Consulting Communities When Patients Cannot Consent

Abstract

Objective To assess the range of responses to community consultation efforts conducted within a large network and the impact of different consultation methods on acceptance of exception from informed consent (EFIC) research and understanding of the proposed study. Design A cognitively pre-tested survey instrument was administered to 2,612 community consultation participants at 12 US centers participating in a multi-center trial of treatment for acute traumatic brain injury (TBI). Setting Survey nested within community consultation for a Phase III, randomized controlled trial of treatment for acute TBI conducted within a multi-center trial network and using EFIC. Subjects Adult participants in community consultation events. Interventions Community consultation efforts at participating sites. Measurements and Main Results Acceptance of EFIC in general, attitude toward personal EFIC enrollment, and understanding of the study content were assessed. 54% of participants agreed EFIC was acceptable in the proposed study; 71% were accepting of personal EFIC enrollment. Participants in interactive versus non-interactive community consultation events were more accepting of EFIC in general (63% vs. 49%) and personal EFIC inclusion (77% vs. 67%). Interactive community consultation participants had high-level recall of study content significantly more often than non-interactive consultation participants (77% vs. 67%). Participants of interactive consultation were more likely to recall possible study benefits (61% vs. 45%) but less likely to recall potential risks (56% vs. 69%). Conclusions Interactive community consultation methods were associated with increased acceptance of EFIC and greater overall recall of study information but lower recall of risks. There was also significant variability in EFIC acceptance among different interactive consultation events. These findings have important implications for IRBs and investigators conducting EFIC research and for community engagement efforts in research more generally.

Evaluating community engagement in global health research: the need for metrics

“…A study that used surveys to assess the acceptability of exception from informed consent for research in emergency settings found that interactive community consultations resulted in significantly higher acceptability and higher level recall of study content than non-interactive consultations [43]. Approaches to evaluating community engagement activities were briefly described in the H3Africa guidelines including use of theory-based methodology, monitoring participation at events and meetings, documentation to track discussions, and use of interviews, focus groups and surveys [39].…”

Patients’ Perspectives of Enrollment in Research Without Consent

“…Findings of lower EFIC acceptance among black respondents are important and have been suggested elsewhere, though these differences were not observed in the larger ProTECT community consultation study (6, 19). Whether the high rate of acceptance among Hispanic subjects would persist in larger samples is unknown.…”

“…EFIC acceptance exceeded acceptance observed in a large study of community consultation participants across 12 ProTECT III sites. In that study, 71% and 54% were accepting of personal and general EFIC enrollment respectively, compared to 78% and 72% here (19). Similar patterns were found in RAMPART-related studies conducted within the same network (6, 13, 23).…”

“…Additionally, the gender-based differences observed in this study highlight the need to assess whether these differences are really driven by the experience of being a patient versus a surrogate. These differences were not observed, for example, in the ProTECT community consultation study (19). …”

“…Demographic and total enrollment data from the ProTECT III trial are included to allow an assessment of representativeness. Previously published demographic data and attitudes toward EFIC among community consultation participants for ProTECT III are included where relevant (19). …”