Zusammenfassung

Improving the informed consent process is a common theme in literature regarding biomedical human subjects research. Standards for appropriate language and required information have undergone scrutiny and evolved over time. One response to the call for improvement is the provision and use of informed consent templates (ICTs) to ensure that documents have a standardized format and quality of content. Little is known, however, about the prevalence of such ICTs or their effectiveness. This article discusses the rationale for creating and using templates, describes the prevalence of and commonalities between templates, and identifies the need for an evaluation of their effectiveness in terms of their ethical and practical implications. The websites of 144 Association of American Medical Colleges (AAMC)-accredited institutions in the United States, 21 institutes in the National Institutes of Health (NIH), and the World Health Organization (WHO) were searched for the presence of ICTs. A total of 105 (72.9%) medical schools, 3 (14.2%) NIH institutes, and the WHO had at least one ICT publicly available on their websites. The templates varied in format, length, style, language, and sections included. The prevalence of ICTs, variability in their content, and lack of published research regarding their effectiveness suggest that ICTs are available, but more research into their effectiveness and standardization of their development are needed.

https://doi.org/10.1177/1747016116649995