Page 176 - DECISION-MAKING IN SEVERE TRAUMATIC BRAIN INJURY PATIENT OUTCOME, HOSPITAL COSTS, AND RESEARCH PRACTICE

Chapter 8
between regions we grouped countries into six regions based on the United Nations geo-scheme (See Suppl Table 1).27 Due to the agreed anonymity of participating sites, it was not always possible to display all differences between countries, as some countries have only 1 or 2 participating sites. Potential differences between centres in one country were analyzed in countries with three or more participating centres. Analyses were performed using R version 3.6.0.
RESULTS
All 57 participating centres completed the provider profiling questionnaire. The majority was completed by principal investigators and medical professionals (N=20), IRB members (N=15), and staff members (N=13). (See Suppl Table 2) Most centers were academic hospitals (91%) with a designation as Level I trauma centre (68%). Thirty (53%) centres had a department of medical ethics and 28 (49%) had extensive neurotrauma research experience, with five or more research applications over the previous five years. (See Suppl Table 3)
Policy
Alternatives for patient informed consent were widely accepted. (Table 1 & Fig 1). Most IRBs allowed the use of proxy informed consent (79%) for acutely mentally incapacitated patients, while consent by an independent physician was less frequently allowed (37%). The majority of centers considered deferred consent (82%) for emergency research to be a valid alternative.
Table 1. Number of study centres (%) that allow the use of an informed consent procedure in acutely mentally incapacitated patients.
Informed consent procedure
Proxy informed consent
Consent by an independent physician Deferred consent
Yes N (%)
45 (79) 21 (37) 47 (83)
No N (%)
11 (19) 30 (53) 7 (12)
Unknown N (%)
1 (2) 6 (10) 3 (5)
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