Regulatory Relief for Researchers

Evenings spent huddled over tedious institutional review board (IRB) applications may be a thing of the past. For too long, IRBs in the U.S. have operated under the regulatory guidance of federal regulations known as “the Common Rule” (45 CFR part 46, subpart A), which outlines the duty of IRBs to oversee basic protections for human subjects participating in research. Frustratingly, these protections are modeled upon patient participation in clinical research and impose unnecessarily burdensome regulatory oversight for human social/behavioral research.

After years of debate and subsequent rule revision at the federal level (beginning in 2011), the Common Rule has finally been amended. Many of the revisions that will be implemented in January 2018 aim to reduce administrative burdens and modernize regulations so that IRB administrators can devote more time to studies posing more serious risks to participants (such as those that might cause physical or psychological harm).

Social scientists and students should welcome this news because the majority of social and behavioral research carries “minimal risk”—no greater than the risk of everyday life. Specifically, research activities utilizing biography, oral history, behavioral and educational assessments; quality improvement or quality assurance activities; routine public health surveillance activities; or secondary analysis of identifiable information (subject to HIPAA regulation) may no longer require IRB review or may be determined as exempt from the Common Rule. Additionally, annual renewal (i.e., continuing review) of studies approved as minimal risk may no longer be required and multi-site studies can now rely upon one IRB to provide oversight rather than the IRB of every investigator’s institution as listed on the protocol.

These are just a few of the changes presented in the revised rule. Naturally, it will take some time and effort for IRBs to figure out how to apply these dramatic changes to current institutional policies and procedures, as well as to educate researchers about the implications for their research activities. Nevertheless, the net result should amount to significant regulatory relief and increased efficiency for IRB offices.