Abstract
Whenever a clinical trial is being designed, the ethical implications have to be considered. All trials have to fulfill the general guidance issued in the declaration of Helsinki, Edinburgh Amendment 2000.1 This has been enshrined in Good Clinical Practice (GCP) guidelines that have been produced by the International Committee for Harmonization (ICH) and adopted by the Food and Drug Administration (FDA) for the USA2 and the Committee for Proprietary Medicinal Products (CPMP) within Europe.3 These cover issues that researchers must consider, such as:
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The anticipated benefit of the trial to the individual subject and society must outweigh the foreseeable risks and inconveniences.
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The protection of the trial subject, which should be the most important consideration.
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The responsibilities of the Institutional Review Board/Independent Ethics Committee (IRB/IEC).
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The responsibilities of the investigator and sponsor.
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The informed consent of the trial subjects.
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The study protocol and investigator’s brochure and the essential documentation required to undertake a clinical trial.
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References
Recommendations Guiding Medical Doctors in Biomedical Research Involving Human Subjects. Adopted by the 18th World Medical Assembly, Helsinki, Finland 1964 and revised by the 52nd World Medical Assembly, Edinburgh, 2000. (Available at http://www.wma.net/e/policy/17c_e.html)
International Conference on Harmonization: Guidelines for Good Clinical Practice. Federal Register 1997; 62: 25691 - 709. ( Available at http://www.fda.gov/cder/guidance/959fnl.pde
The Committee for Proprietary Medicinal Products: Step 5 Note for Guidance on Good Clinical Practice(CPMP adopted July 96): CPMP/ICH/135/95 available at http://www.emea.eu.int/pdfs/human/ich/013595en.pdf or in Volume III of the Rules Governing Medicinal Products in the European Union.
Cummins SR, Black DM, Thompson DF et al. Effect of alendronate on risk of fracture in women with low bone density but without vertebral fractures: results from the Fracture Intervention Trial. JAMA 1998; 280: 077–82.
Harris ST, Watts NB, Genant HK et al. Effects of risedronate treatment on vertebral and nonvertebral fractures in women with postmenopausal osteoporosis. JAMA 1999; 282: 1344–52.
Ettinger B, Black DM, Mitlak BH et al. Reduction of vertebral fracture risk in postmenopausal women with osteoporosis treated with raloxifene: results from a 3-year randomized clinical trial. JAMA 1999; 282: 637–45.
Marshall D, Johnell O, Wedel H. Meta-analysis of how well measures of bone mineral density predict occurrence of osteoporotic fractures. BMJ 1996; 312: 1254–9.
Britton A, McKee M, Black N et al. Choosing between randomised and non-randomised studies: a systematic review. Health Technol Assess 1998;2(13).
Brevin CR, Bradley C. Patient preferences and randomised clinical trials. BMJ 1989; 299: 313–15.
Cooper RG, Grant AM, Garratt AM. The impact of using a partially randomised patient preference design when evaluating alternative managements for heavy menstrual bleeding. Br J Obstet Gynaecol 1997; 104: 1367–73.
Njeh CF, Apple K, Temperton DH, Boivin CM. Radiological assessment of a new bone densitometer the Lunar Expert. Br J Radiol 1996; 69: 335–40.
Njeh CF, Fuerst T, Hans D, Blake GM, Genant HK. Radiation exposure in bone mineral density assessments. Appl Radiat Isot 1999; 50: 215–36.
Recommendations of the International Commission on Radiation Protection, ICRP Publication 60, Ann ICRP 1991; 21: 1–77.
Radiation Protection 99. Guidance on medical exposures in medical and biomedical research. European Commission. Luxembourg: Office for Official Publications of the European Communities, 1998.
Protection of human subjects; Belmont Report: notice of report for public comment. Federal Register 1979;44:23191–7. (Available at: http://grants.nih.gov/grants/oprr/humansubjects/guidance/belmont.htm)
Code of Federal Regulations 50.20 General requirements for informed consent. (A copy and guidance is available at http://www.fda.gov/cdrh/manual/irninv.html)
Kent G. The views of members of Local Research Ethics Committees, researchers and members of the public towards the roles and functions of LRECs. J Med Ethics 1997; 23: 186–90.
Grainge MJ, Coupland CA, Cliffe SJ, Chilvers CE, Hosking DJ. Cigarette smoking, alcohol and caffeine consumption, and bone mineral density in postmenopausal women. The Nottingham EPIC Study Group. Osteoporos Int 1998; 8: 355–63.
Jadad A. Randomised Controlled Trials. London: BMJ Books, 1998.
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© 2002 Springer-Verlag London
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Pearson, D., Miller, C.G. (2002). Ethical Considerations. In: Pearson, D., Miller, C.G. (eds) Clinical Trials in Osteoporosis. Springer, London. https://doi.org/10.1007/978-1-4471-3710-8_3
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DOI: https://doi.org/10.1007/978-1-4471-3710-8_3
Publisher Name: Springer, London
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