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, AMNews staff. Sept. 18, 2006.

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.