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Study finds feasibility review service leads to better protocols

The University of Minnesota’s feasibility review service improves the quality of human subjects research protocols and better prepares them for IRB approval, according to a new study published in the Journal of Research Administration, a publication of the Society of Research Administrators International.

The free service from the Clinical Research Support Center (CRSC) provides University investigators with efficient, comprehensive protocol reviews by clinical research experts.

The study, conducted by CTSI faculty and staff, detailed the feasibility review process and examined 116 studies across eight UMN schools and colleges. It found the process resulted in submissions that received one or fewer protocol-related stipulations from the IRB and led to an investigator satisfaction rating of 4.71 out of 5, on average.  

Additionally, the reviews provided an added bonus of educating study teams on how to write higher-quality protocols in the future, the study found.

A fast path to better research

The feasibility review service was started in 2018 as a way to boost the quality and speed of clinical research. 

Completed within six days, a feasibility review is conducted by a team of research specialists with expertise on topics such as study design, biostatistics, regulatory requirements, recruitment, community engagement, informatics, health systems, budgeting, and more. The team reviews the protocol to note areas of concern, suggest new language and resources, and provide guidance on IRB submission.

Once the review is complete, the team meets with the investigator(s) to share their findings and deliver a written summary of suggestions.

The CRSC is a collaboration among CTSI, the Office of the Vice President for Research, University of Minnesota Physicians, and Fairview Health Services. To request a feasibility review or for more information, contact [email protected].