Lessons from 9/11: Protecting subjects in disaster research
IRBs on the front line relate their experiences with research conducted after the attacks
In the days after the Sept. 11, 2001, terrorist attacks, New York City became a focal point for researchers interested in studying everything from post-traumatic stress disorder to physical complications among workers at the Ground Zero site.
After spending five years reviewing research proposals for these studies — and studying the results — IRB heads at New York City research institutions say we've learned much more about the risks to participants, and how to better protect them in similar research in the future.
One of the most important revelations, says Alan Fleischman, MD, chairman of the IRB at the New York Academy of Medicine, is that studying victims of trauma is not as risky to participants as IRBs may have feared.
"In the past, IRBs, not having any solid data or evidence or articles, tended to consider remembering of (traumatic) events as a retraumatization, and researchers have really debunked that notion," Fleischman says.
"Reactivation of memories or some stress-related symptoms that may occur as one thinks about the trauma are very different from reliving the trauma," he says. "I think that's what we're now seeing in much of the research that's come post 9/11. It may well be that there is some emotional distress associated with research, but it is not at a level that perhaps IRB members or outsiders would have thought."
Despite that fact, Fleischman says that research surrounding mass casualty events such as the Sept. 11 attacks does present some special challenges to IRBs, who might find themselves dealing with emotionally fragile people while operating in a chaotic, time-sensitive environment.
In an event of that kind, an IRB needs to be prepared to work quickly, he says.
"The New York Academy of Medicine IRB convened in emergency session, met with the investigators, developed guidelines, developed consent processes, developed checks and balances, all within three weeks post 9/11," Fleischman says. "We did that because we thought it was a national disaster and a critically important thing to do. But we didn't break any rules or regulations. We were very careful to fulfill all the regulations."
In fact, he says, the academy's IRB has actually taken steps to prepare in the event of a similar attack, by pre-approving research proposals contingent on another disaster. The IRB would not have to be convened to approve the research, but would check on it later to ensure it had been implemented as planned.
"There's nothing in the regulations that says that's not allowed," Fleischman says. "We're preparing so that the IRB isn't a great limiting or obstructionist part of the process."
Learning from Oklahoma City
Fleischman says that the New York Academy of Medicine IRB learned valuable lessons from the 1995 terrorist bombing of the Alfred P. Murrah Federal Building in Oklahoma City.
The academy contacted Oklahoma authorities in the days after the Sept. 11 attacks, after reviewing its own extensive library and finding little information about disaster-related research. Fleischman says it was only then that they learned about the extraordinary steps taken by then, Oklahoma Gov. Frank Keating, who directed that all research conducted with survivors of the bombing be reviewed by the University of Oklahoma's IRB.
"They basically told all the victims' families and those who had been hurt that they should only participate in those projects that had (the university IRB's) stamp of approval," he says. "They had no authority to keep others out. And I'm sure that it would have been difficult if people had actually come in with IRB-approved research projects from (elsewhere). But the governor of Oklahoma was quite clear about that and, in fact, they did coordinate all the studies."
Fleischman says this step helped avoid survivors and their families being overburdened by repetitive attempts to recruit them for studies. He found this idea so compelling that he himself proposed a similar idea to New York City Mayor Rudolph Giuliani and the city's commissioner of health, but he says that proposal was never acted upon.
"I suggested to the mayor and the commissioner of health that we create a blue ribbon panel that would be a clearinghouse and would put a put a star of approval on those protocols they had reviewed in order to try to decrease burden and to bring together collaborative projects that might be doing the same kind of work."
Fleischman's vision was of a panel of past Nobel laureates from the city. The panel would not itself be an IRB, but would tell IRBs which protocols they should consider. He says he still thinks the idea has merit, and could be useful in a future emergency.
Meanwhile, his institution was rapidly developing a set of guidelines to use when the academy's IRB reviewed the first research proposals it would see involving Sept. 11 survivors and others affected by the attacks.
"We developed these guidelines on Sept. 14, when our researchers came to us to say, 'We want to do this work,'" Fleischman says. "And we said, 'We want you to do the work, but we think we ought to worry about this a little bit.' Because we could find no guidance."
Fleischman says one important aspect of protecting participants was providing referrals for necessary mental health treatment for people psychologically affected by the attacks — whether they were survivors, relatives, or New York City residents who witnessed the events in person or on television. In most cases, these were people with pre-existing mental illness whose problems were exacerbated by the attacks.
To address this issue, Fleischman says his institution set up toll-free hotlines for people who needed help. Research assistants who conducted telephone surveys were specially trained to probe for mental illness, and refer the respondent to a hotline.
For severe cases, where it was believed that a respondent needed immediate mental health intervention, psychiatrists were on call.
"We could put them on hold and get a psychiatrist who was on beeper availability," Fleischman says. "We did that twice in 4,000 interviews."
Another concern was the large number of substance abusers in New York City who were suddenly cut off from their drug supply by the shutdown of traffic into the city.
"We were concerned that our drug-using population would have some unique kinds of problems," he says. "So we, in fact, were prepared to refer people to immediate detoxification centers."
Data protection key
At Mount Sinai Medical Center, research with Sept. 11 survivors and families raised different issues, most notably privacy and confidentiality of data.
It's a problem that's not unique to this research, and IRB Chair Jeffrey H. Silverstein, MD, says his organization already had been vigilant about privacy protections, partly in response to the requirements of the Health Insurance Portability and Accountability Act (HIPAA), which had been enacted earlier in 2001.
In addition, "One of our largest portfolios here is our psychiatry department, so the sensitivity of data is something that we as an institution had a tremendous sensitivity about," he said.
With large-scale studies of survivors, including sensitive psychological data, beginning at the same time as the HIPAA prot ections and concerns about identity theft, Silverstein says Mount Sinai officials put a lot of effort into security issues.
"There are a lot of people who want access to these data sets," he says. "So we spent a lot of time thinking about how you secure them, while giving your researchers access to stuff. You can't have people walking around with identifiable data about tens of thousands of people."
There also was the worry that data could be subpoenaed for use in litigation, but Silverstein says that so far, that has not been a problem.
"We've discussed the utility of (obtaining) certificates of confidentiality; however, this is not like a pure data set, it's a clinical data set, so it's probably not going to be protected by a certificate of confidentiality if someone starts trying to use it for litigation purposes."
Silverstein says there has been one major security breach associated with Sept. 11 research at Mount Sinai. Last year, a subcontractor's laptop was stolen containing personal medical information from city workers who were participating in the World Trade Center Medical Monitoring Program.
"We eventually got it back, but we had to write 10,000 letters to people saying we lost it and then we had to write 10,000 letters saying we got it back," he says. "That misadventure has resulted in a tremendous tightening down of security regarding databases in general. It could have happened to any major data set, but it happened to be the World Trade Center data set."
Silverstein says that an institution embarking on this type of huge collection of data needs to ensure it has the necessary infrastructure to store and protect it.
Other issues that Fleischman and Silverstein say that IRBs should consider in dealing with the aftermath of terrorist related disaster:
- Patriotism and duty in voluntary participation — Fleischman says there's been some concern among ethicists about the possibility that people in the throes of a national disaster, especially a terrorist attack, will feel a greater-than-normal compulsion to volunteer for research, seeing it as a patriotic duty.
"I think it was not unusual (in the aftermath of Sept. 11) for Americans to feel they were willing to give of themselves, which is an interesting question in research — whether this becomes an additional concern," he says. "I think it is only a concern in that we shouldn't play on that in the consent process. We should make sure the consent doesn't add this message that 'Americans ought to do this for the sake of the future of America.'
"I'm not overly worried about it. I think it's just a matter of not selling too hard, which is one of the IRB's jobs (to monitor) anyway."
He says special care should be given to protecting firefighters and police officers, whose situations may make them more willing to volunteer for this type of research.
"You have to make sure they are able to give true voluntary refusal," he says. "In that kind of a setting, a quasi-military setting, somebody may not be able to do what he wishes to do in the face of peer pressure."
- Community concerns — IRBs have always been charged with taking local concerns into consideration when reviewing protocols. This becomes doubly important when outside researchers are entering a community on a large scale.
Silverstein says one researcher approached his IRB with a proposal to monitor the population who lived close to the World Trade Center in lower Manhattan.
"He had a set of surveys that were relatively mild, but he wanted to do it only in English," he says. "The IRB pointed out that everybody who lives there lives in Chinatown — they all speak Mandarin.
"Basically, they convinced the investigator that if he really wanted to know what happened to the people who lived under the Trade Center, he'd have to come up with a way of dealing with people in Mandarin."
Fleischman says researchers also needed to work with a distinct community of survivors and their families, bound not by geography or language but by their shared experience.
"In much of the work in New York, we've involved the families of 9/11 victims," he says. "They've been a very vocal group, but they've also been very powerful in helping research. Because they've seen the importance of doing research on how to build safer buildings, how to develop better plans for evacuation, how to educate people about these risks, how to develop community strategies in bioterrorism.
"They're very much in favor of research, but they want it to be effective and useful. They don't want any trivial self-serving research; they want work that's really going to have an impact."
In the days after the Sept. 11, 2001, terrorist attacks, New York City became a focal point for researchers interested in studying everything from post-traumatic stress disorder to physical complications among workers at the Ground Zero site.You have reached your article limit for the month. Subscribe now to access this article plus other member-only content.
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