Design and implementation of community consultation for research conducted under exception from informed consent regulations for the PreVent and the PreVent 2 trials: Changes over time and during the COVID-19 pandemic.
Gugel T, Adams K, Baranoski M, Yanez N, Kampp M, Johnson T, Aydin A, Fajardo E, Sharp E, Potnis A, Johnson C, Treggiari M. Design and implementation of community consultation for research conducted under exception from informed consent regulations for the PreVent and the PreVent 2 trials: Changes over time and during the COVID-19 pandemic. Clinical Trials 2024, 17407745241243045. PMID: 38676438, PMCID: PMC11512686, DOI: 10.1177/17407745241243045.Peer-Reviewed Original ResearchPublic disclosure activitiesCommunity consultationInstitutional review boardConsent regulationsIn-personEmergency researchRegulatory measuresCOVID-19 pandemicPublic disclosureSponsor-investigatorsPublic supportPrevention experimentsCommunity leadersIn-person eventsYear of implementationFood and Drug AdministrationHigher education levelCommunity concernsReview boardSelection biasProportion of respondentsMethod of contactClinical researchLocal communitiesCOVID-19