Understanding the Use of Optimal Formatting and Plain Language When Presenting Key Information in Clinical Trials

Erin D. Solomon, Jessica Mozersky, Matthew P. Wroblewski, Kari Baldwin, Meredith V. Parsons, Melody Goodman, James M. DuBois

Research output: Contribution to journalArticlepeer-review

Abstract

Recent revisions to the Common Rule require that consent documents begin with a focused presentation of the study's key information that is organized to facilitate understanding. We surveyed 1,284 researchers working with older adults or individuals with Alzheimer's disease, supplemented with 60 qualitative interviews, to understand current use and barriers to using evidence-based formatting and plain language in key information. Researchers reported using formatting in 42% of their key information sections, and plain language in 63% of their key information sections. Perceived barriers included lack of knowledge, Institutional Review Board, other members of their team, and the burden associated with implementation. Education and training are required to increase adoption of the practices.

Original languageEnglish (US)
Pages (from-to)177-192
Number of pages16
JournalJournal of Empirical Research on Human Research Ethics
Volume17
Issue number1-2
DOIs
StateAccepted/In press - 2021

Keywords

  • evidence-based health communication
  • formatting
  • implementation science
  • informed consent
  • key information
  • plain language
  • research ethics

ASJC Scopus subject areas

  • Social Psychology
  • Education
  • Communication

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