Deferred consent in emergency trauma research: A qualitative study assessing the healthcare professional's opinions.

INTRODUCTION

Severely injured patients are often incapacitated to provide informed consent for clinical studies. Deferred consent could facilitate unbiased enrollment in studies involving these patients. Little is known about how healthcare professionals (HCPs) perceive deferred consent and how this impacts patient enrollment. The aim of this study was to identify factors that could influence HCPs decision-making during recruitment of patients for interventional studies in (pre)hospital emergency trauma research.

METHODS

This was a qualitative study in which physicians and nurses working in prehospital or in-hospital care were interviewed using a semi-structured interview guide. Interviews were audio-recorded, transcribed, and analyzed according to thematic analysis as described by Braun and Clarke.

RESULTS

Ten semi-structured interviews were conducted with six physicians and four nurses. Eight themes were identified as being relevant consent related factors influencing HCPs' decision-making during patient recruitment in studies using deferred consent: (1) HCPs' lack of knowledge; (2) Patients' and proxies' inability to be informed; (3) Practical (im)possibilities for informed consent; (4) Nature of intervention; (5) HCPs' personal beliefs; (6) Importance of emergency care research; (7) HCPs' trust in legal base; and (8) Communication and collaboration.

CONCLUSIONS

Eight consent-related factors influencing HCPs' decision making were identified. Insufficient knowledge about consent procedures among HCPs leads to significant negative attitudes towards deferred consent.