Banner Health (BH) is the University of Arizona's academic medical partner. This partnership is governed by an Academic Affiliation Agreement (AAA). Research studies covered by the AAA are known as “covered studies." Covered studies must meet the two following criteria:
- Principal Investigator (PI) is a Banner University Medical Group (BUMG) faculty physician and holds a University of Arizona faculty title; and
- Research involves one or more BH resources:
- Research involves a select site (BUMC-T, BUMC-South, BUMC-P, or BH clinics)
- Potential study subjects have or had a treating relationship with BH
- Data is being collected on BH patients
- Biological samples are being collected on BH patients
Research studies that do not meet these two criteria are known as “non-covered studies." These are studies conducted by a PI who is not a BUMG faculty physician.
The University of Arizona IRB reviews all University-affiliated research activity at Banner's hospitals (BUMC-Tucson, South, and Phoenix campuses) or clinics. In addition, all access by UA affiliated faculty, staff, or students to Banner facilities, patients, services, staff, resources as a clinical provider, or access to health records requires a Determination of Human Research approval or IRB approval AND Banner approval before the activity may begin. Multiple processes exist depending on the type of activity proposed as outlined below.
If there are cases in which a study will either perform study procedures or collect data across the Banner system, and 75% or more of said research activity occurs at sites that are not of the three UA- Banner sites listed above, Banner IRB would act as the IRB of Record- not the University of Arizona IRB. For questions on this process, you may contact the Honest Broker Team at: BHHonestBrokerDataRequest@bannerhealth.com. For existing studies that have already been reviewed and approved by the UA IRB, and the investigators propose to expand their study to non-academic medical centers/facilities within Banner, the UA IRB can continue to have IRB oversight over the project. In this case, an IAA would be established to defer oversight from Banner IRB to UA IRB for the non-academic sites.
To conduct research at Banner Health covered sites:
- Submit to the UAHS Research Administration Research Intake Application (RIA). Additional resources and information on clinical trials, coverage analysis, CT.gov requirements, and contracting is also available from UAHS Research Administration.
- UAHS Research Administration will review RIA applications for completeness of information. Fully completed RIA's are submitted to BH Research Operations for feasibility review and approval.
- Be sure to use the required University of Arizona/Banner Health Medical Consent Form.
- If recruiting Banner staff for participation in research, include the required Banner employee addendum in addition to the normal research consent. If you are using a consent disclosure, you may insert the following language into your disclosure form in place of the Banner employee addendum consent:
Completion of the survey and participation in this research project is voluntary. If you complete the survey you are confirming that you voluntarily consent to participate in this research project and you understand that participation in this project is not a condition of employment at Banner Health. You may complete this survey at work. If you elect to complete the survey on your own time, you will not be paid for your time spent on completing the survey.
Any UA affiliated faculty, staff or student who wishes to conduct a non-research project (e.g., quality improvement, program evaluation, case report evaluation, etc.) at a Banner covered site (BUMC-Tucson, South, and Phoenix), the UA IRB must first ensure the project does not qualify as human research. Once the UA IRB has determined the activity does not need further IRB oversight, the project is forwarded to Banner's Non-Research Data Use Committee (NRDUC) for further review.
- Submit a Determination of Human Research form to the UA IRB.
- Include as part of the submission a signed letter of support and supplemental questionnaire with additional information required by Banner Health's NRDUC. A letter of support is NOT required for case reports. When a letter of support is required, it should be signed by a Banner internal owner. The Banner internal owner should be a full-time Banner employee, either a FT employed provider or at manager level or above. This person would need to support the project and find it valuable and desired by the organization.
- If conducting a case report, Banner requires (in most cases) prospective authorization from the patient using a case report HIPAA authorization. Do NOT submit a signed HIPAA authorization as part of the IRB submission, as this information is considered Protected Health Information (PHI) and the IRB does not need to receive or retain this data.
- Banner NRDUC will review requests based on the HIPAA rules governing use, access, and disclosure. Banner will ensure that access to PHI is the minimum necessary to complete the activity.
For questions regarding the NRDUC, please contact Banner's Privacy Office.
For questions related to preparatory to research data requests, please contact Banner's Research Regulatory Affairs Director.
Banner Systems Access Requests & Resources
For more information on how to get access to Banner systems and resources, please visit UAHS Research Administration's webpage for:
- Cerner/EPIC Access
- Banner Security Badges
Access to the Data Warehouse
Two data warehouses exist that researchers may use to obtain data for a research project:
- Banner Clinical Research Data Warehouse (CRDW) - To access data from CERNER (September 19, 2017 – present date), submit to the Research Intake Application (RIA) first and include the CRDW request form. Once BH Feasibility is obtained, submit either an IRB application (if obtaining identifiable data) or a Determination of Human Research (if obtaining de-identified data) to the UA IRB. Please note, RIA approval is not needed if only obtaining de-identified data from the CRDW. Be sure to provide a copy of the IRB approval/determination to the CRDW.
- UA Clinical Data Warehouse (CDW) - To access data from EPIC (November 1, 2013 - September 18, 2017), submit either an IRB application (if obtaining identifiable data) or a Determination of Human Research (if obtaining de-identified data) to the UA IRB. Once IRB approval is obtained, submit a data request to the CDW.
Banner Translation Services
For projects occurring at a Banner Health location (BUMC-Tucson, South, Phoenix, or other Banner Health clinics) that will enroll non-English speaking individuals, all study-related documents seen or utilized by non-English speaking subjects require translation and IRB approval.
Use of Cyracom, Banner's approved translation service, is required for:
- Non-sponsored studies; or
- Sponsored studies where the Sponsor or central IRB will not provide translation of the study documents themselves.
Once English versions of study documents have been approved by the IRB, translation requests can be sent directly through Cyracom’s portal https://portal.cyracom.com/customers/#/sign-in/ or to firstname.lastname@example.org.
Please review the Language Translation Process document for detailed instructions on how to obtain translations through Cyracom.
Nursing (DNP) Projects
Banner Health is vested in ensuring that nursing research is part of the clinical practice. All nursing projects (defined as project lead or PI is a Nurse that is Banner employed) requires Banner review.
If the activity is for a UA student completing a degree program then the UA IRB reviews. If the activity is for a Banner employed nurse, non-UA affiliated, then Banner IRB reviews.
- Jill Arzouman - For studies that involve a UA Doctor of Nursing Practice (DNP) project. Please review the DNP Project Approval Process for more information.
- Wanda Larson - For studies that involve a Banner employed nurse as PI not affiliated with the UA.