Background This article describes how one Institutional Review Board (IRB) chose to implement the issue of waiver of consent for a research study involving brain trauma victims brought to an emergency department.
Methods Presentations were conducted in the state of Mississippi among cultural and ethnic groups representative of Mississippi's demographic composition. Individuals from the neurotrauma research team, including neurosurgeons and nurse study coordinators, conducted all of the presentations. One IRB member served as an objective “community liaison” and attended all presentations. This individual administered evaluation forms to attendees that measured their levels of comprehension and acceptance for the use of waiver of consent in the brain trauma study.
Results All of the 137 attendees in 7 community consultation meetings gave their approval for the use of “waiver of consent.” Continued community consultations are planned for the duration of the brain trauma study.
Conclusion Based on our experience, we conclude that in collaborating with local IRBs, research teams can successfully develop strategies for obtaining “acceptable community consultations” as required by regulatory mandates. We suggest that standardized community consultation guidelines be developed for obtaining waivers of informed consent in emergency research. Such criteria should form the basis for local IRBs to obtain their respective community consultations.
- waiver of consent
- emergency research
- community consultation
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