Centralized IRB could guide research in the aftermath of major disaster
Why not let public know research will be part of response?
Over the past decade, several large-scale disasters have tested emergency response teams and healthcare providers. They've also tested the research community's ability to quickly, efficiently and ethically dispatch investigators to do vital research that could help prevent and respond to future disasters.
Now some researchers and ethicists are suggesting that we need a more centralized IRB response to disasters such as the Sept. 11, 2001, terrorist attacks, Hurricane Katrina or even a medical disaster such as possible outbreak of avian flu. They say the steps to creating such an authority should be in place now, before it's needed.
"We have all these disaster preparedness initiatives," says David Perlman, PhD, former director of the Human Research Ethics Program for the New Jersey Department of Health & Senior Services. "Has anybody thought about preparedness for research?"
Perlman, now an associate at the University of Pennsylvania Center for Bioethics in Philadelphia, PA, also operates an independent ethics education company, Eclipse Ethics Education Enterprises or E4. He recently authored an article in the journal Disaster Medicine and Public Health Preparedness addressing the issue of how IRBs and others should prepare to conduct research in the wake of disaster.1
Reports from IRBs near the sites of the Sept. 11 attacks and in New Orleans after Katrina have shown that individual institutions' IRBs dealt with a huge crush of research proposals in the days and months after those disasters.
Studies conducted in the wake of disasters can range from epidemiological research to social behavioral studies to healthcare services delivery research. All may carry risks to a population that already may be ill or injured, traumatized, homeless or displaced. There may be various types of risk of breaching privacy, depending upon the event, Perlman says.
"Take for example the terrorist attacks on 9/11 — because there were very few parts left of people to identify; they had to do a lot of DNA sequencing," Perlman says. "Of course that raises privacy concerns. Whereas if you had a flu epidemic, you would be able to go out to the actual people who were affected and take samples from them. The issues are different, but the category under which they appear are the same. So privacy is going to be an issue, but it's going to manifest itself differently in each of those disaster contexts."
Another risk in conducting disaster research is the possibility of therapeutic misconception, says Bowen Chung, MD, MSHS, a psychiatrist at the David Geffen School of Medicine at the University of California, Los Angeles.
Chung, who worked on a training project to deliver mental health services to New Orleanians after Katrina, says disaster survivors may see any health care professional who approaches them to be offering therapeutic help. This is a particular problem in areas that traditionally have been underserved before the disaster. Chung wrote an article about ethical issues in disaster research that was published in a recent issue of the journal Ethnicity and Disease.2
"Often the fact that these researchers are not delivering services is not well explained, so people get very confused," he says. "Are these people who look kind of official and are obviously not from this place, are they asking me these questions because they're going to deliver services to me or are they asking me questions because they're doing research?"
A national IRB?
Both Perlman and Chung say they're concerned that different IRBs may have very different ethical approaches to these issues. And working independently of each other, they've both proposed a similar solution: a national or regional IRB, planned in advance, that can swing into action when a disaster occurs.
"Typically, IRB reviews can be very idiosyncratic, and if you had some sort of guiding policy or maybe a national IRB for disaster research, not only would you probably get done quicker, perhaps you would have a better outcome," Perlman says.
Perlman suggests one answer might be a regional network of state health department IRBs who can ensure that post-disaster studies aren't redundant and don't result in additional risks to participants. Chung believes that any such IRB should have local representation, especially among vulnerable populations within a disaster-affected region. He thinks that could be accomplished easily, even within the framework of a national or regional IRB.
"You don't have to be there in person," he says of community IRB representatives. "You could have a virtual IRB. You could do it over the phone, by conference call. There should be a way to figure out how to do this."
Perlman also suggests an approach to disaster research that would borrow from existing guidelines set up for emergency research. Under the FDA's guidelines, emergency research without prospective consent of participants requires prior consultation in the community that is to be affected.
"Why don't we let people know we're planning on doing these kinds of research, should there be an emergency?" Perlman says. "That way, you let people know they might be a participant in that kind of research.
"Each public health department or local health department could reach out to their various communities," he says. "Put an ad in the newspaper. Let people know if there's a disaster this is the kind of thing we'll be doing."
He admits that the emergency research blueprint is itself controversial. "But the emergency guidelines are at least trying to meet the standards set forward in the Belmont Report. It's something that could be adapted (for disaster research)."
Perlman and Chung both say their purpose in bringing up the topic of disaster research was to help jumpstart a conversation in the research community about planning for the next disaster before it happens.
Chung says he'd like to see the National Institutes of Health devote funding to studying the ethical issues surrounding disaster research, as well as HHS guidelines for conducting it.
Perlman hopes to help prompt widespread interest in the topic. "I'd like to see a national bioethics conference on this topic," he says. "I'm hoping other people will take up the charge."
- Perlman D. Public Health Practice vs. Research: Implications for Preparedness and Disaster Research Review by State Health Department IRBs. Disaster Med Public Health Prep 2008 Oct;2(3):185-91.
- Chung B, Jones L, Campbell LX, et al. National recommendations for enhancing the conduct of ethical health research with human participants in post-disaster situations. Ethn Dis 2008 Summer;18(3):378-83. Review.