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

ABSTRACT:

Background

Informed 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

SUBMITTER: Niyibizi NK 

PROVIDER: S-EPMC8962560 | biostudies-literature | 2022 Mar

REPOSITORIES: biostudies-literature