Historical accounts of the biggest human research scandals of the past two centuries primarily involved vulnerable populations.
The list is long and includes orphans, minorities, the disabled, prisoners, and others. (For more information, see timeline of exploited vulnerable populations in this issue.)
“We’ve always had research on vulnerable populations, and in many ways the rules and our policies for protecting human subjects were reactions to scandals,” says Jeremy Block, PhD, MPP, managing partner of Venture Catalyst and adjunct professor at the Marxe School of Public and International Affairs at Baruch College in the City University of New York (CUNY) System in New York City. Block spoke about vulnerable populations and research ethics at the Advancing Ethical Research Conference, held Nov. 13-16, 2016, in Anaheim, CA.
“If you look back through history, all of the big scandals were on what we now call vulnerable populations,” Block says. “These were situations of groups of people exploited, manipulated, physically controlled, influenced, or coerced.”
The research and ethics community have been talking about developing research ethics around vulnerable populations and situations for a long time. IRBs and the regulations that have created the human research protection system of IRB reviews and informed consent now provide ample protection from any systematic attack on vulnerable populations, Block says.
However, there are ways IRBs can ensure that vulnerable populations continue to be protected from even a single research project.
For example, sometimes the vulnerable population being studied is engaged in behavior that could result in stigma or even legal repercussions if individuals’ names are discovered. In this case, IRBs and researchers have an obligation to make certain the research subjects are protected from disclosure to governmental or other authorities, he says.
“You’re allowed to do what you need to do to protect them,” Block says.
For instance, marginalized groups based on their sexual orientation, the LGBTQ community, or people who are refugees or undocumented immigrants can be considered vulnerable.
“We’re creating a climate where there’s a chill among those people,” Block says. “Do you think they’ll want to sign up for a study where all of their information will be kept centrally in a database?”
If someone tries to collect information about a vulnerable population that has been studied for a non-research purpose, then IRBs and the research community should protect the study participants from disclosure and possible harm, he adds.
“There are a significant number of students in my courses who fall into this category of being individuals who are immigrants,” Block says. “I can tell you anecdotally that I received a lot of messages from my students, some who are Muslims who fled violence to come to this country, that they’re afraid of people coming after them.”
Another aspect involving vulnerable populations is its very definition. “It’s not just groups of people like pregnant women, prisoners, or children who are vulnerable,” Block says. “We need a broader understanding of situations that can leave people vulnerable.”
He offers this example. “If you take a middle-aged white man who has a good job, we wouldn’t think of him as automatically vulnerable,” Block says. “But if he has chest pain and is put in the emergency room, then I would argue that he’s vulnerable.”
For people who are acutely ill or at the end of their lives, they could be considered vulnerable based on their situation, he adds.