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

J Empir Res Hum Res Ethics. 2022 Feb-Apr;17(1-2):177-192. doi: 10.1177/15562646211037546. Epub 2021 Aug 19.


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.

Keywords: evidence-based health communication; formatting; implementation science; informed consent; key information; plain language; research ethics.

Publication types

  • Research Support, N.I.H., Extramural

MeSH terms

  • Aged
  • Clinical Trials as Topic / methods*
  • Consent Forms
  • Ethics Committees, Research
  • Humans
  • Informed Consent*
  • Language*
  • Research Personnel