References
- International Conference on Harmonisation. General considerations for clinical trials E8. Geneva: International Federation of Pharmaceutical Manufacturers and Associations; 1997 [cited September, 2009]. Available from: http://www.ich.org/cache/compo/276-254-1.html
- Levine RJ. Informed consent: consent issues in human research. In: Garrad Post, S. ed. Encyclopedia of Bioethics, 3rd edn. Farmington Hills, MI: Gale/MacMillan Reference Library, 2004:1280-9
- Manson NC, O'Neill O. Rethinking Informed Consent in Bioethics. Cambridge, New York: Cambridge University, 2007
- European Medicines Agency. The European Medicines Agency road map to 2015: the agency's contribution to science, medicine, health (draft for public consultation). London: European Medicines Agency; 2010 [cited March, 2010]. Available from: www.ema.europa.eu/pdfs/general/direct/directory/29989509en.pdf
- European Parliament. Directive 2001/20/EC on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use. Publications Office of the European Union; 2001 [cited October, 2008]. Available from: http://eur-lex.europa.eu/smartapi/cgi/sga_doc?smartapi!celexapi!prod!CELEXnumdoc&lg=en&model=guicheti&numdoc=32001L0020
- Eudralex Volume 9A. In: McCully S. Non-interventional Studies. Contin: Compliance Healthcheck Consulting UK; 2010 [cited 2010 Feb 1]. Available from: http://www.chcuk.co.uk/nisresources.html
- McCully S. Non-interventional studies. Contin: Compliance Healthcheck Consulting UK; 2009 [cited 2010 Feb 1]. Available from: http://www.chcuk.co.uk/nisresources.html
- International Conference on Harmonisation. Pharmacovigilance planning E2E. Geneva: International Federation of Pharmaceutical Manufacturers and Associations; 2004 [cited September, 2009]. Available from: http://www.ich.org/cache/compo/475-272-1.html#E2E
- Council for International Organizations of Medical Sciences. International Ethical Guidelines for Epidemiological Studies. Geneva, 2009
- Cuttini M, Saracci R. Commentary: Can we facilitate the ethical approval of international observational studies? Int J Epidemiol 2009;38:1108-9
- Buckley B, Murphy AW, Byrne M, et al. Selection bias resulting from the requirement for prior consent in observational research: a community cohort of people with ischaemic heart disease. Heart 2007;93:1116-20
- Al-Shahi R, Vousden C, Warlow C. Bias from requiring explicit consent from all participants in observational research: prospective, population based study. BMJ 2005;331:942
- Lemaire F. Informed consent and studies of a quality improvement program. JAMA 2008;300:1762-3
- Zoellner P, Kapp H, Smola H. A prospective, open-label study to assess the clinical performance of a foam dressing in the management of chronic wounds. Ostomy Wound Manage 2006;52:34-2
- Tu JV, Willison DJ, Silver FL, et al. Impracticability of informed consent in the Registry of the Canadian Stroke Network. N Engl J Med 2004;350:1414-21
- Miller FG, Emanuel EJ. Quality-improvement research and informed consent. N Engl J Med 2008;358:765-7
- Feinberg J. Harmless Wrongdoing. New York: Oxford University, 1990
- Feinberg J. Offense to Others. New York: Oxford University, 1985
- Beauchamp T, Childress J. Principles of Biomedical Ethics 6th edn. New York: Oxford University, 2008
- Beyleveld D, Brownsword R. Consent in the Law. Oxford: Hart, 2007
- Bielby P. Competence and vulnerability in biomedical research. Dordrecht: Springer, 2008
- Capron AM. Legal and regulatory standards of informed consent in research. In: Emanuel E, Grady C, Crouch RA, et al., eds. The Oxford Textbook of Clinical Research Ethics. New York: Oxford University, 2008:613-32
- Burgess MM. Proposing modesty for informed consent. Soc Sci Med 2007;65:2284-95
- Hansson MO. Balancing the quality of consent. J Med Ethics 1998;24:182-7
- Flory J, Wendler D, Emanuel E. Empirical issues in informed consent for research. In: Emanuel E, Grady C, Crouch RA, et al., eds. The Oxford Textbook of Clinical Research Ethics. New York: Oxford University, 2008:645-60
- Appelbaum PS, Lidz CW, Grisso T. Therapeutic misconception in clinical research: frequency and risk factors. IRB 2004;26:1-8
- Kavasery R, Maru DS, Sylla LN, et al. A prospective controlled trial of routine opt-out HIV testing in a men's jail. PLoS One 2009;4:e8056
- Hewison J, Haines A. Overcoming barriers to recruitment in health research. BMJ 2006;333:300-2
- Clark AM, Findlay IN. Attaining adequate consent for the use of electronic patient records: an opt-out strategy to reconcile individuals' rights and public benefit. Public Health 2005;119:1003-10