Updating Research Oversight for the 21st Century
Authors: Bernard Lo
Journal: Annals of Internal Medicine (2014)

Editorials16 December 2014Updating Research Oversight for the 21st CenturyBernard Lo, MDBernard Lo, MDFrom The Greenwall Foundation, New York, New York.Search for more papers by this authorAuthor, Article, and Disclosure Informationhttps://doi.org/10.7326/M14-2502 SectionsAboutFull TextPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissions ShareFacebookTwitterLinkedInRedditEmail Digital data offer exciting potential for improving health outcomes. Researchers can evaluate the effectiveness and safety of therapies in real-world settings and develop personalized health promotion interventions using routinely collected personal data from mobile devices, the Internet and cell phones, mobile applications, and electronic health records. Such data could include physical activity, food and restaurant purchases, and geolocation. Companies already use these data to develop products and services and send individualized advertisements and offers. However, as the articles in this issue by Grande and colleagues and Simon remind us (1, 2), in addition to potential health benefits, research using digital ...References1. Grande D, Mitra N, Shah A, Wan F, Asch DA. The importance of purpose: moving beyond consent in the societal use of personal health information. Ann Intern Med. 2014;161:855-62. doi:10.7326/M14-1118 LinkGoogle Scholar2. Simon JR. Corporate research ethics: whose responsibility? Ann Intern Med. 2014;161:917-8. doi:10.7326/M14-1669 LinkGoogle Scholar3. Emanuel EJ, Menikoff J. Reforming the regulations governing research with human subjects. N Engl J Med. 2011;365:1145-50. [PMID: 21787202] doi:10.1056/NEJMsb1106942 CrossrefMedlineGoogle Scholar4. Truog RD, Robinson W, Randolph A, Morris A. Is informed consent always necessary for randomized, controlled trials? N Engl J Med. 1999;340:804-7. [PMID: 10072420] CrossrefMedlineGoogle Scholar5. Nass SJ, Leavitt LA, Gostin LO. Beyond the HIPAA Privacy Rule: Enhancing Privacy, Improving Health Through Research. Washington, DC: National Academies Pr; 2009. Accessed at http://iom.edu/Reports/2009/Beyond-the-HIPAA-Privacy-Rule-Enhancing-Privacy-Improving-Health-Through-Research.aspx on 29 September 2012. Google Scholar6. Aalto-Setälä K, Conklin BR, Lo B. Obtaining consent for future research with induced pluripotent cells: opportunities and challenges. PLoS Biol. 2009;7:e42. [PMID: 19243222] doi:10.1371/journal.pbio.1000042 CrossrefMedlineGoogle Scholar7. Greely HT. The uneasy ethical and legal underpinnings of large-scale genomic biobanks. Annu Rev Genomics Hum Genet. 2007;8:343-64. [PMID: 17550341] CrossrefMedlineGoogle Scholar8. Presidental documents. Executive order 13505 of March 9, 2009: Removing barriers to responsible scientific research involving human stem cells. Federal Register. 2009;74:10667-8. FR doc. E9–5441. Accessed at http://edocket.access.gpo.gov/2009/pdf/E9-5441.pdf on 10 October 2014. Google Scholar9. National Bioethics Advisory Commission. Ethical and policy issues in research involving human participants. Springfield, VA: National Bioethics Advisory Commission Publications; 2001. Accessed at http://bioethics.georgetown.edu/nbac/pubs.html on 2 December 2012. Google Scholar10. Lo B, Grady D. Strengthening institutional review board review of highly innovative interventions in clinical trials. JAMA. 2009;302:2697-8. [PMID: 20040559] doi:10.1001/jama.2009.1917 CrossrefMedlineGoogle Scholar Author, Article, and Disclosure InformationAffiliations: From The Greenwall Foundation, New York, New York.Disclaimer: The views expressed in this paper do not reflect the views of The Greenwall Foundation.Disclosures: Author has disclosed no conflicts of interest. Forms can be viewed at www.acponline.org/authors/icmje/ConflictOfInterestForms.do?msNum=M14-2502.Corresponding Author: Bernard Lo, MD, The Greenwall Foundation, One Penn Plaza, 47th Floor, New York, NY 10119; e-mail, [email protected]org. PreviousarticleNextarticle Advertisement FiguresReferencesRelatedDetailsSee AlsoThe Importance of Purpose: Moving Beyond Consent in the Societal Use of Personal Health Information David Grande , Nandita Mitra , Anand Shah , Fei Wan , and David A. Asch Corporate Research Ethics: Whose Responsibility? Jeremy R. Simon The Importance of Purpose: Moving Beyond Consent in the Societal Use of Personal Health Information David Grande , Nandita Mitra , Anand Shah , Fei Wan , and David A. Asch Corporate Research Ethics: Whose Responsibility? Jeremy R. Simon Metrics 16 December 2014Volume 161, Issue 12Page: 919-920KeywordsForecastingInformation technologyInstitutional review boardsPatientsReasoningResearch ethicsSafetyStem cellsTransplantationTriage ePublished: 16 December 2014 Issue Published: 16 December 2014 Copyright & PermissionsCopyright © 2014 by American College of Physicians. All Rights Reserved.PDF downloadLoading ...