The following provides general guidance about the University of Arizona and Banner Health exclusive academic affiliation agreement and what it means for researchers conducting studies at Banner University Medical Centers and provider-based clinics. More detailed guidance will be forthcoming in early 2016.
What Departments and Entities Are Involved in the Banner-UA Clinical Research Collaboration?
What Does the Banner-UA Affiliation Mean to Me As an Investigator?
Which IRB Should Review My Research Activity?
What if I Am Not Conducting Research but Need Access to Patient Information at a Select Site?
How Will Clinical Research Coordinators Work in this New Environment?
How Can UA Staff Obtain Data from the Banner EMR?
What Are the Electronic Medical Record Tracking Requirements?
- The University of Arizona (UA) and Banner Health (BH) entered into an exclusive academic affiliation agreement in February 2015. BH owns and operates three academic medical centers (Banner University Medical Center Phoenix, Tucson, and South), including provider based clinics - known as 'Select Sites.'
- Research conducted at a select site for which the Principal Investigator holds a College of Medicine (Phoenix or Tucson) faculty title or appointment will be considered a covered study.
- Under this new affiliation, covered studies require Banner and the UA to be partners in the review and conduct of study activities including contracting, IRB review, approval of research related procedures and proposed payments.
- BH Hospital-based Research Administration determines access and associated costs for hospital resources, services and permissions.
- University of Arizona Health Sciences (UAHS) Research Administration assists in the coverage analysis, study budget development and access to UAHS resources as applicable.
- UA Institutional Review Board (UA IRB) reviews and oversees human subjects related studies
- UA Contract & Research Support Program facilitates contract terms between study sponsor, Banner and UA entities.
- UA Sponsored Project Services provides administrative and financial services in the management of external funding awards.
- This new partnership requires that many components between BH and UA to be in place to ensure access to patients and facilitation of procedures, as well as ensuring that each research project is conducted in a fiscally and ethically responsible manner.
- Our long-term goal is to provide specific points of contact who will assist investigators through the feasibility and conduct of research projects systematically and efficiently.
- BH and UA leadership continue to meet regularly to logistically establish that process, and to ensure current research initiatives are supported while doing so.
BUMC Phoenix Investigators
- If you are an investigator at BUMCP and hold a UA faculty appointment, the process will largely remain the same, as will your contacts.
- Banner already has Clinical Trial Senior Managers (CTSM) in place to facilitate resource review and assist with study start up.
- The major changes, occurring behind the scenes, include IRB review, conflict of interest reporting, and contracting conducted by the University of Arizona. Your BH CTSMs will assist you through this process.
BUMC Tucson and South Campus Investigators
- If you are an investigator conducting research at BUMCT or BUMCS and hold a faculty appointment, efforts are underway to establish BH Clinical Trial Senior Managers locally who will assist in the initiation and facilitation of research projects at the select sites.
- UAHS has a Director of Clinical Research, Ashwini Roy-Chaudhury, who will be instrumental in working with BH CTSMs to best facilitate research projects for our UA affiliated investigators.
- While BH continues current efforts to hire clinical trial managers, UA affiliated investigators that need assistance in determining the feasibility of their research project should contact Ashwini as a resource.
Director, Clinical Research
A) University of Arizona IRB
- The UA IRB is the IRB of record for all human research studies conducted by:
- UA faculty
- UA staff
- UA students
- BUMC faculty physicians serving as PI for human research conducted at select sites.
- UA IRB is responsible for the review of all research activity for determination if a study meets the definition of human research, including de-identified specimen analysis and de-identified chart review from a BUMC hospital or clinic
- Research activities that have a grant or contract, are conducted for tenure, or any other research activity on behalf of the University, are reviewed by the UA IRB. There are limited exceptions to the activities that are not covered by the UA IRB. Please contact the Human Subjects Protection Program to discuss.
B) Banner Health IRB
- Banner Health has its own IRB that will provide oversight in limited scenarios for non-covered studies conducted by Banner Health network.
- Human research studies conducted by non-UA or non-BUMC faculty physicians, but are using a Select Site, are to be reviewed by the BH IRB.
IRB Contact: Jane Hoverson, CIM, CRC
Research Regulatory Specialist
- BH must review all access to the select sites, including access for quality improvement and case studies.
- For activities that are quality improvement, case studies, or sharing of patient information with colleagues outside of a select site (that is not UA research), BH has a separate review process. Review is conducted by BH Research Determination Committee (RDC).
BH RDC Contact:
Or Cindy Soto, Research Regulatory Specialist, at 480-412-3935
- This is an area BH and UA leadership are currently establishing.
- UA will continue to maintain research coordinators, but there is a long-term goal to establish standardized qualifications and titles for research coordinator roles across UAHS departments.
- BH may have credentialing criteria for UA staff to access the EMR and patients in the select sites. Access needs and permissions will be reviewed on a case-by-case basis.
- Any request for BH staff, such as floor nurses or techs, to perform research-related activities will need to be added as a study budget line item for compensation of hospital-related staff costs and MUST be approved by BH Research Operations.
- For BUMCP faculty, please continue to contact your Clinical Trial Senior Managers for facilitation of approval. For BUMCT and BUMCS, please contact Ashwini Roy-Chaudhury to facilitate approval.
Director, Clinical Research
- The Clinical and Data Warehouse (CDW) is the UAHS centralized, standardized, integrated repository of data extracted from numerous source systems, including the Banner EMR.
- Sponsored projects will be charged at $75/hour. After submitting a request, a member of the UAHS Clinical and Data Warehouse staff will meet with the investigator to provide an estimate of the number of hours to complete the project to be added to the sponsor budget. If funding is not available, a request for data may still be submitted and it will be reviewed for scientific merit for determination of data approval.
- CDW information and data request forms can be found at:azicats.ahsc.arizona.edu/informatics/data-warehousing
If a BH patient is enrolled in a clinical research study, the study team is responsible for linking that patient to the clinical trial in the EMR.
- Linking the patient to the clinical trial in the EMR should be done within 24 hours of the patient signing the informed consent.
- Informed consent forms are scanned in the EMR by the coordinators.
- Once a patient is linked to a research study, the coordinators will have the capability to associate encounters and orders to the research study.
- The encounters and orders that are associated with a research participant will then be pre-bucketed to be charges to either research or the patient’s insurance based on the designation of every service in the research study plan.