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The IRB and me: How does the Institutional Review Board help researchers?

Part 2 of a four-part series about the Institutional Review Board shows how an ecologist learned the ropes of the IRB process.

This story is the second in a four-part series exploring the role of the Institutional Review Board at the University of Utah. Find Part 1 here, Part 3 here and Part 4 here.

Nalini Nadkarni started her scientific career in treetops, studying the ecology of the canopy of rainforests both tropical and temperate. Up there, far above the forest floor, there’s no need to ask trees for written consent as research subjects.

But in recent years, Nadkarni has brought the wonder of the canopy down to the ground and shared it with the people who had little to no access to nature, particularly the incarcerated. Conducting research on how exposure to nature enriched the lives of these people posed a new set of challenges and considerations.

For Nadkarni and every other researcher at the University of Utah that conducts research with human participants, the Institutional Review Board helps at every step of the way to ensure the safety and dignity of those participants. This story is part of a series that will introduce you to what the Institutional Review Board is and what it does to protect people involved in scientific studies. This time we’ll explore the process from the point of view of a researcher who learned how to use the Institutional Review Board a necessary and helpful resource mid-way through her career.

“Learning the process of navigating the IRB has, for me, been a long, somewhat difficult, time-consuming, but ultimately rewarding experience,” said Nadkarni.

Learning to work with the IRB

In the early days of the COVID-19 pandemic, U researchers couldn’t return to their labs to continue research without special permission. While her colleagues in the School of Biological Sciences requested access to their labs to care for plant or animal research subjects, Nadkarni’s special lab permission was for access to a file cabinet.

“I had to get permission to work in the lab on analyses of our surveys of incarcerated men and women, as we are not allowed to remove them from the secure file cabinets that were established with IRB permission,” she said. “That is a small thing, but it made me realize the need for extreme care in the movement of data that pertains to sensitive groups.”

Nadkarni is a passionate science communicator, driven to bring the wonders of science and nature to people who wouldn’t typically seek out science—or may not have access to nature. This includes adults and youth who are incarcerated. To assess how effective her efforts are, she conducts research. To conduct research that includes people, she needs approval from the IRB.

But as a trained forest ecologist, Nadkarni had to learn how to interact with the IRB basically from scratch. Her colleagues in the life sciences did not have experience working with humans in research and weren’t able to offer guidance.

“Initially, I explored the IRB website and perused their trainings,” she said, but found that the trainings assumed at least some familiarity with the process. “So I spent time with officers at the IRB, meeting with them in person. They generously provided time for in-person meetings with me over the course of several months.”

The IRB staff was patient and helpful as she filled out her first applications for review—and then revised them. “My first attempts to submit reviews were ridden with mistakes,” she said. IRB staff was helpful but maintained a distance necessary for an objective review.

“So over the years,” Nadkarni said, “I have learned about the balance that is needed to get critical input from them, while still ‘doing the work’ myself to ensure I am in compliance with my applications and implementation of surveys and interviews.”

Vulnerable populations

People who are incarcerated are considered a vulnerable population in terms of research. Other vulnerable populations include pregnant women and fetuses, newborn babies, children, people with mental disabilities or cognitive and/or decisional impairments, people who are economically or educationally disadvantaged and Native Americans. To protect these people, anytime a research proposal involves a vulnerable population, the IRB includes members that specialize in the issues pertaining to that population in the review of the study. IRB panel meetings with members who oversee studies involving the incarcerated occur with less frequency than regular panel meetings, something that can extend the review process.

“So it is a bit more of an extended and critical process than what other researchers might encounter,” Nadkarni said. “IRB oversights assure me that I am not putting the populations I work with under undue risk.”

Tips for other researchers 

When, in the scientific process, is it time to bring in the IRB? The earlier the better, Nadkarni said, as the IRB can help determine accessibility to human participants, the kinds of data that can be collected and analyzed and the ways results can be reported.

I would urge researchers to secure an appointment and have a conversation with an IRB staff person VERY early in the study process so that they can understand the restrictions that they will face when they submit their protocol for review,” she said. “And to feel free to contact the IRB staff whenever a question arises. Sometimes, I believe that researchers are hesitant to actually talk to IRB staff, but it is perfectly okay to do so, and can save a great deal of time and revising on the part of the researcher, and review work on the part of the IRB.”

Learn more about the IRB in the other parts of this series or on their website here.

Part 1 explores the history and operations of the IRB.

Part 3 tells the story of a research participant who ran into obstacles, and how the IRB is working to remove those obstacles.

Part 4 introduces two IRB members and how they approach reviewing a study.