We intend to invest about $10 million to take the successful product through the FDA regulatory process. We cannot afford to make this magnitude of investment based on research findings that are not accurate, reproducible or lack data integrity.
Shirley Johnston, Director of Scientific Research, Found Animals Foundation
Monday, March 30, 2015

Quality Across Boundaries

Quality Central Team

The Quality Central team, from left, includes Carrie E. Wees, senior scientist/quality coordinator; Margret Tavai-Tuisaloo, administrative assistant; Dr. Rebecca L. Davies, associate clinical professor; and Katrina L. Laube, scientist/quality coordinator.

Quality Central – one of five winners of the Graduate School’s 2014 competition for innovative ideas for enhancing interdisciplinary graduate education – is made up of scientists offering quality assurance support to other scientists, enabling them to meet quality standards and ensure the reproducibility of their research.

Rebecca Davies, University of Minnesota Veterinary Population Medicine associate professor and Quality Central director, and Katrina Laube, Quality Central scientist, want to bring more accountability into the culture of scientific research. They hope that biomedical graduate students can conduct research under a voluntary quality assurance system to maintain data integrity and promote scientific excellence.

A Transformative Experience

The research reproducibility initiative began after Dr. Davies participated in a project that involved incorporating a quality management system into a major laboratory network. She refers to that experience as being "transformative," as it taught her that quality assurance best practices can support scientific effort by demonstrating the soundness of the scientific research or service performed. Davies realized that other groups in the College of Veterinary Medicine could benefit from access to quality assurance tools that would help demonstrate the quality of their work.

The Quality Central team has helped the hospital's Pre-Clinical Investigation Center demonstrate their ability to perform research that meets FDA-regulated work.  They are also working with several research teams, including the Diabetes Institute and the Swine Research Group, in order to integrate quality assurance best practices within their pre-regulatory research programs.

The Quality Central program provides expertise, quality management software tools and training to help other biomedical researchers. "It's an opportunity to showcase the quality of their work and safeguard the integrity and reproducibility of their data," Davies says. A quality system is a management tool that includes equipment, personnel, materials, methods and data management in order to provide credible evidence that data integrity has been preserved. Quality processes involve keeping good records and ensuring consistent procedures which should improve the likelihood that data can be replicated by others.

Giving Students a Competitive Edge

Why is this system important? Davies says that the publication process, a traditional gatekeeper in science, is failing to ensure sound and repeatable science as evidenced by an increase in scientific error, fraud and publication retractions. A winning combination for scientific excellence requires sound scientific principles, appropriate study design and an integration of research quality assurance best practices.  Quality Assurance procedures may also promote the speed of translational medicine because effective use of the procedures will reduce the need to repeat experiments due to lost samples, ambiguous data or the use of un-calibrated or poorly maintained equipment.

"We need to integrate quality assurance into our research training programs to give students a competitive edge," Davies says, adding that biomedical industries and research institutes place a high value on quality assurance practices and they expect new employees to understand how to work within a quality system.

Many funding organizations view quality assurance as extremely important. The Found Animals Foundation has put $50 million towards searching for the development of a nonsurgical sterilant for cats and dogs. "We intend to invest about $10 million to take the successful product through the FDA regulatory process," says Shirley Johnston, director of scientific research. "We cannot afford to make this magnitude of investment based on research findings that are not accurate, reproducible or lack data integrity."

Ensuring Quality Nationwide

With help from the Graduate School, the College of Veterinary Medicine, and a Smithsonian Institution partnership, Quality Central has brought in faculty from other universities to create a collection of training tools and templates for educators and researchers to use. "We are thrilled with the Innovative Ideas grant," Davies says.

So far, the group has designed their research quality assurance training modules.  They envision web-based tools that are freely accessible to scientists to help them manage data associated with procedures, equipment, documentation, personnel, research management and environment, and materials. Eventually, training programs adaptable to institutional or individual level can be designed.  The group will meet again in August and plans to have the toolkit ready in a year. Davies will soon present this Quality Central research reproducibility initiative at a global conference on data integrity in Brazil. 

- Lyra Fontaine