Human Subjects Protection in the Era of the Revised Common Rule

摘要

The last several years have been a time of significant change for the clinical research enterprise, not only at the national level with the revised regulations, but also at the local level with the growth and transitions in our own health system. As the current and former executive chairs of the Ochsner Institutional Review Board (IRB) system, we thank all of the authors and peer reviewers who made this special issue possible. Because of the revised federal IRB regulations (45 CFR §46, Subpart A) that became effective in January 2019, active review is underway at all US IRBs and human research protection programs about how the new regulations should be understood, implemented, and operationalized. We hope this special edition will assist many as they work through the various issues that have been raised by these changes. Highlights of this special edition issue include the following:White reflects on the fundamental reason we have IRBs and why human subject protection is important.