Involving adults who lack capacity in research: ethical and legal challenges for the pre-hospital and emergency medicine context.

There is an increasing number of research projects conducted that requires the recruitment of participants in the pre-hospital or emergency setting. Acomplicating factor in pre-hospital and emergency research (PHER) is that potential participants may lack or lose the capacity to give a valid consent. The lack or loss of capacity is ethically and legally complex for researchers and Research Ethics Committees (REC) whose approval must be gained prior to commencing a study. This paper explores those challenges by drawing upon a number of case studies of pre-hospital research in which adult participants are likely to lack the capacity to consent. The paper begins by outlining the development of the legal provisions for conducting research with participants unable to consent for themselves within the jurisdictions of England and Wales. The paper goes on to explore how researchers can meet the legal requirement for research, how to frame the issues for the purposes of ethical review, as well as offering ethical guidance for practices within the research field