Ethics of medical scientific research: Informed consent and the therapeutic misconception;Ethiek van medisch-wetenschappelijk onderzoek: Informed consent en de therapeutische misconceptie

Nederlands Tijdschrift voor Geneeskunde

Volumn 152, Issue 12, 2008, Pages 679-683

  De Vries, M C ^a   Van Leeuwen, E ^b  

^a LEIDEN UNIVERSITY MEDICAL CENTER   (Netherlands)

^b RADBOUD UNIVERSITY MEDICAL CENTER   (Netherlands)

Author keywords

[No Author keywords available]

Indexed keywords

DOCTOR PATIENT RELATION; HUMAN; INFORMED CONSENT; INSTITUTIONAL REVIEW; LEGAL ASPECT; MEDICAL ETHICS; MEDICAL RESEARCH; PHYSICIAN; REVIEW; RISK ASSESSMENT;

ETHICAL REVIEW; ETHICS COMMITTEES, RESEARCH; ETHICS, RESEARCH; HUMAN EXPERIMENTATION; HUMANS; INFORMED CONSENT; RISK FACTORS;

EID: 41349102397     PISSN: 00282162     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Review

References (22)

1. Besselink MGH, Santvoort HC van, Buskens E, Boermeester MA, Goor H van, Timmerman HM, et al. Probiotic prophylaxis in predicted severe acute pancreatitis: a randomised, double-blind, placebo-controlled trial. Lancet. 2008;371:651-9.
2. Besselink MGH, Santvoort HC van, Buskens E, Boermeester MA, Goor H van, Timmerman HM, et al. Probioticaprofylaxe bij voorspeld ernstige acute pancreatitis: een gerandomiseerde, dubbelblinde, placebo-gecontroleerde trial. Ned Tijdschr Geneeskd. 2008;152:685-96.
3. Santen H van. Patiënten probiotica waren al zieker. NRC Handelsblad januari 25 2008.
4. Paasche-Orlow MK, Taylor HA, Brancati FL. Readability standards for informed-consent forms as compared with actual readability. N Engl J Med. 2003;348:721-6.
5. Grossman SA, Piantadosi S, Covahey C. Are informed consent forms that describe clinical oncology research protocols readable by most patients and their families? J Clin Oncol. 1994;12:2211-5.
6. Tarnowski KJ, Allen DM, Mayhall C, Kelly PA. Readability of pediatric biomedical research informed consent forms. Pediatrics. 1990;85: 58-62.
7. Wendler D. Can we ensure that all research subjects give valid consent? Arch Intern Med. 2004;164:2201-4.
8. Greenley RN, Drotar D, Zyzanski SJ, Kodish E. Stability of parental understanding of random assignment in childhood leukemia trials: an empirical examination of informed consent. J Clin Oncol. 2006;24: 891-7.
9. Ong LML, Haes JCJM de, Hoos AM, Lammes FB. Doctor-patient communication: a review of the literature. Soc Sci Med. 1995;40:903-18.
10. Heneghan AM, Mercer M, DeLeone NL. Will mothers discuss parenting stress and depressive symptoms with their child's pediatrician? Pediatrics. 2004;113(3 Pt 1):460-7.
11. Appelbaum PS, Roth LH, Lidz CW. The therapeutic misconception: informed consent in psychiatric research. Int J Law Psychiatry. 1982;5: 319-29.
12. Appelbaum PS, Roth LH, Lidz CW, Benson P, Winslade W. False hopes and best data: consent to research and the therapeutic misconception. Hastings Cent Rep. 1987;17:20-4.
13. Appelbaum PS, Lidz CW, Grisso T. Therapeutic misconception in clinical research: frequency and risk factors. IRB. 2004;26:1-8.
14. Joffe S, Weeks JC. Views of American oncologists about the purposes of clinical trials. J Natl Cancer Inst. 2002;94:1847-53.
15. Taylor KM. Integrating conflicting professional roles: physician participation in randomized clinical trials. Soc Sci Med. 1992;35: 217-24.
16. National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. The Belmont Report: ethical principles and guidelines for the protection of human subjects of research. Washington: Department of Health, Education, and Welfare; 1979.
17. Blanchard CG, Labrecque MS, Ruckdeschel JC, Blanchard EB. Information and decision-making preferences of hospitalized adult cancer patients. Soc Sci Med. 1988;27:1139-45.
18. Sutherland HJ, Llewellyn-Thomas HA, Lockwood GA, Tritchler DL, Till JE. Cancer patients: their desire for information and participation in treatment decisions. J R Soc Med. 1989;82:260-3.
19. Miller FG, Brody H. A critique of clinical equipoise. Therapeutic misconception in the ethics of clinical trials. Hastings Cent Rep. 2003; 33:19-28.
20. Appelbaum PS. Clarifying the ethics of clinical research: a path toward avoiding the therapeutic misconception. Am J Bioeth. 2002;2: 22-3.
21. Ungar D, Joffe S, Kodish E. Children are not small adults: documentation of assent for research involving children. J Pediatr. 2006;149 (1 Suppl):S31-3.
22. Eder ML, Yamokoski AD, Wittmann PW, Kodish ED. Improving informed consent: suggestions from parents of children with leukemia. Pediatrics. 2007;119:6849-59.