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Include prisoners in clinical trials, say European scientists

By Fiona Barry , 09-Jul-2014

Scientists and ethicists have called for changes to European guidance which excludes prisoners from clinical trials.

New research published in the Journal of Medical Ethics (doi:10.1136/medethics-2012-101059 ) found British prisoners have “extremely limited” ability to take part in studies, a problem because their legal right to receive healthcare equivalent to the rest of the population “arguably implies a right to equal access to research participation.”

Only 0.049% of proposed clinical trials in England and Wales involve prisoners, in part thanks to a backlash against historical exploitation, one of the paper’s authors told Outsourcing-Pharma.com.

Historical exploitation

The history of research on prisoners is “ignoble,” said Hugh Davies, Research Ethics Advisor at the UK Health Research Authority. “In the past, prisons were a ready population for experimentation. There are examples in the 18th century of prisoners given the choice between being exposed to smallpox or hanged.” Around 85% of Phase I studies in the US were conducted on prisoners in the mid-1970s.

Regulators have since responded with a shift to a “protectionist” attitude, viewing prisoners as “vulnerable research participants with limited capacity for informed consent,” since the prison environment is considered “inherently coercive” and a place where confidentiality conditions may not be upheld. But this approach may be out of step with the modern view that prisoners should receive equitable healthcare, said Davies.

While their participation in clinical trials is unlikely to directly improve the quality of their treatment (“the evidence on clinical trials is that you’re probably no worse or better off by joining”), the question of whether prisoners have a right to contribute to science should be considered, he said. “Do you include deprivation of contribution towards research [when you take away prisoners’ freedom]? It’s a social activity.

There needs to be a recognition of past historical malfeasance and they should not be used as [just] a convenient population, but there needs to be an ongoing debate. When you look at conditions that affect them particularly such as mental health, there shouldn’t be even greater regulation – it should be a level playing field.”

Obstacles: moral and practical

The authors surveyed medical researchers and found four obstacles which discouraged them from conducting research among prisoners: restrictive guidelines from regulators, ethical concerns about exploitation, the logistical problems of research in prisons, and the generalizability of data from a prison population.

The biggest of these problems is not moral but practical, said Davies calling research in prisons “a logistical nightmare” that expends too much energy. “Ultimately commercial organisations are not necessarily going to bother” and academic bodies with an interest in prison health “are few and far between,” he said.

The UK’s National Research Ethics Service, which is responsible for approving trials involving National Health Service patients, takes a restrictive line, saying research among prisoners “should relate directly to their healthcare and be of such a nature that it could only be conducted in this population.

The rule “effectively prohibits the involvement of prisoners in research not exclusively relevant to prison populations,” said the scientists.

European-level regulation is slightly more lenient, stating prisoners may be involved in research which benefits them as individuals, as a matter of equality with non-incarcerated patients. So-called “non-beneficial” research is allowed if it is only possible using prisoners, offers them group benefit and poses no more than minimal risk.

The paper’s authors looked at the 14,355 applications for studies in England and Wales to the NRES between April 2010 and March 2012 and found only 100 (0.7%) planned to involve prisoners.

Only seven of these were classed as clinical trials – that is, 0.049% of all research applications during the two-year period. Most prisoner research involved questionnaire studies or tissue samples.

The clinical interventions comprised three studies testing diagnostic procedures, three trialling mental health treatment, and one involving an acute intervention for trauma patients. These reflect the primary health needs of prisoners, who experience disproportionately high rates of mental illness and communicable disease, said the paper’s authors.

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