Balancing risks and benefits
When designing and undertaking research projects, both doctors in charge of the study and the independent ethical review body must undertake as accurate an assessment of potential risks and benefits involved as possible. This should involve both the frequency and magnitude of any risk - both the likelihood of any harm occurring, and the severity of the harm - and the likely distribution of that risk. Will it be participants who will bear harms and enjoy benefits, for example, or will it be other and future inmates? Research projects involving prisoners should be designed, as far as possible, to deliver benefits to the individual participants, as well as to the wider prison population.
Having said this, participants should be informed, to the extent their capacity allows, that, by definition the risks and benefits involved in research cannot be accurately known in advance and that risk is a necessary feature of all procedures. Furthermore, there is a considerable psychological element involved in the perception and assessment of risk. A risky therapeutic intervention may seem much more acceptable to someone who is seriously ill than to a healthy participant, and these factors must be taken into account by researchers. As discussed above, the prison environment can impose unusual psychological pressures on inmates, and the possible effects of incarceration on the perception of risk should be carefully considered.