To explore the experience of research nurses who obtain consent from adults in emergency settings to participate in clinical trials, either prospectively or post enrolment

Abstract

Aim: To explore the understanding and experiences of research nurses who obtain informed consent from adult patients participating in emergency care research.Design: Qualitative phenomenographic descriptive study.Methods: Ten research nurses from six hospitals in England were recruited. Data were collected using semi-structured face-to-face and telephone interviews between January 2019 and March 2019. Interviews were transcribed verbatim and analysed thematically, informed by phenomenography. COREQ was followed.Results: Three main themes were identified: (a) emergency research is different, (b) protecting the patient, and (c) experience and confidence with recruitment. It was found that obtaining patient consent in emergency care research was challenging and timing of the process was crucial. Nurses with more experience of emergency care were more confident in approaching patients and their families. There was variability in out-of-hours recruitment which was a consequence of the range of informed consent processes used and the different levels of engagement of clinical teams. Conclusion:There is a variety of organisational cultures, processes and procedures which affect the way consent is obtained in emergency care research. A team approach was evident in the hospitals where consent rates were high and was more successful than those reliant solely on the presence of a research nurse. Organisations were able to recruit successfully to emergency care research studies irrespective of size and configuration. Further investigation of their models of working and strategies for engagement is needed. Experienced research nurses made a positive difference to recruitment and were more likely to approach patients to obtain consent. Relevance to clinical practice:The understanding and experiences of recruitment to clinical trials in emergency care research by research nurses can help identify barriers to recruitment. This study provides useful insights for healthcare practitioners, clinical trials coordinators and sponsors about how best to develop protocols and policies to increase recruitment to emergency care research.

Trials using deferred consent in the emergency setting: a systematic review and narrative synthesis of stakeholders’ attitudes

“…Five studies reported the views of HCPs and researchers, finding largely positive views towards deferred consent which were consistent across the reported countries [ 24 , 27 , 31 , 40 , 42 ]. The level of research experience may influence HCPs’ and researchers’ views.…”

“…The level of research experience may influence HCPs’ and researchers’ views. Interviews with UK research nurses found those with less experience viewed deferred consent as problematic and felt uncomfortable with the process, tending to avoid enrolling patients into trials when prospective written consent was not possible [ 27 ]. However, experienced nurses recognised the importance of deferred consent and felt more comfortable dealing with the challenges associated with the process [ 27 ].…”

“…Respondents also acknowledged the importance of benefits for future patients. Altruistic motives for supporting deferred consent were commonly expressed as a precondition for emergency research by patients even when direct benefit to those individuals was unlikely [ 26 , 27 , 35 , 44 ]. The need to conduct research in order to advance scientific knowledge was highlighted by several patients who were willing to take part in emergency trials as a result [ 28 , 39 , 44 ].…”

“…HCPs highlighted the inherent delays that research processes can have on participants receiving the intervention and the impact of the consent model on enrolment. In difficult cases with limited time to approach, assess, consent, and randomise patients prior to treatment provision, research nurses tended to avoid enrolment [ 27 ].…”

“…This review found that HCPs with greater research experience were more willing to enrol patients using deferred consent and held more positive views towards the process [ 27 , 31 ]. It is notable that paediatric practitioners with no experience have also reported negative views on deferred consent whereas experienced practitioners described how it had improved recruitment rates and the decision-making capacity of patients consenting for their children in research [ 63 ].…”