SUNY Downstate Medical Center Institutional Review Board
AN HUD MAY BE ADMINISTERED TO A PATIENT ONLY IF APPROVE BY THE CONVENED (FULL) IRB, unless there are exceptions of certain emergencies where prior IRB approval is not required under applicable FDA regulations. For information on emergency use of a HUD, please see Policy IRB-01.
Submission Checklist (REQUIRED):
All required applicable materials and all required signatures must be submitted or the IRB application package cannot be processed. IRB forms and templates are available on the IRB website or on the “Forms and Templates” button on the left menu in IRBNet.
required for all new submissions:
Registration Form.
Application for External IRB (this form).
HUD FDA Approval Letter or documentation
HUD Protocol from manufacturer
HUD Patient Information booklet from manufacturer
HUD Package Insert/Labeling Information
HUD Safety of efficacy data provided by manufacturer
These above HUD documents should be available from manufacturer or on the FDA website at:
http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/DeviceApprovalsandClearances/HDEApprovals/ucm161827.htm
1) GENERAL INFORMATION
a) Title:
b) Principal Clinician:Contact Information:
Phone # (required):
Email (required):
Alternate E-mail (optional): / Dept:
Check Clinical status below (check all that apply):
(1) Clinician at SUNY Downstate
(2) Clinician with privileges at NYC H+H, Kings County REMINDER: STAR approval is also required.
c) (OPTIONAL) If someone, other than the principal clinician will be the main contact for this submission, please provide his/her contact information below:
Name:Role: / Phone: Email:
d) Are you requesting IRB approval for the use of a Humanitarian Use Device (HUD) for research purposes?
Yes, for research purposes only
Yes, for research and clinical purposes
No
If yes, please also complete an IRB Application for Full Board Review.
2) TABLE OF CLINICAL STAFF:
If additional space is needed, please continue on a separate page using the same format.
a.Name & degree / b.
Place of employment
REMINDER: STAR approval is required for NYC +HH, KC / c.
Will this person be obtaining verbal or written Informed Consent/Authorization
SUNY Downstate
NYC +HH, KC
Other: / Yes No
SUNY Downstate
NYC +HH, KC
Other: / Yes No
SUNY Downstate
NYC +HH, KC
Other: / Yes No
SUNY Downstate
NYC +HH, KC
Other: / Yes No
SUNY Downstate
NYC +HH, KC
Other: / Yes No
SUNY Downstate
NYC +HH, KC
Other: / Yes No
SUNY Downstate
NYC +HH, KC
Other: / Yes No
SUNY Downstate
NYC +HH, KC
Other: / Yes No
SUNY Downstate
NYC +HH, KC
Other: / Yes No
3) HUD Information:
a) HUD Name:
b) HUD Manufacturer:
c) HUD Manufacturer’s Number:
d) FDA HDE ID#:
e) Date of HUD Designation:
4) HUD Background, Alternatives, and Compassionate Use Justification:
a) Please describe the condition/disease that indicates the need for an HUD and the indication approved by the FDA for use of the device:
b) Please include information on previous use and a list of any relevant references:
c) Describe any patient follow-up visits, tests, or procedures that will be required of patients who receive the HUD:
d) There are usually alternatives to choose not to receive a HUD. What therapeutic alternatives are available to patients?
e) What is the designated population for which the FDA has approved the use of the HUD?
f) What is the expected duration of the use of the HUD at the Medical Center?
5) HUD Eligibility, Precautions, Benefits, Risk:
a) Indicate the age range of the participants:
b) Estimated number of patients per year:
c) Describe the eligibility criteria; and if applicable, the usual treatment history for a patient that would qualify for the use of the HUD, and the procedures and methods the patient(s) will undergo:
d) Describe any probable potential direct benefits of the procedure to patients:
e) Describe how the HUD may prevent, or alleviate a serious problem affecting the patients in whom it will be used:
f) Describe the contraindications, warnings, and precautions for the use of the HUD:
g) Describe any potential adverse effects of the device on the health of the patient:
h) What are the potential risks/discomforts associated with the procedure?
i) If data are available, estimate:
· the probability that a given harm will occur:
· the severity of the given harm:
· the potential reversibility of the given harm:
If data is not available, please indicate "data not available".
j) What procedures will be used to prevent/minimize any potential risks or discomforts?
k) Explain how the potential benefits of the use of the HUD outweighs the potential risks of using the device, taking into account the probable risks and benefits of alternative therapies:
6) HUD COI:
a) Do any of the physicians on this form requesting authorization to use the device have any stock or patent position with the device company? Yes No
b) Did any of the physicians on this form requesting authorization to use the device participate in the product design or development of this device, or as a company directory or consultant? Yes No
c) Does anyone at the institution have any financial interest related to the use of this HUD? Yes No
7) HUD Financial Considerations:
a) What is the approximate cost of the HUD?
b) Will the patient incur any financial obligation as a result of receiving the device? Yes No
8) HUD STUDY TEAM:
a) Please describe the qualifications of the Principal Clinician/Investigator to use the HUD:
b) Is any additional training required of the PI or other team members who will be administering the HUD (e.g., specific training for research intervention, training required by the sponsor, etc.)? Yes No
9) HUD Clinical Consent:
NOTE: The FDA and HUD regulations do not require written informed consent for research because an HDE provides for marketing approval and does not constitute research or an investigation which would normally require informed consent. However, the IRB may require documentation of written consent. Similarly, a HIPAA Authorization form is not necessary for HUDs unless clinical investigation requirements for obtaining informed consent apply.
a) Will verbal consent to use the HUD with the patient/participant always be obtained? Yes No
i. If YES, upload a copy of the Information Sheet to the new submission package. This form is available in the IRBNet Library of Forms.
b) Will written consent be sought and documented? Yes No
i. If YES, upload a copy of the Informed Consent to the new submission package. The HUD Manufacturer will usually provide a template for this.
c) Will informed consent be obtained through a surrogate? Yes No
i. If YES, upload a copy of the Informed Consent to the new submission package.
d) Will the informed consent be translated into another language? Yes No
i. If Yes is selected, an amendment must be submitted to the IRB after the IRB approves the English version of the consent.
e) Describe the process of clinical consent for the procedure: personnel obtaining consent, screening procedures, assessment of the patient’s capacity to consent, conditions under which consent will be obtained, any steps to minimize undue influence and any steps to enhance the patient’s independent decision-making, such as a waiting period. If non-English-speaking patients are to receive the device, describe provisions in place to assure comprehension. If the patient is a minor, describe how parental or guardian permission will be obtained:
10) ADDITIONAL INFORMATION:
a) Please provide any additional information that you would like for the IRB to consider:
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