| 1. Business Negotiations |
When an industry start-up or established technology company wishes to test out an innovation in the health care delivery environment, they approach CU Innovations as a first step. CU Innovations is aware of the CARE priorities for improvements in patient care, and will forward relevant opportunities to the CARE team for consideration. If the innovation or proposed solution meets a CARE priority and there is a clinician researcher within the UC Health system who could serve as a lead investigator of a clinical trial to investigate the effects of the innovation, CARE convenes the key players to begin the clinical validation process |
| 2. Convening key players |
At this point, CARE will involve mHealth Impact and schedule a conference call between the CARE team, clinical subject matter experts, and mHealth Impact personnel to specify the scope of work and identify the relevant IRB considerations. For each project, the group must consider who will assume responsibility for identification, recruitment, informed consent and enrollment of patient participants in research. They also consider who will assume responsibility for collection, management and analysis of study data, and discuss data access and ownership issues. UCHealth has internal clinical research teams with capacity to perform all these research functions, but they are not always available for research implementation; in such cases, mHealth Impact will step in to provide all or some of the research implementation activities. During this initial partnership-building phase, intellectual property (IP) and non-disclosure agreements (NDA) are also discussed. Typically, IP rests with the technology partner and all parties participate in a non-disclosure agreement; however, some partnerships may involve co-development and co-ownership agreements as appropriate |
| 3. Protocol development |
Many times, the technology partner articulates what they would like to learn from their digital health product and how they can support the work within the AHC. The academic research partner (mHealth Impact) in concert with the internal CARE team and UCHealth clinical research team as they are available then proposes methods and protocols for articulating those claims with appropriate rigor. As noted above, each project includes at least one UCHealth clinician researcher who serves as a subject matter expert. These conversations are facilitated by CARE project management personnel. mHealth Impact will interface with clinician researchers and the CARE team to develop or refine the research protocol and submit it for review to the University institutional review board (IRB) with additional materials as needed to fully address protections for human subjects engaged in research. The focus and scope of the research proposed will determine if a research study is classified as ‘exempt’ from IRB approval or if it represents minimal or greater than minimal risk requiring more extensive oversight |
| 4. IRB processes |
Technology partners may be unfamiliar with human subjects research and the associated regulatory compliance requirements and approvals required by and managed through an IRB. The academic research partner provides critical insight into ethical approaches to scientific clinical trials and into compliance with federal regulations for the protection of human subjects in research. mHealth Impact usually manages the IRB application process using established digital health protocol templates to facilitate application creation. These templates significantly shorten the timelines for review of protocols by the IRB, and facilitate more rapid implementation of research on technology innovation in the care setting |
| 5. Research team development |
Clinical research teams embedded within the UCHealth system and/or teams through mHealth Impact may be engaged to conduct the proposed work. This includes teams with capacity to recruit, obtain informed consent and enroll participants within the AHC such as a research coordinator or team of research assistants to support the appointed clinician principal investigator |
| 6. Implementation and analysis of study |
The implementation of the study depends on the scope of work between the AHC-AIP. In general, these projects require support at the clinic level, study champions at the leadership level, an investigative team, and a project manager to help navigate all aspects of a complex adaptive system. Depending on the scope of work, the analysis of clinical trial data may be the responsibility of the technology partner, mHealth Impact, or an internal group on the AMC campus that specializes in biostatistics and data analytics |
| 7. Study completion and dissemination |
Upon completion or cancellation of the study, two forms of dissemination of knowledge may occur, which are highly dependent on the IP/NDAs established in the early stages of the AHC-AIP. (1) Academic publications help advance the evidence base, but it is essential to do so without revealing and proprietary information that may affect the solution’s development and commercialization potential. (2) Additionally, insights are retained within the technology industry partner to better inform user experience and user interface (UX/UI) design, and future iterations of digital health product |
