Inmate Participation in Clinical Trials Recommended
An Institute of Medicine advisory panel report released on Aug. 1 recommends that the government ease restrictions that limit prison inmate participation in clinical trials, the New York Times reports.
According to federal officials, until the early 1970s, roughly 90% of all pharmaceutical products were tested on prison inmates. However, the practice was reduced significantly in 1974 after cases of abuse were reported.
Regulations passed in 1978 state that prisoners can participate in federally funded biomedical research only if the trials pose no more than "minimal" risks to the subjects, according to the Times. The IOM report, which was initiated at the request of HHS in 2004, advises that experiments with greater risks be permitted if they have the potential to benefit prisoners. It also suggests that prisoners should be allowed to participate in federally funded clinical trials as long as the trials are in the later and less dangerous phase of the FDA approval process.
IOM states that all studies should be subject to an independent review and that at least half the participants be nonprisoners, "making it more difficult to test products that might scare off volunteers," according to the Times. In addition, the report calls for "adequate protections" to avoid "attempts to coerce or manipulate participation" with regard to inmate compensation.
Ernest Prentice, chair of the HHS committee that requested the study and a University of Nebraska genetics professor, said the regulation revision process will begin on Nov. 2 at the committee's next meeting.
The discussion comes at a time when the biomedical industry is facing a shortage of human subjects, the Times reports. Meanwhile, the prison population has more than quadrupled to about 2.3 million over the last 30 years, and many inmates are infected with HIV and hepatitis C -- diseases for which better treatments could be developed if new research were permitted in prisons, some researchers say.
Prentice said, "The current regulations are entirely outdated and restrictive, and prisoners are being arbitrarily excluded from research that can help them."
Alvin Bronstein, a Washington lawyer who helped found the American Civil Liberties Union's National Prison Project, said, "With the help of external review boards that would include a prisoner advocate, I do believe that the potential benefits of biomedical research outweigh the potential risks."
However, Daniel Murphy, a professor of criminal justice at Appalachian State University, said, "Free and informed consent becomes pretty questionable when prisoners don't hold the keys to their own cells, and in many cases they can't read, yet they are signing a document that it practically takes a law degree to understand" (Urbina, New York Times, 8/13).
The IOM report is available online. Note: You must have Adobe Acrobat Reader to view the report.