Abstract
Chapter 13 addresses the special situation where research participation is an alternative to ordinary clinical care. A circumstance that may render the risks and burdens unacceptable and disproportionate, is that the research interfere with necessary clinical interventions and delay or deprive the participant of medically necessary treatment, which consequently harm the participant because he or she does not receive the necessary treatment. The implication of this and the legal framework addressing this issue explicitly is discussed.
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- 1.
This follows from Article 23 (1) as well as the principle of human primacy in Article 3 of the Additional Protocol and Article 2 (1) of the GCP Directive; cf. Section 5.2.5.
- 2.
Cf. Section 5.3.2 on researchers general duty of care.
- 3.
Cf. Section 10.3.6.
- 4.
REC Middle Norway Case 4.2007.1683.
- 5.
Accounted for in Section 11.3.
- 6.
Accounted for in Section 14.4.2.
- 7.
See Section 11.4.4 where the liver biopsy example is discussed more extensively.
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© 2012 Springer Science+Business Media B.V.
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Simonsen, S. (2012). Non-interference with Necessary Clinical Interventions and The No Harm Rule . In: Acceptable Risk in Biomedical Research. International Library of Ethics, Law, and the New Medicine, vol 50. Springer, Dordrecht. https://doi.org/10.1007/978-94-007-2678-9_13
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DOI: https://doi.org/10.1007/978-94-007-2678-9_13
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