This story is the first in a four-part series exploring the role of the Institutional Review Board at the University of Utah. Find Part 2 here, Part 3 here and Part 4 here.

Imagine you’re sitting in your doctor’s office. As part of a routine visit, she tells you about a study at the local university that’s well suited for someone of your age, background or health status. It’s an investigational new drug in clinical trials, and they need volunteers.

Or imagine you’re waiting in the hospital before a procedure, when a hospital staff member comes in to say that, if you’re willing to participate in a study, you may receive experimental treatment in the case of complications.

What would you feel? What questions would you have? Maybe you might ask: “How do I know this won’t cause me harm? Do I know everything I need to make an informed decision? What safeguards are in place? Is the knowledge gained from this research going to be worth the risks?”

It’s OK. Those are the right questions to ask. And at universities throughout the country, including at the University of Utah, an oversight board has already asked them to make sure that every person who participates in a research study is protected from harm and treated with dignity. That board is called the Institutional Review Board, or the IRB.

This story is the first in a series that will introduce you to what the Institutional Review Board is and what it does to protect people involved in scientific studies. In this story, we’ll learn about why we have Institutional Review Boards and how they work. In future stories, we’ll see how the board works through the eyes of researchers, board members and study participants. Each of these perspectives will help us see how the board acts to maintain the integrity of science and the humanity of the people who are a part of the scientific enterprise.

“I want everyone to know that there’s someone that is watching out for them and has their backs,” said Hannah Owen, former Institutional Review Board administrator at the U. “There are so many rules and regulations and policies that have to be followed in order for research to happen. And we want people to know that there are just tons of people looking out for them, especially for folks who have historically been taken advantage of for research.”

History of research ethics

The need for IRBs comes from tragic episodes of research misconduct. Following World War II, the Nuremberg Trials brought to light the war crimes committed by members of the Nazi party, including medical experimentation. In 1947, the verdict against the Nazi researchers included what became known as the Nuremberg Code, which included 10 principles for medical research ethics.

“The voluntary consent of the human subject is absolutely essential,” the code begins, and continues to state that the experiment should “yield fruitful results for the good of society, unprocurable by other methods or means of study, and not random and unnecessary in nature.” The experiment design should hold safety as its highest priority, the code said and should allow the researcher or the participant to halt the experiment at any time if either feels it’s not safe to continue.

In the United States, unethical research practices associated with the Tuskegee Syphilis Study operated from 1932 to 1972, led to the Belmont Report, issued in 1978, containing ethical guidelines for human subject research. The report identified three core principles of ethical research: respect for persons, beneficence (producing good) and justice.

Since then, every research institution receiving federal funding, including most universities, has been required to have an Institutional Review Board that evaluates and approves any research involving human participants.

“In order to uphold those tenants of ethical research,” she said, “you have to have an Institutional Review Board that is overseeing and protecting the human research participants.”

It’s hard to “unring the bell” of the dark chapters in the history of research, Owen said. But Institutional Review Boards exist to protect and advocate for research participants. “People are not a means to an end,” she said. “They’re human beings and their experiences and their needs and wants matter.”

How it works

The U’s Institutional Review Board consists of dozens of members, organized into ten panels of around 15 members, each with a different meeting schedule. Some board members serve on more than one panel. Many of the board members are scientists at the U, but the rest aren’t—some are university employees and others are members of the community. Panels meet once or twice a month and include researchers from both U of U Health and the College of Social and Behavioral Sciences, as well as community members, on every panel.

“We don’t have, for example, an adult oncology board,” Owen said. “We have, however, adult oncologist reviewers on every board. And we also have pediatric cardiologists or cardiac surgeons along with nurses, neurosurgeons and hematology/oncology specialists. Our boards are just a mix of all of those specialties so that each panel is equipped to review any study, essentially.”

You’ll get to meet two board members, one researcher and one community member, in another part of this series.

The U is a highly active research university and keeps the Institutional Review Board busy. Each year, the board receives thousands of new study applications, as well as additional thousands of studies that need amendments or continuing review. “It is a lot,” Owen said.

But a straightforward process helps the board manage their workflow. Research teams submit applications through an electronic system, and the applications are assigned to a team of New Study Administrators.

“We review the application and we send revisions,” she said. “So we say, ‘Tell us more about how you’re recruiting folks,’ or ‘help us understand how you’re going to make sure a particularly vulnerable population is protected.’ We review the new study application and try to get it in pretty good shape.”

Then the application typically makes an appearance before the full board, shepherded by an assigned board reviewer who applies their own expertise as well as federal research ethics guidelines.

“They look at it through a very similar lens, but obviously they have expertise that I do not,” Owen said. “They’re looking at it from the medical and research side of things, which is so helpful because there are just some things that I cannot know.”

Depending on the type of study and level of risk, applications may come back before the Institutional Review Board for continuing review or a progress report every year or every other year.

“This is especially important if the study is investigating a new drug or a new device,” Owen said. “We really like to be able to have our investigators check back in with us after a year and say, ‘Here’s what has happened. Here’s who we enrolled, here are any problems that we encountered and of those problems here are the ones that were related to the study.’”

Applications are very rarely disapproved outright, Owen said. “If the board is very skeptical, they will oftentimes work with the investigator to try to understand the goal for the research. We never want to just deny a research application.” Sometimes researchers will drastically rework such applications, and sometimes the applications are withdrawn.

Avoiding conflicts of interest

Some of the studies that come before the Institutional Review Board may be funded by a biotechnology or pharmaceutical company with a financial stake in the outcome. In those cases, it’s critically important for the board to remain independent of conflicts of interest. It’s also equally important that such financial interests not compromise ethical research practices. The Institutional Review Board administration employs several layers of protection against financial conflicts.

First is the independence of the Institutional Review Board itself. “We don’t have contracts with big pharma,” Owen said. “We don’t really care about the outcome of a trial in the sense that we are not invested in a drug making it to market. We’re invested in making sure the people are protected and not taken advantage of.”

Next is the university conflict of interest committee. “Everyone, myself included, has to fill out annually a business reporting relationship form,” Owen said. “If one of our investigators does a lot of work with Johnson & Johnson, for example, the committee evaluates that relationship and determines if that relationship has the potential to bias someone that works with the Institutional Review Board.” If such a conflict exists, affected board members cannot review studies funded by the companies with which they have a relationship.

Similar policies apply to researchers and study teams. Conflicts are disclosed in participant consent documents and affected researchers stay out of the process of obtaining consent from participants to avoid any potential for coercion. “We’re not going to ask a doctor who has this financial conflict of interest with, say, Pfizer to consent a participant for the study with Pfizer,” Owen said.

Researchers involved in data analysis, for example, also disclose any relevant conflicts in published results for transparency in the scientific process. “There are lots of layers of protection and it’s a huge undertaking, but it’s a very big deal to everyone involved in the human research protection program at the U,” Owen said.

Success stories

Owen provides some examples of how the board’s processes have worked as intended to protect research participants.

One was an application to investigate an experimental wound therapy. Reviewers felt that the proposed treatment didn’t offer a sufficient benefit over established therapies to be worth the risk to participants. In the end, the researcher withdrew the application.

Another was a survey-based research project on domestic violence situations. Reviewers disapproved one of the proposed surveys in the study. They were concerned that any kind of paper trail could create a risk of domestic violence perpetrators finding the survey and inflicting more harm.

“You have instances like that where it’s so important to have people who say, ‘You have to figure out a different way to do this,’” Owen said. “I can tell if an application was filled in really hastily and I’ll send it back and say, ‘I need these responses to be revised. I need to feel that we all are on the same page in terms of why we care about what we’re doing.’”

One more example: Biologist Nalini Nadkarni and colleagues have studied the benefits of nature experiences delivered by video or audio recording for people who are incarcerated. You can find summaries of some of their results here and here.

Here, again, the Institutional Review Board provided helpful insight, since the incarcerated are considered a vulnerable population. It was important to Nadkarni to work with the incarcerated, but the board review expressed concern that the presence of prison guards during study activities could create an intimidating or coercing environment.

“And so we were able to come up with a path forward to work with the prison administration, the board, the staff and also the investigator to tweak this proposal so that we could make sure that the people we were asking to participate in the research didn’t feel undue coercion or a burden to participate,” Owen said.

“I really love those moments because it’s every moving part coming together to figure out how can we do the best research and provide meaningful results to the people that we’re asking to be in the research.”

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

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.

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