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When studies involve terrorism victims, think of three major issues
Ability to consent is not a problem
Studies involving terrorism or disaster victims should receive extra attention and concern from the IRB, but not always for the reasons IRB members suspect, an expert says.
Reviewing studies involving terrorism or disaster victims is not much different from other research in terms of the subjects' vulnerability, says Elana Newman, PhD, associate professor of psychology at the University of Tulsa in Tulsa, OK. Newman has conducted various research studies on the topic of traumatic events, and she has spoken about IRB reviews and terrorism at national conferences. Newman also has been serving as a clinical consultant for the Oklahoma Child Traumatic Stress Treatment Collaborative in Tulsa.
"This type of IRB review is unique because the decision is made under heightened arousal for everybody," Newman says. "Decisions are made quickly."
For example, IRB members often are concerned about whether terrorism or disaster survivors need additional human subjects protections, Newman says.
"Can they make decisions under issues of uncertainty," she says. "And it looks like even people who are upset and under stress can make decisions about research and health care."
Survivors as a group do not have impaired decision-making capacity, Newman says.
"You still need to look at this issue because studies deal with individuals, and it's up to each participant to decide whether or not to participate in the research," she says.
It's fine for IRBs to pay special attention to such protocols, but they do not need to provide the participants with special protections, Newman says.
"They are vulnerable in other ways, but they are not vulnerable in the regulatory sense," she explains.
There are three main issues that arise with the review of studies involving terrorism or disaster victims, Newman says.
1. Research is conducted very quickly. Investigators know that if they want to interview people who have been impacted by disaster or a terrorist act they should begin the study before survivors disperse. This means IRBs might receive such protocols very quickly and be expected to review them in as timely a fashion as they can.
2. Everyone, including IRB members and investigators, might have heightened emotions. "The goal of terrorism is to not just inflict terror on the direct victims, but on all of the bystanders," Newman says. "So these are circumstances where everyone is upset or distressed or concerned."
IRB members will be reviewing a protocol during a time when their feelings are heightened, she says.
Making decisions about research protocols could be impacted by the acute emotions IRB members have about the event.
For instance, they might be more overly concerned about the emotional state and health of the survivors, Newman says.
3. There might be a greater research burden on survivors. This doesn't happen with all disaster and terrorism research, but often there are a finite number of survivors, and there are many researchers interested in studying them.
There might be a redundancy of research and the participant burden can be high, Newman says.
This means there might be issues of coordination that are unique to these situations.
For instance, after the 1995 terrorist bombing of the Alfred P. Murrah Federal Building in Oklahoma City, OK, the governor of Oklahoma designated central agencies and institutions to provide mental health care, crisis care, and research activities. All research activities resulting from the terrorism event were coordinated through the University of Oklahoma Health Sciences Center.
The governor had all research centralized through one institution to ensure that survivors were not bombarded with research requests, Newman notes.
And this would help to expedite the IRB process.
Even when this type of coordination is not required by the government, it's a good idea for institutions and IRBs to form their own collaborative efforts to reduce participant burden, Newman suggests.
For example, an institution could make an IRB member available for consultation to investigators and other IRBs, she says.
Investigators and institutions should prepare for this long before a disaster occurs.
"If people know they are interested in studying disasters, they can work out ahead of time a general protocol that can be modified," Newman says. "IRBs need mechanisms to use in anticipation of this kind of research."
IRBs reviewing a terrorism or disaster protocol have a responsibility to communicate with other IRBs and share information with them, particularly if it was a local event, Newman says.
IRBs can help disaster participants in other ways, as well.
For instance, they could make certain investigators have a mechanism for referring participants to psychological or physical services, depending on the protocol, Newman adds.
"Investigators often think it's a good idea to offer referrals as a public intervention, and that's up to each IRB," she says. "The staff should be trained to recognize when a referral is needed."
IRBs also should make certain the investigator and research staff clearly explain to participants that they will be seen as part of a research study and not to receive typical clinical services, Newman says.
"It's important that participants don't confuse research and clinical services," Newman says.
For instance, would it be okay for an investigator to go to the site of a disaster and say, 'Is it okay if I call you later?' Newman says.
"Each IRB has to figure that out," she says.
The last misconception IRB members might have is that disaster or terrorism victims will be retraumatized or re-victimized if they are asked to relive their traumatic experience.
"It's very important that trauma survivors are treated with respect and that the research doesn't harm them," Newman says. "But at the same time I distinguish between asking people to relive a harmful experience and [literally] putting them into that experience again."
IRB members who are concerned that a research experience might cause a participant to feel distress could ask the researcher to use a tool that measures the participant's reaction to his or her research participation. (See sample research participation reaction tool.)
Most people who participate in such research who report unexpected distress will say that they were more upset than they anticipated but that they're still fine, Newman says.
"A small group of people would say they wouldn't have participated if they'd known, but this group is not based on the extent of trauma exposure," she says.
The best strategy is for an IRB to ask for more information if it looks as though a study might present a problem.
"Ask the first five participants what this experience was like for them," Newman says. "It may make some sense to ask the participant at the end of it, 'Did you feel this was invasive? Do you feel this was dangerous or distressing? Was this a risk for you?'"