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: Airway management; Clinical trial; Community consultation; Emergency care research; Exception from informed consent; FDA 21 CFR 50.24; Resuscitation.
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