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Informed consent when the victim is a black male
Legalese may heighten subjects' fears
Young black men are disproportionately more likely than other groups to be victims of violent crime. But when researchers set out to study this group, they encounter difficulty in recruiting and retaining subjects.
There are a variety of reasons for that difficulty, says Jane Liebschutz, MD, MPH, FACP, associate professor of medicine and social and behavioral sciences at Boston University Medical Center. Some are related to black patients' general distrust of research and researchers. In addition, crime victims may be poorer and harder to reach.
But Liebschutz and research assistant Joel Hoyte say the experience of crime adds a layer of complexity to recruiting that requires careful thought by researchers and IRBs.
For example, Hoyte notes that patients who've been the victims of crime may have fears about crowds and using public transportation that may make it difficult to show up for appointments. Liebschutz says a victim may lose his job or his place to live as a result of his injuries.
"Some of them have really bad (post-traumatic stress disorder), their days and nights can get reversed," she says. "I don't think it's necessarily that different from other poverty issues. But the violence makes those issues more acute."
Liebschutz says her team ran into these problems when they attempted to recruit subjects for two studies on medical and counseling services extended to victims of crimes in Boston. When they began having difficulty, they started to survey subjects about the barriers to enrolling young black men in this type of research. Results from the survey were published in a recent issue of the journal Psychological Trauma.
Problems identified in the survey included a culture that discouraged "snitching" and concerns that researchers might be connected with the police.
But Liebschutz and Hoyte also identify an area that often tripped up potential subjects: The informed consent document, whose language was not only difficult to understand, but had the potential to increase subjects' fears due to poor wording. She says IRBs could help ease this difficulty by allowing flexibility in the language of informed consent.
One obvious example, says Liebschutz: What do you call the person who is leading a study?
"'Principal investigator' is a ridiculous term to use with this particular population," she says. "When else do you use the word 'investigator,' besides in connection with the police?
"Why can't it be 'research director' or 'study director?' That term is really difficult with this population, who already is having some police involvement (as a result of being the victim of a crime)."
'Freaking out' over document
Hoyte, who conducted informed consent conferences for the studies involved, says that when he discussed the studies with potential participants, he had a script that used more lay language to explain the informed consent elements.
Then, says Liebschutz, "they'd look at the consent form and freak out."
In one case, she says, a 19-year-old man agreed to participate, then took the consent home to his mother and came back the next day because of concerns she had raised. The form explained that his information would be confidential, but included required language that detailed circumstances under which it might have to be released. Further discussions with the man and his mother helped clear up the misunderstanding.
In studies such as this, certificates of confidentiality obtained through the National Institutes of Health can help allay fears about potential disclosures – as long as they're explained carefully to subjects, Hoyte says.
"It helps in the qualitative portion (of a study) where you're disclosing details of the (crime) incident itself," he says. "We really emphasized that in the interviews, that it was completely confidential."
He says IRBs should be looking at the informed consent process to ensure subjects really can understand the information. Are they asked whether they have questions? Does the researcher have them repeat back important information?
"Because sometimes people are actually not very informed," he says. "And it can cause mistrust and questions afterward."
Other issues that IRBs should consider when reviewing studies that involve victims of violent crime, says Liebschutz:
"Gangs are not huge in Boston, but they were concerned that we not be exposing one participant with another with whom he might have some history," she says. "In those cases, there can be concerns about individual safety."