U-wide team adds clarity to the ancillary review process

The University of Minnesota’s Clinical Research Support Center (CRSC) co-facilitated a collaborative project aimed at accelerating the research process. The process improvement effort brought together stakeholders from across the University clinical research community and led to the creation of several new ancillary review resources available on the Human Research Protection Program (HRPP) website. 

Resources are designed to help researchers understand, navigate, and streamline the ancillary review process, which refers to the approvals a research project may need to comply with federal or state regulations, Institutional Review Board (IRB) policy, or institutional requirements.

Resources for submitting ancillary reviews

For example, the work group created a high‐level workflow that provides best practice details on how to time ancillary review submissions during the start-up process.

There are also job aids that provide detailed guidance on if, when, and how to facilitate ancillary reviews, such as with: 

  • All University Radiation Protection Committee (AURPC) 
  • Center for Magnetic Resonance Research (CMRR) 
  • Cancer Protocol Review Committee (CPRC) 
  • Fairview
  • Health Information Privacy and Compliance Office (HIPCO) 
  • Institutional Biosafety Committee (IBC)
  • Investigational New Drug (IND) and Investigational Device Exemption (IDE)

In addition, there is a simplified review process for studies that only use retrospective data obtained via CTSI’s Best Practices Integrated Informatics Core (BPIC), often eliminating the requirement for HIPCO and Fairview Ancillary Review. 

Work group members were Linnea Anderson, Amanda Galster, Rana Leed, Jessie Oslowski, and Sydney Viel.

Support for the review process

Process improvement efforts are central to the mission of the CRSC, a partnership among the Clinical and Translational Science Institute, the Office of the Vice President for Research, Fairview Health Services, and University of Minnesota Physicians.

In addition to driving the creation of these resources, the CRSC offers a wide range of services for researchers. This includes support related to the ancillary review process, such as guidance on the IRB submission process and IND/IDE application support.