Prisoners Unfairly Excluded From General Clinical Research


Company News Release

May be time to review current restrictive guidance in UK and elsewhere

Prisoners are being unfairly excluded from taking part in potentially beneficial clinical research, on the grounds that it would be too difficult and expensive to do so, indicates a study published online in the Journal of Medical Ethics.

And current guidance governing research in prisons is too ‘protectionist’ and restrictive, denying prisoners the chance to access the same research opportunities as the rest of the population, conclude the authors, adding that it may be time to review this.

They reviewed UK applications to carry out research involving prisoners to the National Research Ethics Service (NRES) between 2010 and 2012.

The NRES takes the view that prisoners are a vulnerable group who have been exploited in the past, and that they should only be involved in research that directly relates to their healthcare and that can only be carried out in prisoners.

The authors also canvassed the views of 69 UK health researchers and 192 members of the NRES research ethics committees on the subject of prisoners taking part in clinical studies.

Between 2010 and 2012 14,355 applications were made to NRES, of which just 100 (0.7%) planned to involve prisoners/prison service. Almost two thirds (61%) of these studies involved mental health or infection: common health problems among prisoners.

But only seven studies involved potentially beneficial treatments for conditions that were not specific to prisoners. Of these, only one offered prisoners the chance to take part in a clinical trial on the same basis as the rest of the population.

The questionnaire responses showed that few of the researchers or ethics committee members knew the NRES guidance or were aware that it discouraged prisoners from taking part in any general clinical research.

The strongest factors prompting researchers to exclude prisoners were the perceived difficulties/costs of recruiting and involving them, with over half (59%) citing this.

Yet most researchers (61%) and committee members (57%) agreed that prisoners should be treated the same as everyone else and given the chance to take part in ‘non-prison specific research.’ Only 15% and 28%, respectively disagreed.

The researchers acknowledge that prisoners have been exploited in the past as a captive population on which to experiment, but they suggest that there are good reasons why they should be included in general clinical research, with the appropriate safeguards in place.

These include a shift in attitude towards research from one of paternalism to one emphasising equality and access and the potential health benefits prisoners stand to gain from being involved in trials offering cutting edge treatments that would otherwise not be available.

But the strongest argument may simply be that prisoners should have access to the same healthcare and research opportunities as the population of the country in which they are detained, and have the same opportunities to decide whether they want to take part in research, say the authors.

The perceived obstacles cited by researchers are not grounds for exclusion; rather consideration should be given to how to overcome them, they add.

And they conclude: “Current UK guidance appears protectionist, and our study has shown that prisoners are rarely offered access to participation in research. While the practice of routinely exploiting prisoners must never be repeated, the current approach protects to the point of inequitable exclusion.”

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