1. Guidelines around the world use different terms to refer to such research. The CIOMS and Kenyan guidelines refer to ‘biomedical’ research, while the Ugandan guidelines consider ‘health’ research and the U.S. guidelines cover ‘human subjects’ research. For present purposes, we can consider these terms to be essentially equivalent and need not consider the extent to which the various regulations may cover somewhat different activities.
2. R.R. Faden & T.L. Beauchamp.A History and Theory of Informed Consent.New York: Oxford University Press, 1986: 274; T.L. Beauchamp & J.F. Childress.Principles of Biomedical Ethics, 5th edition. New York: Oxford University Press, 2001.
3. National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research.The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research.Washington, DC: U.S. G.P.O.: 1979:5.
4. Clinical Trials and Medical Care: Defining the Therapeutic Misconception
5. International Conference on Harmonization. Good Clinical Practices. E6 4.8.10. Available at: http://www.emea.eu.int/pdfs/human/ich/013595en.pdf.