Evaluation of clinical innovation: A gray zone in the ethics of modern clinical practice?

Journal of General Internal Medicine

Volumn 23, Issue 1 SUPPL., 2008, Pages 27-31

  Patenaude, Johane ^a   Grant, Andrew M ^a   Xhignesse, Marianne ^a   Leblanc, Frédéric ^a   Courteau, Josiane ^b  

^a UNIVERSITY OF SHERBROOKE   (Canada)

^b CENTRE HOSPITALIER UNIVERSITAIRE DE SHERBROOKE   (Canada)

Author keywords

Care giving; Decision analysis; Decision making; Ethics; Innovation; Practice variation

Indexed keywords

ARTICLE; CANADA; CLINICAL PRACTICE; DIAGNOSTIC TEST; HEALTH CARE; MEDICAL ETHICS; MEDICAL RESEARCH; RISK ASSESSMENT; VALIDATION PROCESS;

EID: 37349117644     PISSN: 08848734     EISSN: 15251497     Source Type: Journal    
DOI: 10.1007/s11606-007-0410-2     Document Type: Article

References (26)

1. Kerridge I, Lowe M, Henry D. Ethics and evidence based medicine. BMJ. 1998;316(7138):1151-3.
2. Lind SE. Innovative medical therapies: Between practice and research. Clin Res. 1988;36:546-51.
3. Wilfond BS. Screening policy for cystic fibrosis: the role of evidence. Hastings Cent Rep. 1995;25:S21-3.
4. Tonelli MR. The philosophical limits of evidence-based medicine. Acad Med. 1998;73(12):1234-40.
5. Desjardins L. Le consentement à l'expérimentation clinique: Quelles sont les limites de l'acceptable et de l'inacceptable? Le Journal du Barreau. 1997;29(4). Available at: http://www.barreau.qc.ca/journal/vol29/no4/ consentement.html. Accessed December 18, 2006.
6. Canadian Institutes of Health Research, Natural Sciences and Engineering Research Council of Canada, Social Sciences and Humanities Research Council of Canada. Tri-council policy statement: ethical conduct for research involving humans. Ottawa: 1998. Updated June 2003.
7. Fost N. Ethical dilemmas in medical innovation and research: Distinguishing experimentation from practice. Semin Perinatol. 1998;22(3):223-32.
8. Weisstub DN, Verdun-Jones S. Pour une distinction entre l'expérimentation thérapeutique et l'expérimentation non thérapeutique. Revue de Droit, Université de Sherbrooke. 1996-97;27:49-87.
9. Prentice ED, Gordon BG, Lin MH. Determining when a clinical activity should be classified as research requiring institutional review board review. J Extra-Corpor Technol. 1997;29(2):88-91.
10. American College of Physicians. Ethics manual. Fourth edition. American College of Physicians. Ann Intern Med. 1998;128:576-94.
11. National Institute of Health. Institutional Review Board for studies involving human participants at the National Institute of Environmental Health Sciences. Available at: http://www.niehs.nih.gov/about/orgstructure/boards/irb/ terms.cfm. Accessed August 29, 2007.
12. Conseil d'évaluation des technologies de la santé. La transplantation au Québec, rapport préliminaire sur l'efficacité, les coûts et les caractéristiques organisationnelles, Montréal 1991;2-3.
13. Kouri RP, Philips-Nootens S. L'expérimentation et les soins innovateurs: l'article 21 C.c.Q. et les affres de l'imprécision. Revue de Droit, Université de Sherbrooke. R.D.U.S. 1996-1997;27:89-137, p.101.
14. Edgar H, Rothman DJ. The institutional review board and beyond: Future challenges to the ethics of human experimentation. Milbank Q. 1995;73(4):489-506.
15. Moutel G, Leroux N, Hervé C. Analysis of a survey of 36 French research committees on intracytoplasmic sperm injection. Lancet. 1998;351(9109):1121-3.
16. Agich GJ. Ethics and innovation in medicine. J Med Ethics. 2001;27:295-6.
17. Hearnshaw H. Comparison of requirements of research ethics committees in 11 European countries for a non-invasive interventional study. BMJ. 2004;328:140-1.
18. Silverman H, Hull SC, Sugarman J. Variability among institutional review boards' decisions within the context of a multicenter trial. Crit Care Med. 2001;29(2):235-41.
19. Shah S, Whittle A, Wilfond B, Gensler G, Wendler D. How do institutional review boards apply the federal risk and benefit standards for pediatric research? JAMA. 2004;291:476-82.
20. Valli N, Georges A, Corcuff JB, Barat JL, Bordenave L. Assessment of brain natriuretic peptide in patients with suspected heart failure: Comparison with radionuclide ventriculography data. Clin Chim Acta. 2001;306(1-2):19-26.
21. Maron BJ, Tholakanahalli VN, Zenovich AG, et al. Usefulness of B-type natriuretic peptide assay in the assessment of symptomatic state in hypertrophic cardiomyopathy. Circulation. 2004;109:984-9.
22. Tashakkori A, Teddlie C. Handbook of Mixed-Methods In Social & Behavioral Research. Thousand Oaks, CA: Sage; 2003. See Creswell, chap.8, pp. 209-40.
23. Gubrium JF, Holstein JA. The New Language of Qualitative Method. New-York: Oxford University Press; 1997.
24. World Medical Association. World Medical Association Declaration of Helsinki: ethical principles for medical research involving human subjects. JAMA. 2000;284:3043-5.
25. McDonald M, Dickens B, Knoppers BM, et al. The Governance of Health Research Involving Human Subjects (HRIHS). Law Commission of Canada. 2000.
26. Wheeler R. One person's innovation is another's experiment. BMJ. 2000;320:1548.