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IRB-HSR > Special Issues > Devices > IRB-HSR Device Procedures

 

 

 

 

 

 

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 Principal Investigator should communicate with the sponsor (device manufacturer) and the FDA to confirm that all FDA requirements are being met for emergency use.
  • If Emergency Use is approved by the Sponsor/ FDA consent should be obtained from the patient using a consent form provided by the sponsor.
  • If the patient is unable to give consent, the physician must provide written documentation from him/her and another physician not involved in the clinical trial, verifying the following criteria:
    • The subject is confronted by a life-threatening situation necessitating the use of the test article.
    • Informed consent cannot be obtained because of an inability to communicate with , or obtain legally effective consent from the subject
    • Time is not sufficient to obtain consent from the subject's legal representative
    • No alternative method of approved or generally recognized therapy is available that provides an equal or greater likelihood of saving the subject's life.
  • The device may then be given to the patient.
  • The Principal Investigator must notify the IRB-HSR in writing within 5 working days stating that he/she has used the Emergency Use provision.  A copy of the consent form or the documentation verifying consent could not be obtained should be attached.  IRB-HSR Notification Template
  • Following the next IRB-HSR meeting the Principal Investigator will receive notification from the IRB verifying that the board concurred with the emergency use.

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:

  • 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 for device.
  • HDE #
  • Protocol Information Form for Humanitarian Use Devices
  • New Medical Device Request Form.  This form is completed on line.  Once you have completed it, print out a copy and submit with IRB-HSR application.  You do not need to wait for approval from Clinical Engineering to submit to IRB-HSR.

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:

  • The drug/device is intended to treat or diagnosis a serious or immediately life-threatening disease or condition
  • There is no comparable or satisfactory alternative drug/device available to treat or diagnose the disease or condition in the intended patient population.
  • The drug/device is under investigation in a controlled clinical trial for the same use under an approved Investigational Device Exemption (IDE) or Investigational New Drug (IND) application, or all clinical trials have been completed; AND
  • The sponsor of the controlled clinical trial is pursuing marketing approval/clearance of the investigational drug/device with due diligence.

IRB-HSR Process

  • The Principal Investigator either through the sponsor or directly with the FDA must obtain a "Treatment Use IND/IDE"
  • The Principal Investigator would then submit a new protocol application to the IRB-HSR following procedures outlined in Protocol Builder for a Full Board study.
  • Two exceptions will be allowed for a   Treatment Use protocol by the IRB-HSR:
    • The IRB-HSR will allow concurrent review of the protocol by the PRC and the IRB-HSR.
    • The investigator needs to answer the questions in protocol builder, however the he/she may submit the sponsors protocol in place of writing the protocol following the IRB-HSR protocol template.  The consent form, however, must be written using the IRB-HSR template created with Protocol Builder. 

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.