A Flawed Revision of the Common Rule

Ideas and Opinions19 July 2016A Flawed Revision of the Common RuleSteven Joffe, MD, MPH and David C. Magnus, PhDSteven Joffe, MD, MPHFrom University of Pennsylvania Perelman School of Medicine, Philadelphia, Pennsylvania, and Stanford Center for Biomedical Ethics, Stanford University, Stanford, California.Search for more papers by this author and David C. Magnus, PhDFrom University of Pennsylvania Perelman School of Medicine, Philadelphia, Pennsylvania, and Stanford Center for Biomedical Ethics, Stanford University, Stanford, California.Search for more papers by this authorAuthor, Article, and Disclosure Informationhttps://doi.org/10.7326/M16-0119 SectionsAboutFull TextPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissions ShareFacebookTwitterLinkedInRedditEmail In September 2015, sixteen federal agencies released a Notice of Proposed Rulemaking (NPRM) that outlined far-reaching changes to the Common Rule. The Common Rule is the regulatory framework for all federally funded human subjects research; many U.S. institutions extend it to nonfederally funded research as well. There have been increasing calls for revising the Rule, which has been essentially unchanged since 1991. In responding to these calls, the NPRM aims to “modernize, simplify and enhance the current system of oversight” and “strengthen protections for human research subjects while facilitating important research” (1). Laudable changes include moving much minimal-risk sociobehavioral research ...References1. U.S. Department of Health and Human Services. Notice of proposed rulemaking for revisions to the Common Rule. Fed Regist. 2015;80:53931-4061. Google Scholar2. Hudson KL, Collins FS. Bringing the Common Rule into the 21st century. N Engl J Med. 2015;373:2293-6. [PMID: 26509903] doi:10.1056/NEJMp1512205 CrossrefMedlineGoogle Scholar3. Emanuel EJ. Reform of clinical research regulations, finally. N Engl J Med. 2015;373:2296-9. [PMID: 26536071] doi:10.1056/NEJMp1512463 CrossrefMedlineGoogle Scholar4. American Society of Investigative Pathology. Comment letter on the Notice of Proposed Rulemaking—Common Rule. 2015. Accessed at https://www.asip.org/SciencePolicy/documents/ASIPCommentsNPRMCommonRule.pdf on 16 January 2016. Google Scholar5. Kass NE, Faden RR, Goodman SN, Pronovost P, Tunis S, Beauchamp TL. The research-treatment distinction: a problematic approach for determining which activities should have ethical oversight. Hastings Cen Rep. 2013;43:S4-15. [PMID: 23315895] doi:10.1002/hast.133 CrossrefMedlineGoogle Scholar6. Platt R, Kass NE, McGraw D. Ethics, regulation, and comparative effectiveness research: time for a change. JAMA. 2014;311:1497-8. [PMID: 24626256] doi:10.1001/jama.2014.2144 CrossrefMedlineGoogle Scholar7. Secretary's Advisory Committee on Human Research Protections. Draft Recommendations Regarding Investigator Responsibilities. 2012. Accessed at www.hhs.gov/ohrp/sachrp/mtgings/2012%20Oct%20Mtg/revisedinvestigatorresponsibilities.pdf on 16 January 2016. Google Scholar8. Presidential Commission for the Study of Bioethical Issues. Moral Science: Protecting Participants in Human Subjects Research. 2011. Accessed at http://bioethics.gov/node/558 on 29 March 2016. Google Scholar9. Verrill Dana. Decision Charts to Help You Navigate the Common Rule NPRM's Proposed Landscape of Covered Research, Exclusions, and Exemptions. 2015. Accessed at www.verrilldana.com/decision-charts-to-help-you-navigate-the-common-rule-nprms-proposed-landscape-of-covered-research-exclusions-and-exemptions/ on 16 January 2016. Google Scholar Author, Article, and Disclosure InformationAffiliations: From University of Pennsylvania Perelman School of Medicine, Philadelphia, Pennsylvania, and Stanford Center for Biomedical Ethics, Stanford University, Stanford, California.Disclosures: Disclosures can be viewed at www.acponline.org/authors/icmje/ConflictOfInterestForms.do?msNum=M16-0119.Corresponding Author: Steven Joffe, MD, MPH, Department of Medical Ethics and Health Policy, 423 Guardian Drive, BH1413, University of Pennsylvania Perelman School of Medicine, Philadelphia, PA 19104; e-mail, [email protected]edu.Current Author Addresses: Dr. Joffe: Department of Medical Ethics and Health Policy, 423 Guardian Drive, BH1413, University of Pennsylvania Perelman School of Medicine, Philadelphia, PA 19104.Dr. Magnus: Stanford Center for Biomedical Ethics, Stanford University, 1215 Welch Road, Modular A, Stanford, CA 94305.Author Contributions: Conception and design: S. Joffe, D.C. Magnus.Drafting of the article: S. Joffe, D.C. Magnus.Critical revision of the article for important intellectual content: S. Joffe, D.C. Magnus.Final approval of the article: S. Joffe, D.C. Magnus.This article was published at www.annals.org on 5 April 2016. PreviousarticleNextarticle Advertisement FiguresReferencesRelatedDetails Metrics Cited byImpact of Federal Regulatory Changes on Clinical Pharmacology and Drug Development: the Common Rule and the 21st Century Cures ActWhat do revised U.S. rules mean for human research?Effect of the CRF1-receptor antagonist pexacerfont on stress-induced eating and food craving 19 July 2016Volume 165, Issue 2Page: 143-144KeywordsBioethicsComparative effectiveness researchDisclosureInstitutional review boardsMedical ethicsPopulation statisticsQuality improvementResearch ethicsResearch facilitiesResearch laboratories ePublished: 5 April 2016 Issue Published: 19 July 2016 Copyright & PermissionsCopyright © 2016 by American College of Physicians. 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