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Vulnerability issues not clearly outlined in regs
PRIM&R faculty member offers advice
Helen McGough, MA, CIP, is retired from the office of research at the University of Washington in Seattle, WA, and has worked as a faculty member of PRIM&R. McGough also has worked with the Collaborative IRB Training Initiative (CITI), and she served on an IRB for many years. McGough discussed with IRB Advisor how vulnerability in research is determined and what IRBs might do to expand their understanding of the topic.
IRB Advisor: When do IRBs make assumptions about research participants' vulnerabilities when they shouldn't?
McGough: Every IRB administrator or chair has his own list of anecdotes about when assumptions are made. But they are implicit assumptions, and we often make them without recognizing that that's what they are.
For example, are pregnant women really vulnerable? And how do we deal with adolescents who are regulated by a subpart [of human subjects regulations] that deals with children? A lot of adolescents are straddling the competence and borderline [of adulthood] and may be less vulnerable than we think.
It's hard to know what we don't know. Other subjects with vulnerability are parents of kids who have recently died. Also, trauma victims are a common vulnerable group. We assume trauma victims are in a fragile condition and that asking them to take part in research would perhaps add to their fragility. But I'm not sure that's the case. We don't have a lot of data yet to answer that question.
People who have been through a difficult situation, especially nurse researchers and public health researchers, want information from these people to help them minimize their problems or help them recover better. But the dilemma is the question of whether they are so vulnerable that they cannot participate in that research.
IRB Advisor: So how do you decide what a vulnerability is and how do you handle it?
McGough: We need more research. We certainly have identified some populations that we assume are vulnerable. A first step is actually doing empirical research to find out if something is correct or not.
In terms of an IRB, I think one of the best things an IRB can do is invite a consultant or contemporary of the IRB who deals with a population over and over again to inform the IRB about what steps to take. So if you're dealing with parents of children who've died, then have a consultant speak about which issues those parents deal with.
The only danger is that you're [receiving the information] from just one person. So it would be better to have research on the subject.