In 2006, the Institute of Medicine (IOM), the health arm of the US National Academy of Sciences, released a special report on the ethics of conducting research on prison inmates. The report deemed existing guidelines convoluted and suggested updates to improve prisoners' ability to participate in trials. In a special supplement published last month by the journal Bioethics, experts renewed the call for such changes while also suggesting that the US should take inspiration from European regulations in this area.

“I look at access to research as a human right,” says Anne Spaulding, of Emory University in Atlanta, who studies infectious diseases that are common in prisons, such as HIV. In their article in the Bioethics supplement, Spaulding and Bernice Elger, of the University of Geneva Medical School, call on the US government to restructure the guidelines concerning research in prisons.

Currently, the US Office of Human Research Protection (OHRP) considers prisoners a special population and, as such, only allows studies that stand to benefit prisoners specifically. For example, a researcher wanting to study diabetes in prisons would not be able to get clearance from the OHRP unless they could show a direct tie between diabetes and prisoners.

Spaulding and Elger agree with this stance, but they suggest that US regulatory bodies take a page from the EU guidelines for prisoner research, which are generally more risk based. Both the current US guidelines and the IOM's 2006 report put more emphasis on relevance rather than on the risk that potential studies pose to prisoners.

Spaulding says regulators would be doing a disservice to prisoners if they made the research guidelines too restrictive, though. Unfortunately, prisoners are notoriously underserved by the research community, she says, in large part because the regulatory hurdles can be daunting. For example, prisons represent one of the largest populations affected by substance abuse and diseases related to substance abuse, such as HIV and hepatitis, yet prison inmates are rarely included in research on these conditions. Of course, prisoners can benefit from studies conducted on the general public, but Spaulding says they would benefit most from research that considers their specific circumstances.

However, experts note that the prisoner research restrictions are there for good reason: biomedical studies have taken advantage of captive prison populations in the past. “The current guidelines can be a little limiting, but research involving prisoners needs to be carefully monitored, and it's important for the guidelines to be stringent,” says Kent Kiehl, a psychologist at the University of New Mexico who conducts research in prisons.

Although there was talk of loosening US prisoner research guidelines a few years ago (Nat. Med. 12, 3; 2006), the OHRP has yet to make any major changes to the regulations. In the meantime, bioethicists continue to discuss how the current system might be improved. “It's important for human rights issues in correctional institutions to be brought to the forefront,” says Elger.