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Does Informed Consent Have an Expiry Date? A Critical Reappraisal of Informed Consent as a Process

Published online by Cambridge University Press:  11 January 2011

GERT HELGESSON  and
STEFAN ERIKSSON
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Extract

Informed consent is central to modern research ethics. Informed consent procedures have mainly been justified in terms of respect for autonomy, the core idea being that it should be every competent individual’s right to decide for herself whether or not to participate in scientific studies. A number of conditions are normally raised with regard to morally valid informed consent. These include that potential research subjects get adequate information, understand those aspects that are relevant to them, and, based on that information, make a voluntary decision whether or not to participate. These conditions are meant to guarantee that participation is genuinely the individual’s own choice and is coherent with his or her authentic interests.

Type
Special Section: Open Forum
Information
Cambridge Quarterly of Healthcare Ethics , Volume 20 , Issue 1 , January 2011 , pp. 85 - 92
Copyright
Copyright © Cambridge University Press 2011

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References

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3. See note 2, Beauchamp, Childress 2009 and Kihlbom 2008.

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8. See note 4, Wendler, Rackoff 2002:5.

9. See note 4, Wendler, Rackoff 2002; see note 6, Geller et al. 1997.

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11. See note 4, Wendler, Rackoff 2002.

12. See note 4, Wendler, Rackoff 2002:4.

13. See note 4, Wendler, Rackoff 2002.

14. See note 4, Wendler, Rackoff 2002:4–5.

15. See note 4, Wendler, Rackoff 2002.

16. See note 4, Wendler, Rackoff 2002.

17. See note 7, Prentice et al. 2007:2.

18. See note 7, Prentice et al. 2007:1.

19. See note 10, Eriksson, Helgesson 2005.

20. The issue of whether or not to report research results back to research subjects is complicated. It seems reasonable in some kinds of studies and not so in others. We cannot discuss this in detail here, but suggest the following general principle: If research is conducted in a clinical setting, then participating patients will most likely perceive research as part of clinical procedures (which, in a sense, it is). In such situations, research results should be reported back if they can be expected to be relevant to the treatment and care of the patient. If research is not conducted in a clinical setting, as when research is carried out on previously collected biobank samples, then results should not be reported back. Exceptions to the latter principle should be considered if consequences otherwise would be dire to those concerned. In principle, research and treatment of patients are different activities and should be treated as such when research subjects could be expected to perceive the difference (the last condition is important for the sake of people’s trust in both research and healthcare).

21. See note 4, Wendler, Rackoff 2002.

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23. See note 7, Prentice et al. 2007:2.

24. See note 7, Prentice et al. 2007:3.

25. Swartling, U, Helgesson, G. Self-assessed understanding as a tool for evaluating consent: Reflections on a longitudinal study. Journal of Medical Ethics 2008;34:557–62CrossRefGoogle ScholarPubMed; see note 10, Eriksson, Helgesson 2005.

26. Chamot, E, Charvet, AI, Perneger, TV. Variability in women’s desire for information about mammography screening: Implications for informed consent. European Journal of Cancer Prevention 2005;14:413–8CrossRefGoogle ScholarPubMed; O’Neill, O. Some limits of informed consent. Journal of Medical Ethics 2003;29:4–7CrossRefGoogle ScholarPubMed; see note 10, Eriksson, Helgesson 2005; see note 25, Swartling, Helgesson 2008.