Like many of its counterparts, the IRB at New York State Psychiatric Institute (NYSPI) evaluates any complaint from a research participant on an individual, case-by-case basis. IRB Advisor spoke with Corinne Rogers, MS, CIP, NYSPI IRB director, to find out more about her research-related dispute procedures.

“Thankfully, we don’t get a whole lot of [disputes] since we are a smaller research institute,” Rogers says. Usually, the complaints start with her because she is the director, and she begins the initial investigation. Sometimes, she learns an investigator has spoken with a participant who is planning to launch a complaint. Other times, the person who complains approaches Rogers directly.

First, Rogers gathers as much information about the complaint as possible. “If they email me, I will respond to them and see if they want to have a telephone conversation. If they call me, then I take a detailed account of exactly what the complaint is. I gather all the information that I need, including which protocol they participated in. If they don’t know the protocol number, then they can give me the name of the investigator and what type of protocol it was.”

Once she has the details, Rogers contacts the investigator to obtain similar information from him or her based on the subject complaint. Then, she and the investigator try to move toward a resolution, but the process depends on the type of complaint. For example, a common complaint is about not receiving a payment for participating.

“That’s kind of easy for us to resolve if I can get in touch with the investigator and let them know that this is not acceptable,” she says. “The consent form says that [participants] were supposed to have received compensation in a certain time frame and in a certain way. If that didn’t happen, I can generally get the investigators to get on top of that very quickly.”

Another of the more common complaints is participants are upset because they were excluded from participation. “They don’t think they should have been, and they want to know why. That one can be a little tricky sometimes depending on the nature of the protocol. We do psychiatric research, and some people may get hung up on feeling that they should have been allowed to be in a study and weren’t.” In these cases, Rogers works with the investigator to try and find the best way to approach the issue. “If we are not really getting anywhere in that department, then I might ask my IRB chair, who is a psychiatrist, to step in and assist with trying to resolve the situation to where the participant feels they’ve been validated. That’s generally the process for how we can go most of the complaints.”

The resolution process may change if an investigator receives multiple complaints. This would require a more thorough inquiry into the investigator’s processes, Rogers says. “If it turns out that it’s a pattern, then I would bring my compliance monitor to [oversee] their whole process to see what’s going on and why there’s a breakdown in the system.”

Complaints on social media can add a public element to the complaint process. Rogers says NYSPI has not experienced this. A public comment probably would be handled differently, she says, with the potential of the institute’s legal and public relations departments becoming involved with the resolution.

Take Detailed Notes

When handling complaints from clinical trial participants, Rogers says taking detailed notes is crucial. “In my experience, documentation is really important,” she says. “We’ve had a couple of instances where we’ve had the same person come back and complain about the same thing for a couple of years. It was obvious that this person has some behavioral issues, but that doesn’t mean that we shouldn’t be responsive to their complaints and their concerns. That’s why documentation is so important because you want to be able to have everything in front of you each time you have to revisit the situation.”

It also makes sense to put standard operating procedures in place in case the person who normally handles complaints is unavailable at the time. “These things need to be handled very carefully. In my experience, it’s important to make sure that there is a channel for the complainant to get to the person that they are trying to reach quickly,” Rogers says. “If you are the person who is dealing with the complaint, you must look at the consent form that the participant signed to see what they were entitled to. A lot of times, reviewing the consent form solves a lot of these problems because the information will be right there.”

For example, the consent form might say participants can expect payment in two to four weeks. “When someone calls to complain that it’s three weeks now and they haven’t received the payment, it’s very easy to say, ‘The consent form gives it up to four weeks. Let’s give it another week. If you still haven’t received it, please get back to me and I’ll follow up on it.’”

The consent form also helps with exclusion and inclusion complaints. The consent form might not provide full details about the inclusion and exclusion criteria, in part to keep participants from misrepresenting themselves to get into a study. However, the consent form could say a participant may not be pregnant or currently in treatment to be included in the study.

Exclusion complaints are easier to handle if the criteria are clearly spelled out in the consent form, Rogers says. If an exclusion complaint is more nuanced or begins to escalate, then the complaint process could include the assistance of a licensed medical professional outside the IRB. “At this point, that [complainant] may need a little bit more of a clinical interaction,” she says. “We do have a lot of participants in our studies who have some significant mental illnesses.”

Check for Resolution

When the complaint process is completed, Rogers follows up with the participant to ensure the complaint has been resolved. “I make sure that I either get confirmation from the investigator that the issue has been resolved in terms of payment being received by the complainant, or I will have a conversation with the complainant myself to make sure that their complaint has been resolved.”

If a person is upset because he or she was excluded from a trial, then that issue may not be fully resolved. “The best we can do is take efforts to make sure that the participant understands why they couldn’t be included and perhaps offer some other opportunities for studies where they may be able to be participate,” she says.

Occasionally, a complainant has emailed the institutional official directly. “They have every right to do that,” Rogers says. “Our IRB always gets involved in that, however. I don’t have any recollection of an instance where we weren’t able to resolve any of those things, and I clearly only remember that happening once. [The complaints] always basically come through my office.”

Overall, it is important for IRBs to take complaints from clinical trial participants seriously, Rogers says. “People participate in research. It’s a big thing,” she says. “Although you might think that the complaint is trivial, it’s not. People should be able to reach out to the IRB if they feel like they were treated in any way fairly or unfairly, or if they don’t get what they think they are entitled to. Every effort should be made to resolve the situation for the participant to feel like they were validated so that they don’t regret participating, and [that they] will continue to volunteer to participate in research studies. If they don’t, we suffer as a whole.”