The current system of ethical oversight in the United States is based on Institutional Review Board (IRB) review. The system was established in response to well-known and egregious mistreatment of subjects in both biomedical and social and behavioral research. In the decades since the research regulations were enacted, reaction to the burden of…

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…