Seminars in Nuclear Medicine
Volume 40, Issue 5 , Pages 385-392 , September 2010

The Institutional Review Board

  • Raffaella Hart, BS, CIM, CIP

      Affiliations

    • Corresponding Author InformationAddress reprint requests to Raffaella Hart, BS, CIM, CIP, Biomedical Research Alliance of New York, 1981 Marcus Avenue, Suite 210, Lake Success, NY 11042
  • ,
  • Michael Belotto, MPH, CCRC, CCRA

References 

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  3. National Institutes of Health, Nuremberg: Code. http://ohsr.od.nih.gov/guidelines/nuremberg.htmlAccessed February 28, 2010
  4. National Archives and Records Administration. View of the defendants in the dock at the International military tribunal trial of war criminals at Nuremberg. http://www.ushmm.org/wlc/media_ph.php?lang=en&ModuleId=10007069&MediaId=5141Accessed March 8, 2010
  5. Harvard Law School Library. Introduction to NMT case 1: USA v. Karl Brandt et al: Nuremberg Trials project. http://nuremberg.law.harvard.edu/php/docs_swi.php?DI=1&text=medicalAccessed March 1, 2010
  6. Leaning J. War crimes and medical science. BMJ. 1996;313:1413–1415
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  8. March of dimes. Thalidomide (Professionals and Researchers). http://www.marchofdimes.com/professionals/14332_1172.aspAccessed March 1, 2010
  9. US National Library of Medicine. Dr. Frances Kathleen Oldham Kelsey. http://www.nlm.nih.gov/changingthefaceofmedicine/physicians/biography_182.htmlAccessed March 1, 2010
  10. National Library of Medicine. Frances O. Kelsey receives the president's award for distinguished Federal Civilian Service from President John F Kennedy, 1962. http://www.nlm.nih.gov/changingthefaceofmedicine/gallery/photo_182_1.htmlAccessed March 8, 2010
  11. United States Food and Drug Administration. This week in FDA history—June 20, 1963. http://www.fda.gov/AboutFDA/WhatWeDo/History/ThisWeek/ucm117831.htmAccessed March 1, 2010
  12. World Medical Association. WMA declaration of Helsinki. http://www.wma.net/en/30publications/10policies/b3/index.htmlAccessed March 1, 2010
  13. US Department of Health and Human Services. Protection of human subjects (45 CFR 46). http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htmAccessed March 1, 2010
  14. United States Food and Drug Administration. Guidance for industry: E6 good clinical practice. http://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM129515.pdfAccessed March 1, 2010
  15. Office of Health, Safety and Security. The development of human subject research policy at DHEW. http://www.hss.energy.gov/healthsafety/OHRE/roadmap/achre/chap3_2.htmlAccessed March 1, 2010
  16. Beecher H. Ethics and clinical research. N Engl J Med. 1966;274:1354–1360
  17. Brunner B. The Tuskegee syphilis experiment (Tuskegee University). http://www.tuskegee.edu/Global/Story.asp?s=1207586Accessed March 1, 2010
  18. The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. The Belmont report. http://www.hhs.gov/ohrp/humansubjects/guidance/belmont.htmAccessed March 1, 2010
  19. Silverio A. HIV research in Africa (Stanford Journal of International Relations). http://www.stanford.edu/group/sjir/3.2.05_silverio.htmlAccessed March 1, 2010
  20. White R. Institutional review board mission creep: The common rule, social science, and the nanny state. Independent Rev. 2007;11:547–564
  21. US Department of Health and Human Services. IRB membership (45 CFR 46.107). http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm#46.107Accessed March 1, 2010
  22. Association of the Accreditation of Human Research Protection Programs, Inc.. Evaluation instrument for accreditation (Element II.1.E). http://www.aahrpp.org/Documents/D000229.PDFAccessed March 1, 2010
  23. US Department of Health and Human Services. Criteria for IRB approval of research (45 CFR 46.111). http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm#46.111Accessed March 1, 2010
  24. United States Food and Drug Administration. IND content and format (21 CFR 312.23). http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=312.23Accessed March 1, 2010
  25. United States Food and Drug Administration. Report of prior investigations (21 CFR 812.27). http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm?fr=812.27Accessed March 1, 2010
  26. US Department of Health and Human Services. Criteria for IRB approval of research (45 CFR 46.111). http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm#46.111Accessed March 1, 2010
  27. US Department of Health and Human Services. General requirements for informed consent (45 CFR 46.116). http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm#46.116Accessed March 1, 2010
  28. US Department of Health and Human Services. Assuring compliance with this policy—Research conducted or supported by any federal department or agency (45 CFR 46.103). http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm#46.103Accessed March 1, 2010
  29. US Department of Health and Human Services. IRB review of research (45 CFR 46.109). http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm#46.109Accessed March 1, 2010

PII: S0001-2998(10)00030-9

doi: 10.1053/j.semnuclmed.2010.03.007

Seminars in Nuclear Medicine
Volume 40, Issue 5 , Pages 385-392 , September 2010