The US Department of Health and Human Services released a major revision to the Federal Policy for Protection of Human Subjects (the Common Rule). The Common Rule, along with 45CFR46, has been the guiding policy since 1991. In 2015, HHS put forth a proposal to change the rules to "modernize, strengthen, and make more effective" the policies protecting human subjects.
One key change: HHS is guiding PIs to ensure Informed Consent Documents are readable for subjects and focus on an explanation of the research, the risks and potential benefits to subjects, and alternatives available, all in straight forward language. HHS cautions that the Informed Consent Document can no longer to be developed as a "legal document" to protect institutions, but must be an information document for subjects.
