Why might approval be needed for use of AI in health research?
In summary, healthcare organizations (HCOs) might need to know about, and approve, Artificial Intelligence (AI) you plan to use for your study, if your research:
- could impact clinical care at the HCO
- uses the HCO's data
Reasons AI might need approval by an HCO
Possible reasons why the use of AI in your study might need approval by an HCO:
Contact CB2 if you plan to use AI in a manner:
- that is used in clinical workflows
- that affects, interacts directly with, or is integrated into, health systems (inc. Banner)
- that is used in, or influences, clinical decision making; including: diagnosis, treatment recommendations, prediction, or any other clinical action; or replaces clinical consultation
- that uses Protected Health Information (PHI), especially if the PHI would be provided to a third party
- where data from a health system (inc. Banner) will be kept by the AI company, or used to improve their products
Overview
In order to guide researchers, the Center for Biomedical Informatics and Biostatistics (CB2) compiled the above possible reasons approval might be needed for use of AI; plus AI information which might be needed, which is summarized directly below, with more details in the accordion sections below this section. However, please see the disclaimer at the bottom of this page as CB2 nor U of A may not be aware of all the details.
Regardless of How you plan to use AI
It is helpful to include the following information in your IRB protocol:
- Intended use of AI in the study
- What is the intended use in the study
- Where it will be used (at Banner and/or another HCO)
- How it will be used (for clinical care, or for research only)
- Data Handling / Storage for AI
- What HCO data is being used
- Where it will be handled, stored, and shared, inc. if Banner's or other HCO's data will be shared with AI company(-ies)
- Which of the following steps, if relevant, are done:
- validation
- regulatory docs
- approval(s)
- and/or legal agreements
Provide details if AI is being used as listed above
HCOs, including Banner Health, will need to know, and possibly approve, at least some of the information listed on this page. Some of what you might need to specify is in brackets [] in the example sections below.
- Use at Banner / Existing Agreements: [State/specify if:]
The AI interface [is (OR is not)] used in Banner clinical workflows and [is (or is not)] integrated into the EMR (electronic medical record) or IT (information technology) systems. - [Specify the person] who will work on, if needed, getting a BAA/DUA (Business Associate Agreement / Data Use Agreement) with the company [specify AI company with whom you are working], once a RAP submission is received by Banner.
- Name of AI system: [Specify]
- Protocol Title: [specify, from UA eIRB]
- UA IRB#: [specify, from UA eIRB]
- Good Compliance: [specify, if applicable]
- Score: [specify, if applicable]
- AI Executive Steering Committee, if needed, will approve at a meeting. If applicable, [specify when] meeting did or will happen or approval was or will be obtained
- Intended use [State/specify if:]
- The study is intended [to (OR to not)] evaluate the utility to support patient understanding and augment physician consultation, and gauge patient perceptions.
- It [is (OR is not)] to influence decision making or replace clinical consultation.
- All treatment decisions [will (OR will not)] remain entirely between the patient and their treating physician. Therefore, this study [does (OR does not)] evaluate patient perceptions of AI explanations, not the clinical validity of AI recommendations.
- Data Handling / Storage: [State/specify if:]
- The AI system [does (OR does not)] store, receive, or process any participant data.
- All participant data [are or will be] collected directly in REDCap and stored in Box Health, both HIPAA-compliant and restricted to authorized research staff.
- Regulatory Status: [State/specify if:]
- The AI interface [is (OR is not)] regulated by the FDA because it is not used for diagnosis, treatment recommendations, prediction, or clinical action.
- It [does (OR does not)] meet criteria for Software as a Medical Device (SaMD).
- Prior Research Validation: [State/specify if:]
- The AI system used in this study [does (OR does not)] provide medical advice, make recommendations, or guide clinical decision-making.
- It [does (OR does not)] simply deliver evidence-based educational explanations drawn from reputable medical sources (e.g., NCCN, JAMA) through the Open Evidence Model.
- While patients [can (OR cannot)] interact with the system and ask questions, its role [is (OR is not)] limited to summarizing published literature not diagnosing or advising treatment.
If using PHI, [State/specify if:]
- [No (OR Yes)]. We [are (OR are not)] proposing a zero-PHI study design:
- Inputs [are (OR are not)] limited to structured fields, which are: [specify high-level list of inputs here].
- [No OR specify which] names, record numbers, addresses, phone numbers, email, exact dates, small geographies, or images are shared.
- Patients may ask clarifying follow-up questions, but [no OR specify which] PHI is transmitted.
[State/specify if:] [Yes (OR No).] There [is (OR is no)] PHI flowing to the third party, and there [is (OR is no)] Banner data being kept or used to improve products. If Banner ever wished to explore a different arrangement in the future, we understand that would require separate review and appropriate compensation.
Contact CB2 if you still have questions
About the information on this page
Updated: Spring/Summer 2026
Thank you to the following for the above information: the U of A IIT Review Committee.
Disclaimer
The reasons approval might be needed and other lists on this page may not be comprehensive as CB2 nor U of A may not be aware of all the details. The information on this page, which is based on what the U of A IIT Review Committee needs to be able to appropriately evaluate a study using AI, do not necessarily reflect the information Banner’s, or any other HCO's, AI committee would need for their review. We do not have a list of the criteria Banner uses to evaluate studies using AI: the information on this page has been annotated by CB2 to inform researchers using AI what Banner or any other HCO might need. Please Contact CB2 if any information on this page might be missing or incorrect, so CB2 can direct you to the appropriate person(s) with proper authority and verify the information.
