The Feasibility Review process
The Clinical Research Support Center (CRSC) houses multiple resources an investigator will need to bring a clinical research study to fruition at the University of Minnesota. The resources and experts within the CRSC are poised to offer knowledge and guidance throughout the study process, with a focus on supporting the study’s start-up.
The Feasibility Review is an optional, free of charge, early step researchers can take advantage of at the CRSC, and focuses on preparing a study for approval and successful recruitment. This review is made up of a group of experienced research professionals from more than 12 research functions and facilitated by the Research Preparation Group (RPG). Their expertise covers compliance with federal regulations of clinical research, participant recruitment and community engagement, budget analysis, logistics resources and timelines, and quality, safety, and integrity of the research. Using a collaborative approach, reviewers will offer suggestions to help a study protocol reach its full potential.
A researcher undergoing a Feasibility Review can expect:
- Early identification of potential barriers or concerns
- Study-specific recommendations to strengthen the protocol
- Connections to helpful resources and tools across the University
- A decrease in the start-up timeline
How it’s helping researchers
A crucial outcome of using a Feasibility Review for a researcher’s study protocol is a faster timeline to putting the study into practice. Decreasing the time from concept to first participant enrolled means less wasted resources in revising the study plan, and a human health solution that is available to the public earlier.
Using a Feasibility Review means the study may get faster approval from the Institutional Review Board (IRB), a component of the Human Research Protection Program that must approve studies before they can take place. Amy Krentzman, PhD, Principal Investigator with the School of Social Work, shared that the Review allowed her study to pass through the IRB approval more quickly, ultimately decreasing the time before her study protocol could advance.
Françoise Crevel, PharmD, Lead Clinical Research Specialist with CTSI’s Clinical and Translational Research Services office, has already seen the difference in researchers’ experience since the Feasibility Review started.
“Feasibility Review was created to ensure studies are successful right from the beginning, and to prepare and support researchers through the process of getting studies approved,” she said. “This is an opportunity to get expert feedback before even getting to the review stage — we are taking expertise that is already available at the University and making it accessible and easy to find. In our first year, we’ve seen that this was a needed resource that helps researchers across the University get through a complex process more quickly.”
There have been 42 projects that benefited from the Feasibility Review service since it started a year ago, and this number continues to grow.
How to participate in a Feasibility Review
The Feasibility Review service is optional and free of charge. To find out if a Feasibility Review is right for your study, stop by the CRSC during walk-in hours, or contact the CRSC by phone or email at [email protected] to find out more.