Informed consent as an ethical requirement in clinical trials: an old, but still unresolved issue. An observational study to evaluate patient's informed consent comprehension

Author:

Sanchini Virginia,Reni Michele,Calori Giliola,Riva Elisabetta,Reichlin Massimo

Publisher

BMJ

Subject

Health Policy,Arts and Humanities (miscellaneous),Issues, ethics and legal aspects,Health (social science)

Reference25 articles.

1. National Institutes of Health. Nuremberg Code. Office of Human Subjects Research. Trials of war criminals before the Nuremberg military tribunals under Control Council Law no 10, vol 2, pp 181e182. Washington, DC: US Government Printing Office, 1949. history.nih.gov/research/downloads/nuremberg.pdf (accessed 19 Sep 2012).

2. World Medical Association. Declaration of Helsinki, ethical principles for medical research involving human subjects, revised October 2008. http://www.wma.net/en/30publications/10policies/b3/index.html (accessed 19 Sep 2012).

3. Council of Europe. Convention for the protection of Human Rights and dignity of the human being with regard to the application of biology and medicine: Convention on Human Rights and Biomedicine, Oviedo 1997. http://conventions.coe.int/Treaty/en/Treaties/Html/164.htm (accessed 19 Sep 2012).

4. 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 Biomedical and Behavioral Research. DHEW Publication N. 78-0012, Washington, 1978. http://www.hhs.gov/ohrp/humansubjects/guidance/belmont.htm (accessed 19 Sep 2012).

5. Council for International Organizations of Medical Sciences (CIOMS) in collaboration with the World Health Organization (WHO), International Ethical Guidelines for Biomedical Research Involving Human Subjects, Ginevra 2002. http://www.cioms.ch/publications/guidelines/guidelines_nov_2002_blurb.htm (accessed 19 Sep 2012).

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