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Past abuses tar studies with prison populations
OHRP issues updated guidance
For years, inmates of a Philadelphia city jail, known as Holmesburg Prison, participated in medical experiments. From the mid-1950s to 1974, when medical testing was banned, research, ranging from dermatological treatments to the effects of mind-altering drugs, was conducted at the jail. Inmates were paid $2 to $3 per day while the jail collected hundreds of thousands of dollars in fees from the likes of Dow Chemical, Johnson & Johnson, and the U.S. military.
Three years ago, the office for Human Research Protections (OHRP) ordered the University of Texas Medical Branch at Galveston and the University of Miami to discontinue some of their research with prisoners. In their findings, OHRP listed problems with informed consent; the fact that some trials involved administration of an impermissibly risky drug; and possible conflicts of interest involving IRB members charged with approving protocols.
"Throughout the 1960s and the 1970s, there were disclosures of research involving prisoners in which it was clear that the prisoners were used because they were a convenient and captive population," Michele Russell-Einhorn, a director in the Global Pharmaceuticals and Life Sciences practice and the leader of the human subject protection advisory services group for PricewaterhouseCoopers, based in Washington, DC.
Such practices were unethical then. Today they would likely be considered illegal as the Depart-ment of Health and Human Services has strict guidelines for research involving prisoners.
In a guidance issued May 23, OHRP reminded IRBs about the special care that should be taken when reviewing protocols that use prisoners as research participants.
"It is important for IRBs to remember that research must fit into one of four very limited categories," says Russell-Einhorn. These categories include:
In addition to the four categories, other special consideration by IRBs should include:
To ensure that prisoner concerns inform protocol design and the informed consent process, IRBs must have prisoner advocates on their boards.
"A prisoner advocate should not be the warden of the prison or an individual whose first loyalty is to the prison system," says Russell-Einhorn. "A prisoner advocate could be a public defender, a lawyer, a former prisoner, or a social worker from outside the prison."
Put simply, "the role of the prisoner advocate is to advocate on behalf of the prisoner," she says. "The prisoner advocate should be an individual who is familiar with and can understand the issues confronting people who are incarcerated, such as 1) limitations on their ability to communicate with people outside the prison; 2) limitations on amenities within the prison; 3) limitations on the food they eat and when they eat it; 4) how prisoners spend their time during the day."
When Cindy Struckman-Johnson, professor of psychology at the University of South Dakota in Vermillion, conducted research in 1994 on sexual coercion involving women in Nebraska prisons, there was no prisoner advocate on her university’s IRB. She took on that role, de facto, and designed her study with an eye on confidentiality and ensuring that inmates did not feel coerced into participating.
"Inmates are a captive population," Struckman-Johnson says. "Any information they give out could hurt the prison administration, which has retaliatory power, so they have to have special protections. I had to be careful about coercion and ensure that there would be no silent penalty for participating or not participating."
The issue of confidentiality had an impact on the informed consent process, she says. "Typically, when you get informed consent, you get a signature and that’s your proof that they understand the study and that you have their permission. For that particular study, it was extremely important that inmates not have to put their names on anything linking them to the study."
Struckman-Johnson created a passive consent form, which stated that returning the questionnaire was their "voluntary agreement to be in the study."
The form also included an address and instructions that participants could contact her if they had additional questions or concerns. Some prison administrations didn’t like that but, says Struckman-Johnson, "when I explained that I had an ethical obligation to respond to concerns I was allowed to do so."
Currently, her university IRB has a consultant who serves as the prison advocate when the need arises. "Her background is in prison research," Struckman-Johnson explains. "She has studied prisons her whole career, so she’s very knowledgeable about the concerns of prisoners."
This year, Struckman-Johnson was called in to be the prisoner advocate on a study concerning sexual assault. The one flag for her was the investigators’ proposal to collect names. She advised against it. "If confidentiality is lost, many penalties, some of them life-threatening, could result for inmates."