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Protecting illegal immigrants in behavioral, clinical research
IRBs should be sensitive to groups' unique vulnerabilities
As the national debate about illegal immigration heats up across the country, researchers continue to work to include such immigrants in their studies.
It can be a difficult task convincing immigrants to overcome their fears of deportation and assuring protection of the data collected from them.
But researchers say it's important to study the health of this large and important group. The Pew Hispanic Center, a non-partisan research organization based in Washington, DC, estimated last year that there were 11.5 million to 12 million undocumented immigrants in this country, about half of them from Mexico.
"I think it is a very sensitive issue, but I think it's an issue that this country needs to have a conversation about and be informed about," says E. Richard Brown, PhD, director of the Center for Health Policy Research at the University of California, Los Angeles. "And the best way to have an informed conversation is for there to be good research conducted with and about this population."
Even clinical research, which brings more risk to a vulnerable population, can and should be ethically conducted with this group, says Ken Goodman, PhD, director of the Bioethics Program at the University of Miami in Miami, FL.
"Clinical research is ultimately done for the sake of the people who are going to show up in clinics," Goodman says.
"The whole engine is so driven by profits and careers that we sometimes forget that we do the research for the sake of the populations we have the privilege of serving," he says. "If you're in California, Texas, Florida, Illinois, or New York, that's going to include a fair number of undocumented immigrants. And to say we're going to exclude them because we can't get our act together is, I think, to surrender."
Medical research involving the undocumented population benefits the public as a whole, says Marc L. Berk, PhD, senior vice president for health policy and evaluation at the National Opinion Research Center at the University of Chicago, Chicago IL.
"Even a policy maker who's very anti-immigrant can still understand the argument that no matter how you feel about immigrants, it's really not good to have thousands of people running around with infectious diseases," he says. "Despite all the problems, it's a population that needs to be studied. There's a lot of noise out there, but not enough good research."
Berk and others believe that the recent public debate regarding immigration policies already has affected the willingness of illegal immigrants to participate in research, just as it has made them more reluctant to seek out health care.
"We know the debate is affecting participation in [health care] programs," he says. "I'm positive that it would affect survey participation, which after all is not as important as getting health care."
In social-behavioral research, the greatest threat faced by undocumented participants is the threat that government officials will learn their identities and attempt to deport them.
So, researchers who actively recruit this population put much of their energies into devising means of protecting the identities of participants from eventual disclosure.
These methods vary from study to study, depending upon the researcher and how much information he or she needs. Berk and Michele Shedlin, PhD, a senior fellow at the Hispanic Health Disparities Research Center at the University of Texas, El Paso, both say that the privacy safeguards they include in their studies are extremely stringent, often going beyond the normal requirements of their IRBs.
The most common protection sought is a certificate of confidentiality issued by the National Institutes of Health. The certificate protects the researcher from having to release identifying information in response to a court order or subpoena.
According to the NIH, the legality of the certificate has been upheld in the courts, but some still worry about possible limits of its authority.
Berk, who has surveyed undocumented immigrants regarding their access to health care services, specifically asked participants their immigration status. When determining how to maintain the confidentiality of the data, Berk's group came up with an extreme solution — they destroyed all identifying data after they determined they had the information they needed.
"The IRB did not insist on that. We decided to do that," he says. "As we went into the field, we talked to people and learned what their risks were. We informed the IRB and they were fine with it."
Berk noted that his research was not government funded — it was funded by the Robert Wood Johnson and Kaiser Family foundations, which he says gave him less protection against forced disclosure.
"I didn't want to run into a situation where a law enforcement agency in Texas would say, 'You've got a list of hundreds of undocumenteds, we'd like to have it,'" he says. "The only way to be absolutely sure that we wouldn't be in that situation was to destroy everything."
He notes that that approach precluded the possibility of conducting a longitudinal study with the participants. He says it's ironic that had the government funded his study, it would have strengthened the protections afforded participants — but he believes undocumented workers would have been less likely to trust a government-funded study.
Shedlin, who has studied HIV and substance- abuse issues, took a different approach when dealing with migrant farm workers in Long Island, NY. She did apply for and receive a certificate of confidentiality — "everybody needs to get that if they're working with undocumented community residents" — but she also limited the amount of personal identifiers she collected. In fact, she never specifically asked participants if they were in the country illegally, despite the fact that she knew most of them were.
"There's no question that a large percentage of these people were undocumented," she says. "We took no identifiers. We have demographic characteristics of our sample, but we did not ask for names. So there were no records to keep."
Shedlin says researchers and IRBs dealing with an undocumented population should think very carefully about how much information is really necessary for the research.
"It's something we all do, we always collect too much information," she says. "But if you don't need identifiers, then why collect it? That doesn't mean you don't collect information about who your sample is and what their characteristics are, but it does mean that if you don't need names and addresses, you don't collect them."
Taking care with incentives
Another thorny ethical issue in research with undocumented immigrants is the practice of offering incentives for everything from filling out a form to testing a drug.
Because the undocumented population can be extremely poor, the incentives can be a powerful force in a participant's decision to take on risks.
Berk notes that part of his research involved putting together focus groups of illegal immigrants to talk about their health care situation. Those involved in the groups were offered $40 to participate.
When the facilitator asked the group why they came, "they all said it was the $40," Berk says. "Some of them were quite worried that it was a [government] trap, but they weren't about to turn down the $40.
"A woman actually came with her suitcase. She wasn't willing to give up the money, but she thought the odds that this was a trap were so high that she had packed."
Berk sees an ethical challenge in crafting an incentive level that does not unduly influence a poor population, but adequately compensates them for their time and effort.
Shedlin agrees, saying she feels strongly that participants should receive incentives.
"They are collaborating on a research project and giving their time and spending carfare and these kinds of things — of course they should be compensated," she says.
She says community workers who spend a lot of time with the immigrants being studied should be consulted to arrive at a fair amount.
"Community-based organizations, (non-governmental organizations), hospitals — the people working with these populations — have a very good idea of what would be compensation and what might be coercive.
"It's a fine line, it's always a fine line," Shedlin says. "But in combination with all the other protections, I think you can work well to establish a fair compensation."
Conducting biomedical research with illegal immigrants adds a whole layer of risk, since immigrants who are not in the country legally could be constrained from reporting any unethical behavior or adverse outcomes.
But Shedlin notes that other vulnerable populations, such as drug users or non-English speaking legal immigrants, face some of the same obstacles to reporting problems.
The potential for exploitation was brought into sharp focus in Miami a few years ago when news reports alleged safety and ethical lapses by a private firm operating a clinical trial site in the city. Later stories alleged that immigrant subjects were threatened with deportation if they didn't refute the charges in the earlier articles.
The company has since closed its Miami operation; the testing center was demolished after the county board deemed it unsafe.
Goodman says he doesn't believe exploitation of undocumented immigrants in research is a widespread problem, but he believes it deserves further study. He says some of the factors in the Miami case illustrate the obstacles faced in protecting immigrants and other vulnerable populations.
"I want very much to believe that people running clinical research projects would not threaten someone with deportation because they chose to exercise their rights to communicate," he says. "I believe it's an aberration, although it's an aberration borne of the idea that a lot of these Phase I trials need to be farmed out to for-profit corporations."
When he visited the site, Goodman says he saw participants — not all of them in the country illegally — approach a window and ask "What [studies] do you have for $2,500 today?"
"IRBs, especially IRBs at academic medical centers, are accustomed to a much more genteel process," he says. "The idea that an advertisement would draw people off the street who were there shopping for protocols was a real eye opener — and a real source of concern."
While IRBs need to be attuned to the vulnerabilities of this population, Goodman says it shouldn't be a reason to close off research to undocumented immigrants.
"Depending on the research, it might very well be the case that including undocumented immigrants as subjects would be a way to improve health care for undocumented immigrants," he says. "To be sure, it's a vulnerable population, but we've got some experience with managing vulnerable populations — protecting their rights, protecting their interests, and so forth. And through mechanisms such as certificates of confidentiality and robust IRB review, we've been able to see our way clear to do research, which I believe on balance helps this population."