Humanitarian Use Device (HUD)
A Humanitarian Use Device (HUD) is a device that is intended to benefit patients in the
treatment and diagnosis of diseases or conditions that affect or are manifested in fewer than 4000
individuals in the United States per year. The sponsor must get a HDE designation from the
FDA’s Office of Orphan Products Development. The Federal Food, Drug, and Cosmetic Act
and the HDE regulation do not require informed consent because a HDE provides for marketing
approval, and so use of the device does not constitute research or an investigation which would
normally require informed consent. The sponsor may provide the patient with patient labeling to
assist the patient in making an informed decision about the use of the device. Even though the
device is not considered investigational, IRB review is required. The initial review must by done
by full board, although continuations may be done by expedited review. Please see the
submission deadlines for full board meetings at
http://www.virginia.edu/vprgs/irb/hsr_meetings.html
The Principal Investigator needs to submit the following documentation to the IRB-HSR for full
board review:
1. Cover letter requesting HDE approval. This letter must include the maximum # of subjects
planned to use the device and a statement that the device will only be used according to the
indications approved under the HDE.
2. Investigational Brochure or equivalent documentation for device.
3. HDE #
4. Protocol Information Form (see next page for form)
Protocol Information Form
Humanitarian Device Exemption
Sponsor Protocol #______________(If Applicable)
Title:_________________________________________________________________________________
Do you/will you have a contract with an outside sponsor for this protocol?
Yes
No
If yes- name of group you will have contract with:_______________________
Does this study involve the use of radiation for research purposes?
Yes
No If Yes, Radiation Safety Board approval is required unless standard wording from the
IRB-HSR Website is used.
Will any part of this study be done in the GCRC?
Yes
No
If Yes, GCRC approval required. Attach one copy of GCRC submission.
GCRC#___________
Will this study require approval by the Cancer Center PRC?
Yes
No
If Yes- PRC #_______
Does this study involve the use of recombinant DNA, biological vectors or infectious agents?
Yes
No
If Yes, IBC approval required. IBC#____________
To avoid any conflict of interest are any IRB-HSR members/alternates listed on the protocol or 1572
form?
Yes
No
If Yes, please list names below.
______________________________________
_________________________________
Will you collect any specimens from a human? Yes No
Will all collection (i.e. blood drawing) and processing (i.e. anything that
involves the specimen container to be opened) occur in a UVA clinic/hospital or
clinical lab?
Yes No
If No- attach approval from the Institutional Bio-safety Board
IBC#__________
If you need to register with the IBC go to http://keats.admin.virginia.edu/bio/home.html
The following documents are included with this submission (please check all that apply):
_____ Cover letter requesting HDE approval. This letter must include the
maximum # of subjects planned to use the device and a statement that the device
will only be used according to the indications approved under the HDE.
_____ Investigational Brochure or equivalent documentation
_____ HDE #
_____ Protocol Information Form (this form)
PLEASE NOTE THAT ALL PERSONNEL LISTED ON THIS FORM MUST HAVE
COMPLETED IRB-HSR ONLINE TRAINING IN HUMAN SUBJECT RESEARCH
PROTECTION BEFORE PROTOCOL WILL BE REVIEWED BY IRB-HSR.
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PLEASE NOTE:

If an individual is a UVA employee, please list his/her official UVA registered e-mail address. Do not list an alias e-mail address on IRBHSR forms. Ex: use srh@virginia.edu, not SRHoffman@virginia.edu.

ALL individuals having contact with subjects or their identifiable information for this protocol must be listed below.

All e-mails from the IRB-HSR regarding a protocol will be sent to the PI, Study Coordinator , Department Contact and IRB Departmental
Coordinator (if applicable)
Principal Investigator: (First) _________________ (Last)____________________________________(Degree)____________
Phone ____________________ E-mail___________________________ Messenger Mail Address _________________________
School _____________________________________________
Department ___________________________________________ Division______________________________________
Note: only 1 person may be listed as the PI by the IRB-HSR- please list others as sub-investigators. If the PI is NOT a faculty member a faculty
member must be listed as a sub-investigator. Students are not allowed to be the Principal Investigator.
Study Coordinator: (First) ____________________ (Last)____________________________________(Degree)____________
Phone____________________ E-mail___________________________ Messenger Mail Address__________________________
School _____________________________________________
Department___________________________________________ Division______________________________________
Note: only 1 person may be listed as the study coordinator by the IRB-HSR- please list others as sub-investigators.
Department Contact: (First) ___________________ (Last)___________________________________(Degree)____________
Phone___________________ E-mail_____________________________ Messenger Mail Address_________________________
School _____________________________________________
Department___________________________________________ Division______________________________________
Note: Usually a person who knows how to get in touch with the PI or Study Coordinator if they’re unavailable (i.e. PI secretary/department manager). The Department Chair should not be listed
as the Department Contact.
Departmental IRB Coordinator: (First) ___________________ (Last)___________________________________(Degree)____________
Phone___________________ E-mail_____________________________ Messenger Mail Address_________________________
School _____________________________________________
Department___________________________________________ Division______________________________________
Note: This is applicable ONLY to the Pediatric Department, the Cancer Center and the GCRC.
Sponsor/Granting Agency Name: ______________________________________________________________________
Address: ________________________________________ Phone: _______________________ Fax: _________________
City, State, Zip: ______________________________________________________________________________________
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Sub-Investigators
List ALL individuals who will have contact with subjects or will have access to research data that has identifying information (e.g.subject name or medical record number)
Sub-investigator: (First) ______________________(Last)__________________________________(Degree)________
Phone_______________ E-mail___________________________ Messenger Mail Address_________________________
School _____________________________________________
Department___________________________________________ Division______________________________________
Sub-investigator: (First) ______________________(Last)__________________________________(Degree)________
Phone_______________ E-mail___________________________ Messenger Mail Address_________________________
School _____________________________________________
Department___________________________________________ Division______________________________________
Sub-investigator: (First) ______________________(Last)__________________________________(Degree)________
Phone_______________ E-mail___________________________ Messenger Mail Address_________________________
School _____________________________________________
Department___________________________________________ Division______________________________________
Sub-investigator: (First) ______________________(Last)__________________________________(Degree)________
Phone_______________ E-mail___________________________ Messenger Mail Address_________________________
School _____________________________________________
Department___________________________________________ Division______________________________________
Sub-investigator: (First) ______________________(Last)__________________________________(Degree)________
Phone_______________ E-mail___________________________ Messenger Mail Address_________________________
School _____________________________________________
Department___________________________________________ Division______________________________________
Sub-investigator: (First) ______________________(Last)__________________________________(Degree)________
Phone_______________ E-mail___________________________ Messenger Mail Address_________________________
School _____________________________________________
Department___________________________________________ Division______________________________________
Are there additional sub-investigators?
Yes
No
If Yes, attach additional pages.
Revised 5-12-06
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