guide
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Basic Folder Information

27.3 IRB Requirements


approval date

Review Responsibility:

IRB Policy and Procedure Committee

Current Approval Date:

August 24, 2008



policy

FDA regulations and UM IRB policy permit an exception to the requirement for prior IRB review and approval (21 CFR 56.104[c]) for purposes of “emergency use” if all conditions described in 21 CFR 56.102(d) exist.  This exemption is allowed only for a one-time institutional use of a test article without prospective IRB review.  Any subsequent use of the investigational product must have prospective IRB review and approval.  If there is uncertainty as to whether emergency use of a particular investigational drug or device has occurred at UM, relevant information should be sought from the HSRO prior to the “emergency use.”

If possible prior to an “emergency use”, the physician seeking to provide the life-saving treatment should notify the HSRO of this intent by any available means (Note – a Pre-Emergency Use Notification Form is available on the HSRO website at HSRO.miami.edu).   This notification must include: 

  1. a description of the circumstances that warrant the administration of a test article without IRB approval.
  2. a statement that the subject is confronted with a life-threatening situation that requires immediate medical intervention before the IRB can be convened 
  3. confirmation that no alternative method of approved or generally recognized therapy is available to provide an equal or greater likelihood of saving the subject's life.
  4. a description of how the test article will be used.
  5. a  copy of the informed consent document to be used; or
    1. A statement that the informed consent document cannot be obtained because of difficulty in communication with the subject and/or insufficient time to contact the subject's legal representative.
    2. Both the primary physician and a physician who is not participating in the clinical administration of the test article must sign this document.

The HSRO shall forward the physician’s notification to the IRB chair or designee who will review the circumstances of the “emergency use” to verify whether it meets the conditions of 21 CFR 56.102 and he/she, or the HSRO, shall so notify the physician.  This notification should not be construed as IRB approval. Rather, the HSRO shall use this prior report to initiate tracking to ensure that the investigator files a report within the five day time-frame required by 21 CFR 56.104(c).

Physicians authorizing the “emergency use” of the test article should follow as many subject protection procedures as possible including:

  1. obtaining an independent assessment by an uninvolved physician
  2. obtaining authorization from the IND/IDE holder (as appropriate) 
  3. notifying institutional officials as specified by clinical/institutional policies
  4. obtaining informed consent from the patient or a legal representative
  5. notifying the HSRO

Within five (5) working days following the emergency use of a test article, the physician must notify the IRB in writing of the emergency use of a test article pursuant to FDA regulations at 21 CFR 56.104(c).  This report should include an explanation of the use, how and when the use took place, and justification based on FDA criteria for “emergency use” including why prospective IRB review was not possible, the informed consent process, and, if applicable, how IND/IDE requirements were met.   This report should include a copy of the properly executed (signed) informed consent document or a statement that informed consent document could not be obtained because of difficulty in communication with the patient and/or insufficient time to contact the patient’s legal representative.  The report should also include follow-up information on the condition of the patient in the days after the test article has been administered.  An “Emergency Use Report Form” is available on the HSRO website to ensure that all required issues are addressed.  The form should be submitted with a copy of the consent form that was (or is about to be) signed by the subject or the subject’s authorized representative. 

If further uses of a test article are anticipated, a study application must be submitted for review and approval by the convened IRB in addition to the submission of the 5-day report.  Subsequent use of the test article is contingent upon this IRB approval and an FDA-approved IND/IDE. 

There are two options available to applications for further uses of a test article. 

  1. Not collecting data for research:  If the test article use does not include collecting data for research purposes, a treatment IND/IDE should be obtained from the FDA and a corresponding study application should be submitted for IRB approval.  IRB approval is required for the use of a treatment IND even if the use does not involve research.  
  2. Collecting data for research:  if research data is collected pursuant to the use of the test article, a research IND/IDE should be obtained from the FDA and a corresponding study application should be submitted for IRB approval.

Note - FDA acknowledges that it would be inappropriate to deny emergency use of an investigational drug or biologic considered necessary for the treatment of a second individual if the use was unexpected and the only obstacle is  that the IRB has not had sufficient time to convene a meeting to review the issue.  Subsequent emergency use the unapproved article may not occur unless the physician or another person obtains approval of an IND/IDE.  If the application for subsequent is disapproved by the FDA, the article may not be used even if the  circumstances constituting an emergency exist.  Manufacturers or developers of  investigational articles that could be used in emergencies should anticipate the likelihood of emergency use and should obtain an IND/IDE for such uses. 

FDA regulations do not permit expedited IRB approval in emergency situations and terms such as “interim,” “compassionate,” or “temporary,” may not be used to authorize an expedited approval process.  IRB approval of an emergency use requires review by the convened panel or, if the conditions of 21 CFR 56.102(d) are met and it is not possible to convene a quorum within the time available, the emergency use may proceed without an IRB approval (providing all requirements are met).



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