Abstract
Chapter 16 addresses what happens when the risk-benefit ratio changes during the course of the research project. If the risk rises during the course, may it then become disproportionate and unacceptable? Should the research project then be stopped or may the researcher carry on because they had an initial approval?
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Notes
- 1.
Paragraph 127.
- 2.
Paragraph 127.
- 3.
Report on the Norwegian Meningococcal B Vaccine Trial (2007, pp. 148–150).
- 4.
The trial, including the risks, burdens, and potential benefits, are accounted for in Sections 11.3 and 11.4.
- 5.
Trotta et al. (2008, p. 1347).
- 6.
In Norway this follows from § 23 and § 24 in the Norwegian Health Research Act.
References
Report on the Norwegian Meningococcal B Vaccine Trial 2007: Ad hoc investigatory commission appointed by the Norwegian Ministry of Health. Report on the Norwegian Meningococcal B Vaccine Trial. Oslo: Ministry of Health.
Trotta, F. et al. 2008. Stopping a trial early in oncology: For patients or for industry? Annals of Oncology 19:1347–1353.
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Simonsen, S. (2012). Later Developments During the Course of the Research. 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_16
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DOI: https://doi.org/10.1007/978-94-007-2678-9_16
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