ࡱ>  4bjbj}} yC,:F.%.%~%~%~%$%%%P%&%Y' )"***k+,-HpXrXrXrXrXrXrX$Z]xX~%/I+"k+//X.%.%**EX 666/.%8*~%*pX6/pX66Lf%O*3 aZn.0hN,\XX<YNL^0^XO^~%O|-h3.J6}.<.---XX3---Y////^--------- #: *IRB #:________  SAINT LOUIS UNIVERSITY Institutional Review Board (IRB) 3556 Caroline St., Room 110 Phone: (314) 977-7744 HUMANITARIAN USE DEVICE New Submission Form The definition of a 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 4,000 individuals in the United States per year. A Humanitarian Device Exemption (HDE) is an application that is similar to a pre-market approval (PMA) application. An approved HDE authorizes marketing of a Humanitarian Use Device (HUD). This is not used for systematic investigations (research), only for clinical use of a non-FDA approved device. Because the 91Ů IRB must conduct an initial review and continuing reviews of humanitarian use device submissions, 91Ů clinicians will need to complete and submit this form. For additional guidance on HUDs, please visit the HYPERLINK "/research/faculty-resources/research-integrity-safety/institutional-review-board-irb/irb_assets/guidelines_hud.doc"HUD guidelines. Clinician/Physician: Administrative Contact: Department: Test article used: E-Mail: Phone: HDE number:  HDE/Project Title:  SPONSOR INFORMATION: Please provide information so the IRB can call the sponsor to discuss the device. Sponsor Name: Address: Sponsor Contact: E-Mail: Phone:  Are you using this HDE as part of a research study?  FORMCHECKBOX Yes, we are using the HDE as part of a research study to systematically evaluate its use, safety, and/or effectiveness. STOP! Do not proceed any further. Rather than completing and submitting this form you must instead submit a full IRB application in eIRB:  HYPERLINK "https://eirb.slu.edu/" https://eirb.slu.edu/.  FORMCHECKBOX NO, we are only using the HDE for clinical care (this is not a systematic investigation). Please continue with this form and submit to the IRB.  Describe the device and how you intend to use it:   State the age range of intended patients: Clinical Team and Training 4a. Describe what kind of training is required to use the device:  4b. Will the clinician(s) receive a certificate for training?  FORMCHECKBOX  Yes before the device is ever used. You must submit a copy of the certificate for all clinicians who will use the device before the use of the HDE can be approved.  FORMCHECKBOX  Yes after_____ proctored/monitored cases. You must submit the certificates as soon as they are available.  FORMCHECKBOX  No In the table below, list names of all members of the clinical team, their degrees, academic rank or title, department or outside organization (if not affiliated with 91Ů), experience and assigned duties. In the third column, provide sufficient detail regarding a clinicians experience to reflect his/her ability to capably perform the duties listed in the fourth column. The clinical team includes all individuals (faculty, staff, or students) who have contact or interactions with patients or with patients private identifiable information or individuals who are specifically designated to perform an integral component of treatment. By submitting the protocol, the treating physician affirms that each individual named has reviewed the protocol and has consented to his or her inclusion. The treating physician and clinical team must have completed human subjects education and HIPAA training (an online course is available on the 91Ů IRB website). Name(s), DegreeAcademic Rank and Department or describe non-91Ů Affiliation Experience (Specify experience which reflects the ability to capably perform study related duties such as certification (if applicable), other trials conducted, related courses completed, etc.)Describe responsibilities administering treatment using HUD1.  2. 3. 4. You may add members to the table above by expanding as needed (place cursor in the last box of the table, right side, and hit the tab key). SITE(S) 5a. Indicate where the treatment will be administered:  FORMCHECKBOX  91Ů, Medical Center Campus  FORMCHECKBOX  SSM Health St. Marys  FORMCHECKBOX  91Ů, Frost Campus  FORMCHECKBOX  SSM Health Cardinal Glennon  FORMCHECKBOX  91ŮCare Locations  FORMCHECKBOX  SSM Health 91Ů Hospital 5b. Will there be any in-patient SSM Health (91ŮH or other) Hospital procedures?  FORMCHECKBOX  No  FORMCHECKBOX  Yes. Please submit a copy of this form to the appropriate hospital review committee. PATIENT CONSENT It is 91Ů policy to obtain patient consent to treat with a HUD when practicable. Please prepare and submit a consent document using the HYPERLINK "/research/faculty-resources/research-integrity-safety/institutional-review-board-irb/irb_assets/hud_consent_form.doc"91Ů HUD Consent Form Template and provide details of the consent process below. If consent cannot practicably be obtained, provide justification for a  HYPERLINK "/research/faculty-resources/research-integrity-safety/institutional-review-board-irb/irb_assets/consent_waiver.doc" waiver, below. Note: in emergent cases, consent can be waived prior to treatment, but should be obtained at the earliest opportunity thereafter.  CONFLICT OF INTEREST Indicate whether you, your spouse or dependent children have, or anticipate having, any income from or financial interest in a sponsor or device manufacturer of this HUD. Please remember that you are responding for you and any other clinician participating in treatment. Financial Interest includes but is not limited to: consulting; speaking or other fees; honoraria; gifts; licensing revenues; equity interests (including stock, stock options, warrants, partnership and other equitable ownership interests). Check one of the following. Please remember you are answering for yourself, your spouse, dependent children and any investigator on the study, his/her spouse and dependent children. 1.)  FORMCHECKBOX  No Equity Interest and/or Financial Interest less than or equal to $5K2.)  FORMCHECKBOX  Any Equity Interest and/or Financial Interest exceeding $5K but not exceeding $25K in the past year or expected in the current year3. )  FORMCHECKBOX  Financial Interest exceeding $25K in the past year or expected in the current year(Check all those that apply):  FORMCHECKBOX  Consulting  FORMCHECKBOX  Speaking Fees or Honoraria  FORMCHECKBOX  Gifts  FORMCHECKBOX  Licensing agreement or royalty income  FORMCHECKBOX  Equity interests, including stock, stock options, warrants, partnership or equitable ownership interests), or serving on a scientific advisory board or board of directors  FORMCHECKBOX  Other fees/compensation(Check all that apply):  FORMCHECKBOX  Consulting  FORMCHECKBOX  Speaking Fees or Honoraria  FORMCHECKBOX  Gifts  FORMCHECKBOX  Licensing agreement or royalty income  FORMCHECKBOX  Equity interests, including stock, stock options, warrants, partnership or equitable ownership interests), or serving on a scientific advisory board or board of directors  FORMCHECKBOX  Other fees/compensation If you have marked box #2 or #3, please contact  HYPERLINK "mailto:coi@slu.edu" coi@slu.edu to initiate review of this study and provide the following information: A Conflict of Interest Management Plan has been approved for this study  FORMCHECKBOX ; is pending  FORMCHECKBOX ; has not been initiated  FORMCHECKBOX  Describe who has, and briefly explain, the conflict of interest and indicate specific amounts for each subcategory checked: __________________________________________________________________________________________________________________________________________________________________________________________________ Note to Provider(s) Reporting a Potential Conflict of Interest Investigator(s) must have: Current, up-to-date Conflict of Interest Disclosure Form on file with the 91Ů Conflict of Interest in Research Committee (COIRC) that describes any financial relationship indicated above. This information must be disclosed on the 91Ů confidential Conflict of Interest Disclosure Form and reviewed by the COIRC before accruing research subjects in this study. If your current Disclosure Form does not contain this information, you are required to submit an updated Disclosure Form to the COIRC. You may not begin your study until your Disclosure Form has been reviewed and any required management plan has been approved by the COIRC for this study. To initiate COIRC review of your study, please contact  HYPERLINK "mailto:coi@slu.edu" coi@slu.edu. In signing this form, the PI certifies that he/she has read the Universitys Conflict of Interest Research Policy and has checked the appropriate boxes above. In addition, the PI certifies that, to the best of his/her knowledge, no person working on this project at 91Ů has a conflict of interest or if a conflict of interest does exist, that an appropriate management plan is in place. By his/her signature, the CHAIR certifies that, to their knowledge, no conflict of interest exists or a conflict does exist for which a management plan has been approved or is under review.  HDE Enclosures: check all that apply.  FORMCHECKBOX  FDA HDE approval letter (REQUIRED)  FORMCHECKBOX  All information from the sponsor concerning the device [protocol, model consent, etc.] (REQUIRED)  FORMCHECKBOX  HUD Consent Form and any other information given to patient (REQUIRED)  FORMCHECKBOX  Training Certificates for all treating physician(s) (REQUIRED if certification is performed)  FORMCHECKBOX  Other Information:note: You are required under 21 CFR part 803 medical device reporting to submit a report to THE fda whenever a device with an approved hUMANITARIAN dEVICE eXEMPTION may have caused or contributed to a death or serious injury, or has malfunctioned and would be likely to cause or contribute to a death or serious injury if the malfunction were to recur. ASSURANCES: The signature of the Treating Physician and the Department Chairperson or advisor indicates that the Treating Physician has the requisite funding, credentials, training and any necessary hospital privileges, if needed, to carry out all procedures and treatments involved in the protocol. The signatures also affirm that the activities involving patients will not begin without prior review and approval by the Institutional Review Board, and that all activities will be performed in accordance with state and federal regulations and 91Ůs Assurance with the Department of Health and Human Services. The undersigned assures that if members of the 91Ů clinical team access protected health information from a 91Ů covered entity in order to seek consent / authorization for treatment, such access is necessary for the treatment, is solely for that purpose, and the information will not be removed from the covered entity without IRB authorization or approved waiver. 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