Factors cited in IRB's decision to deny study
Who was the subject? Investigator, IRB disagree
When the University of California, San Francisco's IRB denied a plan to have volunteers attempt to buy single cigarettes illegally at neighborhood stores, they cited the following concerns:
• Legal issues - The study's principal investigator, Ruth E. Malone, RN, PhD, FAAN, a professor of health policy at the UCSF School of Nursing, says volunteers in the program faced no legal risk since the state penal code makes it only illegal to sell the cigarettes, not to buy them.
In dealing with the potential legal risk to the store clerks, she says the group consulted with the local district attorney, explaining what they wanted to do, and gained his assurance that he would not prosecute store owners or clerks who sold cigarettes to volunteers as part of the study.
But IRB Chairman Victor Reus, MD, says the district attorney in question has since left office, and the IRB was concerned at the time that his assurance wouldn't be binding on his successors.
• Confidentiality - Malone proposed to report findings from the study only in the aggregate, without naming either individuals or stores at which single cigarettes were sold.
Carol McGruder, BA, co-principal investigator on the study, says it would have been possible to collect useful information while protecting the identities of the stores and store clerks.
"We could have done it. We would have done it," she says. "All research is an agreement. It's about being ethical and respecting whatever you're saying your guidelines are. We would have done that."
But Reus is less convinced that the investigators could achieve the confidentiality they promised.
"If you're talking about a very small community and a small number of stores as institutions, I would suggest that those are readily identifiable," he says. "If you have a document that says six out of eight grocery stores within this region committed this act, it's not going to be a big problem for people to figure out which ones these are."
Reus says he also was concerned that community volunteers participating in the study might not keep the information confidential.
• Potential risk and liability - While investigators believed that an observational study represented a potential risk to the volunteers, Reus says that the modified study could have posed risks as well.
"The committee expressed the concern that if, in fact, this subterfuge were detected, there might be some altercation that might result," he says. "The storekeeper might try to evict the person doing it or some unpleasant activity could occur."
Malone says she was surprised when, in one of its responses, the IRB referred her group to the university's risk management department, which eventually referred them back to the IRB.
"We were just dumbfounded," she says. "I think they just thought it was too much: 'We can't deal with this. Go talk to somebody else.' I think it was just a sort of avoidance thing."
Reus says the proposal was never actually referred to risk management, although the IRB did raise issues of the university's liability in case something went wrong.
"If a shopkeeper discovers that he has been an unwilling participant in this research project and that, in turn, results in a boycott of his store by the community at large, does he have a cause of action against the university?" he says. "If an altercation results, what is the role of the university?
"These are questions that somebody needs to think about," Reus says.
• 'Entrapment' and informed consent - Reus says this represented the heart of the problem with the proposal. Store clerks and storekeepers who had not been told they were part of a study could be led into committing an illegal act.
"The IRB was obviously concerned about protecting all the individuals who are involved," he says. "From the IRB's point of view, the community included the people who were the shop owners and the people who worked in the shops in question."
Malone argues that the individuals selling the cigarettes, and even the owners of the stores, were not the subjects of the study. The group instead was looking at the institutional practice of single-cigarette sales.
"Normally, on a research subject, you collect data like age, demographic data, whatever," she says. "We didn't care if they were blue, fat, old, young — we didn't care about any of that. We were only assessing whether when we went to that store, we could buy a cigarette."
Reference:
Malone RE, et al. "It's Like Tuskegee in Reverse": A Case Study of Ethical Tensions in Institutional Review Board Review of Community-Based Participatory Research. Am J Public Health. 2006;96:1914-1919.
When the University of California, San Francisco's IRB denied a plan to have volunteers attempt to buy single cigarettes illegally at neighborhood stores, they cited the following concerns:You have reached your article limit for the month. Subscribe now to access this article plus other member-only content.
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