IRB refusal of behavioral study garners attention
Individual vs. institutional behavior
A California IRB that had turned down a proposed study of cigarette sales in two San Francisco neighborhoods, instead found itself to be the object of scrutiny — in the form of a journal article about its decision.
The author of the article, Ruth E. Malone, RN, PhD, FAAN, a professor of health policy at the University of California, San Francisco, School of Nursing, says she was trying to make the best of a disappointing decision by the IRB not to let her pursue the study, which would have looked at the illegal sale of single cigarettes in African-American neighborhoods.
"Writing this paper was really our effort to sort of make some lemonade out of the huge effort that we made to try to gain their approval," she says.
Malone says her experience pointed to an area of research that needs greater IRB understanding — the behavior of institutions, as opposed to individuals, in affecting the health of a community.
"I think there is a message, in terms of considering whether there is activity worth studying that does not constitute individual behavior," she says.
But Victor Reus, MD, a psychiatry professor and chairman of the board that turned down Malone's proposal, says the IRB was concerned that the investigators' plans to send volunteers into liquor stores to attempt to illegally purchase single cigarettes constituted entrapment of clerks, who had not consented to participate in the study.
"I still stand by the reviews and the feedback [Malone] got," Reus says. "Sometimes you second-guess decisions and say this could have been done better, but I really don't see it in this case."
Reus says he was surprised to see the article in print in the November issue of the American Journal of Public Health, since no one from the journal had contacted him to get the IRB's response to Malone's complaints.
He was particularly offended by the article's title: "'It's Like Tuskegee in Reverse': A Case Study of Ethical Tensions in Institutional Review Board Review of Community-Based Participatory Research."
"To basically connect you with one of the worst violations of medical ethics in the last century. . .a lot of people will just read the title and think, 'What is UCSF doing?'" Reus says.
He says he asked for an opportunity to write an article in rebuttal, and was offered a chance to submit a letter to the editor instead. Attempts to interview editorial staff from the journal regarding their decision were unsuccessful.
PHAT project
The study in question grew out of a project called Protecting the 'Hood Against Tobacco (PHAT), which looked at tobacco use in two predominately African-American neighborhoods in San Francisco.
As part of the PHAT project, Malone and others created community focus groups to discuss strategies for addressing tobacco problems in the community.
Among those involved in the PHAT project was Carol McGruder, BA, director of the San Francisco African American Tobacco Free Project and the community co-principal investigator on Malone's study.
McGruder says her experience on an IRB at the research consulting company where she works was helpful in navigating the problems with the UCSF IRB for the PHAT project.
"If I had been someone from the community who hadn't had this broader experience, I probably would have been just rolled over by the whole thing." McGruder says.
When focus groups for the PHAT project discussed factors that they saw as problems in controlling tobacco use, they focused on the sale of single cigarettes, Malone and McGruder say. Although it is illegal in California to sell single cigarettes or "loosies" from an open pack, they say the practice is widespread at small stores in poor neighborhoods.
McGruder says the sale of "loosies" is particularly harmful to the neighborhoods because it allows people who can't afford a full pack of cigarettes, including minors, to maintain a smoking habit, as well as giving storekeepers an enormous markup on a pack.
"I think they sell them for 25 cents apiece," she says. "It's so exploitive, because you're making three times as much off of a pack of cigarettes."
In addressing the issue, the community members wanted to see how widespread the practice was.
The original proposal was for volunteers to monitor the small liquor stores in the neighborhoods to record the sale of loosies. But after the IRB had approved the observational study, the community members rethought the plan, Malone says.
McGruder says it became clear that an observational study wasn't feasible in this case and could, in fact, endanger the volunteers.
"You can't just hang around these stores and observe, watching what's going on" she says. "Stores get robbed. Someone would think they were casing the place. It could make trouble."
Malone and her team returned to the IRB with a revised plan, this time calling for volunteers to enter the stores and attempt to buy the cigarettes themselves, recording how often they were successful.
The IRB denied the amended proposal, citing a number of concerns. Reus says the most important consideration was the lack of informed consent for store clerks and storekeepers whose businesses would have been targeted.
And while he says deception is sometimes a legitimate tool of research, in this case, the IRB did not find that it outweighed the risks, especially when other designs could gain the needed information.
"We would have approved an observational design," he says. "If [single-cigarette sales] were really as common a practice as they were describing, they should have been able to get some pretty good data. And it would have been real data. It wouldn't have been an artificial situation as constructed by them."
Malone, however, thinks the concern about the informed consent of the storekeepers misses the point about the subject of the research. She says the group was not planning to record any information about the individuals selling the cigarettes, but wanted aggregate data about the institutional practice of selling them.
She says the investigators' difficulty in making their case to the IRB is a reflection of an American culture that focuses on individuality.
"We often don't see collective activity and institutional activity except as a collection of individual activities, but I think that's one of the distinctions we realized was really important here," she says.
Malone worries that a focus solely on individual behavior could make it difficult for researchers to conduct important research into public health matters.
"There's an increasing interest in studying the corporate contribution to health and health disparities and health problems," she says. "I think there could be a lot of very useful research in terms of institutional practices within communities that have effects on health that would be precluded if every IRB took this stance."
Third denial
After the UCSF IRB first denied the amended request, Malone and McGruder resubmitted it twice more, attempting to answer the IRB's concerns. They obtained assurance from the district attorney that no one would be prosecuted as a result of the study. Malone and McGruder themselves appeared before the board to argue their case.
Finally, after a third denial, the community partners decided to do the study independent of the PHAT project. Ironically, McGruder says, that meant that all of the safeguards they had promised, including the agreement with the district attorney, were no longer binding on the volunteers.
"We did actually give some of the information to the city," she says. "If we had done it under PHAT, we wouldn't have because it was one of the conditions we had agreed to."
She says the group found that about 30% to 40% of the liquor stores in the area they studied were illegally selling single cigarettes.
McGruder says that even given her previous IRB experience, she found the IRB review of the PHAT project frustrating. In particular, she disagreed with the board's emphasis on protecting the stores that sold the cigarettes illegally.
"They were looking to defend the people who were preying on my community," she says. "They were worried about what their rights were. I was worried about the effect that it has on my community."
McGruder says she was the source of the "Tuskegee" quote used in the journal article and its headline.
"Many of these boards have come about because of [researchers] preying on us," she says. "So we're harmed by Tuskegee, and then we're harmed by the process that was put in place to protect us from these kinds of things. I found it to be very ironic."
Since the article was published, Malone has heard from other researchers who have had difficulties with IRB review.
"I was actually somewhat surprised at how many people seem to be having problems with IRBs, particularly people doing more social science or policy-related research," she says.
But Reus says he doesn't believe this was a case of an IRB failing to understand behavioral or community participatory research. He says his IRB has worked with other community groups, including AIDS awareness groups, monitoring unsafe sexual activity in sex clubs.
"The article suggested that our IRB isn't appreciative of, or sensitive to, community participation or psychosocial design, and while that may be true at some institutions and on certain IRBs, it is certainly not true on this IRB," he says.
"We have ample representation of individuals who are appreciative of behavioral design, understand it very well, and who have sympathy for the intent of acquisition of this type of data. This was not a biomedical review that didn't appreciate this type of research."
A California IRB that had turned down a proposed study of cigarette sales in two San Francisco neighborhoods, instead found itself to be the object of scrutiny in the form of a journal article about its decision.You have reached your article limit for the month. Subscribe now to access this article plus other member-only content.
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