Final Rule Issued to Protect Human Subjects Research Participants

​A final rule strengthening protection for individuals who volunteer as research subjects was issued on January 18, 2017, by 16 federal agencies, including the U.S. Department of Health and Human Services (HHS). The rule is designed to offer increased protection for human subjects, while ensuring that the oversight does not add unnecessary administrative burdens, HHS said. It is also designed to allow flexibility within the ever-changing research environment. Much has changed since current regulations, known as the Common Rule, were issued in 1991 (see HRC Alerts, September 16, 2015).