Abstract 291: A Targeted Approach to Community Consultation for an Exception from Informed Consent Study: More Support than Willingness to Participate

Abstract

Objectives: Community consultation (CC) is a key part of research conducted under the FDA Exception from Informed Consent (EFIC) framework. The best practices to achieve CC remain uncertain. We report results from a targeted approach that surveyed at-risk members of a health maintenance organization. Methods: The Resuscitation Outcomes Consortium (ROC) Amiodarone, Lidocaine, or Placebo Study (ALPS) is being conducted under EFIC. As part of the CC effort, we designed a survey with the Kaiser Permanente Northwest Center for Health Research. Surveys were mailed to 2,000 Kaiser members between the ages of 48-78 residing in a 3 county region served by participating EMS agencies. The age group was considered representative of the population-at-risk for out-of-hospital cardiac arrest (OHCA). The survey described ROC-ALPS and the opt-out option. Respondents were asked if the study was important to do, whether the benefits justified doing it under EFIC and if they would be willing to be enrolled in the study. Responses were recorded using a 5-point Likert scale. Demographic information collected included age, gender and race. Descriptive statistics were used to tabulate responses to survey questions. Pearson chi- square test was used for sub-group analyses. Results: Of the 2,000 mailed surveys, 1951 were delivered and 337 returned (17.2% response rate). Respondents were 48.8% male with a mean age of 63.1 years. Most respondents were white (89.3%) and representative of the study community. A majority (88.3%) of respondents agreed that EFIC research is important, and 73.9% felt that the benefits justify this method of research. Fewer respondents (53.1%) expressed a willingness to be enrolled in ROC-ALPS. There were no gender differences in question response. More respondents under the age of 65 expressed a willingness to be enrolled in the study. (p=0.002). However, those ≥ 65 were more likely to agree that the benefits justify the risk in EFIC studies. (p =0.029) Conclusions: A majority of at-risk HMO community member respondents expressed support for EFIC research and more than half expressed a willingness to be enrolled in the ROC randomized placebo control ALPS study. The response rate was low and differences were identified between respondents in relation to age.