Do IRB meetings follow the Common Rule?

Subjective rules part of problem

Too often, IRBs spend precious meeting time debating the merits of a study’s scientific and other subjective fine points, overlooking issues that have a greater impact on human subject safety, experts say.

A recent study found that of the chief Common Rule criteria regarding items that IRBs should address, only informed consent was universally discussed at each IRB meeting. Others, including risk minimization, risk-benefit comparison, equitable subject selection, data monitoring, privacy protection, and protection of vulnerable subjects were far less consistently addressed during IRB meetings.1

While all IRBs talk about informed consent, the risks-benefits issue is often overlooked, says Charles Lidz, PhD, a research professor and sociologist in the department of psychiatry at the University of Massachusetts Medical School in Worcester.

Lidz was the lead author of a study of IRB meeting discussions at 10 academic medical centers receiving the most federal funding from the National Institutes of Health (NIH). The study found that many IRBs failed to discuss most of the Common Rule criteria.1

For instance, 21% of IRB reviews failed to address risk minimization, 57% made no mention of a risk-benefit comparison, and 60% did not discuss equitable subject selection.1

“These are institutions with enough resources that they should be able to do this well,” Lidz notes.

“The broad pattern is pretty clear,” Lidz says. “If you have a committee making a decision, then at least the sorts of things identified as critical should be acknowledged at the IRB meeting.”

Researchers often find the IRB review process frustrating precisely because of the subjective focus of many ethics boards, says Robert Klitzman, MD, professor of clinical psychiatry and director of the masters and certificates in bioethics program at Columbia University in New York City.

“The IRB’s mandate in the Common Rule is to make sure risks are minimized and risks are commensurate with benefits,” Klitzman says.

A study’s risks and benefits often are not what IRB meetings focus on, he adds.

Instead, IRBs are over-focusing on certain subjective issues at the expense of others, and this creates problems, Klitzman says.

The larger issue is that the regulations are subjective rules, and IRBs might think they are interpreting the regulations the one and only way, but they’re not, he says.

“IRBs say, ‘We represent our community values, so that is the way it will be interpreted,’ but in fact that’s not the case,” Klitzman says. “You have five or six IRBs at one institution, and they’ll review the same study at the same institution differently.”

For example, how can an IRB say when a stipend paid to a research participant is too much and unduly influencing subjects?

“Is $100 okay, but $150 is not?” he says. “There’s no hard and fast rule.”

The concept of undue influence is only one of the subjective philosophical concepts IRBs encounter. There are other areas in which an IRB’s misinterpretation of the regulations can lead to problems, Klitzman says.

“One area would be the quality of science,” he explains. “Researchers often say IRBs are getting involved in redesigning the science of a study when they should not do that.”

IRBs also could be spending an unnecessary amount of time on the details involving the informed consent document, Lidz suggests.

One IRB member who heard of the IRB meeting study’s results commented, “That’s exactly what we see — we spend all of our time fussing about the wording of the consent form.”

While the wording is important, it also is beside the point, which should be the protection of human subjects, Lidz says.

“Whether or not the wording of the consent form follows an IRB’s wording in describing what sorts of health care benefits a person might get if they are harmed is all very nice, but people don’t read 18-page consent forms,” he says. “I’m not sure an 18-page consent form protects anybody.”

Lidz and Klitzman suggest IRBs improve their study review meetings by making these changes:

Use checklists to enhance and focus discussions: Some IRBs use checklists at meetings, and some research sites have checklists built into their application forms.

An IRB coordinator and/or chair could keep a checklist on hand with the list of Common Rule criteria and help direct discussions to these areas, making sure all are at least addressed.

But in some cases, checklists are used less than optimally, Lidz notes.

In researching the study, Lidz noticed that some IRBs have checklists regarding vulnerable populations, but there would be no discussion about why some vulnerable populations were excluded from a study, he says.

“There is a lot of discussion about various medications we study in adults, but we never know whether they work the same way for children or any other vulnerable populations, so why do we exclude them?” Lidz says.

Invite more specialists and experts to serve on boards: “If I’m a cardiologist and I’m reviewing a kidney protocol, I probably don’t know enough by myself to tell what the risks of the protocol were,” Lidz says. “I know more than a sociologist, but these are tremendously complicated things when testing a new medical intervention.”

This is why it’s important for boards to have members who are experts in the areas of studies that come before the IRB.

“It would be helpful if we had a system of having reviews outsourced to highly specialized people, much like you would with a journal review,” Lidz suggests. “IRBs have good people on their committees, but I still wonder if that is enough.”

Small ethics boards, especially, have limited substantive expertise to handle questions of risks, he adds.

Recognize the subjectivity of IRBs’ decisions: “IRBs need to become more aware that what they’re doing is subjective,” Klitzman says. “They need to be open to the fact that others might see what an IRB decides differently than what they see, and other views might be legitimate.”

Just as a literature student might interpret the novel War and Peace differently from another literature student, one IRB’s interpretation of undue influence might not match another board’s interpretation, he adds.

Create industry-accepted guidelines for interpretation of regulations: The Office of Human Research Protections (OHRP) or a professional human subjects research organization need to create a set of guidelines for interpretation of the regulations, Klitzman suggests.

If IRBs had guidelines as a reference, they could make less subjective decisions about whether a particular protocol’s informed consent is adequate, and this would help create a more consistent and fair study review process, he explains.

“We know there are huge problems with how IRB reviews vary, and that holds up multisite studies,” Klitzman says. “There should be a consensus.”

Reference

1. Lidz CW, Appelbaum PS, Arnold R, et al. How closely do institutional review boards follow the Common Rule? Acad Med. 2012;87:1-5.