Abstract 149: The Method Matters: Community Consultation Methods Influence Attitudes and Understanding of Proposed Trial Using Exception from Informed Consent for Research in Emergency Settings
Background- Resuscitation research often requires an exception from informed consent (EFIC). EFIC regulations require community consultation (CC) during development and approval. CC is conducted many ways entailing varying effort and expense, but little is known about the effect of CC methods on participants’ feedback or understanding of study content. We sought to assess whether participants in more interactive CC methods (e.g. meetings and discussions) are more knowledgeable and accepting of EFIC research than those in less interactive methods (e.g. surveys).
Methods- This study was nested within PROTECT IIITM, a Phase III RCT of a treatment for traumatic brain injury (TBI). After development and cognitive pretesting, the survey was administered at CC events to 2612 participants at 12 US centers. Separate multivariate logistic regression models were used to assess domains of acceptance and understanding, adjusting for demographics, TBI experience, and method interactivity.
Results- 56% of participants agreed EFIC was acceptable in the proposed study; 72% were accepting of personal EFIC enrollment. Acceptance was higher among participants in interactive versus non-interactive CC events of EFIC in general (64% vs. 50%) and personal EFIC inclusion (78% vs. 67%). There was no significant difference in overall recall of study details among interactive versus non-interactive CC participants (41% vs. 39%). However, interactive CC participants were more likely to recall possible benefits (64% vs. 47%) and less likely to recall potential risks (58% vs. 72%).
Conclusion- Interactive CC methods were associated with increased acceptance of EFIC. Unexpectedly, interactive methods were associated with greater recall of potential benefits but lower recall of risks, a discrepancy warranting further investigation. This study demonstrates that choice of CC method has implications for the nature of feedback and extent to which participants understand study content.
- © 2012 by American Heart Association, Inc.