The IRB and Site Authority (Banner Healthcare) approval processes are very complicated and ever-changing. All projects, once fully completed and with all required documents attached, must be submitted to the IRB and the Banner Portal by Susanne Olkkola, firstname.lastname@example.org. You are strongly advised and encouraged to reach out to Susanne early in and throughout the process because it is a very formidable process.
Please note that many of these forms (referenced below) are having trouble loading, it depends on the browser, luck, etc. The IRB is aware of the problem and is trying to address the issues. It seems to work if you click on the download (arrow) icon at the top right corner of the page that has the large heading Please Wait and then open it with Adobe. If you cannot download the pages go directly to the HSPP submission site.
1. Discuss project with Susanne, email@example.com, to get sense of what is needed in terms of approvals, i.e. from whom, Banner, AHSC, UA, IRB.
2. Not sure if it is human subjects research? Complete Determination form.
3. Complete the new HSPP IRB Application form for all projects.
4. Additional forms that may be needed for proposals :
a. List of Research Personnel
b. Consent forms and templates
i. Waiver of consent
ii. Social and Behavioral
iii. Medical Consents (read paragraph on linked page to follow procedures for Banner vs. non-Banner medical consents)
c. Appendices for vulnerable populations (children, Native Americans, etc.)
d. Protocol, usually provided by study sponsor
e. Data Collection tools, if available
f. Device manual, if devices are being used
g. PI biosketch or CV
h. Multi-site research, please discuss with Susanne
5. If any of the research staff, investigators and/or PI has ANY disclosures, they must update their Conflict of Interest form for EACH PROJECT.
6. If the project uses ANY Banner resources: space; staff; residents; procedures, etc., must complete a Schedule of Events. A schedule of events (table of the sequence of protocol-specified events) is a required document. This is generally included in the study protocol; however, investigators writing their own protocols will be expected to provide a schedule of events.
7. If the project is sponsored (outside, non-federal funding), the project will have to be submitted to the UA contract office for budget negotiation and contract development and agreement. Please discuss with Susanne.
8. For all projects that have procedures that are billable, a coverage analysis will be required. The coverage analysis must be completed for all human subject research studies prior to subject enrollment. The coverage analysis determines the Medicare qualifying status of the study and appropriate billing designations for all services performed in accordance with the study protocol. Completion of a coverage analysis prior to participant enrollment ensures that the informed consent, budget and clinical care expenses related to an active study are consistent and congruent.
9. Amendments, Renewals and reporting requires: see Susanne.
For DEM Projects: When all forms are completed, the entire packet still needs to be emailed to Susanne for review and to obtain departmental signatures. Susanne will then submit to (1) the IRB for feedback, review and approval; to (2) Banner for review/approval; and to (3) AHSC Research Administration for approval via the research intake form.
Please contact Susanne Olkkola, 520-626-8819, if you have any questions, concerns, issues and/or need assistance.