Abstract
The participation of humans as subjects in any biomedical research is subject to ethical review of the appropriateness and value of the research, both to the individual and to society as a whole. When this research involves nuclear medicine, either as the primary focus of research or as an adjunct, considerations of the risks associated with the exposure to ionizing radiation must be taken. This chapter reviews the ethics of clinical studies involving humans, with an emphasis upon studies incorporating nuclear medicine.
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Notes
- 1.
The benefit may not necessarily accrue to the participant in the study but can reflect a societal benefit.
- 2.
The full title is the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) and which is a program which brings together regulatory authorities and representatives from the pharmaceutical industry from the European Union, Japan and the United States. It may be found at: http://www.ich.org.
- 3.
The Directive may be found at http://euopa.eu/eur-lex/pri/en/oj/dat/2001/l_121/l_12120010501en00340044.pdf.
- 4.
An example, in the UK, being The Medicines for Human Use (Clinical Trials) Regulations 2004.
- 5.
The current version of the Declaration of Helsinki may be found at http://www.wma.net/e/policy/b3.htm.
- 6.
Of interest is the proposal by Huda and Scrimger (1989) of a limit of 50 mSv to be applied to healthy volunteers participating in a nuclear medicine study. Such a value would not be tolerated in this era for healthy volunteers however it is possible to consider scenarios (e.g., studies involving multiple PET/CT examinations of patients with late-stage cancer) where such a limit might be considered acceptable in a clinical trial.
- 7.
ICRP Publication 62 characterized the total detriment due to ionizing radiation exposure to be 2–3 times greater in children than in adults and, for adults aged 50 years or more, to be 10–20% of that of younger adults. This reflects the difference between the latency period for a radiogenic cancer to express itself in the irradiated adult and the normal life expectancy of the same.
- 8.
This recommendation by the ICRP clearly cannot be followed if the therapeutic radionuclide emits solely charged particles without any photon emissions that can aid external assessment of the biodistribution.
References
Huda W, Scrimger JW (1989) Irradiation of volunteers in nuclear medicine. J Nucl Med 30:260–264
ICH (1996) ICH tripartite guideline for good clinical practice E6(R1). International Conference on Harmonisation of Technical Requirements for Registration of Pharamecuticals for Human Use, Geneva
ICRP (1991) Radiological protection in biomedical research – ICRP Publication 62. International Commission on Radiological Protection. Pergamon, Oxford
WHO (1977) Use of ionizing radiation and radionuclides on human beings for medical research, training, and nonmedical purposes – WHO Technical Report Series 611. World Health Organization, Geneva
WMA (2008) World Medical Association Declaration of Helsinki – ethical principles for medical research involving human subjects. http://www.wma.net/e/policy/pdf/17c.pdf
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McParland, B.J. (2010). The Ethics of Using Human Subjects in Clinical Trials Involving Radiopharmaceuticals. In: Nuclear Medicine Radiation Dosimetry. Springer, London. https://doi.org/10.1007/978-1-84882-126-2_16
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DOI: https://doi.org/10.1007/978-1-84882-126-2_16
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