Approved by: Human Protections Administrator, Director of OPRS, and Executive IRB Chair
AAHRPP REF#: 200
AAHRPP Elements: I.5.A.
DEFINITIONS
- HUMANITARIAN USE DEVICE (HUD): A device that is intended to benefit patients
by treating or diagnosing a disease or condition that affects fewer than 4,000
individuals in the United States per year. - HUMANITARIAN USE DEVICE EXEMPTION (HDE): Food and Drug Administration
(FDA) approval of an HDE permits the marketing of an HUD, subject to restrictions
on charges and use. Specifically, HUDs cannot be sold for profit, except in the
limited circumstance when indicated for use in children, and can only be
administered in facilities after IRB approval is obtained, except in certain
emergencies. Approval of an HDE requires evidence of safety and probable benefit
but does not require establishing effectiveness.
POLICY
The entire board receives copies of items A, F and H, while all items are provided
PROCEDURE
materials to the IRB for review and approval of the use of a HUD:
order, summary of safety and probably benefit, labeling and patient
information);
to the primary reviewers. All IRB members have access to the complete protocol
file, containing items A through H.
treating or diagnosing a patient with a HUD.
consent for clinical use are provided on the UIC HUD consent template.
document may substitute for certain required sections of the UIC consent,
including “Why does my doctor want to use this …”, “What will be involved
with use of the HUD”, “Risks”, “Benefits”, and “Alternative.”
manufacturer is to be provided and reviewed with the patient prior to use of the HUD
regardless of whether it is being used as part of the consent process. The plan for
how this will be conducted is to be described in the UIC HUD application.
CFR 56.111 as much as possible, including:
risks are minimized,
the proposed use of the device,
their legally authorized representative,
the safety of subjects.
labeling and does not exceed the scope of the FDA-approved indication.
training and expertise to use the device.
FDA-approved labeling or may impose more stringent criteria for use of the
HUD as deemed necessary to provide additional protections.
whether it may occur by expedited procedures.
application reviewed and approved by the IRB.
prevent the use by unapproved personnel or the use of the device in an
unapproved manner.
appropriate to the degree of risk, but no less than once a year.
Chair or member designated by the Chair.
HUD-specific information that should be provided the IRB reviewer includes:
deviations since the last review.
Other sites or any annual reports to the FDA, and
reports.
be submitted for IRB review and approval using the UIC Amendment application.
The amendment application should be accompanied by 1). the FDA’s approval of the
modification, 2). the HDE holder’s amendments to the HUD product labeling, clinical
brochure, and/or other pertinent materials corresponding to the requested
modification(s), and 3). the revised clinical consent form with the modifications
indicated. .
with its Approved Indication(s).
the HDE-holder for the HDE-approved indication may occur under the HDE
without the need to obtain an Investigational Device Exemption (IDE).
research) and, as with other FDA-regulated clinical studies, IRB approval and
informed consent are required.
approval.
HUD application and Consent Form designated for completion when safety
and effectiveness data are being collected for an FDA-regulated clinical
investigation or other research activity.
patient (or waiver of authorization) under the HIPAA Privacy Rule is required
for protected health information to be used or disclosed. HIPAA authorization
language is incorporated into the UIC HUD consent form.
and Continuing Review Biomedical Review Guide along with the criteria
outlined for the clinical use of a HUD in sections IV and V.
and efficacy related to use of the HUD for its approved indication by the
investigator for activities meeting the OHRP or FDA definition of human
subject research (see UIC HSPP policy Institutional Authorization for
Determining whether Research or Other Activities Represent Human Subjects
Research) must follow the additional submission and review requirements
described here for those activities representing FDA-regulated studies.
of the HUD at UIC becomes aware of information, from any source, that
reasonably suggest that a HUD has or may have caused or contributed to the
death or serious injury of a patient, the physician or health care provider must
report such findings to the FDA and the UIC IRB as soon as possible, but no
later than 10 working days after the Investigator first learns of the effect or
problem. The UIC Prompt Reporting Form should be used to submit this
information to the IRB.
Problems and Other Events Requiring Prompt Reporting, should be adhered
to with the use of the HUD.
FDA actions regarding the HUD to the IRB within 10 working days of being
notified.
indication) or without prior IRB approval in an emergency situation. The
UIC Policy on “Emergency Use of Test Article” must be followed, including obtaining
concurrence of the IRB chair or designee, informed consent from subject or legally
authorized representative, independent assessment from a uninvolved physician and
authorization from the HDE holder.
where the device is the only option available for a patient faced with a serious or lifethreatening
condition that does not meet the criteria of an emergency. A use is
commonly referred to as “compassionate use”. Unlike emergency use, prior FDA
approval is required before compassionate use occurs. As a first step, the clinician
should seek the approval of the HDE holder and provide them with the following
information: 1). description of the patient’s condition and circumstances
necessitating, 2). discussion of why alternative therapies are unsatisfactory, an
identification of any deviations from the approved HUD labeling required to treat the
patient and patient protection measures that will be followed. The HDE holder must
then submit an IDE(HDE) supplement to the FDA for approval. Once FDA approval
is obtained, the investigator should submit the materials listed in I. along with
documentation of FDA approval of the compassionate use to the IRB for review and
approval.
REFERENCES
Replaces (#, date)
Summary of changes 1.1, 2/04/2012 1., 6/23/2009 Policy: Section IV, concerning off-label drugs. Procedure, Section VIII, added information concerning JBVAMC.
REVISION LOG
Version (#, date)