APPLICATION FOR HUMANITARIAN USE DEVICE
UNDER A HUMANITARIAN DEVICE EXEMPTION
AT AMITA HEALTH
IRB # ______
PRODUCT: ______
DESCRIPTION OF DEVICE:
______
______
______
______
DESCRIPTION OF FDA APPROVED INDICATIONS FOR THE HDE:
______
______
______
SPONSOR: ______
HDE Number: ______
Is this product U.S. FDA approved for use with humans? ____ Yes ____ No ____ N/A
In which AMITA Health facilities will you use this device:
____ AMITA Health Adventist Medical Center, Bolingbrook
____ AMITA Health Adventist Medical Center, GlenOaks
____ AMITA Health Adventist Medical Center, Hinsdale
____ AMITA Health Adventist Medical Center, La Grange
____ AMITA Health Alexian Brothers Behavioral Health Hospital, Hoffman Estates
____ AMITA Health Alexian Brothers Medical Center, Elk Grove Village
____ AMITA Health Alexian Brothers Women & Children's Hospital, Hoffman Estates
____ AMITA Health St. Alexius Medical Center, Hoffman Estates
____ AMITA Health Alexian Brothers Rehabilitation Hospital, Elk Grove Village, in partnership with Rehabilitation Institute of Chicago
____ Other: ______
Has this HDE been previously reviewed by the AMITA Health, Alexian Brothers Hospital System, or Adventist Midwest Health IRB? ____ No ____Yes; IRB:______
Has this product been submitted to any other IRB by the Applicant listed on Page 2 of this application? ____ Yes ____ No
Institution(s): ______
Action: ____ Approved ____ Pending ____ Disapproved
Status: ____ To be started ____ In progress ____ Completed
Please identify any benefits/advantages to the patient: ______
______
______
Please identify significant adverse reactions and other risks: ______
______
______
______
Please identify alternative therapies: ______
______
______
PLEASE IDENTIFY THE PATIENT POPLULATION:
Inpatients______Outpatients______Age range: ______
Diagnosis(es): 1)______2)______3) ______
If INPATIENTS, will outpatient follow-up be required: ____Yes ____No
If YES, where will the patient be seen? ____Outpatient ____Office
If OUTPATIENTS, where will the patients be seen?
____Outpatient ____Office
Name of Principal Applicant: ______
Name(s) of sub-applicant(s): (1)______
(2) ______(3)______
(4)______(5)______
Have all applicants been trained in the use of this device? ____Yes ____No
Please attach signed and dated Curriculum Vitae, Medical License, and Certification of Training in the Use of this Device for All Applicants
Does the Principal Applicant or any sub-applicants have any financial interest in the organization sponsoring this product? ____Yes ____No
If Yes, please describe: ______
Please attach unbound, single-sided copies of the HUD Manufacturer’s Product Labeling, Patient Information Sheet and/or Package Insert, other pertinent Manufacturer informational materials, FDA HDE Approval Letter, proposed Consent, and all Brochures or Advertisements relating to the proposed product.
In order to allow committee members appropriate time to review materials and to properly discuss products, the AMITA Health Institutional Review Board application and reporting guidelines are:
1. Applications, product information, and/or addenda must be submitted to the IRB Chairman (via the IRB Administrative Coordinator) no later than four weeks (20 working days) prior to the next scheduled meeting.
2. The primary applicant (or his/her physician alternate) may be required to be present at the meeting to discuss the product use and answer committee members’ questions.
3. In the event that more protocols are submitted than can be reviewed at one meeting, it may be necessary to delay review of some protocols until the next meeting. Applicants will be informed of such delays. The IRB will make arrangements to hold additional meetings when appropriate.
Applicants are requested to personally contact the AMITA Health IRB Chairman in the event that strict adherence to these guidelines would impose inappropriate treatment denial to a patient(s).
The Applicant is responsible for reporting all unexpected and serious adverse reactions or unanticipated problems to the Chairman of the AMITA Health IRB. The reporting process shall be the same as that required of the Applicant to the product sponsor and/or the FDA. For the purposes of this reporting, a “serious adverse reaction” is defined as one that is life threatening, is permanently disabling, or causes inpatient hospitalization, results in death, causes cancer or a congenital anomaly, or results in overdose.
The undersigned accepts responsibility for assuring that all FDA, DHHS and IRB regulations relative to the protection of the rights and welfare of the patients/subjects covered in this application are adhered to. The undersigned also agrees to respond to the IRB requests for Continuing Review of the HDE, to be submitted not less than once per year.
The undersigned acknowledges that approval of this application for implementation at AMITA Health in no way infers endorsement of the product or of subsequently published findings by AMITA Health.
The undersigned agrees, in accordance with policy and if requested, to be in attendance at the IRB meeting, or authorize a co-applicant to attend, for review and approval of the Application.
______
Principal Applicant Signature Date
Revised September 2015