Assessment of consent models as an ethical consideration in the conduct of prehospital ambulance randomised controlled clinical trials: a systematic review

Armstrong, Stephanie; Langlois, Adele; Laparidou, Despina; Dixon, Mark; Appleton, Jason P.; Bath, Philip M.W.; Snooks, Helen Anne; Siriwardena, A. Niroshan

Abstract

Background

We sought to understand the main ethical considerations when conducting clinical trials in the prehospital ambulance based setting.

Methods

A systematic review of the literature on randomised controlled trials in ambulance settings was undertaken. A search of eight databases identified published studies involving recruitment of ambulance service users. Four independent authors undertook abstract and full-text reviews to determine eligibility and extract relevant data. The data extraction concentrated on ethical considerations, with any discussion of ethics being included for further analysis. The resultant data were combined to form a narrative synthesis.

Results

In all, 56 papers were identified as meeting the inclusion criteria. Issues relating to consent were the most significant theme identified. Type of consent differed depending on the condition or intervention being studied. The country in which the research took place did not appear to influence the type of consent, apart from the USA where exception from consent appeared to be most commonly used. A wide range of terms were used to describe consent.

Conclusions

Consent was the main ethical consideration in published ambulance based research. A range of consent models were used ranging from informed consent to exception from consent (waiver of consent). Many studies cited international guidelines as informing their choice of consent model but diverse and sometimes confused terms were used to describe these models. This suggests that standardisation of consent models and the terminology used to describe them is warranted.

Citation

Armstrong, S., Langlois, A., Laparidou, D., Dixon, M., Appleton, J. P., Bath, P. M., Snooks, H. A., & Siriwardena, A. N. (2017). Assessment of consent models as an ethical consideration in the conduct of prehospital ambulance randomised controlled clinical trials: a systematic review. BMC Medical Research Methodology, 17(1), Article 142. https://doi.org/10.1186/s12874-017-0423-4

• Journal Article Type: Article
• Acceptance Date: Sep 7, 2017
• Publication Date: Sep 16, 2017
• Deposit Date: Sep 22, 2017
• Publicly Available Date: Sep 22, 2017
• Journal: BMC Medical Research Methodology
• Electronic ISSN: 1471-2288
• Publisher: Springer Verlag
• Peer Reviewed: Peer Reviewed
• Volume: 17
• Issue: 1
• Article Number: 142
• DOI: https://doi.org/10.1186/s12874-017-0423-4
• Keywords: Ethics, Consent, Ambulance, Prehospital, Clinical trials
• Public URL: https://nottingham-repository.worktribe.com/output/883101
• Publisher URL: https://doi.org/10.1186/s12874-017-0423-4
• Contract Date: Sep 22, 2017