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Protecting suicidal teens in research requires care
Participants bring special risks, but research is vital
Research with adolescents who are at risk for suicide can create daunting ethical and practical challenges for investigators and IRBs.
But a researcher who has been working with suicidal teenagers for 20 years says it's possible to craft protocols that protect them as much as possible while still providing valuable data. And she notes that the need for such research is vital: Suicide is the third most prevalent cause of death among youths ages 13-19.1
Cheryl King, PhD, ABPP, chief psychologist in the Department of Psychiatry at the University of Michigan in Ann Arbor, says dealings with her IRB over the years have been relatively untroubled.
The key, she says, is communication between the IRB and investigator, especially when a protocol involves unusual issues or particularly vulnerable subjects. In fact, she recommends that the investigator be present at the IRB meeting to answer questions and explain details in those instances.
"I recommend a chance for that back-and-forth discussion," King says, noting it saves a lot of time that otherwise would be spent sending written notes back and forth.
One important point for IRBs, King says, is that they understand the teens being sought for these studies, and the inherent risks they bring with them. She says an IRB may look at a suicide intervention protocol as too risky when it's not the intervention that carries risks, but the subjects themselves.
"They're at risk because of their condition," she says. "We know that multiple suicide attempters are at higher risk than others for suicide and if someone has made a suicide attempt, they're at higher risk than someone who has only thought about it."
In reviewing her first intervention study with suicidal youth, King's IRB initially asked her for very frequent adverse event reporting.
Because of the nature of her work, "we have a lot of adverse events. By definition, if they end up in the emergency department, it's an adverse event. If they're re-hospitalized – and a certain percentage of these are going to be re-hospitalized—it's an adverse event."
Within a year of her launching the study, the IRB told King she could start reporting every six months instead.
King says researchers in her field now routinely list suicidality and potential suicide attempts as an anticipated outcome in informed consent documents, based on long-term outcome studies of teens at high risk.
"An outcome study on what happens to those youth over the next five to 10 years is very relevant to understanding the cohort," she says. "IRB members should understand what we expect as outcomes and try to differentiate between what is anticipated or expected and what is unanticipated or unexpected."
King routinely uses a data safety monitoring board, even though her minimal risk studies generally don't require them. "I think between the IRB and the data safety monitoring board, we have a collaborative effort going to be sure that we're balancing scientific rigor with protections for the subjects."
Consent and assent
Another common issue in research with suicidal teenagers is the relationship between those teens and their parents or guardians, who must give consent. Everyone must understand and approve the youth's participation. Usually, King says, she approaches the parents first, and then meets with the teen either with his parents or separately, depending upon the circumstances.
Disagreements over whether the teen should participate aren't common, but make up "a significant minority," she says.
"Emotionality is often high if a youth has just been psychiatrically hospitalized and they really don't want to be," she says. She says that while the parent has initial veto power, it should be clear to everyone involved that the youth has the final say.
King says there may be unusual situations where it may be necessary to bypass parental consent – when the parents are suspected of abuse or when the child is homeless, for example. Those are the cases where she suggests an investigator should meet with an IRB in person.
"There are a lot of nuances to this, and as long as you understand what your question is, and how you can answer it while protecting the subjects, IRBs can understand and approve special circumstances," she says.
"I think sometimes, IRBs may be working from a template, almost as if they're going through a checklist. But I do think it's possible for the investigator to give a clear rationale for the problem, how they're going to address it, the protections for the subject and a cost/benefit determination. And the IRB will look at it as something that falls outside the usual template but that is justifiable and meets all the federal regulations of adequate protections."
In one case, King consulted with a subcommittee of the IRB before submitting a protocol in order to iron out thorny details.
Other points for IRBs to keep in mind, King says:
-Limits to confidentiality – Often, King says, her investigators must end up revealing something a teen has said, usually having to do with harm to the youth or someone else. She says it's essential that the limits of confidentiality be spelled out clearly in the informed consent.
"You don't want a big breach of trust," she says. "They need to know up front when they sign that if we have serious concerns about any safety issue, including self-harm, that we will let someone know who can take care of it."
-Clarity of informed consent – Long, complex documents are often too much for parents to understand, let alone teens. King says she had a study where the reading level on the informed consent was judged to be too high "and it was all the IRB required language. This is a problem because I was working in a disadvantaged urban area with this study and the reading levels aren't that high."
King says she's been working with her IRB to simplify consent documents so they still cover the required elements but are understandable to families who are going through a crisis and already feel overwhelmed.
She says informed consent documents that describe an intervention should make clear the difference between research and treatment, and should describe any alternative treatments that are available.
-A risk management plan—King says every investigator who works in this area should include in IRB submissions a risk management protocol detailing how problems will be handled. Team members should be trained in how to carry out the protocol.
"Who's going to be paged, for instance, if a follow-up assessment is done with a youth off-site and it looks like that youth is at high risk? I can't have the assessor, who may or may not be a mental health professional, leave the home when they've just found out a youth is acutely suicidal until I'm paged and we intervene."
She says such plans are not always required by IRBs. "But I can't imagine working in this area without one."