Assessment of consent models as an ethical consideration in the conduct of prehospital ambulance randomised controlled clinical trials: a systematic review
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 iden...
| Main Authors: | , , , , , , , |
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| Format: | Article |
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BioMed Central
2017
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| Online Access: | https://eprints.nottingham.ac.uk/46625/ |
| _version_ | 1848797371221147648 |
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| author | Armstrong, Stephanie Langlois, Adele Laparidou, Despina Dixon, Mark Appleton, Jason P. Bath, Philip M.W. Snooks, Helen Anne Siriwardena, A. Niroshan |
| author_facet | Armstrong, Stephanie Langlois, Adele Laparidou, Despina Dixon, Mark Appleton, Jason P. Bath, Philip M.W. Snooks, Helen Anne Siriwardena, A. Niroshan |
| author_sort | Armstrong, Stephanie |
| building | Nottingham Research Data Repository |
| collection | Online Access |
| description | 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. |
| first_indexed | 2025-11-14T20:02:49Z |
| format | Article |
| id | nottingham-46625 |
| institution | University of Nottingham Malaysia Campus |
| institution_category | Local University |
| last_indexed | 2025-11-14T20:02:49Z |
| publishDate | 2017 |
| publisher | BioMed Central |
| recordtype | eprints |
| repository_type | Digital Repository |
| spelling | nottingham-466252020-05-04T19:07:11Z https://eprints.nottingham.ac.uk/46625/ 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 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. BioMed Central 2017-09-16 Article PeerReviewed Armstrong, Stephanie, Langlois, Adele, Laparidou, Despina, Dixon, Mark, Appleton, Jason P., Bath, Philip M.W., Snooks, Helen Anne and Siriwardena, A. Niroshan (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). 142/1-142/10. ISSN 1471-2288 Ethics Consent Ambulance Prehospital Clinical trials https://doi.org/10.1186/s12874-017-0423-4 doi:10.1186/s12874-017-0423-4 doi:10.1186/s12874-017-0423-4 |
| spellingShingle | Ethics Consent Ambulance Prehospital Clinical trials Armstrong, Stephanie Langlois, Adele Laparidou, Despina Dixon, Mark Appleton, Jason P. Bath, Philip M.W. Snooks, Helen Anne Siriwardena, A. Niroshan Assessment of consent models as an ethical consideration in the conduct of prehospital ambulance randomised controlled clinical trials: a systematic review |
| title | Assessment of consent models as an ethical consideration in the conduct of prehospital ambulance randomised controlled clinical trials: a systematic review |
| title_full | Assessment of consent models as an ethical consideration in the conduct of prehospital ambulance randomised controlled clinical trials: a systematic review |
| title_fullStr | Assessment of consent models as an ethical consideration in the conduct of prehospital ambulance randomised controlled clinical trials: a systematic review |
| title_full_unstemmed | Assessment of consent models as an ethical consideration in the conduct of prehospital ambulance randomised controlled clinical trials: a systematic review |
| title_short | Assessment of consent models as an ethical consideration in the conduct of prehospital ambulance randomised controlled clinical trials: a systematic review |
| title_sort | assessment of consent models as an ethical consideration in the conduct of prehospital ambulance randomised controlled clinical trials: a systematic review |
| topic | Ethics Consent Ambulance Prehospital Clinical trials |
| url | https://eprints.nottingham.ac.uk/46625/ https://eprints.nottingham.ac.uk/46625/ https://eprints.nottingham.ac.uk/46625/ |