Page 183 - DECISION-MAKING IN SEVERE TRAUMATIC BRAIN INJURY PATIENT OUTCOME, HOSPITAL COSTS, AND RESEARCH PRACTICE

Informed consent in patients with an inability to provide consent
than national juridical policies. Fourth, it is important to bear in mind that CENTER- TBI is an observational study, although IRBs in three countries considered it to be an interventional study as blood samples were requested. Results on consent policy and practice might be different for interventional studies or randomized controlled trial. This is because the consequences of participation might be bigger and effective retrospective refusal of study participation is not possible as study interventions have already taken place. Although our data are derived from a patient population with TBI, the identified problems and insights have relevance for other conditions that could cause an inability to provide informed consent.
CONCLUSIONS
Alternatives to patient informed consent are essential for studies including TBI patients with an acute inability to provide informed consent. The substantial variation in reported and used informed consent procedures in Europe could be caused by several reasons and could indicate that clear national or European legislation is unavailable or that knowledge of such legislation may be inconsistent amongst clinicians and researchers. Future research initiatives could benefit from clear and harmonized regulations for this subcategory of patients.
HIGHLIGHTS
1. Variation is reported in consent procedures between and within European countries.
2. Discordance between reported consent policy and observed practice was common.
3. Deferred consent was accepted in many countries, but not frequently used.
4. Harmonisation of consent procedures is needed to improve research
efficiency.
5. Researchers should verify and document a patients ability to provide
informed consent.
Supplementary files
Available online: https://doi.org/10.1016/j.jcrc.2020.05.004
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