Abstract
Chapter 15 addresses what level of risk and burdens it is acceptable to expose others than the participant to, such as family members of the research participants, the environment, the society and other people. The question is not explicitly addressed in the existing legal instruments, but the answer can be derived from the more general principals identified earlier in this book.
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Notes
- 1.
Note that the relevancy of risks and burdens to others presupposes that both causes in fact and causes in law (proximity of cause) can be established, cf. Chapter 7.
- 2.
Cf. Chapter 10.
- 3.
See http://Section 5.2.4.
- 4.
Slovic (2000); the risk of dying in any one year from the release of radiation from nearby nuclear power station is approximately 1 in 10 000 000 (BMJ Living with Risk 1987, p. 23).
- 5.
Resnik and Sharp (2006).
- 6.
Bergkamp (2004, p. 65).
- 7.
See World Commission on the Ethics of Scientific Knowledge and Technology (COMEST) (2005, p. 22).
- 8.
EU communications (2000).
- 9.
Cf. http://Section 7.3 which discusses the concept of “(known) unknown risks”.
- 10.
Accounted for in http://Section 11.4.5.
- 11.
Cf. http://Section 8.4.
References
Bergkamp, L. 2004. Medical research involving human beings: Some reflections on the main principles of the international regulatory instruments. European Journal of Health Law 11:61–69.
Resnik, D.B., and R.R. Sharp. 2006. Protecting third parties in human subjects research. IRB 28:1–7.
Slovic, P. 2000. The perception of risk. London: Earthscan Publications.
European Commission. 2000. Communication on the Precautionary Principle, adopted January 2000.
World Commission on the Ethics of Scientific Knowledge and Technology (COMEST). 2005. The precautionary principle. Paris: UNESCO.
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Simonsen, S. (2012). Acceptable Risks and Burdens to Others than the Participant. 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_15
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