"I don't like that, it's tricking people too much...": Acute informed consent to participation in a trial of thrombolysis for stroke

Journal of Medical Ethics

Volumn 34, Issue 10, 2008, Pages 751-756

  Mangset, M ^a   Forde R ^a   Nessa, J ^b   Berge, E ^c   Bruun Wyller, T ^a  

^a UNIVERSITY OF OSLO   (Norway)

^b UNIVERSITY OF BERGEN   (Norway)

^c ULLEVÅL UNIVERSITY HOSPITAL   (Norway)

Author keywords

[No Author keywords available]

Indexed keywords

AGED; ARTICLE; ETHICS; FEMALE; FIBRINOLYTIC THERAPY; HUMAN; HUMAN EXPERIMENT; INFORMED CONSENT; MALE; MENTAL CAPACITY; MIDDLE AGED; NORWAY; PATIENT SELECTION; PSYCHOLOGICAL ASPECT; RANDOMIZED CONTROLLED TRIAL; RESEARCH SUBJECT; STANDARD; STROKE;

AGED; AGED, 80 AND OVER; FEMALE; HUMANS; INFORMED CONSENT; MALE; MENTAL COMPETENCY; MIDDLE AGED; NORWAY; PATIENT SELECTION; RANDOMIZED CONTROLLED TRIALS AS TOPIC; RESEARCH SUBJECTS; STROKE; THERAPEUTIC HUMAN EXPERIMENTATION; THROMBOLYTIC THERAPY;

EID: 56749157971     PISSN: 03066800     EISSN: 14734257     Source Type: Journal    
DOI: 10.1136/jme.2007.023168     Document Type: Article

References (27)

1. Ruyter KW. Det informerte samtykket i medisinsk forskning - mellom selvråderett og beskyttelse. In: Ruyter KW, ed. Forskningsetikk. Beskyttelse av enkeltpersoner og samfunn. Oslo: Gyldendal Akademisk, 2003:109-29.
2. Beauchamp T, Childress JF. Principles of biomedical ethics. New York: Oxford University Press, 2001:77-80.
3. Appelbaum PS, Roth LH, Lidz C. The therapeutic misconception: informed consent in psychiatric research. Int J Law Psychiatry 1982;5:319-29.
4. Snowdon C, Garcia J, Elbourne D. Making sense of randomization; responses of parents of critically ill babies to random allocation of treatment in a clinical trial. Soc Sci Med 1997;45:1337-55.
5. Featherstone K, Donovan JL. "Why don't they just tell me straight, why allocate it?" The struggle to make sense of participating in a randomised controlled trial. Soc Sci Med 2002;55:709-19.
6. Gammelgaard A, Rossel P, Mortensen OS. Patients' perceptions of informed consent in acute myocardial infarction research: a Danish study. Soc Sci Med 2004;58:2313-24.
7. Ågård A, Hermerén G, Herlitz J. Patients' experiences of intervention trials on the treatment of myocardial infarction: is it time to adjust the informed consent procedure to the patient's capacity? Heart 2001;86:632-7.
8. Bosk CL. Obtaining voluntary consent for research in desperately ill patients. Med Care 2002;40(Suppl 9):P64-8.
9. Luce JM. Is the concept of informed consent applicable to clinical research involving critically ill patients? Crit Care Med 2003;31(Suppl 3):P153-60.
10. World Medical Association. Declaration of Helsinki. 2007. http://www.wma.net/e/policy/b3.htm (accessed June 2008).
11. Blixen CE, Agich GJ. Stroke patients' preferences and values about emergency research. J Med Ethics 2005;31:608-11.
12. Koops L, Lindley RI. Thrombolysis for acute ischaemic stroke: consumer involvement in design of new randomised controlled trial. BMJ 2002;325:415-17.
13. Donovan J, Mills N, Smith M, et al. Quality improvement report: improving design and conduct of randomised trials by embedding them in qualitative research: ProtecT (prostate testing for cancer and treatment) study. Commentary: presenting unbiased information to patients can be difficult. BMJ 2002;325:766-70.
14. Mangset M, Berge E, Førde R, et al. Two percent isn't a lot, but when it comes to death it seems quite a lot anyway: patients' perception of risk and willingness to accept risks associated with thrombolytic drug treatment for acute stroke. J Med Ethics 2008;34:
15. Malterud K. Shared understanding of the qualitative research process. Guidelines for the medical researcher. Fam Pract 1993;10:201-6.
16. Giorgi A. Sketch of a psychological phenomenological method. In: Giorgi A, ed. Phenomenology and psychological research. Pittsburgh: Duquesne University Press, 1985:8-22.
17. Miller FG, Brody H. A critique of clinical equipoise. Therapeutic misconception in the ethics of clinical trials. Hastings Cent Rep 2003;33:19-28.
18. Kass NE, Sugarman J, Faden R, et al. Trust, the fragile foundation of contemporary biomedical research. Hastings Cent Rep 1996;26:25-9.
19. Stead M, Eadie D, Gordon D, et al. "Hello, hello - it's English I speak!": a qualitative exploration of patients' understanding of the science of clinical trials. J Med Ethics 2005;31:664-9.
20. Nessa J. Autonomy and dialogue: about the patient-doctor relationship. In: Thomasma DC, Weisstub DN, Hervé C, eds, Personhood and health care. Dordrecht, The Netherlands: Kluwer Academic Publishers 2001:355-62.
21. Joffe S, Manocchia M, Weeks JC, et al. What do patients value in their hospital care? An empirical perspective on autonomy centred bioethics. J Med Ethics 2003;29:103-8.
22. Mann H. Thrombolysis for acute ischaemic stroke. Trial participants need to be informed of uncertainty principle. BMJ 2002;325:1363.
23. Kassirer JP. Incorporating patients' preferences into medical decisions. N Engl J Med 1994;330:1895-6.
24. O'Meara JJ, McNutt RA, Evans AT, et al. A decision analysis of streptokinase plus heparin as compared with heparin alone for deep-vein thrombosis. N Engl J Med 1994;330:1864-9.
25. Fleck LM, Hayes OW. Ethics and consent to treat issues in acute stroke therapy. Emerg Med Clin North Am 2002;20:703-15, vii-viii.
26. Schmitz D, Reinacher PC. Informed consent in neurosurgery - translating ethical theory into action. J Med Ethics 2006;32:497- 8.
27. Tranøy K. Medisinsk etikk i vår tid. Bergen: Sigma Forlag, 1994:106-8.