References
- Lader E, Cannon CP, Ohman MO, et al. The clinician as investigator. Participating in clinical trials in the practice setting. Circulation 2004; 109: 2672–9.
- Robertson K, Gan TJ. Clinical research and good clinical practice. Best Practice and Research Clinical Anaesthesiology 2001; 15(4): 655–67.
- Hukkanen J, Jacob P III, Benowitz NL. Metabolism and disposition kinetics of nicotine. 2005. 57(1): 79–115.
- Acosta C, Galindo CM, Ochiai RL, et al. Implementation of good clinical practice guidelines in vaccine trials in developing countries. Vaccine 2007; 25: 2852–7.
- WHO. Handbook for Good Clinical Practice (GCP). Guidance for implementation, World Health Organization; 2002. Geneva. Switzerland.
- ICH. ICH Harmonised Tripartite Guideline for GCP, Institute of Clinical Research. Medicine and Healthcare Products Agency (MHRA); 1996. London, United Kingdom.
- The Nuremburg Code. Trials of War Criminals before the Nuremberg Military Tribunals under Control Council Law No. 10”, Vol. 2, pp. 181–182.
- Washington, D.C.: U.S. Government Printing Office, 1949.
- The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research (1979), Report of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. Commissioned by Department of Health, Education and Welfare. US Department of Justice.
- Farthing M. Research misconduct. Gut 1997; 41: 1–2.
- Gilbert F, Denison AR. Research misconduct. Clin Radiol 2003; 58(7): 499–504.
- CIOMS. International Ethical Guidelines for Biomedical Research Involving Human Subjects. Geneva: The Council for International Organisations of Medical Sciences; 2005.
- WHO. Developing the Ethical Review Process. TDR News 2002; 61.
- Benatar S, Singer PA. A new look at international research ethics. BMJ 2000; 321(7264): 824–6.
- Beauchamp T, Childress JF. Principles of Biomedical Ethics. New York: Oxford University Press; 1994.
- Touitou Y, Portaluppi F, Smolensky MH, Rensing L. Ethical principles and standards for the conduct of human and animal biological rhythm research. Chronobiology international 2004 Jan; 21(1): 161–70.
- Appelbaum P, Grisso T. Assessing patients' capacities to consent to treatment. N Engl J Med 1988; 319: 1635–8.
- Roberts LW. Informed consent and the capacity for voluntarism. Am J Psychiatry 2002; 159(5): 705–12.
- CIOMS. Management of Safety Information from Clinical Trials, Report of CIOMS Working Group VI. Identification and Evaluation of Risk from Clinical Trial Data; 2005.
- Zimmerman J. The importance of standard operating procedures for investigators. Available from www.impactcg.com/docs/SOCRA_11.99_SOPs.pdf. (Accessed 17th June 2008)