First and foremost, we applaud HHS for proactively and thoughtfully engaging in this review of the Common Rule and human subjects research regulation. Too often regulations represent reactions to adverse events; this ANPRM presents a rare opportunity to focus, in a positive way, on a very important common goal: to ensure the highest standards of protection for volunteers who participate in research studies that ultimately benefit society through improvements in health, enhancements of living standards, advancements in knowledge, and/or economic progress.