By Kirsten Ellis
Studying pain—or conducting any type of research involving people—requires a system of checks and balances to protect the rights, welfare, and privacy of participants.
Before launching a clinical trial or study, researchers must seek approval from an institutional review board, or IRB. These independent committees are tasked with reviewing research plans to ensure they are scientifically sound and respectful of participants’ rights. They have the authority to approve, reject, or request changes to a study, and they continue to monitor research as it progresses.
IRBs don’t conduct research themselves—but they ensure the people involved are treated fairly and safely. They are in place not to obstruct progress, but to uphold ethical standards.
Dan Clauw, MD, director of the Chronic Pain and Fatigue Research Center at the University of Michigan, has ample experience with IRBs, and now guides his research trainees and students through the process of working with them.
“People have a tendency to look at IRBs negatively like they’re police, but no—if you follow the rules and get approval, the IRB will protect you,” he says. “They are your friend.”
Who serves on an IRB?
Federal regulations require IRBs to include five or more members:
—At least one member with a scientific background
—At least one non-scientist or layperson
—At least one person unaffiliated with the institution conducting the research
—A diversity of gender, race, and cultural backgrounds
If the research involves vulnerable populations—such as children, incarcerated individuals, or people with impaired decision-making—boards are encouraged to include someone with relevant experience.
These requirements help researchers avoid tunnel vision, Clauw explains.
“It gives a broad perspective,” he says. “I’m glad we have this neutral third party.”
‘The patient has full control’
Clauw and his team work with four IRBs that support the wide range of studies underway at his center. Some board members have ethics training or statistical expertise, adding layers of diligence and accountability.
IRBs may simplify language for participants, adjust dosages, or scrutinize procedures that involve withholding information—ensuring participants are fully informed and never coerced.
By upholding transparency, accountability, and participant autonomy, IRBs help transform research from a clinical transaction into a human-centered collaboration.
“The longer you do research, and the more your study staff are accustomed to what the IRB wants in different types of research, the less back-and-forth there is,” says Clauw.
This is especially critical in pain research, where studies may involve inducing discomfort to measure responses. Informed consent becomes more than a form to sign—it becomes a promise.
“If the participant wants to pull their hand out, they can. If they say, ‘I’m done,’ they can do that,” Clauw says. “It is always their choice to continue in the study. You want to make sure that the research patient has full control.”