Understanding the Use of Optimal Formatting and Plain Language When Presenting Key Information in Clinical Trials.
evidence-based health communication
formatting
implementation science
informed consent
key information
plain language
research ethics
Journal
Journal of empirical research on human research ethics : JERHRE
ISSN: 1556-2654
Titre abrégé: J Empir Res Hum Res Ethics
Pays: United States
ID NLM: 101273949
Informations de publication
Date de publication:
Historique:
pubmed:
20
8
2021
medline:
3
3
2022
entrez:
19
8
2021
Statut:
ppublish
Résumé
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.
Identifiants
pubmed: 34410175
doi: 10.1177/15562646211037546
pmc: PMC8712347
mid: NIHMS1726503
doi:
Types de publication
Journal Article
Research Support, N.I.H., Extramural
Langues
eng
Sous-ensembles de citation
IM
Pagination
177-192Subventions
Organisme : NIA NIH HHS
ID : R01 AG058254
Pays : United States
Organisme : NCATS NIH HHS
ID : UL1 TR002345
Pays : United States
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