From Contributor to Leader: How a Nurse can Undertake the Role of Principal Investigator (PI) in Clinical Research in the UK

Abstract

Under UK law, an investigator is defined as an “authorised health professional responsible for the conduct of a trial at a site, and if the trial is conducted by a team of authorised health professionals at a trial site, the investigator is the leader responsible for that team” [1]. Whilst the umbrella term “authorised health professional” encompasses registered nurses, midwives and allied health professionals, in addition to medics, research currently tends to be medically led (ie, whereby the Principal Investigator is a doctor). At Chelsea and Westminster Hospital (CHW), a 12 month activity mapping exercise highlighted that only 4% of clinical research studies opened had a PI who was a nurse. However a more in-depth review highlighted that 98% of all clinical research studies opened during that same time period had involvement of nurses as contributors as opposed to leaders. Resultantly a local strategic decision was taken to encourage engagement of, and to enhance opportunities for, nurses to lead on clinical research studies, as appropriate. Collaboration with the existing multi-professional research forum and steering group at CWH facilitated open discussion regarding the key reasons why more nurses (along with midwives and allied health professionals) were not leading on clinical research studies. Three key explanatory factors resulted from this, and a systematic action plan followed to boost the number of nurse PIs. Many individual and organisational benefits were recognised as a result of this programme of work. The experience at CWH confirms that nurses are more than capable of acting as PIs on clinical research studies providing that appropriate support and monitoring are in place. It is therefore the recommendation of this paper that nurses are encouraged and developed to transition from the role of contributor to leader in clinical research.