Emergency Research: Using Exception from Informed Consent, Evaluation of Community Consultations

Abstract

Background: In 1996, the U.S. Food and Drug Administration approved regulations authorizing an exception from informed consent (EFIC) for research conducted in emergency settings when obtaining prospective informed consent is not possible due to the potential subject's critical illness or injury. The regulations require that investigators conduct community consultation (CC) efforts before initiating a study and require that institutional review boards review the results of CC prior to approving a study. However, little is known about how communities view EFIC research or the CC process.

Single-site Community Consultation for Emergency Research in a Community Hospital Setting

“…Ramsey and colleagues suggest involving "community advocates for research" (CARs) in the community consultation process-people who are viewed as leaders in communities or groups where outreach may be otherwise limited. 6 The TBI study did not implement this strategy, though having representatives from communities at high risk of TBI or where response rate was expected to be low may have been beneficial. Significantly more women and persons over the age of 65 provided feedback to researchers than what was expected according to service area demographics.…”

“…5,6 As such, it can be difficult to perform rigorous comparisons to other studies where community consultation took place. However, in published reports of community consultation and the TBI study, we see three themes around which feedback questions are often focused: support for the research, willingness to participate, and informational or meeting-specific satisfaction.…”

“…RAMPART investigators report that 88% of their survey respondents "felt the researcher heard the community concerns" (meeting satisfaction) and that 92% of respondents were "very satisfied" with their community consultation meeting. 6 For the TBI study, 87.4% of respondents said they received enough information (informational satisfaction). In the RAM-PART trial, 88% of respondents indicated support for the research while 98.8% of TBI study respondents viewed the research as beneficial.…”

Research in Emergency and Critical Care Settings: Debates, Obstacles and Solutions

“…In the UK, an amendment has been made to the European Union Clinical Trials Directive (2006) to allow research without consent in emergency situations through approval from ethics committees (Department of Health, United Kingdom 2006). In the US, post-implementation of the regulations for exception from informed consent (EFIC) using community consultation demonstrated high levels of satisfaction and trust in physicianinvestigators as indicated by surveys (Govindarajan et al 2013).…”

Does Community Consultation Matter?

“…In this issue of Academic Emergency Medicine, Govindarajan et al 10 describe the responses given by participants of CC activities when they were asked what they thought about the CC process. They were also asked what they learned about EFIC and a proposed EFIC study, RAMPART.…”