Notification of Pending Emergency Use of Investigational Drug, Biologic or Device (Prior to Administration of the Test Article)
Office of Research Division of Research Integrity and Compliance
For IRB Staff only: IRB Tracking #:_________
Biomedical Institutional Review Board
OHRP Federalwide Assurance: FWA00001669 FOR INSTRUCTIONS AND A SUBMISSION CHECKLIST FOR THIS FORM, GO TO: http://www.research.usf.edu/cs/irb_forms/emergency_prior_instruct.doc SECTION 1 – DEMOGRAPHIC INFORMATION PRINCIPAL INVESTIGATOR RESPONSES Please make sure all cells contain a response. Cells will expand to allow additional space for responses.
IRB QUESTIONS Principal Investigator Information 1 Physician Requesting Emergency Use 2 Indicate status 3 USF Employee Number
[ ] Resident
[ ] Fellow
[ ] Faculty
(If not associated with USF, please provide an alpha numeric code consisting of the first 3 letters of your last name & the month and day of your birthdate [abcmmdd]).
4
USF Department/College or other institution affiliation 5 Mailing Address (where you prefer to receive IRB correspondence) 6 E-mail Address Telephone Number: [Please specify] 7 Telephone and Fax Numbers Contact Person (Person designated to serve as primary contact for all IRB communications). 8 Name and Degree(s)
Notification of Pending Administration of Emergency Use Test Article - Prior Version: 2008-12-10
Fax Number: [Please specify]
USF Institutional Review Board Page 1 of 6
9 Primary Role 10 Mailing Address (where you prefer to receive IRB correspondence) 11 E-mail Address 12 Telephone and Fax Numbers Investigational Article Information 13 Name of Investigational Drug or Biologic: 14 IND #: OR 15 Name of Investigational Device: 16 IDE #: 17 Has there been a previous Emergency Use of this test article at this site? (Please note: FDA regulations will only permit one emergency use of a test article at an institution.) 18 Will the sponsor require acknowledgement by the IRB before it will ship the test article? 19 Please explain why this condition qualifies as a life-threatening situation 20 Please justify your opinion that there is no alternative method of approved or generally recognized therapy available that provides an equal or greater likelihood of saving the participant's life. 21 Please explain why you believe there is not enough time to obtain IRB review and approval prior to administration of the test article. 22 Please describe/ explain the test article that will be administered. 23 Indicate when the test article will be
Telephone Number: [Please specify]
Fax Number: [Please specify]
[ ] Yes. STOP. Use of this article again will require full board review. Contact the Division of Research Integrity and Compliance at 813-974-9343 to discuss how to most expeditiously get this study reviewed [ ] No. Explain how you have verified this information: [ ] Yes [ ] No
Notification of Pending Administration of Emergency Use Test Article - Prior Version: 2008-12-10
USF Institutional Review Board Page 2 of 6
administered. 24 Indicate how the test article will be administered.
Notification of Pending Administration of Emergency Use Test Article - Prior Version: 2008-12-10
USF Institutional Review Board Page 3 of 6
23 Please describe how informed consent will be obtained (include a description of the consent process, who will be giving informed consent, e.g., the participant or a legally authorized representative, and provide a copy of the informed consent document to be used).
Independent Assessment by an Uninvolved Physician:
I concur with the following:
the patient identified to receive this test article is in a life-threatening condition; the use of this test article for this patient is appropriate; and there is no generally acceptable alternative available for treating the patient.
____________________________________________ Signature of Independent Physician ____________________________________________ Printed Name of Independent Physician
___________________ Date
Notification of Pending Administration of Emergency Use Test Article - Prior Version: 2008-12-10
USF Institutional Review Board Page 4 of 6
Principal Investigator Statement of Assurance
I confirm that this notification of pending use of an investigational drug, device or biologic meets the Food and Drug Administration criteria for Emergency Use. I also confirm the accuracy of this report. I understand that any subsequent use of this test article at this Institution must first be reviewed and approved by the full IRB at a convened meeting. I understand that I must obtain prior approval from the IRB before amending or altering this emergency use request. I agree to provide the IRB with a copy of the signed informed consent document used for this emergency administration of the test article. I understand that it is my responsibility to submit any scientifically significant data regarding this test article to the Food and Drug Administration. I agree to notify the IRB of the outcome of the administration of the test article including the individual’s condition after that administration with any follow-up information requested by the IRB.
____________________________________________ Signature of Physician Administering Test Article ____________________________________________
Printed Name of Physician Administering Test Article
__________________________________ Date
Notification of Pending Administration of Emergency Use Test Article - Prior Version: 2008-12-10
USF Institutional Review Board Page 5 of 6
IRB staff use only [ ] This use of this test article meets federal criteria for emergency use of a test article. [ ] This use of this test article does not meet the federal criteria for emergency use of a test article.
__________________________________________ Signature of IRB Chair or Designee
___________________ Date
Notification of Pending Administration of Emergency Use Test Article - Prior Version: 2008-12-10
USF Institutional Review Board Page 6 of 6