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The IRB and me: What’s it like to be an Institutional Review Board member?

Part 4 of a four-part series about the Institutional Review Board introduces two board members and shows how they advocate for research participants.

This story is the fourth in a four-part series exploring the role of the Institutional Review Board at the University of Utah. Find Part 1 here, Part 2 here and Part 3 here.

In this series we’ve often talked about “The IRB” in a way that makes it sound almost monolithic. But the IRB is composed of people, each with something to contribute to the process of evaluating research proposals and safeguarding participants’ safety and dignity.

Specifically, the University of Utah IRB is composed of around 120 people, organized into ten panels of usually 15 people each. Some are scientists with particular expertise in the fields of research covered in the studies. Others are non-scientists, sometimes community members unaffiliated with the U, who may also be advocates for vulnerable populations.

In this story, we’ll meet two IRB members, one a scientist and faculty member and one a non-scientist and community member. Each has a different background and a different pathway to the IRB—and even different methods of reviewing studies. But both of them know, passionately and personally, how important it is to protect and inform human participants in research. And both bring crucial and valuable perspectives that help the IRB make research better.

First, let’s meet Paul White. He’s an associate professor in the Department of Psychology. He studies the three Ps of social psychology: persuasion, prejudice/ethnic issues and the factors that motivate or undermine performance. Visits to his office, overlooking Rice-Eccles Stadium, are memorable; it’s filled with figurines and comic clippings testifying to his fandom of science fiction and pop culture. His main interaction with the IRB prior to joining was as a researcher, submitting his own studies for approval. In the IRB, he’s classified as a scientist member.

Next, let’s meet Sarah George. She has 20 years of experience as a nanny and is a mom of two kids. “I do a lot with children,” she said. But her kids have, in her words, a lot of medical complexities. So she’s become an advocate for children with special needs, including speaking with the Utah Legislature.

“We always say to our kids, ‘We don’t have the luxury of disappearing in a crowd.’ So my son’s wheelchair is yellow. This is who we are and this is what we do and we’re unapologetic for it.” She is classified as a non-scientist community member.

Getting involved 

White joined the IRB about 15 years ago as a part of his faculty service to the university. “When I was placed on the board, it wasn’t me wanting to volunteer for it, but since then I’ve come to really like it,” he said.

Since then he’s served as a member of a panel, reviewing studies and applications for renewal.

But in the last five years, he’s also taken on duties as a panel vice chair. That role includes shaping the rules and policy of the IRB, as well as conducting expedited reviews, which don’t go before full IRB panels.

George’s sister worked for the IRB and invited her to join as a community member. Community voices, especially advocate voices, are valued members of the IRB since rarely does the board face issues that are purely scientific. And George, her children and even her father-in-law have all participated in research studies, both through the U and through the Mayo Clinic. That experience is highly valuable in looking out for the needs and experiences of research participants.

George initially resisted. “I said, ‘No, I’m busy. We’re good.’ She said, ‘No, really, we could use your voice. It’s only once a month.’ And it’s been almost five years now that I’ve been doing it.”

Evaluating a study

When sitting down to review a study, White doesn’t start with the application form or the protocols — he starts with the consent forms.

“I’ll download those first, read through those and see, okay, based on this, what would I think I am doing as a participant?” he said. “Then I’ll go to their actual application to see the questions they are trying to answer and the rationale for the study.”

He pays particular attention to how the researchers will handle data confidentiality, including audio and video recordings and medical records. He also looks for policies that are in place to stop the study if participants could be physically or psychologically harmed, and plans for support if participants may face psychological distress.

Then he goes back to the consent forms and to any questionnaires or surveys.

“I’m looking for things like typos, grammatical errors. . . Are they talking about paying participants, but they do not discuss how people are being paid in the consent form? Do they have certain parts of the consent form that need to be there in terms of risk and benefits and the length of times someone’s going to be in a study? Are you in the study for five minutes or are you in the study for five years? Sometimes little things like that can get left out.”

Because she’s classified as a non-scientist, George doesn’t need to vet the scientific merit and statistical methods of studies—other board members review those parts of the study.

“I read that anyway because I’m a science-loving nerd,” she said.

She first looks at the application regarding participants, locations and safety protocols, then looks specifically for data safety monitoring and confidentiality, and if any vulnerable populations are involved.

Then she goes to the consent forms, which she reads carefully. She tries to read them from the perspective of someone who may be encountering medical terminology for the first time. She runs through a checklist, including making sure the language is accessible and written ideally at an eighth-grade reading level.

She pays attention to some things that researchers may overlook.

“One that I think I’m infamous for is the hours of availability.” Researchers must include contact information on their consent forms. “I’ve said, ‘You can’t just say call this number, because you all have different hours of availability you can use.’” She recalls once waiting on hold for hours to talk to one of her child’s doctors. “I am a person,” she said of her patient-centered perspective, “and I do have value and worth and my time is also valuable.”

As a designated advocate for children, who are a vulnerable population, George subjects the studies involving children to additional scrutiny.

“We have to decide what the level of risk it is,” she said. “And then we have to decide, based on that, how many parents need to consent. And if there’s a placebo, we decide what designation the placebo falls under.”

She even calls out grammatical errors, which can interfere with reading and understanding. But she emphasizes that she and the other IRB reviewers aren’t trying to block studies. They’re not the enemy.

“I really want them to succeed,” George said. “And I want their study to succeed. Because these are great studies and if they just change a few little things, they can get more participants to sign up and be so much more effective.”

Then, after completing her review, she goes to board meetings where she and the study’s primary reviewer (usually a scientist) present what they’ve found. Other board members present on other studies as well.

“I rely on the other board members to do their job well so that I can trust their review,” George said.

Bringing unique perspectives

White helped the IRB transition from two boards, which separately handled studies from University of Utah Health and lower campus, to one combined board.

“That was a rough transition,” White said. He was tasked with helping shape the policies and to guide the newly combined board through the challenges of evaluating cross-disciplinary studies. For example, in many of White’s psychology studies, it’s important that the participants do not know the purpose of the study.

“And so I was trying to craft policies so that when you’ve got a physician looking at our research and asking, ‘Why are they deceiving these people, this is unethical,’ that we can say ‘no, we can do this in an ethical way through debriefing and other things.’” It’s not that different, he said, from a pharmaceutical study that’s set up to be double-blind, where neither the participant nor the physician knows if the participant is receiving a treatment or a placebo.

George’s experiences navigating the health care system have also yielded valuable insights. When reviewing one study, she looked at the phone number listed for the emergency contact, recognized it, and knew it would need to be changed.

“I said, ‘They cannot use that number as their emergency contact number.’ And everyone looked at me. I said, ‘That is like the black hole of scheduling at Primary Children’s. It doesn’t even take you to a doctor. It takes you to scheduling and you get lost in there for hours at a time. If this is an emergency contact number, it needs to go to a human that picks up.’”

Her fellow board members said they never would have known that. “It’s great to be able to bring that perspective of someone who has been living it and come and say, ‘This is what it really is like in the trenches. I know what we hope it would be like, but this is really what’s happening.’’

Memorable moments

As an IRB member, White learns about interesting and impactful research long before the rest of the world. He recalls attending a taping of NPR’s “Wait Wait… Don’t Tell Me!” at the Eccles Theater in Salt Lake City featuring U professor emerita Nalini Nadkarni (featured in another story in this series). As Nadkarni talked about her research career, both in ascending to treetops and taking the wonder of science into prisons, White thought, “Why does this sound familiar to me?” Years ago, it turns out, White was one of the reviewers for Nadkarni’s protocols for studying science education in prisons.

“I remember seeing this and going, ‘Man, this is cool stuff,’” White said.

He also remembers the early applications for Distinguished Professor of geology Marjorie Chan’s study of mineral formations in Southern Utah that can teach us about the geology of Mars. Or the work of psychology professor David Strayer on how infotainment systems in cars can lead to distracted driving.

“Now it’s mainstream,” he said. “I knew it was cool years ago!”

George has also re-encountered the studies she’s reviewed. Sometimes at the hospital, she’ll point out a flyer on the wall to her children. “I worked on that study,” she’ll say. “I know what that’s all about.”

Once, during one of her son’s hospital stays, a staff member came to his room to recruit participants for a gene heredity study. Both George and her son knew she’d worked on the study through the IRB—but the recruiter didn’t.

“We kind of pushed her a little bit to see how well prepared she was.” The recruiter, George said, did great.

Why the IRB is important

The IRB safeguards science, White said.

“There should be something in place that helps participants to understand and learn their role in the research, their role in the scientific process,” White said. “Participants should walk away from research knowing something different. They should also be part of this learning process, not just us researchers.”

The IRB’s work also safeguards the legitimacy and validity of the scientific process. White said he sometimes hears comments, especially in social science, to the effect that research only confirmed something that seemed intuitive.

“Well, yes,” he answers. “Because we should not go on assumptions of how things are going to go and how things are going to work.” Throughout the COVID-19 pandemic, for example, the scientific process of challenging and objectively testing assumptions has led to evolving understandings of how the virus spreads, how masking can prevent transmission and how effective vaccines are as protections against severe illness and death.

“Policies and information and suggestions are going to shift as the data comes in and we get to know more about it,” White said. “The IRB can do a job in helping people be engaged in research as participants, but also be engaged in research in trying to understand what science means and what science does and what we’re trying to convey to people.”

Safeguarding science took on another meaning during the early days of the pandemic as the IRB, along with so many others, adapted to a new remote workflow. “Everything just shut down and the IRB staff had to, on the fly, create different ways to do things,” White said. “But we could still function as a board because the research wasn’t stopping.”

The IRB safeguards people, George said.

“It keeps the scientific community thinking about how these people are actual people,” she said. “It helps them remember the humanity of it all.”

The IRB, she said, provides vital review and oversight of the scientific process to keep safety and humanity at the forefront.

“If we don’t have humanity, what’s the point of science? You can do science for purely scientific reasons, but without humanity, it does no good to help humankind.”

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 2 shows how the IRB interacts with and helps researchers.

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