Protecting suicidal teens in research a daunting task
February 1, 2009 3 minutes read
Protecting suicidal teens in research a daunting task
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. 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."
King says researchers "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 in her field now 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. 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."
Meet the parents
A 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. Other points for IRBs to keep in mind, include knowing the limits to confidentiality, she says.
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."
Reference
- King, CA, Kramer AC. Intervention research with youths at elevated risk for suicide: meeting the ethical and regulatory challenges of informed consent and assent. Suicide Life Threat Behav. 2008 Oct;38(5):486-97.
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