Institutional Review Board for Health Sciences Research (IRB-HSR)

Special Issues

IRB-HSR Device Procedures

Additional Information may be found on the FDA website at IDE Early/ Expanded Access.  
Compassionate Use
Emergency Use
Humanitarian Use
Treatment Use
Continued Access

 Compassionate Use of Devices

FDA Requirements
Compassionate Use (or Single Patient/Small Group Access)

IRB-HSR Process

NOTE:  The researcher at UVa should not submit an application to the IRB prior to a patient being identified and the sponsor having submitted a new IDE submission to the FDA for that particular patient.

  1. The Principal Investigator either through the sponsor or directly with the FDA must submit an IDE supplement requesting approval for a protocol deviation under section §812.35(a) in order to treat the patient under Compassionate Use.   The FDA review time for IDE submissions is 30 days from the date of their receipt of the submission so please plan accordingly.
  2. The IDE supplement should include:
    1. A description of the patient's condition and the circumstances necessitating treatment;
    2. A discussion of why alternatives therapies are unsatisfactory and why the probable risk of using the investigational device is no greater than the probable risk from the disease or condition;
    3. An identification of any deviations in the approved clinical protocol that may be needed in order to treat the patient; and
    4. The patient protection measures that will be followed. (Informed consent, concurrence of IRB chairperson, clearance from the institution, independent assessment from uninvolved physician, authorization from IDE sponsor)
  3. Submit the New Medical Device Form to Clinical Engineering
  4. Submit the following items to the IRB:
    • Cover letter stating request for compassionate use of a device.
    • Copy of IDE supplement to FDA for compassionate use
    • Copy of consent form from sponsor to be used to consent subject
    • Copy of protocol currently being used in ongoing clinical trial
    • IDE# (This must be a different IDE # from the IDE# for the ongoing clinical trial )
    • Copy of New Medical Device Form you submitted to Clinical Engineering. This form is NOT required if the device is already being used at UVa under an ongoing clinical trial.

 Emergency Use of Devices

FDA Requirements

Emergency Use


IRB-HSR Process

The FDA allows for only one emergency use of a test article without prospective IRB approval.  See FDA Requirements above for additional information.  If you expect to have an additional patient who will need the same test article- please begin work on submitting a protocol to the IRB.

 Humanitarian Use Device

FDA Requirement
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.

 Additional information may be found at

Emergency Use of a Humanitarian Use Device
For additional information on the emergency use of a HUD see:  HUD Emergency Use

IRB-HSR Process
The Principal Investigator needs to submit the following documentation to the IRB-HSR for full board review:

The protocol is processed like any other new approval by the full board except that a protocol, consent form, Investigator's Agreement and Human Subject Protection Training are NOT required. 

 Treatment Use of Devices

FDA Requirements
Additional information may be found on the FDA website.
"Treatment Use" is described in the federal regulations to facilitate broader availability of promising new therapies to desperately ill patients as early in the development process as possible.  Under these regulations, patients faced with a serious or life-threatening disease/condition for which no alternative exists may receive investigational therapy outside of the controlled clinical trial.
Treatment Use may be considered when:

IRB-HSR Process

THE IRB-HSR STRONGLY ENCOURAGES THE INVESTIGATOR TO CONTACT THE IRB-HSR STAFF PRIOR TO WRITING THE DOCUMENTS TO VERIFY THEIR PROTOCOL MEETS THE CRITERIA FOR A TREATMENT USE PROTOCOL. 

 Continued Access of Devices

FDA Requirements
Continued Access

IRB-HSR Process

Researchers wishing to open a continued access protocol may use a central IRB as the IRB of record for the trial.  The PI will submit the appropriate paperwork to the central IRB and the IRB-HSR.  If the central IRB to be used is WIRB, please use IRB-HSR AG# 3-19 .  If the central IRB to be used is one of the National Cancer Institute's Central IRB's- please see IRB-HSR AG # 3-18. 

Last Modified: Tuesday, 18-Jul-2017 14:17:29 EDT