Clinical paperCommunity attitudes towards emergency research and exception from informed consent☆
Introduction
One of the regulatory requirements for research using the emergency exception from informed consent (EFIC) is community consultation with members of the community in which the research is to be performed and members of the community of potential research subjects if those communities are not the same. The nature, content and intensity of community consultation is not completely prescribed by federal regulations, in order to allow site specific application. However, community consultation must include a two-way communication, in which the communities are educated to the content of the EFIC study, and the meaning and need for EFIC.
Although community consultation is not meant to provide community consent or disapproval, the IRB is required, in its deliberations on the proposed EFIC study, to consider questions and concerns from members of the communities. In preparation for a national EFIC trial of pre-hospital interventions for status seizures, we developed a community consultation plan together with our IRB to reach a broad base of the general population of our state (the community in which the research is to be performed), as well as specific community members at risk for the disease under investigation (the community of potential research subjects).
The current study was directed towards a broad population of Minnesotans. In addition to specific discussion of the planned EFIC trial, we also hoped to assess public attitudes towards research in general and emergency research in particular. We wanted to determine respondent characteristics associated with specific attitudes or understanding about research. We hoped to use this information to determine effective methods of community engagement for future EFIC research trials.
Section snippets
Methods
This was a survey of persons visiting the emergency medicine display located in the University of Minnesota education building at the Minnesota State Fair. Data were collected on three afternoons and evenings for a total of 13.5 h, during August 2008. About 16,000 persons walk through the education building each day of the State Fair. It is a common location for the performance of surveys and health screening examinations. This study was reviewed and approved by the IRB at the University of
Results
One thousand nine hundred and one persons participated; the demographics of the respondent group are shown in Table 1. All responses were self-reported; classification as rural or urban was based on zip codes and state definitions. The distribution of ages, educational levels, and household incomes are listed in Table 2. Thirty-five percent of respondents knew someone who or themselves had experiences seizures.
Fifteen percent (n = 290) had previously participated in a research study and 8% (n =
Discussion
As part of community consultation targeting the population in which our planned EFIC trial will take place, we surveyed a large number of persons at a popular public venue, the Minnesota State Fair. For the most part, the demographic characteristics of the study population reflect those of the state (Table 1). Given the similarities between the state and study populations, we believe the opinions we gathered provide a reasonable representation of public attitudes of Minnesotans towards
Conclusions
Emergency research and the proposed EFIC trial are supported in the community in which the research will occur. The concept of EFIC is better supported when a specific trial is described and when respondents answer for themselves. Specific respondent characteristics are associated with attitudes or no opinions about EFIC and research; with this information, community consultation can be tailored to be more meaningful.
Conflict of interest statement
Dr. Biros serves as a member of data and safety monitoring committees on industry and federally funded research related to critical care. Dr. Biros is the principle investigator for the University of Minnesota Hub of the Neurological Emergencies Treatment Trials (NETT) Network. This involvement would not influence the research presented here. The remaining authors also have no financial or personal relationships that would influence or bias this work.
Funding source
This study was completed as part of the pre-study work for the RAMPART (Rapid Anticonvulsant Medications Prior to Arrival Trial). RAMPART is funded by the Department of Defense and BARTA and is being conducted through the federally funded NETT (NINDS 5U01NS056975-07). The funding agencies had no involvement in the design, execution or analysis of the work presented here.
Acknowledgements
The authors express profound gratitude to Drs. James Miner and Marjorie Ireland for their assistance in the statistical evaluation of our data.
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2018, ResuscitationCitation Excerpt :In fourteen prior studies, eight [7,15–21] showed no relationship of age or educational level to study approval, however three [7,15,21] did note racial differences in EFIC approval. Two trials [11,22] showed greater EFIC acceptance among younger and more educated patients while two other trials [23,24] showed increased acceptance with increasing age, one [25] showed increased acceptance with less education, and several [26,27] showed increased acceptance with middle age, and less acceptance in the young and elderly groups as well as a racial difference in acceptance. Soliciting and obtaining an online group of respondents was the most expensive method of community consent at $15.63 per completed survey and was not time-efficient.
Research in the emergency care environment
2017, Clinical and Translational Science: Principles of Human Research: Second Edition
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A Spanish translated version of the summary of this article appears as Appendix in the final online version at doi:10.1016/j.resuscitation.2009.08.019.