Recollection of Informed Consent and Study Participation in Acute Spinal Cord Injury Clinical Studies: A 12-Year...

Scientific advancements in spinal cord injury (SCI) have focused on early interventions. However, research in the acute SCI setting presents ethical challenges, particularly the durability of informed consent. Given trauma's effects on cognition, we assessed participants' recollection of the consent process and willingness to participate in future research. A 15-item questionnaire was administered to 119 participants previously enrolled in one of three acute SCI studies at our institution between 2010 and 2022. Of 32 responses, 47% recalled the consent process, 30% were unsure, and 23% had no recollection. Recall of specific details was also inconsistent. Of 11 participants who recalled receiving a study treatment, only 4 (36%) were in an interventional arm. While injury severity and level did not affect recollection, time since injury and age at the time of the survey were associated with recall differences. Notably, all 18 subjects who recalled their enrollment also recalled follow-up visits from study personnel, suggesting ongoing contact may reinforce awareness of their involvement. In the acute SCI setting, physical and psychological distress challenge the informed consent process. Our survey revealed significant inaccuracies in participant recall, undermining the intent of informed consent. We propose that practices like continuous consent, coupled with regular study-related interactions, may improve participants' understanding and retention of information, thereby strengthening the ethical foundation of acute SCI research.