Postgraduate Training Course in Reproductive Health/Chronic Disease

Ethical issues in research – informed consent

Effy Vayena, PhD

See presentation

BIBLIOGRAPHY

On-line sources:

• Helsinki Declaration (http://www.wma.net/e/policy/17-c_e.html)
• International Ethical Guidelines for Biomedical Research Involving Human Subjects, CIOMS, 2002 (http://www.cioms.ch/frame_guidelines_nov_2002.htm)
• Report: The ethics of research related to healthcare in developing countries, Nuffield Council of Bioethics, 2002 (http://www.nuffieldbioethics.org/publications/pp_0000000013.asp)
• University of Minnesota Web-based instruction on informed consent (http://www.research.umn.edu/consent/orientation.html)
• Family Health International: On-line research ethics training curriculum
  (http://www.fhi.org/en/topics/ethics/curriculum/intro.htm)
• Operational Guidelines for Committees that Review Biomedical Research, WHO, 2002 (http://www.who.int/tdr/publications/publications/ethics.htm)

Other selected references:

• Angell M. The ethics of clinical research in the third world. New England Journal of Medicine 1997;337:847-49.
• Emanuel EJ, Wendler D, Grady C. What makes clinical research ethical? JAMA 2000 May;283:2701-11.
• Holmes-Rovner M. Improving informed consent; insights from behavioral decision research. Medical Care 2002;40:V30-V38.
• Koski G. Risk, benefits, and conflicts of interest in human research: ethical evolution in the changing world of science. Journal of Law and Ethics 2000;28:300-31.
• Macklin R. Understanding informed consent. Acta Oncologica 1999;38:83-87.
• Sanchez S. et al. Informed consent procedures: responsibilities of researchers in developing countries. Bioethics 2001; 15:398-412.