Review Committee Suggests Overhaul of Prisoner Research Regulations

WASHINGTON — Nearly 30 years after the U.S. government implemented legislation restricting scientific research performed on prisoners, an independent medical committee published a report stating that prisoners could benefit from clinical trials if government-regulated supervision and rigorous safeguards are established to protect inmates.

Following a request from the U.S. Department of Health and Human Services, the Institute of Medicine review panel investigated current research practices to determine if federal regulations ensure the ethical treatment of prisoners or if revisions are needed.

After finding that a majority of the research involving prisoners takes place outside the scope of federal regulations, frequently without the inspection of an institutional review board, the committee recommended major changes that would provide an updated ethical framework for conducting research with prisoners.

Federal guidelines outlining protections for prisoners consider prisoners to be only those who are incarcerated. The definition needs to be expanded to include those who are on parole, probation or in transition programs, the report states. In 2004, only 30 percent of those under the supervision of the criminal justice system were actually incarcerated, according to national statistics.

Systematic oversight of research involving prisoners needs to be created to ensure that research is being conducted within uniform guidelines and ethical standards, regardless of funding sources, states the report.

The Office for Human Research Protections monitors research funded by three of 17 federal agencies, but not research that is funded by the Bureau of Prisons or other federal, state and private organizations that support research with prisoners.

The report also recommends that all proposals for research programs that enroll prisoners should be reviewed based on the risks and benefits for individual subjects so prisoners are not exposed to unnecessary risks.

Current regulations state that certain categories of research are permissible in prisoner populations, regardless of individual benefit-to-risk ratios.

Clinical trials should be subject to an independent review board and an on-site prisoner advocate, who would ensure that procedures are carried out ethically, states the report.

The committee also suggests a collaborative approach involving prisoners, prison administrators and health care officials when designing and conducting a new study. This approach would allow for open communication and interaction among research participants, guarantee immediate access to health services for test subjects, and it would also take specific circumstances of the correctional facility into consideration.

While the history of prisoner research is colored by instances of abuse by scientific investigators, committee members are optimistic that research involving prisoners can help reduce substance abuse and recidivism and address the physical and mental illnesses facing inmates.