Why research oversight bodies should interview research subjects

IRB Ethics and Human Research

Volumn 39, Issue 2, 2017, Pages 8-13

  Elliott, Carl ^a  

^a UNIVERSITY OF MINNESOTA   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

EID: 85054646227     PISSN: 01937758     EISSN: 23262222     Source Type: Journal    
DOI: None     Document Type: Article

References (28)

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2. Dykhuis D. University of Minnesota Human Research Protec-tion Program, letter to Carl Elliott, June 5, 2015. https://www. scribd.com/doc/281844393/Debra-Dykhuis-Letter-to-Carl-Elliott-June-5-2015.
3. See ref. 1, Baillon 2014.
4. See ref. 1, Baillon 2014.
5. FTI Consulting. Independent Assessment of a University of Minnesota Institutional Review Board (IRB) Noncompliance Deter-mination. March 15, 2011. https://www.scribd.com/doc/312577176/FTI-Consulting-Report-on-Robert-Huber-Case; Webb P. University of Minnesota Research Compliance Office report. January 27, 2016. https://www.scribd.com/doc/312577568/Research-Compliance-Office-Report-on-Robert-Huber-Case-University-of-Minnesota-January-27-2016.
6. Dykhuis D. University of Minnesota Human Research Protec-tion Program, letter to Robert Huber, May 6, 2015. https://www. scribd.com/doc/264627742/Letter-from-Debra-Dykhuis-of-Univer-sity-of-Minnesota-Research-Protection-to-Robert-Huber-regarding-bifeprunox-study-May-6-2015.
7. See ref. 2, Dykhuis 2015.
8. Personal communication to the author from C. Loose, Food and Drug Administration Office of Regulatory Affairs, May 18, 2006. See also U.S. Department of Health and Human Services, Food and Drug Administration, Compliance Program Guidance Manual for FDA Staff, Compliance Program 7348.811, Bioresearch Monitor-ing: Clinical Investigators, December 8, 2008, http://www.fda.gov/ ICECI/EnforcementActions/BioresearchMonitoring/ucm133562.htm.
9. Weber M (trans. and ed. Gerth HH, Mills CW). From Max We-ber: Essays in Sociology. New York: Oxford University Press, 1958, p. 216.
10. Kaboli PJ et al. Assessing the accuracy of computerized medi-cation histories. American Journal of Managed Care 2004;10:872-877.
11. Ruder DR. Malpractice claims analysis confirms risks in EHRs. Patient Safety and Quality Healthcare 2014;11(1):20-23.
12. Allen A. Electronic record errors growing issue in lawsuits. Politico. April 4, 2015. http://www.politico.com/story/2015/05/electronic-record-errors-growing-issue-in-lawsuits-117591#ixzz47bsGneMk.
13. Wilson D, Heath D. Uninformed consent: What patients at “The Hutch” weren’t told about the experiments in which they died [4-part series]. Seattle Times. 2001. http://old.seattletimes.com/unin-formed_consent/.
14. Uninformed consent: Questions and answers about “The Hutch.” Seattle Times. March 25, 2001. http://old.seattletimes.com/uninformed_consent/qa.html.
15. Office of the Legislative Auditor, State of Minnesota. A Clinical Drug Study at the University of Minnesota Department of Psychiatry: The Dan Markingson Case. March 19, 2015. http://www. auditor.leg.state.mn.us/sreview/markingson.pdf.
16. Matson S. FDA Establishment Inspection Report, Stephen Olson MD. Report no. FEI 3004927371. July 22, 2005. https://www. scribd.com/doc/49641428/FDA-Inspection-Markingson-suicide.
17. Tosto P, Olson J. Dan Markingson had delusions. Pioneer Press (St. Paul). May 18, 2008. http://www.twincities.com/ci_9292549.
18. Laws of Minnesota 2009, chapter 58, codified as Minnesota Statutes, 253B.095, subdivision 1(d)(4) and (e). See also Olson J, Minnesota House, Senate unanimously pass limits on researchers’ use of mentally ill patients, Pioneer Press (St. Paul), May 8, 2009.
19. See ref. 15, Office of the Legislative Auditor, State of Minnesota 2015.
20. Gioia DA. Pinto fires and personal ethics: A script analysis of missed opportunities. Journal of Business Ethics 1992;11(5):379-389.
21. Dowie M. Pinto madness. Mother Jones. September-October 1977. http://www.motherjones.com/politics/1977/09/pinto-madness.
22. See ref. 20, Gioia 1992..
23. See ref. 20, Gioia 1992.
24. See ref. 20, Gioia 1992.
25. See ref. 9, Weber 1958, p. 216.
26. See ref. 20, Gioia 1992.
27. See ref. 5, FTI Consulting 2011 and Webb 2016.
28. See ref. 20, Gioia 1992, p. 387.