Funding for this research was provided by:
Health Technology Assessment Programme (14/190/01)
the Joint Global Health Trials, Medical Research Council, Department for International Development, Global Challenges Research Fund, and the Wellcome Trust (MRM0092111)
J P Moulton Charitable Foundation (n/a)
Received: 2 June 2020
Accepted: 12 August 2020
First Online: 11 November 2020
Ethics approval and consent to participate
: Most patients with TBI are unable to provide informed consent to participate in a clinical trial due to the nature of their injury. As per the Declaration of Helsinki, patients who are incapable of giving consent are an exception to the general rule of informed consent in clinical trials. In the CRASH-3 trial, consent was sought from the patient’s relative or a legal representative unless no such representative was available, in which case the study proceeded with the agreement of two clinicians. If the patient regained capacity, they were told about the trial and written consent was sought to continue participation. If either the patient or their representative declined consent, participation was stopped. If patients were included in the trial but did not regain capacity, consent was sought from a relative or legal representative. We adhered to the requirements of the local and national ethics committees.
: Not applicable.
: The authors declare that they have no competing interests.