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PhD research assistants help PIs complete IRB submission forms
Paid position educates both sides
The University of Louisville in Louisville, KY, has developed a program that serves as a dual-purpose human subjects research educational program, helping both doctoral students and experienced research professors and others.
A few years ago, the vice president for research started a research assistanceship program for PhD students who have an interest in serving on the IRB and working with principal investigators (PIs), says Robert J. Barney, MSW, PhD-candidate and IRB member at the University of Louisville. Barney has been a research assistant for the past three years.
The goal of the program is to provide one doctoral student in the Kent School of Social Work with a paid position that also assists with the student's tuition. In return, the student serves on the IRB and works with researchers as they prepare protocol submissions for the board.
Barney serves as a consultant to researchers, and it complements his role as an IRB member.
"It's an amazing experience," Barney says. "I've done dozens of continuations and amendments and have learned the process of the IRB, while having the experience of interfacing between researchers and the IRB."
So Barney has learned how the decisions are implemented and experienced by researchers.
The research assistant typically works 20 hours per week assisting with any IRB-related matters. This includes helping to build protocols, prepare IRB applications, working with amendments, etc., Barney explains.
"It's through my experience with the IRB that I've learned the applications," he says. "I started as an alternate member of the IRB at the same time I became a research assistant."
The two positions complement one another and helped expedite his learning process, he adds.
When researchers are sent IRB notices, Barney also receives a copy.
"Any time a notice is sent to the PI, it's also sent to me," he says. "I follow up and offer help that way."
Barney also assists with preparing applications and making certain protocols contain all of the correct elements for human subjects research protection.
"I bounce ideas and considerations off the PIs, maybe talking with them about the implications of the research that they may not have considered," he adds. "If there's something they might not have considered, then the IRB might ask for further changes, and I can mitigate some of those requests by the advice I give researchers."
Barney works mainly with new investigators, typically starting by directing them to the educational requirements of the IRB.
"I make sure they understand the processes required by our particular IRB," he says. "We have federally-mandated guidelines, but each IRB is able to interpret those in a unique way and impose a set of requirements unique to that university."
The goal is to get PIs up to speed with the University of Louisville's requirements, he adds.
"I use a lot of informational materials provided by the IRB," Barney explains. "In a lot of cases I look back to the protocols and submissions made in previous years with previous studies to help me understand what was required."
When new issues arise, Barney will compare studies that have the same issues looking for a new twist on an old issue or a new concept that needs to be considered.
"I stay in close contact with the chair and director of the IRB, consulting with them," Barney says. "It's a bit of mentorship that's available to me, as well."