Streamlined system will improve, expedite human research oversight

Man working on laptop

A new online platform, over a year in the making, will go live next month to streamline and enhance oversight of research involving human participants at the University of Minnesota.

The Ethical Oversight Submission System, or ETHOS, is an online platform that allows researchers to submit applications to the U’s Institutional Review Board for review and approval. The system will cater to the nearly 10,000 faculty, staff and students involved in research with human participants, as well as to researchers conducting similar studies at Fairview Health Services and Gillette Children’s Specialty Healthcare, which both send studies for review at the U’s IRB.

ETHOS, run by the U’s Human Research Protection Program, uses software developed by Huron Consulting Group that has been adapted for use at U of M. Many prominent research universities — including Pennsylvania State University, Northwestern University and Harvard University — use this software to handle submission, review, storage and communication related to studies that need IRB review and approval.

“This tool is an important part of our mission to advance human research protections at the University,” said Debra Dykhuis, HRPP director. “ETHOS makes communication between researchers, IRB reviewers and IRB staff easier, and will support more efficient oversight of human research. Investigators entering new protocols in ETHOS will experience a more efficient review process and can get approved projects started sooner.”

Many researchers had asked HRPP staff for greater transparency in the IRB review process. The new ETHOS system meets that request by displaying each step researcher submissions go through, which step comes next and who is responsible for completing that step. Tracking their submissions’ progress will allow researchers to better anticipate when they can begin their study.

ETHOS streamlines four separate and disconnected systems into one, making it easy for submissions to flow through the review process. The system communicates seamlessly with other widely used university systems, such as OnCore (clinical trial management), EFS (financial system), PeopleSoft (human resources) and ULearn (for tracking and reporting training). Instead of grappling with incompatible file types and different means of file transfer, this fluid system provides a space for multiple Human Research Protection Program offices to access information in a central location.

Researchers should begin submitting all new IRB applications through ETHOS after the system’s launch on March 27. Existing studies will all migrate to the new system by October 2018.

A culture of research ethics

As its name suggests, the ETHOS system is part of a University-wide mission to cultivate a culture of research ethics. This effort, which began in early 2015, centered on protecting human research participants, upholding the highest ethical standards and improving research oversight at every step of the process.

Since then, the U has implemented more than 60 improvements to its human research protections, Dykhuis said.

“The ETHOS system marks the culmination of a comprehensive effort to strengthen our human research practices,” she said. “Moving forward, we will continue to evaluate the effectiveness of our new processes and ensure that we maintain the highest standards around human research protections.”

See the ETHOS page for more information, or contact ethosirb@umn.edu with questions.