Greater MN Clinical Research Initiative

• Establish mutual partnerships with bidirectional input and learning to generate equity and trust with the host sites – recognizing their expertise and experience
• Allow host sites and communities to define areas of need and priorities in research — identified UMN researchers and programs that fit with host sites research interests—push instead of pull model
• Select research projects that offers equitable opportunity to be a part of research for all participants regardless of geographic location
• Practice humility, learn cultural sensitivity, and respect all involved —respect the host site and local community history, strengths, experience and knowledge
• Be accountable by setting up regular evaluation of programming to reduce unintended consequences or negative outcomes.
• Aim for sustainable research programing by utilize existing structures that are working – aim to strengthen and build capacity–diversify portfolio of funding

• Establish sustainable partnerships between the UMN and hospitals, clinics, and physicians in Greater MN and with rural MN communities, on an organizational rather than a PI by PI basis.
• Design trials to minimize participant travel to the Twin Cities with most of the interactions with research participants occurring in their own home clinic, a nearby clinic or hospital, or virtually.
• Create policies, procedures, and tools to support this work that are tailored to meet the health system’s and community’s needs.
• Create informational documentation about the program and ensure that resources are available to UMN faculty to support multi-site trial development, including technology for virtual visits and travel to greater Minnesota communities to support recruitment, participant visits, and relationship building.

2023
Phase 1:

• Establish partnerships with first clinical organization
• Collate key program documentation
• Submit first research study to IRB & ancillary reviews
• Identify second researcher interested in partnering with us

Phase 2:

• Engage in partnership conversations second clinical organization
• Identify third researcher interested in partnering with us
• Receive IRB approval for first research study and begin enrollment
• Have a study development plan in place for first interventional trial

Phase 3:

• Identify an additional 1-2 research projects to bring to program, including at least one interventional trial
• Seek & establish partnerships with additional clinics/hospitals
• Obtain regulatory approval for 2nd research study

2024
Phase 4:

• Continue to engage with current clinical partners through research strategy discussions and seek new partnerships
• Continue enrollment on 2 ongoing studies

• Obtain regulatory approval for next research study(ies)

2024/2025
Phase 5:

• Enrollment goal of 200 participants across all program studies
• Enroll 150 participants on first observational trial
• Enroll an additional 50 across additional studies
• Continue to engage in research strategy discussions with partners

All studies will be reviewed against the following criteria:

• The researcher has obtained funding to support the study operations/implementation expenses, including the cost of study management at partnering host sites
• If the researcher is submitting a proposal to the initiative prior to grant submission, the grant application will include a request for funds to support the study operations/implementation expenses, including the cost of study management at partnering host sites
• The researcher is able to comply with department specific resource review requirements, which may include seeking preliminary resource review as part of a grant partnership within the initiative
• The research under study falls within an area of interest or need by one or more host sites and associated local communities
• The researcher has shown interest or made partnership connections with one or more host site clinicians. Note that this can be through project design and/or grant inception discussions, percolator events, or through conversation with the Research Office.
• The study offers equitable opportunities for eligible participants within the existing clinical population of the host site(s)
• There is staffing capacity to take on the study, or there is an opportunity to hire
• The proposed study will not negatively impact enrollment for active studies recruiting the same clinical and geographic population
• The researcher is willing and able to follow Greater MN Clinical Research Initiative requirements, including:
  • Following the Greater MN Clinical Research Initiative's SOPs, or providing departmental SOPs in appropriate circumstances.
  • Utilizing Florence eBinders for maintenance of regulatory files
  • Partnering with initiative staff members on the management of clinical study activities conducted at collaborating host sites
  • Providing clinical study oversight consistent with principal investigator (PI) responsibilities per GCP, federal regulations, and institutional policies, or identifying an appropriate study PI to take on this role.

• Services and Cost Structure
  Coming soon

The initiative can support a wide variety of research trials, from observational studies to interventional clinical trials, including drug/device and behavioral interventions. Studies are chosen based on the research interests of clinical and community partners around Greater MN. Some examples of research topics include aging research, addiction studies, oncology, diabetes, obesity, Lyme’s disease, although proposals for other research topics are welcome.

Yes! This research initiative is designed to create partnerships with researchers across Greater MN. We would be happy to initiate a partnership discussion and meet with you to discuss your research plans and interests.

The Greater MN Clinical Research Initiative can support researchers in the planning, development, and execution of selected research studies. We can provide consultation on grant and protocol writing, facilitate and provide guidance on study logistics, and manage trial activities across clinical sites.

Yes. We can collaborate with your team to advance your project. Please contact us if you any questions about study resourcing.

Yes! The Greater MN Clinical Research Initiative has experience in managing multicenter research trials and has developed processes and documentation for efficient communication and oversight of clinical trial sites.