Consent to involvement in research
With the possible exception of some vulnerable subgroups, research, both in prisons and in the wider community, can only be carried out with the valid consent of the participant. The fact that an individual is incarcerated for punitive purposes, while it may remove some of his or her rights, in no way affects the right to freely consent or refuse to participate in research projects.
In any research involving human beings, every potential participant must be adequately informed of the aims, methods, anticipated benefits and potential hazards of the proposed study and any discomfort it may entail. Participants should also be explicitly informed that they are at liberty to withdraw their consent to participation at any time. The physician should then obtain the participant’s freely given informed consent, preferably in writing.
Researchers and participants should recognise that consent is a process rather than a one-off event. Participants should be kept informed of the progress of the study, and should be updated if any significant information arises, particularly if it might affect their willingness to continue in the research. If payments or incentives are being offered, these should be pro-rated and not dependent upon the participant’s completion of the trial. Where participants request information, researchers must give truthful and relevant answers.
Both researchers and participants need to be aware that research involves uncertainty, and that it is not always possible to accurately predict the kinds of risk participants may be exposed to. It should be pointed out that the future benefits and harms of the trial are unknown, which is why it is being undertaken. When discussing risks and benefits researchers should discuss both the probability of an adverse event, and its likely magnitude, in a manner that participants can understand. The manner and context in which information is conveyed is as important as the information itself.