Download Humanitarian Use Device (HUD) Application

McLeod Health
Institutional Review Board
Application for Humanitarian use Device (HUD)
Complete this form in its entirety. Do not alter, add or delete this form as it will be returned for correction.
Information must be typed.
Date of Submission:
Title of Device or Drug:
Manufacturer:
Date of Service:
Full Board Review Date:
Date scheduled for surgery/implant:
Principal Physician:
Co-Principal Physician:
Address:
E-mail address:
Research Nurse:
Telephone:
Name and address of all facilities where implant of device will be conducted:
Regular usage
Other:
IRB Concurrence
Off label usage:
Emergency
Compassionate
scientific supported usage
Informed consent from patient:
Yes
No
Purpose of intended usage(s):
Device
Procedure
Drug
Other:
Length of Use:
Expected number of patients:
Expected results of usage:
How will the patient be monitored?
Is there a conflict of interest:
Yes
No
Documentation to be submitted with this form (checklist)
Attach a copy of the proposed informed consent document, if utilized
Attach any pertinent documentation: Manufacturer’s product labeling, patient brochure, etc.
Attach the FDA HDE approval letter.
Attach Physician/Presenter Financial Disclosure Form
Attach a copy of the contract agreement with the Sponsor.
Attach a current copy of Principal Investigator CV.
This study has been reviewed administratively** (VP for area - i.e. Oncology,
Cardiology, Ortho). Signature required before submitting to the IRB (see page 2).
Is there a Data Safety Monitoring Board?
No, please explain how safety is monitored.
Yes, please attach a copy of the most recent report.
Has the physician(s) involved signed a Physician Financial Disclosure form?
Yes
No
Excerpt from the IRB HUD Policy:
The HUD clinical consent form should be generally modeled after other clinical consent forms for invasive
procedures to include the following. It shall be the responsibility of the physician to explain risks and
benefits and alternative treatment to patients more fully as set forth below in A-F.
A. A description of an HDE/HUD approval process; e.g.
Application for HUD Form
June 2013
McLeod Health
Institutional Review Board
Your medical care will involve the use of (specify device), which has been approved by the U.S.
Food and Drug Administration (FDA) as a Humanitarian Use Device (HUD). A HUD is a device
used to diagnose or treat a disease or condition that affects fewer than 4000 individuals in the
United States per year and for which no comparable device is available. The FDA approves the
clinical use of a HUD based primarily on evidence that it does not pose a significant risk of injury
to the patient and that the potential benefit of the device to the health of the patient outweighs the
risks of its use. The FDA approval of a HUD is based on limited data documenting its
effectiveness in humans. Its use does not involve research.
B.
A description of the HUD and how this device will be used in the clinical setting. Based
on this description, it should be clear to the patient why she/he is a candidate for the use of this
device.
C.
A discussion of possible risks, side effects, and/or adverse events associated with the
HUD and its proposed clinical use.
D.
A discussion of the possible benefits associated with the clinical use of the HUD.
E.
A discussion of any alternative treatments or procedures (if any) that the patient may
wish to consider in lieu of clinical application of the HUD.
F.
Voluntary Consent statement(s) with patient signature and date lines.
Comments:
Principal Physician (printed):
Principal Physician Signature:
_________________
____________
_____
Date:
**Administrator (VP) (printed):
**Administrator (VP) Signature:
Co-Principal Physician (printed):
Date:
___________________
_
Co-Principal Physician Signature
Date:
_______
IRB USE ONLY:
Primary Reviewer (printed):
Primary Reviewer Signature:
Date:
Please send this original application along with the entire protocol and informed consent form
electronically to*:
Natalie S. Bee, IRB Coordinator
McLeod Health - Research Department
FOR IRB USE ONLY:
(843) 777-2013
[email protected]
Approved
Deferred
No action required
Initial Approval
IRB Approval Date:
Conditional approval
Disapproved
Continuing Review
IRB Expiration Date:
*PLEASE BE SURE TO SEND ALL DOCUMENTS TO NATALIE BEE ELECTRONICALLY.
1/09, 3/11, 6/13
Application for HUD Form
June 2013