The boardroom on the sixth floor of University Hall commands a striking vista of UC. To the right stretch the rolling greens and architectural medley of West Campus; to the left rise the urban density and hospital towers of Medical Campus. Appropriately, it is here that the UC Institutional Review Board meets nearly every Wednesday morning. The view must remind the IRB of its crucial responsibility: to oversee the proper conduct of human subjects research by anyone associated with the university.
Doing Research Right: The Institutional Review Board
The Human Research Protection Program office, which oversees the IRB’s activities, is located at University Hall Suite 300 and is open from 8 AM to 5 PM Monday through Friday.
Human Research Protection Program Office –
Angela Braggs-Brown, Director –
Kareemah Mills, Assistant Director –
Claudia Norman, Senior Regulatory Compliance Specialist – 513-558-5784, firstname.lastname@example.org
Graduate students are no exception. All human subjects research, from clinical trials to psychological surveys, must be approved by the IRB before it can begin. But in the words of IRB member and assistant professor in bioinformatics Brett Harnett, graduate students often feel like they are submitting their protocols “into the black box, into the void, into the other side.” This lack of transparency can be frustrating, but understanding how the board handles its duty of protecting human subjects can help graduate researchers navigate its regulations and conduct better, more ethical work.
The bulk of the IRB’s activity actually takes place outside of its meetings. Each new experiment proposed to the board by UC-affiliated researchers and students is assigned for review to a board member with particular expertise in that field. A study examining the impacts of a new classroom intervention, for example, might be scrutinized by someone from the School of Education, while one looking into a novel depression medicine might be handled by a psychiatrist from the College of Medicine. If the research poses no more than minimal risk to its subjects, the review can be expedited, with that single reviewer as the only step in the process. Examples include medical studies that analyze hair or saliva samples from healthy volunteers, as well as the vast majority of social science interview and survey work.
But studies with greater potential for risk must instead be approved by a majority of the IRB members present at one of the board’s weekly meetings. From the full roster of approximately 40 members, 15 or so gather along the two long sides of a heavy wooden conference table, carefully examining regulatory documents on their laptops as the assigned reviewers present from a projector at the head of the room. Doctors in white lab coats sit next to suited academics and administrators in business casual; this diverse team helps the board to handle the wide range of research conducted at UC and its affiliates. Federal regulations also demand a range of perspectives: studies can only be approved by a quorum of at least eight members, which must include someone affiliated with the university, someone from the outside community, a scientist and a nonscientist.
Claudia Norman, IRB member and senior regulatory compliance specialist in UC’s Human Research Protection Program, says that regardless of their academic backgrounds, the board members share a common goal. “We’re looking at [research] from a different angle,” Norman explains. “[A researcher’s departmental] committee is looking at it from a research perspective, and we’re looking at it from a participant’s perspective.” The IRB identifies aspects of studies that could be problematic when translated from the page to the lab. In one recent case, the researchers wanted to compare different doses of an experimental drug for which the side effects hadn’t been clearly established. The board advised the scientists to test the increasing dosages sequentially rather than simultaneously; Norman acknowledges “that’s going to slow [their study], but it might give side effects a chance to show up.”
This perspective is particularly important when considering informed consent documents, the forms that research participants sign to indicate that they understand the risks of the study and have not been coerced into taking part. Dr. Peter Grubbs, vice chair of the IRB and an associate professor of clinical medicine at the College of Medicine, notes that researchers too often write these forms at reading levels far beyond that of the layperson. “There was one about a month ago that was 23rd grade! Let’s see, is that the second PhD that you’re working on?” he jokes. Grubbs advises researchers to keep a more general audience in mind as they write consent forms. “My mother, she’s a smart lady, though she only did a year of college,” he says. “I think, ‘If my mom read this, would she understand it?’” The IRB spends much of its effort ensuring that research participants can easily determine whether they feel comfortable with joining a given study.
The board also helps researchers keep up with changes in the general climate of research. Harnett notes that while advances in information technology have helped scientists collect greater volumes of data more quickly, they have also exposed participants to greater risk. “Hackers are getting better and faster and quicker, more efficient at stealing data,” he says. “We’re looking at ways to make sure that what they’re doing is going to cause minimal risk, and that includes financial risk based on their data.” Recent federal regulations have toughened the required protections for participant data, and the IRB ensures that scientists keep those concerns in mind when designing studies. Harnett says that UC offers very secure, centralized systems for data management and encourages researchers to take advantage of those resources: “We don’t want them to have to worry about that,” he says. “We want them to focus on their science; that’s what they’re good at.”
After the IRB considers these and other issues, the board members vote on whether to approve the research. In general, its evaluations are quick and unanimous; the board’s collective experience allows it to pinpoint where a study needs work and recommend the appropriate action. Occasionally the board will disagree, but in these cases, it tends to err on the side of caution. Harnett remembers one meeting where the board argued back and forth on a particular concern with a research protocol, seemingly with no end. Finally, he exclaimed that “the investigator should recognize that the full board spent 17 minutes discussing this topic!” By generating that much debate, the issue revealed itself as being more serious than the board had initially thought.
The IRB also conducts ongoing reviews of longer-term studies, ensuring that the protocols and procedures it previously approved are still being followed. The board’s oversight is a safeguard, Norman says, against situations such as that of the infamous Tuskegee syphilis study. This experiment began in 1932 to study the progression of syphilis in black males. “It started out being something very small that was only going to last six months,” Norman explains, but without regular review, it grew beyond its initial approval into a 40-year study. The researchers neither obtained proper consent from their participants nor treated them with penicillin after that drug was shown to cure syphilis in 1945.
Grubbs stresses that while these larger ethical violations are mostly a thing of the past, the IRB must remain vigilant for research that doesn’t pass what he calls “the smell test.” Every year when examining new studies, he says, the board “picks up on a few things that really, when you peel away all of the layers, probably shouldn’t be done.” If a study does need work, the board almost always opens a dialogue with the investigator instead of slamming the door on the research. “I think I can count on one hand the number of times we’ve disapproved a study since I’ve been here at UC,” says Norman, who has been associated with the IRB since 2001. Harnett agrees, saying that “no one’s trying to put a barrier up. These things go back and forth, and we’re trying to get them through.” Although the process can take time, it is indispensable for protecting both research participants from harm and researchers from litigation.
For graduate students new to dealing with the IRB, the board suggests that communication is key. When it comes to clarifying what regulatory requirements are necessary, Norman suggests that the best option is often pick up the phone. “I think people are sometimes intimidated to do that, that they’re afraid they’ll get in trouble if they do. But that’s why we have phone numbers posted, because sometimes that’s really the best.” Harnett adds that seeing examples of previously successful protocols can also be very helpful. “You need a mentor who has gone through this process. Use one of their protocols as a template, that’s probably the easiest way to do it.” Although every study is different, each submission to the IRB must address the same basic concerns.
By definition, research involves the exploration of the unknown. “If every piece of research had no risk in it, research wouldn’t be that powerful,” Harnett emphasizes. The IRB must therefore constantly balance the chances of valuable scientific discovery against the harms an experiment might cause. Through its caution, expertise and unceasing focus on the participant’s perspective, the board promotes work that expands the boundaries of knowledge in an ethical way. Grubbs summarizes, “We really are here to try to make sure that research is done right.”
Written by Daniel Walton, Graduate Assistant for the Graduate School Office