Please provide contact information for a representative who can answer any questions that the IRB might have concerning this submission:
Name:
Position:
E-mail:
Phone #:
Pager #:
2nd Contact: / name + e-mail or phone #
Group:
Form Instructions:
· You must obtain IRB approval before using your Humanitarian Use Device (HUD) with Humanitarian Device Exemption (HDE).
· Any changes to your HDE must be approved by the IRB prior to implementation.
· The Report must be signed by the Principal Investigator and all other investigators who will use the device on the signature lines at end of report.
· Make sure your Microsoft Word program is set to display “Hidden Text”. This document contains helpful information, examples, and instructions that are only visible (and will never print) when the “Hidden Text” feature is enabled. “Hidden Text” will be displayed highlighted yellow, italics, and underlined. Go to the “Tools” menu, “Options”, on the “View” tab make sure “Hidden Text” has a check mark, and click “OK”. (Word 2007 users can download how to display Hidden Text at: http://irb.ufl.edu/docs/hidden07.doc).
· Submit one electronic copy and the signed original copy of your submission to the IRB-03 office.
· This report must be typed.
· Submissions that do not meet our Submission Acceptability Standards will be returned to the PI. Visit http://irb.ufl.edu/irb01/formsubmit.htm for more information.
Date:Principal Investigator:
PI UF ID#:
HDE/Project Title:
1. Are you using this HDE as part of a research study?
Yes, we are using this HDE as part of a research study to systematically evaluate its use, safety, and/or effectiveness. STOP! Do not proceed any further. Rather than completing and submitting this form you should instead submit an Introductory Questionnaire, Protocol, and Informed Consent Form
No, we are only using this HDE for clinical care (this is not a systematic investigation). Please continue to complete this form and submit it to the IRB in order to receive initial approval for this project.
2. Describe the device and how you intend to use it:
3. List everyone who will use the device and describe their qualifications:
4. Where will the device be used? (e.g. Shands at UF, satellite clinic located at…, etc)
Note: Any changes to the above information must be approved by the IRB prior to implementation. Thus, the device cannot be used by new staff or in a new location/building until after the IRB approves a requested revision to add the staff/locations.5. Describe how the HDE devices will be kept secure so that unauthorized use is prevented:
6. Describe what kind of training is required to use the device:
6.a. Will the investigator(s) receive a certificate for training?
Yes – before the device is ever used. You must submit a copy of the certificate for all investigators who will use the device before the use of the HDE can be approved.
Yes – after proctored/monitored cases. You must submit a copy of the certificate for all investigators who will use the device as soon as they are available.
No.
7. Is there any other pertinent information that could assist the IRB with its review of this submission?
Yes. Please describe:
No.
8. Do you, the University of Florida, or any of the sub-investigators hold a patent or license for any material, object, or process used in this project?
Yes. No.
9. Is a patent or license pending or under consideration or is there any intention to file a patent application at a later date? Yes. No.
10. Do you, the University of Florida, or any of the sub-investigators own stock in the company sponsoring the project? Yes. No.
11. Do you or any of the sub-investigators give presentations for or serve as a consultant to the sponsoring company on their behalf? Yes. No.
12. Do you or any of the sub-investigators have any other possible conflict of interest?
Yes. No.
If yes, explain:
NOTE 1: If your answer is yes to any of the questions 8 through 12 you must contact:UF: Michael Scian, Ast. Director of Compliance, at 352-846-3533 or for institutional management of your conflict.
NOTE 2: you are required to inform the IRB immediately if any of the answers above for questions 8 through 12 needs to be changed from “No” to “Yes” for any of the investigators participating in this project, including any new investigators who are added to the study at a later date.
13. Please indicate what documents you are including with this submission:
REQUIRED: FDA HDE approval letter
REQUIRED: all information from the sponsor concerning the device
REQUIRED: all information given to subjects
Training certificates for all investigators (REQUIRED if certification is performed)
Other information
Other investigators:
Name / Signature / Date
Human Device Exemption Page 1 of 4
IRB Version: 11/24/2009
PI Version date: