Measuring the cost and effect of current community consultation and public disclosure techniques in emergency care research

  • Gerald Matchett
    Correspondence
    Corresponding author at: Department of Anesthesiology & Pain Management, University of Texas Southwestern Medical Center 5323 Harry Hines Blvd, Dallas, TX, 75390-9068, United States.
    Affiliations
    Department of Anesthesiology and Pain Management, The University of Texas Southwestern Medical Center, Dallas, TX, United States
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  • Timothy J. Ryan
    Affiliations
    Department of Political Science, University of North Carolina at Chapel Hill, Chapel Hill, NC, United States
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  • Mary C. Sunna
    Affiliations
    Parkland Health and Hospital System, Dallas, TX, United States
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  • Simon C. Lee
    Affiliations
    The UT-Southwestern Department of Clinical Sciences, United States
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  • Paul E. Pepe
    Affiliations
    The UT-Southwestern Department of Surgery, United States

    The UT-Southwestern Department of Internal Medicine, United States

    The UT-Southwestern Department of Emergency Medicine, United States
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  • Affiliations
    Department of Anesthesiology and Pain Management, The University of Texas Southwestern Medical Center, Dallas, TX, United States

    Department of Political Science, University of North Carolina at Chapel Hill, Chapel Hill, NC, United States

    Parkland Health and Hospital System, Dallas, TX, United States

    The UT-Southwestern Department of Clinical Sciences, United States

    The UT-Southwestern Department of Surgery, United States

    The UT-Southwestern Department of Internal Medicine, United States

    The UT-Southwestern Department of Emergency Medicine, United States

    The UT-Southwestern Department of Neurology and Neurotherapeutics, United States

    The UT-Southwestern, Department of Neurological Surgery, United States

      Abstract

      Aim

      U.S. federal regulations for research involving exception from informed consent (EFIC) include stipulations for community consultation (CC) and public disclosure (PD) (FDA 21 CFR 50.24). Published descriptions of PD campaigns include letters to community leaders, media outreach, paid advertising, and community meetings. Whether or not these activities provide measurable impact is unknown, as few prior works have evaluated PD activities with probabilistic polling. The aim of this study is to use polling to assess how much public awareness PD efforts generate.

      Methods

      A 3-month PD campaign similar in scope and scale to PD campaigns described in several recent publications was implemented across a large urban county (pop. 2.55 million). PD included a study website (www.evktrial.org), letters to 300 community leaders/organizations, bilingual media outreach and also phased roll-outs, weeks apart, of newspaper advertisements, mass e-mail messaging, and paid advertising in Facebook® and Twitter® augmented by volunteer social media outreach. During PD we used repeated zip code-targeted online polling via Google Consumer Surveys® to assess community awareness of the proposed EFIC study.

      Results

      Over 3-months all-source exposures to >1 million individuals were estimated, generating ∼5,000 website visits (12-month cumulative, ∼9000). However, general community awareness evaluated through repeated county-wide polling never rose above baseline measurements. CC/PD campaign costs were estimated at $60,000 (USD).

      Conclusion

      A PD campaign in scope and scale common for EFIC studies may not provide measurable impact in a community. Investigators, review boards and regulators could consider these findings when re-examining and/or creating policies for PD for EFIC studies.

      Keywords

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      References

      1. Title 21– Federal Regulations, Part 50–Protection of Human Subjects, Section 50.24 Exception From Informed Consent. U.S. Food and Drug Administration. Revised April 1, 2017 and Accessed December 28, 2017. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=50.24.

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