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Dollars and Deadlines: Rule Reforms in Short Time Frames
Schonfeld, T., M. Gormley, AND D. Nelson. Dollars and Deadlines: Rule Reforms in Short Time Frames. American Journal of Bioethics. Taylor & Francis, Inc., Philadelphia, PA, 17(7):62-64, (2017).
IMPACT STATEMENT: The “Common Rule” refers to the federal regulations that govern research involving human subjects. These regulations have been largely unchanged since 1981, while the research they cover has continued to evolve. After a 6-year rulemaking process, the Common Rule was revised and published in Jan 2017, with an effective date of Jan 2018. Because of the far reaching impact of these changes, this upcoming issue of the American Journal of Bioethics is devoted to articles about the new regulations and the process for change. The practice of this journal is to invite “Peer Commentaries” on target articles, and our commentary will compare and contrast the experience of one agency (EPA) in a similar rulemaking process.
ABSTRACT: In "At Last! Aye, and there's the Rub" (i.e., the target article for this commentary), Capron describes challenges related to the timing for development, adoption, and revision of the Common Rule. Specifically, what the National Commission thought would be a 180 day process for other agencies to sign onto the original Common Rule ultimately took 20 times longer than expected, and Capron argues that the difficulty of making changes over those ten years created an "all or nothing" atmosphere. That is, because of the effort required, agencies were loath to make changes little-by-little and instead "take up every possible revision at once" with the process that culminated in the recently revised Rule. In this commentary, we briefly describe the efforts of one agency -- the U.S. Environmental Protection Agency (EPA)-- that did make interim changes to its human subjects protections within a 180 day time frame, and the opportunities and challenges that such an ambitious goal created.