Page 201 - DECISION-MAKING IN SEVERE TRAUMATIC BRAIN INJURY PATIENT OUTCOME, HOSPITAL COSTS, AND RESEARCH PRACTICE
P. 201

Informed consent procedures for emergency interventional TBI & stroke research
The use of deferred consent or exception from informed consent or waiver of informed consent procedures seems necessary and acceptable in traumatic brain injury and ischaemic stroke emergency interventional research. The seriousness of the potential threats to the welfare and protection of study participants, the scientific integrity of a trial, and public trust in research should however never be underestimated. 70,71 Independent institutional review boards or steering committees are charged with the protection of patients, researchers, and the public as a whole, balancing and judging their interests. Several safeguards are used in the process: a rigorous evaluation of study protocols, oversight in study procedures such as patient screening, recruitment, consent procedure, and independent safety monitoring. 7 Other safeguards could consist of including and consulting more representatives of patients on institutional review boards to weigh in on the ethics of different trial approaches in patients where patient or proxy informed consent before intervention is not possible.
Panel 4. A list of prerequisites for the use of deferred consent and exception from consent procedures.
9
 General prerequisites for the use of deferred consent and exception from consent procedures
1 The patient has an acute life-threatening situation or an acute medical
condition that necessitates urgent (study) procedures because delayed treatment can negatively affect intervention effectiveness or patient outcome. Due to the urgency of the situation, the patient or proxies are unable to provide valid informed consent before intervention.
2 The medical condition causes an inability to provide informed consent before intervention by patient or proxy.
3 There is scientific information that supports the potential for the study treatment to provide a direct benefit to the patient. Available standard treatments are unproven (the scarcity of high-quality evidence that the treatment is effective) or unsatisfactory (the treatment is unsatisfactory due to safety or efficacy issues that require investigation).
4 The risks and burden of study participation are considered acceptable compared with standard treatment, given the potential direct benefit of the study treatment.
5 Researchers or physicians are unaware of any objections for study participation (eg, a written advanced directive).
 199























































































   199   200   201   202   203