The Informed Consent Process (ICP) is a keystone of Good Clinical Practice (GCP). Although the elements of informed consent are spelled out in the FDA Code of Federal Regulations and ICH GCP E6, there are differences in how the ICP is implemented at the site based on subject populations and settings. Based on a brief survey of clinical research professionals, findings will be presented that illustrate differences. Ultimately, these differences should be addressed to implement best practices when consenting human subjects. Based on feedback from the presentation of preliminary data at the ACRP 2012 Global Conference, the survey was reissued to refine the survey.
Review varying methods of consenting and identify key factors that contribute to the process.
Describe the impact of these variables on best practices for conducting ICP.
Examine results of refined survey based on feedback from presentation at ACRP 2012 Global Conference.