Researchers punt subject complaints to IRB — but then what do you do?
Research, review, report, CAP
It’s a long-standing issue with IRBs: Studies are approved, participants are enrolled, study interventions and visits occur — and someone complains. But then what?
"We dealt with subject complaints on the research side all the time, but generally they are punted to the IRB as ombudsman," says Stephanie Collins Reed, PhD, an IRB administrator at the New York State Psychiatric Institute in New York City. Reed is an assistant professor of clinical neurobiology in psychiatry at Columbia University Medical Center in New York. She worked in research for a decade prior to working as an IRB administrator.
The question from an IRB perspective is: How do they handle complaints? Is each complaint subject to a new process, or should standard operating procedures (SOPs) be written?
"All IRBs deal with this issue, and everyone has their own way of doing so," Reed says. "We were interested in operationalizing the way we handle complaints, including writing an SOP and presenting it on a larger scale."
Systemize the IRB’s approach
Reed has dealt with research complaints from both sides — the researcher side and the IRB side. "This is what interested me in taking part in this project," she says.
Reed offers the following suggestions for systemizing an IRB’s approach to handling study participant complaints:
1. Categorize complaints and check consent.
All complaints are viewed by the executive director, who starts the complaint handling process, Reed says.
"You need to identify the complaint and put it in a category," Reed says. Complaints could be about confidentiality, compensation issues, adverse events, and other factors.
"You can bucket it according to who needs to review it," she adds.
For instance, does the complaint involve an allegation of gross negligence or a study medication, or is it a minor complaint that can be handled by the study team?
"Also, we look over the consent form and make sure all the bases were covered in the consent form and there wasn’t an oversight," Reed explains.
Studies that involve numerous procedures might have incidental findings that could be shared with study participants, and sometimes they’ll file a complaint if they do not receive this information, Reed notes.
"This is a bigger issue going forward with a lot of institutions doing biomedical research," she adds. "Incidental findings are a big issue in genetics."
One solution is to have policies in place with the right language about how these are handled. So when a participant complains, the policy can be used as a reference.
Resolutions to the more serious complaints might include making the informed consent form clearer, reporting a problem to the FDA or OHRP, or handling it internally through the corrective action plan, Reed says.
Depending on the complaint, it might involve input from Reed, a protocol manager, an operations director, legal department, IRB chair, and the full board.
2. Research and review the complaint.
"Gather complaint information from the complainant, the principal investigator, and the study team," Reed suggests. "Get both sides of the story."
One challenge is to determine the validity of the complaint. "That’s a tricky one because it often ends up being a he said,’ she said’ thing," she adds.
The complainant might feel wronged, but the IRB can determine if there was wrongdoing or something else going on.
Once the complaint has been researched, determine the next level of review.
For instance, a complaint might be about a late subject compensation check. This can be handled easily by the research site.
Other complaints could be resolved by the study team and IRB office, and still others might require more serious attention. For instance, a complaint might involve informed consent or an allegation of misconduct that should be brought to the attention of the full board, Reed says.
Complaints also can be reviewed by an institution’s legal office and even sent to the Food and Drug Administration (FDA).
"There can be many levels of review at this point," Reed says. "About 75% of complaints are handled relatively quickly, while the rest go to the full board."
3. Develop an action plan.
An IRB or research compliance office might require an investigator to develop an action plan to resolve a complaint. The action plan might be simple, i.e., pay a subject who felt he or she was not compensated as promised. Or it could grow into something more complex, Reed says.
"The goal is to come up with a resolution that is satisfying to everyone," she adds.
For the simpler complaints that do not require the full IRB to weigh in, there is a fast track approach involving a meeting with the study team and complainant to discuss finding a resolution, Reed explains.
"Often those things revolve around compensation issues, and the study team usually agrees to give the compensation the participant feels is due," she says.
Other simple cases might involve the participant experiencing a side effect that the person did not think was fully explained. Sometimes that kind of complaint can be handled by simply listening to the study participant.
"When complainants feel they’ve been heard, they will say, I’ve said my piece. Make sure you address this in the future with other people,’" Reed says. "When these aren’t major issues, the complainants often just want to be heard and to make sure it doesn’t happen in the future."
Complaints involving confidentiality might result from a miscommunication. These also might be resolved through listening to a participant’s concerns and providing more information about the steps the research site has taken to ensure confidentiality.
"A big complaint we see is about a study’s strict inclusion/exclusion criteria," Reed says. "When people are ruled out for a study, we often cannot pinpoint the exact reason, but can say it’s for their safety and protection."
This is a hot button issue for people who are upset about being excluded, she adds.
"These complaints are tricky to handle because they’re not major issues where you have to bring in regulatory or legal officials, but the reasons for exclusion are difficult to explain to people," Reed explains. "They become upset about it."
So the human research protection executive director will talk with the complainant and sometimes ask the investigator to become involved too, Reed says.
"Usually, we just have to say the same thing over and over to them, emphasizing the safety issues and how it’s for their benefit to not include them in the study, and that it is not a personal issue," she adds.
4. Handle more serious complaints and determine the next level of reporting.
For the one in four complaints deemed serious, the IRB chair gets involved, determining whether it should be brought before the full board, Reed says.
When the full board sees the complaint at its next scheduled meeting, the IRB will help determine the corrective action plan (CAP). The executive director will discuss the actions being taken with the person who complained so the complainant will know it’s being addressed, she adds.
"The IRB’s big decision is whether or not to report the complaint to the Office for Human Research Protections (OHRP)," Reed says.
The IRB and IRB staff also look at the regulations and definitions to see if the complaint alleges regulatory violations.