Help IRBs deal with common frustrations
IRBs can be part of problem
IRB members and chairs often deal with investigators’ outrage over the IRB process, but sometimes it’s their own frustrations that are difficult to resolve, an expert notes.
"There are two parts to dealing with frustrations to improve the process," says Melissa Abraham, PhD, chair of Partners Human Research Committee, Massachusetts General Hospital, Brigham & Women’s Hospital, and assistant clinical professor, Harvard Medical School in Boston.
"First, you are dealing with the frustrations of trying to improve the process — dealing with the things that make an IRB member frustrated, and the other is dealing with frustrating investigators," Abraham says.
IRB chairs, reviewers, and investigators sometimes are outraged over perceived unfairness in the process. This perception can occur when IRB chairs are viewed as enforcers — those who discipline others — rather than as customer service representatives or allies who guide people to improve the review process, she notes.
"We need to recognize that IRBs contribute to this climate, one where it’s difficult to manage misconduct, because there is so much mistrust on both sides," Abraham says.
IRB chairs and members should think about how they contribute to the frustrations and problems that erupt. For instance, mission creep is something an IRB could acknowledge as a potential issue, she adds.
"You have investigators who see this as a bureaucratic exercise and want to get through it, and they can be defensive," Abraham explains.
Abraham offers these strategies for reducing IRB and investigator frustration:
• Assess style of communication. IRBs should look at their written and vocal communication. For instance, look at how staff answer the phone, Abraham says.
Also, communication should be focused on the business issues and avoid personal references. IRB members and staff should be very clear about what they expect and clearly state the remedies that need to be done, she says.
"Be specific and give facts, as opposed to making it personal," Abraham adds.
"This might mean the IRB will check in with staff to make sure the letters they’re writing are polite and respectful," he says.
An example might be to slightly rephrase certain IRB directives: "Instead of starting a sentence with You must change the word on page 3 to this,’ change it to Please change the wording of this to this word,’" Abraham suggests.
These small changes can make a difference.
Another example would be a change in phrasing in a letter requiring changes: "The IRB could start a letter with, We recognize it can be difficult to implement the recruitment methods that are required by our policy. However, requiring this extra phone is ’" Abraham says.
"Or the IRB could say, Please do this,’" she adds. "Those styles of communication make a big difference in how people perceive that letter."
A third example shows how a less direct approach to handling an investigator site that is resisting corrections in its faulty processes might succeed. An IRB could say in its letter that it doesn’t understand why an investigator is doing what he or she doing, or it could write, "Please continue your thinking on this important problem," or "While it may be difficult to implement this ," Abraham suggests.
• Do not always assume the other side did something wrong. One of the results of mistrust between IRBs and investigators is that each side will think the other did something wrong when there’s a mistake. IRBs should start with the assumption that they may have missed something, Abraham says.
"If you find when you review a study that it doesn’t look like they’ve made the appropriate changes, then instead of saying, You still haven’t changed that,’ you can say, We may have missed something. Please indicate where in your file we can find the change,’" she says.
Also, move away from the assumption that investigators are trying to get in the IRB’s way, Abraham says.
• Look for root causes of problems. IRBs should ask a few questions of investigators to determine why a required action was not taken. It could be that the investigator thought everything was done correctly, but had not been the one to do that particular task.
If that’s the case, then the root cause is improper delegation of a task, Abraham notes.
"The investigator might say, I didn’t know this happened. I told the research assistant to take care of it,’" Abraham says. "So there was delegation without appropriate training."
When IRBs suspect there is a pattern of this, then they can send someone to discuss the issue with the principal investigator, she suggests.
"There are delegation logs, and they are supposed to keep track of key tasks and who these are delegated to," Abraham explains. "The first time it happens, assume it was a mistake; the second time, say, Maybe we’re missing something, so help us understand how you are doing this.’"
• Calmly deal with difficult investigators. "Sometimes an investigator has no respect for the rules," Abraham says. "They’ll say, Yes, we’ll do that,’ but there’s no real learning curve, and no matter how much you educate, they do not make the changes going forward."
When this happens, the IRB can continue to be polite, avoiding hostile and sarcastic comments, but let the investigator know that his or her behavior is getting in the way of an expeditious review of the study, she suggests.
Let the investigator know that when the IRB sees a pattern of repeated problems, it results in IRB members worrying about the overall quality of the investigator’s research operation, Abraham says.
"You can let them know they are hurting themselves," she adds.
Most investigators try to do the right thing, but there are always those who frustrate the IRB with their lack of concern for the regulations and rules, she notes.
• Create solutions to common misunderstandings. An IRB should assess the issues raised by investigators and research staff, looking for trends that could be solved systematically.
For instance, IRBs sometimes receive questions about quality improvement projects and whether a particular one will require an IRB review, Abraham says.
If this question pops up regularly, then the IRB could create a checklist, available online, that assists investigators with determining whether a project is a quality improvement project or research, she adds. (See sample checklist for QI vs. research projects, below.)
Another area that can cause misunderstandings involves using deception in research, she notes.
"We developed a guidance document on when deception can be used and when not," she says. "We gave talks in the community about it."
"Bite off a piece you can fix and get information out there, publicizing it," Abraham says.