IOM panel recommends changes to review of prisoner research

Enhanced OHRP, new focus on risk vs. benefits, among recommendations

The world of a prisoner in a correctional institution is all about control, or the lack of it. The time you wake up, when you eat, where you go, whom you speak to — all is controlled by officers.

Under those circumstances, is true voluntary participation in research even possible? It's a question that researchers and IRBs have struggled with for years, trying to find ways to protect prisoners in their unique environments without closing the door to research entirely.

Now a committee of the Institute of Medicine has weighed in on the issue, recommending systemic changes in the way that prisoner research in the United States is reviewed and monitored.

The committee makes the case that prisoner research is valuable to science, and can provide benefits to the participants as well. But members say the current regulations to protect prisoners are focusing on the wrong issues, and are not applied evenly.

The committee had been commissioned by the Office for Human Research Protections (OHRP) to review the current state of prisoner research and suggest improvements.

The panel, which included IRB professionals, ethicists, prisoner representatives and a former prisoner, concluded that much prisoner research now under way is eluding IRB review — in some cases because it's being conducted without funding of the Department of Health and Human Services, or by a prison system that has its own in-house review procedures.

In addition, IRBs that do review prisoner research may or may not be applying the requirements of 45 CFR 46, Subpart C — the section of the federal regulations that provide specific protections for prisoners — says Wendy Visscher, PhD, a committee member who is director of the Office of Research Protection and Ethics at Research Triangle Institute (RTI) International, Research Triangle Park, NC.

The result, she says, is a system in which prisoner research is reviewed differently depending upon the prison system, the institution conducting the research and the funding source.

"All of this made us come to one of our recommendations: That we needed to have universal protection for prisoners," Visscher says. "All prison research really needs to fall under the same regulations, get the same level of review. That's just not happening right now."

The panel also recommended a change from the current Subpart C, which requires that all prisoner research fall into certain categories, such as studies of the causes and effects of incarceration, or studies of conditions such as HIV that affect prisoners as a class.

Members say they found the categories to be overly rigid and unhelpful in determining whether a study poses an undue risk to prisoners, or provides them any benefits. Instead, the committee proposes a modification of the current Subpart D section, which applies to research involving children, and is based on risk and individual benefits.

"What we didn't like about Subpart C was that those categories are really artificial," Visscher says. "They were developed back in the 1970s when there was a lot of abusive (prisoner) research going on. It was meant to be very, very restrictive.

"But there are studies that can be done, very ethically and very appropriately, that can offer benefits to prisoners but that you cannot fit into those categories," she says. "We wanted to bring the IRBs back to their roots and have them thinking about risks and benefits, which is what they should be doing anyway."

Under this system, the inclusion of prisoners in Phase 1 and Phase 2 clinical trials still would be prohibited. IRBs could use risk vs. benefit analyses to determine whether to approve Phase 3 studies.

Resisting calls for a ban

The IOM committee resisted calls to ban all medical research with prisoners on the grounds that the prison environment is so inherently coercive that a prisoner cannot give true informed consent.

One of those voices was from an IOM committee member, G. David Curry, PhD, a professor of criminology and criminal justice at the University of Missouri in St. Louis.

Curry, a former prisoner, says prisoners considering a research study face a number of pressures — from other inmates, from guards, from the medical staff and from the unrelenting boredom that might drive some to agree to a study just to spend time in a different building or in a different routine.

He noted that in many prisons, access to health care is problematic, and prisoners might be persuaded to sign up for a clinical study to get access to health care or the attention of the prison medical staff.

"I really didn't want to recommend any changes in the regulations, and I kept that position on the committee for a long time," Curry says. "I finally realized there are 15 other people there, and I'd have to compromise."

Among the terms he insisted on: An absolute prohibition against cosmetic testing, which had been among the most notorious of the abusive studies of the past; and a rule that in any biomedical study, prisoners should make up no more than 50 percent of the subjects, in order to fairly distribute the research burden.

Among the other recommendations of the IOM committee:

Expanding the definition of prisoner — Visscher says that when the current regulations were written, nearly all those in the custody of the criminal justice system were men and women literally behind bars. Now, a much greater number are in less restrictive environments, including halfway houses, those on house arrest, or on probation or parole.

The current regulations only address the protection of so-called brick and mortar prisoners, although those in less restrictive environments may still encounter some of the same pressures, including wanting to please a parole officer, or the risk of loss of privacy.

Monika Markowitz, PhD, director of the Office of Education and Compliance Oversight in the Vice President's Office for Research at Virginia Commonwealth University (VCU) in Richmond, VA, was one of the IRB representatives who addressed the committee as it worked on the report.

Markowitz says she agrees with the committee that IRBs need to be sensitive to the special risks involved in research with people in various stages of supervision, such as probationers.

She says VCU's IRBs do look at those subjects' particular situations to determine potential risks.

"We really have recognized that people under different levels of criminal justice supervision are as vulnerable, if perhaps not even more so (than those in brick-and-mortar prisons)," Markowitz says. "The IRB really has to look at the potential risks to their participation and their ability to give voluntary informed consent.

"But I wouldn't necessarily want all those people labeled as prisoners, because there are different levels of supervision," she says. "There ought to be different kinds of risk assessment for people in those different levels."

The expansion would not apply to studies in which someone outside a prison, such as a parolee, voluntarily enrolls in an outside study which doesn't focus on or ask about his status as a prisoner.

Introducing on-site prisoner advocates — These prison research subject advocates (PRSAs) would be based at the prison, but would be independent of the facility and accessible to prisoners. Their role would be to monitor the study to ensure the protection of the subjects — for example, overseeing informed consent or ensuring that privacy protections are adequate. They would used in cases where the study was especially sensitive or complex and could they serve on more than one study at a time at an institution.

The investigator would have to identify and pay the PRSAs using his or her grant money, Visscher says.

"I think the IRB will like it, because this person would serve as the eyes and ears of the IRB," she says. "I think there would be some resistance from the investigators because they're going to have to pay for it."

But Markowitz worries that the requirement could be impractical on the ground.

"In our IRB's experience, and from what I've heard in the field, it's really difficult even to find prisoner representatives to serve on the IRB," Markowitz says. "I don't know how they hope to get those PRSAs in place in all the different locations that they would need to be."

Building a nationwide database of prisoner studies — Many members say they were shocked by the lack of basic information about prisoner research.

"The only informational database that exists, to my knowledge, is the Office for Human Research Protections, and they don't even have a comprehensive list of prisoner research," says Michael Hamden, JD, executive director of North Carolina Prisoner Legal Services and prisoner representative for RTI International's IRB. Hamden served on the IOM committee. "They have a very limited staff for enforcement and it extends to all research, not just prisoner research."

Eliminating the current OHRP certification process, while expanding OHRP's authority — Currently, an IRB reviewing a proposed study that involves prisoners must submit it to OHRP for certification.

Markowitz says the two IRB panels that review prisoner research at her institution have found the OHRP certification process can take a month or more, although the agency rarely disagrees with the IRB's findings.

"That particular component just seems to be something that creates a lot of effort without a lot of extra value or extra protection to the subjects, which is really what we're about," she says.

The IOM committee proposes doing away with the certification step, while expanding the authority of OHRP (or some other designated federal agency) to establish a uniform system of safeguards for all prisoner research, regardless of funding.

OHRP, or this other designated agency, also would have to maintain the national registry, enforce the new regulations and provide assistance to IRBs.

This would require many more resources than the current OHRP has, and likely would need congressional approval, says Lawrence Gostin, JD, chair of the IOM committee and a professor of public health at Johns Hopkins University, Baltimore, MD.

"We think our proposals will require either a new oversight body or an enhanced OHRP, and how the federal government chooses to work through this is a matter for them," Gostin says. He says he's had several meetings with government officials about the committee's recommendations but declines to detail them.

Bill Hall, a spokesman for DHHS, says that at this point, his department is still looking at the report. The next step in the process would be to work with congressional staff to make any changes the department would implement from among the committee's recommendations.

Mary Faith Marshall, PhD, a professor of bioethics at the University of Minnesota in Minneapolis, who had made a presentation to the committee, says she is "delighted" with its final report.

Marshall says she sees the issue of prisoner research as a pendulum, which swung far to the side of protection after the excesses of the 1970s, and now may be swinging back to a position of more inclusion of prisoners.

"We want to be protective, but research does have benefits, and we don't want to exclude a population from benefits," she says. "I think the sense was we don't want to commit the error of precluding research that would be important within that population."

To access the full report by the IOM's Committee on Ethical Considerations for Revisions to DHHS Regulations for Protection of Prisoners Participating as Subjects in Research, visit www.nap.edu/catalog/11692.html. The publication also is available for sale at that site.