Abstract
Chapter 14 addresses topical questions concerning randomized clinical trials (RCT), including the use of placebo in controlled clinical trials. The assessment of proportionality becomes more complicated when participation in research consists of multiple alternatives, typically because the participants will be divided into several groups, where each group will be subject to different interventions, and thus different risks, burdens and potential benefits. The legal framework concerning the use of placebo is investigated, and the assessment of acceptable risk randomized clinical trials is clarified.
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Notes
- 1.
See, for example, Wendler (2009a); Mangset et al. (2008, 2009); see Section 5.4.3.
- 2.
- 3.
Cf. Chapters 11 and http://12.
- 4.
Cf. Section 3.8 where “vulnerable person” is defined.
- 5.
See Jones (1993); accounted for in Section 4.5.3.
- 6.
As described in Chapters 10, http://11, and http://12.
- 7.
Paragraph 120.
- 8.
Rothman (2000, p. 444).
- 9.
Rothman (2000, p. 444).
- 10.
This issue is addressed in the Commentary on Guideline 11 of the CIOMS Guidelines; see also The Nuffield Council on Bioethics [UK], The Ethics of Research Related to Healthcare in Developing Countries, 2002. A starting point it is clear that the law as clarified here also applies when doing biomedical research in developing countries, see Article 29 of the Additional Protocol and CIOMS Guidelines.
- 11.
§ 2-1 of the Norwegian Patients’ Rights Act of 1999 state: “The patient is entitled to emergency care …” [public, but unofficial, translation]; See Kjønstad (2005a, pp. 137–211).
- 12.
Kjønstad (2005a, pp. 171–174).
- 13.
Bergkamp (2004, p. 63).
- 14.
Mangset et al. (2009).
- 15.
See, for example, Wendler (2009a) (Must research participants understand randomization?).
- 16.
See, for example, Cyna et al. (2011).
- 17.
The placebo vaccine consisted of: Aluminium hydroxide (0.33%); Thimersalnatrium (0.01%); Sukrole 3% injection fluid ad (0.5 ml). The active vaccine also consisted of Outer membrane protein (25 μg).
- 18.
Cf. Chapters 11 and http://12.
- 19.
Rothman (2000).
- 20.
Paragraph 121.
- 21.
CIOMS Guidelines: “Placebo may be used: when there is no established effective intervention”; The Declaration of Helsinki : ”The use of placebo, or no treatment, is acceptable in studies where no current proven intervention exists”.
- 22.
Accounted for in Section 13.1.
- 23.
See Chapter 11.
- 24.
Case 4.2006.2893 REC Middle Norway.
- 25.
Researchers application to REC.
- 26.
These limits have been clarified above in Chapters 9, http://10, http://11, http://12, and http://13.
- 27.
Cf. the discussion in Section 10.3.8.
- 28.
Cf. Chapter 10.
- 29.
Cf. Chapters 11, http://12, and http://13.
- 30.
Cf. Chapters 11, http://12, and http://13.
- 31.
Cf. Section 10.3.6.
- 32.
Cf. Section 5.4.4.
- 33.
See Section 5.2.5.
- 34.
The US National Bioethics Advisory Commission, Final report (2007, pp. 79 et seq.).
- 35.
Discussed in Section 10.3.8 above.
- 36.
See Chapters 7 and http://8.
- 37.
ECtHR Olsson v. Sweden A 130 (1988).
- 38.
See Chapter 7 above that investigates which risks, burdens and potential benefits that are relevant in the assessment of proportionality.
- 39.
Cf. Chapter 5.
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.
Cyna, A.M., D. Costi, and P. Middleton. 2011, June 14. Wiewpoint: Randomised controlled trials using invasive ‘placebo’ controls are unethical and should be excluded from Cochrane Reviews. Cochrane Database of Systematic Reviews 8:ED000029.
Jones, J.H. 1993. Bad blood. The scandalous story of the Tuskegee experiment – when government scientists played God and science went mad. New York, NY: Free Press/Collier Macmillan.
Kjønstad, A. 2005a. Helserett. Oslo: Gyldendal.
Mangset, M., E. Berge, R. Førde, J. Nessa, and T.B. Wyller. 2009. “Two per cent 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. Journal of Medical Ethics 35:42–46.
Mangset, M., R. Førde, J. Nessa, E. Berge, and T.B. Wyller. 2008. “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 34:751–756.
Rothman, K.J. 2000. Declaration of Helsinki should be strengthened. BMJ 321:442–445.
Wendler, D. 2009a. Must research participants understand randomization? American Journal of Bioethics 9:3–8.
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Simonsen, S. (2012). Especially on Randomised Clinical Trials, Including Placebo Controlled Clinical Trials. 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_14
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