For Researchers Testing Human Subjects, Approval Requirements Shift
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For Researchers Testing Human Subjects, Approval Requirements Shift

To better conform to federal guidelines and other universities’ practices, the Institutional Review Board at the University of Wisconsin-Stevens Point is changing its requirements for research applicants seeking the board’s approval.

The board is responsible for approving or rejecting research proposals concerning human test subjects. Its members seek to ensure that any proposed research conforms with the ethical standards of its field as well as federal guidelines.

The changes are all about staying as true as possible to this objective, said Melanie Duncan, a board member focusing on sociology and social work.

“It’s really meant to protect all parties involved, so not only the participant, but the researcher and also the institution itself,” she said.

One change is in the application process. Since September, there have been two submission forms that applicants can choose between to seek board approval – one is a revised version of the other. Starting in January 2016, all applicants will have to use the revised form to submit research proposals.

“Sometimes questions come up during the review process that are rather similar every single time, so the new form is really meant to guide people through the process,” Duncan said. “The goal is really to streamline the process. This is something that you’re seeing across the entire UW System and also making sure that everyone’s kind of consistent across the board in the questions they’re asking.”

The revised submission form is 12 pages, while the original was 5.

The board is also changing its certification requirements for researchers.

According to Tom Wetter, a board member focusing on health promotion and human development, the board previously required researchers to go through a “PowerPoint” of standard practices, federal guidelines and research ethics, with some questions at the end.

The new certification process, called CITI, consists of several “modules”, each teaching and testing a specific area. Staring in January 2015, all researchers submitting research proposals to the board must complete CITI training, with a certification longevity of three years.

Each test consists of 3-10 multiple choice questions and requires an 80 percent or higher success rate to pass, affording only one error in most modules. Modules can be retaken for a better score, but new questions are randomly generated. According to Wetter, the process will take about three hours for most researchers.

The changes, he said, are all about maximizing protecting for human test subjects.

“Our goal is to protect the subjects. That’s our main role,” Wetter said. “We want to minimize the risk any human subjects have when doing a study.”

 

Matthew Wiltzius

Reporter

Matthew.R.Wiltzius@uwsp.edu

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