TY - JOUR
T1 - Understanding the Use of Optimal Formatting and Plain Language When Presenting Key Information in Clinical Trials
AU - Solomon, Erin D.
AU - Mozersky, Jessica
AU - Wroblewski, Matthew P.
AU - Baldwin, Kari
AU - Parsons, Meredith V.
AU - Goodman, Melody
AU - DuBois, James M.
N1 - Publisher Copyright:
© The Author(s) 2021.
PY - 2022/2
Y1 - 2022/2
N2 - 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.
AB - 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.
KW - evidence-based health communication
KW - formatting
KW - implementation science
KW - informed consent
KW - key information
KW - plain language
KW - research ethics
UR - http://www.scopus.com/inward/record.url?scp=85113174123&partnerID=8YFLogxK
U2 - 10.1177/15562646211037546
DO - 10.1177/15562646211037546
M3 - Article
C2 - 34410175
AN - SCOPUS:85113174123
SN - 1556-2646
VL - 17
SP - 177
EP - 192
JO - Journal of Empirical Research on Human Research Ethics
JF - Journal of Empirical Research on Human Research Ethics
IS - 1-2
ER -