Dollars and Deadlines: Rule Reforms in Short Time Frames

In “At Last! Aye, and there’s the Rub,” (2017), Capron describes challenges related to the timing for development, adoption, and revision of the Common Rule. Capron argues that the difficulty of making changes over the ten years required before agencies adopted the original Common Rule created an “all or nothing” atmosphere. That is, because of the effort required, agencies were loath to make incremental changes and instead “take up every possible revision at once” with the process that culminated in the recently revised Rule. Here we briefly describe the efforts of one agency -- the U.S. Environmental Protection Agency (EPA) -- that made interim changes to its human subjects protections within a 180 day time frame, and the opportunities and challenges that such an ambitious goal created.