U.S. Research Regulations: Do They Reflect the Views of the People They Claim to Protect?

Editorials19 May 2015U.S. Research Regulations: Do They Reflect the Views of the People They Claim to Protect?John D. Lantos, MDJohn D. Lantos, MDFrom Children's Mercy Hospitals and Clinics, Kansas City, Missouri.Author, Article, and Disclosure Informationhttps://doi.org/10.7326/M15-0632 Annals Author Insight Video - John D. Lantos, MD In this video, John D. Lantos, MD, offers additional insight into his editorial, "U.S. Research Regulations: Do They Reflect the Views of the People They Claim to Protect?" SectionsAboutFull TextPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissions ShareFacebookTwitterLinkedInRedditEmail In this issue, Cho and colleagues (1) suggest that the public's ideas about research ethics, particularly about informed consent for research on widely used medical practices, differ from the ideas reflected in federal regulations. This is not surprising. Federal regulations have been harshly criticized by many groups, including AIDS activists, consumer groups, professional societies, bioethicists, and leaders of the National Institutes of Health (2–6).The current regulatory system for clinical research is cumbersome, creaking with age, and conceptually inadequate. It was created before desktop computers, smart phones, and the Internet. It relies on ambiguous interpretations of basic concepts, such as ...References1. Cho MK, Magnus D, Constantine M, Lee SSJ, Kelley M, Alessi S, et al. Attitudes toward risk and informed consent for research on medical practices. A cross-sectional survey. Ann Intern Med. 2015;162:690-6. doi:10.7326/M15-0166 LinkGoogle Scholar2. Epstein S. The construction of lay expertise: AIDS activism and the forging of credibility in the reform of clinical trials. Sci Technol Human Values. 1995;20:408-37. [PMID: 11653331] CrossrefMedlineGoogle Scholar3. Kaye J, Curren L, Anderson N, Edwards K, Fullerton SM, Kanellopoulou N, et al. From patients to partners: participant-centric initiatives in biomedical research. Nat Rev Genet. 2012;13:371-6. [PMID: 22473380] doi:10.1038/nrg3218 CrossrefMedlineGoogle Scholar4. Infectious Diseases Society of America. Grinding to a halt: the effects of the increasing regulatory burden on research and quality improvement efforts. Clin Infect Dis. 2009;49:328-35. [PMID: 19566438] doi:10.1086/605454 CrossrefMedlineGoogle 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 Cent Rep. 2013;Spec No:S4-S15. [PMID: 23315895] doi:10.1002/hast.133 CrossrefMedlineGoogle Scholar6. Faden RR, Beauchamp TL, Kass NE. Informed consent for comparative effectiveness trials [Letter]. N Engl J Med. 2014;370:1959-60. [PMID: 24827051] doi:10.1056/NEJMc1403310 CrossrefMedlineGoogle Scholar7. Ramsey P. The Patient as Person. New Haven: Yale Univ Pr; 1970. Google Scholar8. Guttentag OE. The problem of experimentation on human beings. II. The physician's point of view. Science. 1953;117:207-10. [PMID: 13038476] MedlineGoogle Scholar9. Katz J. The education of the physician-investigator. Daedalus. 1969;98:480-501. Google Scholar10. Terry SF. A call for participatory oversight. Genet Test Mol Biomarkers. 2014;18:71-2. [PMID: 24506510] doi:10.1089/gtmb.2014.1552 CrossrefMedlineGoogle Scholar Author, Article, and Disclosure InformationAffiliations: From Children's Mercy Hospitals and Clinics, Kansas City, Missouri.Disclosures: Disclosures can be viewed at www.acponline.org/authors/icmje/ConflictOfInterestForms.do?msNum=M15-0632.Corresponding Author: John D. Lantos, MD, Center for Bioethics, Children's Mercy Hospitals and Clinics, 2401 Gillham Road, Kansas City, MO 64108; e-mail, [email protected]edu.This article was published online first at www.annals.org on 14 April 2015. PreviousarticleNextarticle Advertisement Annals Author Insight Video - John D. Lantos, MD In this video, John D. Lantos, MD, offers additional insight into his editorial, "U.S. Research Regulations: Do They Reflect the Views of the People They Claim to Protect?" FiguresReferencesRelatedDetailsSee AlsoAttitudes Toward Risk and Informed Consent for Research on Medical Practices Mildred K. Cho , David Magnus , Melissa Constantine , Sandra Soo-Jin Lee , Maureen Kelley , Stephanie Alessi , Diane Korngiebel , Cyan James , Ellen Kuwana , Thomas H. Gallagher , Douglas Diekema , Alexander M. Capron , Steven Joffe , and Benjamin S. Wilfond Attitudes Toward Risk and Informed Consent for Research on Medical Practices Mildred K. Cho , David Magnus , Melissa Constantine , Sandra Soo-Jin Lee , Maureen Kelley , Stephanie Alessi , Diane Korngiebel , Cyan James , Ellen Kuwana , Thomas H. Gallagher , Douglas Diekema , Alexander M. Capron , Steven Joffe , and Benjamin S. Wilfond Metrics Cited byThe ethical justification for inclusion of neonates in pragmatic randomized clinical trials for emergency newborn careA comparison of institutional review board professionals' and patients' views on consent for research on medical practicesParticipants' Role Expectations in Genetics Research and Re-consent: Revising the Theory and Methods of Mental Models Research Relating to RolesThe Role of Patient Perspectives in Clinical Research Ethics and Policy: Response to Open Peer Commentaries on "Patient Perspectives on the Learning Health System"Acquisition, Analysis, and Sharing of Data in 2015 and Beyond: A Survey of the Landscape 19 May 2015Volume 162, Issue 10Page: 731-732KeywordsDisclosureFearMedicareQuality improvementResearch ethicsRisk managementSafetySafety studiesSyphilis ePublished: 19 May 2015 Issue Published: 19 May 2015 Copyright & PermissionsCopyright © 2015 by American College of Physicians. All Rights Reserved.PDF downloadLoading ...