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Research ArticleArticle

Bioethics in Practice: Therapeutic Misconception

Joseph Breault and Meredith Miceli
Ochsner Journal December 2016, 16 (4) 429-430;
Joseph Breault
1Department of Family Medicine and Institutional Review Board Chair, Ochsner Clinic Foundation, New Orleans, LA
2The University of Queensland School of Medicine, Ochsner Clinical School, New Orleans, LA
MD
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Meredith Miceli
3Department of Legal Affairs and Risk Management, Ochsner Clinic Foundation, New Orleans, LA
JD
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REFERENCES

  1. ↵
    1. Henderson GE,
    2. Churchill LR,
    3. Davis AM,
    4. et al.
    Clinical trials and medical care: defining the therapeutic misconception. PLoS Med. 2007 11 27; 4 11: e324. pmid:18044980
    OpenUrlCrossRefPubMed
  2. ↵
    The Belmont Report. Office for Human Research Protections. U.S. Department of Health and Human Services. http://www.hhs.gov/ohrp/regulations-and-policy/belmont-report/. Published April 18, 1979. Accessed September 26, 2016.
  3. ↵
    1. Pentz RD,
    2. White M,
    3. Harvey RD,
    4. et al.
    Therapeutic misconception, misestimation, and optimism in participants enrolled in phase 1 trials. Cancer. 2012 9 15; 118 18: 4571- 4578. doi: 10.1002/cncr.27397. pmid:22294385
    OpenUrlCrossRefPubMedWeb of Science
  4. ↵
    General requirements for informed consent. 21 CFR 50.20 et seq. Revised April 1, 2016. http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm?fr=50.20. Accessed September 26, 2016.
  5. ↵
    Basic HHS policy for protection of human research subjects. 45 CFR 46.101 et seq. Revised January 15, 2009. http://www.hhs.gov/ohrp/regulations-and-policy/regulations/45-cfr-46/. Accessed September 26, 2016.
  6. Uniform consent law. La. R.S. 40:1157.1 et seq. http://legis.la.gov/legis/Law.aspx?d=964692. Accessed September 26, 2016.
  7. ↵
    Elements of informed consent. 21 CFR 50.25. Revised April 1, 2016. http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm?fr=50.25. Accessed September 26, 2016.
  8. ↵
    A Guide to Informed Consent – Information Sheet. U.S. Food and Drug Administration. http://www.fda.gov/RegulatoryInformation/Guidances/ucm126431.htm. Updated January 25, 2016. Accessed September 26, 2016.
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Bioethics in Practice: Therapeutic Misconception
Joseph Breault, Meredith Miceli
Ochsner Journal Dec 2016, 16 (4) 429-430;

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Joseph Breault, Meredith Miceli
Ochsner Journal Dec 2016, 16 (4) 429-430;
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