As part of an ongoing effort to enhance oversight of human research, the University of Minnesota Human Research Protection Program is implementing a new web-based platform for research applications this month.
University officials say the new system — called the Ethical Oversight Submission System, or ETHOS — will improve the way researchers apply to the Institutional Review Board by increasing transparency.
In the current system, researchers who want to conduct research with human participants must submit an application detailing research process, among other things, for IRB approval. This system is antiquated, and an update was long overdue, said IRB member Niki Gjere.
“There’s different forms you need to complete. There’s emails that go back and forth between IRB staff and the researchers, so it’s a very cumbersome system, and it’s quite fragmented,” she said. “It’s kind of difficult to have a good sense of what’s happening.”
Through ETHOS, researchers will complete and track IRB applications online as well as communicate with IRB staff to provide updates or ask questions, Office of the Vice President for Research spokesman Kevin Coss said in a February post for the University’s research blog.
The system will help the IRB keep reviews more consistent, and lets researchers track their research applications and consolidate all their documents in one spot, streamlining communication among researchers and IRB staffers, said Debbie Dykhuis, HRPP executive director.
However, the new system doesn’t fix communication gaps between researchers and subjects, Gjere said. Researchers and IRB staff can access the IRB-approved research protocol, but subjects still have no way of knowing if a researcher strays from the procedure approved by the board, she said.
“We rely on the integrity of the researchers to do what they’re supposed to do, and if they don’t, it’s really difficult to know what the protocol is,” Gjere said. “If details aren’t communicated to other people besides the research team, [ETHOS] won’t help with that.”
ETHOS is a type of software from Huron Consulting Group that has been adapted for University use, Coss said in the blog post.
The market for these systems is narrow, and the University decided to use the Huron software because it included support for a workflow that meets regulations in the review process, said Office of the Vice President for Research Information Technology Director Thierry Boudet.
Northwestern University uses the same Huron Consulting Group software adapted for the school’s IRB submission system. The submission process for researchers is smooth, said Denise Roe, Northwestern’s IRB executive director, though some involved in the business processes — or those charged with maintaining the workflow — expressed dissatisfaction for the first year-and-a-half of use.
She said this has improved since the institution started an ongoing workgroup.
The University’s IRB system switch comes as part of a years-long push to improve the school’s research oversight. In 2015, several investigations revealed ethical concerns with how the University conducted research, prompting the implementation of 62 changes to research oversight that were completed last year.
The HRPP was reaccredited last December after the Association for the Accreditation of Human Research Protection Programs, Inc. required the University to meet certain criteria before regaining full accreditation status.
Correction: a previous version of this story incorrectly attributed a quote to Debbie Dykhuis when it should have been attributed to Niki Gjere. The error has been corrected.
