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Data protection, informed consent are key for illegals
IRBs should be flexible, seek out expertise
As IRBs review research proposals that may include illegal immigrants — or even recruit them outright — those who work with this population say there are a number of issues boards should consider:
• Protection of data – Because of the risks of disclosure, IRBs should insist on the tightest possible protection of records, particularly those that may contain identifiers. Certificates of confidentiality should be sought to protect records from the threat of subpoena or court order.
And Shedlin notes that it's not always necessary to collect incriminating data. "If you don't need identifiers, don't collect them."
• Informed consent – The consent process can help assure prospective participants that their information will be protected, says Ken Goodman, PhD, director of the Bioethics Program at the University of Miami in Miami, FL. That, in turn, decreases the risk of exploitation, since participants know they're safe from exposure.
"You say explicitly that come what may, you're not going to be reported to the immigration authorities," he says. "People who are outside of this study are not going to have access to the records."
The informed consent process itself can be intimidating to immigrants, particularly those from countries with authoritarian governments, says Michele Shedlin, PhD, a senior fellow at the Hispanic Health Disparities Research Center at the University of Texas, El Paso.
"They come from an environment where these things are not done, and there's certainly no understanding of research," she says. "You win enough confidence and rapport for people to agree to do an interview, and then you read them this long, legally mandated, complicated thing, and they freak out.
"They ask, 'What is this government document? Why do we have to sign this?' Sometimes it takes a very, very long time and a very careful explanation."
Shedlin says this can add substantially to the length of the consent process, but is vital to ensure that participants understand how they are protected.
And, of course, as with all populations that are non-English speaking, consent forms must be in the appropriate languages.
Give investigators flexibility
• Flexibility – Researchers may need to deviate from planned methodologies or consent procedures in order to address risks as they learn about them. IRBs should be ready to weather those changes as well, say Shedlin and 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.
Berk says his interviewers dress far more casually than they do for other surveys in order to put respondents at ease. They're also given leeway to deviate from the script when necessary to build trust.
Shedlin says that as an anthropologist, she does initial exploratory field work on her studies, which can lead to changes. She cites an example, not involving illegal immigrants: While surveying homeless women in a welfare hotel in New York, she learned that drug dealing was rampant in the building, and that women would be coerced into participating through threats that their children could be taken away by authorities.
So she scrapped plans for focus groups in which women were to discuss their difficulties obtaining pediatric health care, since the discussions might expose vulnerabilities that could be used against the women later. Women were interviewed individually instead.
"I reported back to the IRB why the methodology changed," Shedlin says. "These are the kinds of things that you tailor to vulnerable populations in response to specific vulnerabilities. An IRB can't always know them ahead of time and, sometimes, neither can the investigator until they're in the field."
• Financial incentives – Researchers advise IRBs to be sensitive to the financial incentives offered to illegal immigrants, since some face severe financial hardships and could be unduly influenced by large payments.
Legality of incentives
There is a legal aspect to financial incentives as well. Many researchers working with undocumented participants provide incentive payments in cash to avoid having to identify recipients by name.
When asked whether payment for a study would be considered illegal "employment" under federal law, the response from the U.S. Citizenship and Immigration Services (formerly the Immigration and Naturalization Service) was less than clear.
"This is the kind of relationship that can be said to be on the margins of 'employment' because it is not what we normally think of by that term," according to the response from the USCIS counsel's office. "However, the regulatory definition of employment is quite expansive, and does include many relationships that may be short term or different in other ways from the more classic salaried or waged position type of employment."
Sonal Ambegaokar, a health policy attorney with the National Immigration Law Center in Los Angeles, CA, says she believes institutions and researchers aren't putting themselves at undue risk by providing incentive payments to research subjects.
"I would see it as compensation, but I don't think it's an employment relationship," Ambegaokar says.
• IRB membership – Shedlin says IRBs that deal with studies involving illegal immigrants should include members who understand the unique vulnerabilities of the population.
"People who have either worked in areas of immigration and migration, people who have worked in the countries involved, who know something about where these folks are coming from," she says. "Many of these people have gone through horrendous trauma and hardship and violence in getting here. Not only are they new immigrants and may be undocumented, but they may be suffering from post traumatic stress disorder, as well as other issues.
"I think it's good for IRBs to have some orientation about the issues of these populations, not just whether they're legal or not legal," she says.
• Local laws – In the past few years, states, and even municipalities, have passed laws and ordinances restricting dealings with undocumented immigrants. Shedlin says individual IRBs should be alert to any changes, as well as possible implications for research.
"We need to be very aware of what the changes are in the laws, so that we protect our institutions and researchers and participants," she says. "We don't want to do things that aren't legal, obviously."