IRB chair's concerns had chilling effect on project
Important knowledge can be stymied
When investigators interviewed 22 children in 1992, the IRB had questions, but the project was approved, leading to one of the few studies conducted in its area of interest.
When investigators attempted to update this study more than a decade later and move toward using the resulting information to develop a pilot program, their experience was far different, recalls Joanne Riebschleger, PhD, MSW, an assistant professor of social work at Michigan State University in East Lansing, MI.
"We didn't get very far with the project this time," Riebschleger says.
Investigators could have pursued it, but their time was limited and there were other projects to consider, so this one was abandoned after their initial discouragement from the IRB, she notes.
So what was the project? "We wanted to interview children of parents who have a serious mental illness," Riebschleger says. "Basically, our claim is that there are a whole lot of them, and they're very much an invisible population with significant needs for information about mental illness and for support."
Specifically, the proposal called for interviewing children, ages six to 17.
"We knew that we were dealing with a number of protected classes, including women, people with mental illness, and children," Riebschleger says. "I anticipated that it would be important to think about the risk and how we could minimize or ameliorate it, and, hopefully, eliminate the risks."
When the study was conducted in 1992, there were no problems resulting among the children and their parents, she recalls.
So Riebschleger spoke with the IRB chair from a large, East Coast university about the project and how the purpose was to ultimately develop a series of groups for the children in whom they could learn about mental illness and coping skills.
The problem the IRB chair identified had to do with rather the parents were competent to provide consent for their children to participate in the study, she says.
The IRB chair's main question was: "Is the person diagnosed with a serious mental illness of such a sound mental state to give consent for their child to talk to someone about their life?" she says.
This shows how differently investigators and IRB members view certain research issues, particularly when it relates to social-behavioral research.
With 20 years of mental health field experience, Riebschleger knew that the vast majority of mentally ill people are competent and are perfectly typical parents and guardians.
Some mental illnesses are cyclical, but medication support helps people remain functional, she says.
"If people knew how many people they knew who were walking around with significant mental illnesses, they'd be really surprised," Riebschleger says. "And these include people sitting on IRBs."
From a mental health care perspective, the study would be well monitored with mental health services case managers and therapists assisting, she says.
"If a person was truly delusional, there would be a common sense element of the interviewer not interviewing the child of a person who was delusional," Riebschleger adds. "The mental health staff would tell investigators if there were any problems."
According to the IRB chair's interpretation of regulations, investigators would have needed to put the parents of child participants through psychological testing to prove they were competent to give consent for their children to talk with investigators about mental illness, Riebschleger says.
"This did not make sense," she says. "While I completely support the idea of human subjects review, particularly with the historical abuses of people with mental illness, when have we gotten to the point of protecting them so much that they can no longer consent for their children to participate in a study?"
Such an attitude amounts to presuming these parents are incompetent until proven competent, Riebschleger says.
The IRB chair also raised a concern about the parents becoming violent toward their children, she says.
"While any study involving children would need to consider how to deal with actual or suspected child abuse or neglect, this concern seemed to go beyond that in that there was almost an assumption of potential violence toward the child," Riebschleger explains. "As the investigators in the study are mandatory reporters, it would be something you'd have to share up front with the parent and child."
At this point, the IRB chair referred investigators to the Belmont Report, which they read, attending to the section about impaired persons.
"It referred to the very great need to make sure people with impairments were protected and not harmed in any way, or taken advantage of," Riebschleger says. "But there also was a section about how to not suppress research that could help that population, if the benefit to risk ratio merited it."
This confirmed for researchers that the intent of human subjects protection goes both ways: "It would be considered not okay to take away from people with impairments the right to have research done to improve their conditions," Riebschleger says.
"In addition, there is within the mental health system a strong movement of consumer-oriented practice and client empowerment that would not put up with such a thing as this," she says.
"So we thought about how we could educate the people who serve on IRB boards about the strengths of people with mental illness," Riebschleger says. "We want to educate them that the vast majority of mentally ill people are not violent, unless they have a substance abuse disorder."
Also, IRB members should take a look at the stereotypes to which they have been exposed, including the idea that mentally ill people are mad and bad, she says.
"If there's a crime committed, the newspapers still typically report the mental health status of the alleged perpetrator, but they do not report the substance use status," Riebschleger says. "That's only done because there's an assumption by the general public that mental illness equals violence, and that's not true."
Meantime, researchers may neglect what mental health experts call the "invisible kids," who have grown up with a parent who has a mental illness, Riebschleger says.
"The other piece of this is in social science research, it's hard to show benefits," she notes. "But I think there's strong enough evidence that giving people information and giving children and teenagers information about mental illness when they're living with someone who is mentally ill can have some benefits."
Children often blame themselves for a parent's mental illness, so an educational intervention would be of significant benefit, Riebschleger adds.
Since it's clearly not in this population's best interest to chill out research projects like this one, there may be a way to address an IRB's concerns.
For example, investigators of similar research could add a section on parenting to the mental health agency form, which is used to conduct consumer planning. And the mental health professionals could advise parents that researchers would like to talk to the children about support for handling their daily activities, and if the parents said they did not object, this could be passive consent for the child interviews, Riebschleger explains.
Further, researchers could develop a safety monitoring plan in which the mental health staff communicates directly with the parent on child, monitoring for any unanticipated negative effects. Also, the interviews would begin with the oldest children, and outcomes would be reported to the IRB before interviews progressed to younger children, she adds.
When investigators interviewed 22 children in 1992, the IRB had questions, but the project was approved, leading to one of the few studies conducted in its area of interest.You have reached your article limit for the month. Subscribe now to access this article plus other member-only content.
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