Profession

IOM panel wants prisoners to be available for research

■ Proponents say clinical trials could help the prison population, but critics are wary of the idea.

By Kevin B. O’Reilly — Posted Sept. 18, 2006

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Clinical investigators ought to be allowed to solicit prisoners' participation as biomedical research subjects under a strict set of safeguards, an Institute of Medicine panel said in a July report. Critics, pointing to a history of abuse, argue that the proposed changes to federal regulations governing research involving prisoners would not sufficiently protect inmates' rights.

Federal regulations in place since the 1970s have greatly impeded biomedical research involving prisoners. Even studies of how prison conditions might impact inmates' health require approval from the Health and Human Services secretary. Most current research involving prisoners is of a social-scientific nature.

"The problem we heard again and again from institutional review boards and researchers was that very important research ... was delayed or not undertaken," said Lawrence O. Gostin, chair of the IOM panel and health law and ethics editor of the Journal of the American Medical Association. "There were even some people saying that it was tough to get programs to improve literacy in prisons approved."

The report, requested by the Health and Human Services Office for Human Research Protection, will be considered at a November meeting of an HHS advisory committee. To change current regulations, key IOM proposals must go through HHS' months- or even years-long regulatory process, while others must be enacted by Congress.

But prisoner advocates and some bioethicists said prisons aren't equipped to ensure that research is conducted ethically. "The state of prisons would have to improve significantly before I'd have any faith in informed consent, [institutional review board] oversight or even just adherence to protocol," said Arthur L. Caplan, PhD, director of the University of Pennsylvania Center for Bioethics.

The new IOM report argues that prisoners, a disproportionately minority population beset by hepatitis, HIV/AIDS, tuberculosis and mental illness, could benefit from participating in clinical trials under the following conditions:

Proposed interventions already have demonstrated some efficacy and safety, as in phase III of FDA trials.
Prisoners are no more than half of research subjects for any trial.
Federally regulated, independent institutional review boards pay attention to ethical and health issues related to the correctional setting.
An independent prison research subject advocate continually monitors trials with access to investigators, prisoners and prison officials during the trial.
Researchers respect prisoners' privacy, and experiments involve only prisoners who volunteered.

If there is a condition unique to the prison population, the panel said a trial involving prisoners could go forward even if efficacy and safety haven't yet been demonstrated or with mostly inmate research subjects. But OHRP would have to approve the project first. The report also calls for a national, publicly available registry of all research trials involving prisoners and for OHRP's role to shift more toward compliance and enforcement and away from routine review of proposed research projects.

Is prison research ethical?

Some advocates for stricter research regulations said drugmakers' need for a more diverse research-subject population drove the IOM report, "Ethical Considerations for Research Involving Prisoners."

"They're doing this because they can't get volunteers who have the option of saying no," said Vera Hassner Sharav, president of the New York-based Alliance for Human Research Protection. "They're desperate for bodies."

Jonathan D. Moreno, PhD, an IOM panel member and director of the University of Virginia Center for Biomedical Ethics, said the research-subject shortage was not a motivating factor.

"What we are worried about is how to ensure more adequate protections while at the same time addressing the medical problems that prisoners have," Dr. Moreno said. "It's the easiest thing to say that it's too hard to do research in prisons, but it's much harder to say, 'Let's have the best protections we can have while at same time learning about medical conditions prevalent among the prison population that we don't currently know how to handle.' "

Looming over the debate is the specter of decades of unsupervised biomedical research involving prisoners that the 1970s-era regulations were meant to halt. Thousands of prisoners were experimented upon, paid and otherwise rewarded for consenting to participate in research trials.

"That whole chapter in American medical history was pretty horrendous," said Allen M. Hornblum, author of a 1998 book, Acres of Skin, that examined the experiments at Philadelphia's Holmesburg Prison. "I don't want to see us turn the clock back."

Dr. Moreno said the IOM proposals are meant to ensure that such abuses are not repeated. "It's not useful to only talk about the history. We have to start from where we are now."

The AMA has no policy directly addressing clinical research involving prisoners and had no comment on the IOM's recommendations.

ADDITIONAL INFORMATION

Pennsylvania prison research abuses documented in book

Many of those who are leery of opening the door to medical research using prisoners as human subjects point to a sordid history of abuses. In some circles, the Holmesburg Prison experiments are of a piece with the notorious Tuskegee Syphilis Study.

From 1951 until 1974, University of Pennsylvania dermatologist Albert M. Kligman, MD, led a team of researchers that conducted thousands of unsupervised experiments on inmates at Philadelphia's Holmesburg Prison. Most of the experiments were for cosmetics, but trials eventually included giving inoculations of Staphylococcus aureus; administering radiation doses that burned the skin; implanting hair transplants; yanking fingernails; and giving near-lethal doses of the acne treatment retinoin A. While there's no documentary evidence of deaths linked to the research, scores of prisoners came away with permanent injuries. In a press interview, Dr. Kligman has defended the experiments saying they were ethical and beneficial.

A critical history of the medical experiments is captured in Acres of Skin: Human Experiments at Holmesburg Prison, a 1998 book by Allen M. Hornblum, an urban studies instructor at Temple University in Philadelphia who came face to face with the experiments when he worked as an adult literacy instructor at the prison in the early 1970s.

"One time, I walked in and saw scores of men strapped and wrapped in all sorts of adhesive bandages," Hornblum said. "I thought, 'This must be an awfully violent prison for all these prisoners to need such medical attention.' " A Holmesburg prison guard told Hornblum that the men had just received tests of perfume as part of research being conducted for the University of Pennsylvania.

After a while, Hornblum said, the prison guard tired of his inquiries and said, "I'm new here. The experiments aren't." Hornblum is now at work on a sequel, Sentenced to Science, that will focus on one former Holmesburg prisoner's story.