Experimenting with modifications to consent forms in comparative effectiveness research: understanding the impact of language about financial implications and key information

BMC Medical Ethics 23 (1):1-10 (2022)
  Copy   BIBTEX


BackgroundInformed consent forms are intended to facilitate research enrollment decisions. However, the technical language in institutional templates can be unfamiliar and confusing for decision-makers. Standardized language describing financial implications of participation, namely compensation for injury and costs of care associated with participating, can be complex and could be a deterrent for potential participants. This standardized language may also be misleading in the context of comparative effectiveness trials of standard care interventions, in which costs and risk of injury associated with participating may not differ from regular medical care. In addition, the revised U.S. Common Rule contains a new requirement to present key information upfront; the impact of how this requirement is operationalized on comprehension and likelihood of enrollment for a given study is unknown.MethodsTwo online surveys assessed the impact of changes to compensation for injury language and changes to the key information page on both likelihood of enrollment in and understanding of a hypothetical comparative effectiveness trial.ResultsLikelihood of enrolling was not observed to be different between the standard and tailored language forms in Study 1 ; however, the tailored language group had a higher frequency of understanding the compensation for injury process specific to the trial. Modifications to the key information sheet in Study 2 did not affect likelihood of enrolling ; however, understanding of randomization differed by form.ConclusionsThese findings suggest that refining consent forms to clarify key information and tailoring compensation for injury language to the nature of the study, especially in the context of comparative effectiveness trials, may help to improve study comprehension but may not impact enrollment.



    Upload a copy of this work     Papers currently archived: 76,101

External links

Setup an account with your affiliations in order to access resources via your University's proxy server

Through your library

Similar books and articles

The Hydra.Carl E. Schneider - 2010 - Hastings Center Report 40 (4):9-11.


Added to PP

1 (#1,498,577)

6 months
1 (#447,139)

Historical graph of downloads

Sorry, there are not enough data points to plot this chart.
How can I increase my downloads?

Citations of this work

No citations found.

Add more citations

References found in this work

No references found.

Add more references