Barriers to Informed Consent, and How to Overcome Them

Informed consent is an ethical and legal requirement for research involving human participants. It involves a process in which study candidates are informed of all sentinel aspects of a research protocol in order to render a decision regarding participation. The importance of informed consent for research has been carefully articulated within the Nuremberg Code, the Declaration of Helsinki and the Belmont Report. Codified within the U.S. federal regulation nearly 40 years ago, it was further developed in the recently revised Common Rule. Yet, despite the longevity and evolution of informed consent, its practice often falls short of its intended goals. Numerous barriers to successful informed consent exist, some more insurmountable than others. This presentation will offer solutions to problems inherent in the consent process. We will consider findings from empirical studies on consent, and engage in case-based discussion to highlight best practices in human subjects research.