References
Development of research governance awareness to support pre-hospital studies
Abstract
Background:
Development of new evidence to support pre-hospital emergency care benefits both patients and practitioners. Clinical research must be conducted within a formal governance framework but it is challenging for paramedics to access traditional good clinical practice (GCP) training due to high service demands and some content is of little relevance to the pre-hospital setting.
Objective:
To establish the content and format of easily accessible research governance awareness training for use by paramedics and other members of the ambulance service as and when appropriate.
Methods:
A systematic literature review identified descriptions of pre-hospital research training. An online survey sought views about the formal research training undertaken by NHS paramedics and an expert consensus process confirmed the content of training materials.
Results:
Research governance training was rarely acknowledged in pre-hospital clinical trial literature and was recalled by only one in eight respondents who had assisted with clinical research. A pre-hospital orientated slide set and matching assessment questions were reviewed in two cycles by an expert panel to achieve a consensus on the content and format.
Conclusions:
Through a structured process of literature review, stakeholder engagement and expert consensus we have developed training and assessment materials which can be used flexibly to prepare paramedics and the wider ambulance workforce for safe hosting of low-risk research activities.
The future direction of emergency care will extend ambulance service responsibilities and increase the need for evidence-based paramedic-initiated interventions (NHS England, 2015). Although services welcome opportunities to improve patient care, paramedic involvement in the development of new treatments and processes is hindered by a number of factors including traditional professional boundaries and a lack of standardised training that reflects pre-hospital clinical and research responsibilities (Wood, 2012; Ankolekar et al, 2014).
For instance, it is expected that clinicians supporting research will regularly complete good clinical practice (GCP) training to reinforce and update principles of research governance, but as the content originates from hospital-based pharmaceutical trials, it does not routinely include study designs used in the pre-hospital setting or specifically focus upon the narrower role played by ambulance service personnel. Many influential pre-hospital trials do not involve traditional consent processes, or randomisation to a new medication. The research responsibilities of ambulance personnel are further constrained by time-limited contact with patients, and in the context of clear guidance from modern study protocols, they are unlikely to need the same in-depth knowledge of research governance frameworks as a hospital-based investigator.
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