Syllabus/achievement requirements

Mandatory readings

• Ballantyne A, How to Do Research Fairly in an Unjust World, The American Journal of Bioethics, 2010; 6: 26-35.
• Benatar, S.R. (2002). Reflections and recommendations on research ethics in developing countries. Social Sience and Medicine 54; 1131-1141.
• Emanuel, E. et al (2004). Participants in the 2001 conference on ethical aspects of research in developing countries, moral standards for research in developing countries: From ¡®reasonable availability¡¯ to ¡®fair benefits,¡¯. Hastings Center Report 2004, 34 (3), 17¨C27.
• R. Cash, D. Wikler, A. Saxena and A. Capron (Eds.). Case Book on Ethical Issues in International Health Research. WHO 2009, 212 pp.
• Carse, A. L., & Little, M. O. Exploitation and the enterprise of medical research. In J. Hawkins & E. Emanuel (Eds.), Exploitation. Princeton University Press: Princeton & Oxford: 206-245.
• Dawson AJ. Ebola: what it tells us about medical ethics. J Med Ethics 2015,41:1 107-110.
• Gordijn B, ten Have H. Disaster Ethics. Med Health Care and Philos (2015) 18:1¨C2.
• Gordijn, ten Have H. The methodological rigor of anticipatory bioethics. Medicine, Healthcare and Philosophy 2014; 17, 3: 323-324.
• London AJ. Justice and the human development. Approach to international research
• Hasting Center Report 2005, 35(1), 24¨C37.
• Mallia P. Towards an ethical theory in disaster situations. Medicine, Health Care and Philosophy 2015, 18, 1: 3-11.
• Marshall A, Batten S. Researching Across Cultures: Issues of Ethics and Power. FQS, Volume 5, No. 3, Art. 39, 2004.
• Molyneux, C. S., D.R. Wassenaar Peshu, N., & Marsh, K. (2005). Even if they ask you to stand by a tree all day, you will have to do it (laughter)y!¡¯: Community voices on the notion and practice of informed consent for biomedical research in developing countries, Social Science & Medicine, 61, 443¨C454).
• O¡¯Math¨²na DP. Conducting research in the aftermath of disasters: ethical considerations. Journal of evidence bases medicine, 2010, 3,2: 65-75 (accessible at: http://onlinelibrary.wiley.com/doi/10.1111/j.1756-5391.2010.01076.x/full).
• O¡¯Math¨²na DP. Research ethics in the context of humanitaria emergencies. Journal of evidence bases medicine, 2015, 8, 1: 31-35 (accessible at: http://onlinelibrary.wiley.com/doi/10.1111/jebm.12136/epdf).
• Patr?o Neves, M (2009). Respect for human vulnerability and personal integrity. In. H.A.M.J. ten Have and Jean, MS (Eds.). The UNESCO Universal Declaration on Bioethics and Human rights. Background, principles and application. UNESCO Publishing, Paris: 155-164.
• Sanjari M et al. Ethical challenges of researchers in qualitative studies: the necessity
• to develop a specific guideline. Journal of Medical Ethics and the History of Medicine, 7,14, 2014.
• Solbakk, J.H. (2011). In the ruins of Babel: Pitfalls on the way towards a universal language for research ethics and benefit sharing, Cambridge Quarterly of Health Care Ethics, 20: 341-355.
• Solbakk, J.H (2011). The principle of respect for human vulnerability and global bioethics. In: Chadwick R, ten Have H and Meslin E. (Eds), The SAGE Handbook of Health Care Ethics: Core and Emerging Issues. SAGE, Los Angeles/London/New Delhi/Singapore/Washington DC: 228-238.
• Solbakk JH, Vidal SM. Clinical research in resource-poor settings. In: H. ten Have & B. Gordijn. Compendium and Atlas of Global Bioethics. Springer, 2014: 527-550.
• Sumathupala A et al. Ethical issues in post-disaster clinical interventions and research: A developing world perspective. Key findings from a drafting and consensus generation meeting of the Working Group on Disaster Research and Ethics (WGDRE) 2007. Asian Bioethics Review, 2010, 2.2: 124-142

Optional readings

• Glickman, S. W., McHutchison, J. G., Peterson, E. D., Cairns, C. B., Harrington, R. A., Califf, R. M., et al. (2009). Ethical and scientific implications of the globalization of clinical research. The New England Journal of Medicine, 360, 816¨C823.
• Collogan LK et al. Ethical issues pertaining to research in the aftermath of disaster. Journal of Traumatic Stress, 2004, 17.5: 363-372.
• Grady, c. (2015).Enduring and Emerging Challenges of Informed Consent, NEJM, 372;9, 2015: 855-862.
• Hofmann, B (2009). Broadening consent - and diluting ethics? J Med Ethics;35:125-129 doi:10.1136/jme.2008.024851.
• Kilpatrick DG. The Ethics of Disaster Research: A Special Section. In: Journal of Traumatic Stress, 2004, 17.5: 361-362.
• Kodama S. Tsunami-tendenko and morality in disasters. J Med Ethics 2015, 41:5 361-363.
• Lie RK, Emanuel E, Grady C, Wendler D. The standard of care debate: the Declaration of Helsinki versus the international consensus opinion. J med Ethics 2004;30: 190-93.
• London, A. J. Justice and the human development. Approach to international research.
• Hasting Center Report 2005, 35(1), 24¨C37.
• Macklin, R. (2003). Bioethics, vulnerability, and protection. Bioethics 17(5¨C6): 472¨C486.
• Macklin, R. (2004). Double standards in medical research in developing countries (pp. 99¨C130). Cambridge: Cambridge University Press 2004.
• Nussbaum, M. C. (2011). Creating Capabilities. The Human Development Approach. Cambridge, MA, London UK: The Belknap Press of Harvard University Press.
• Pogge T. W. M. (2008). World poverty and human rights. (2nd ed.). Cambridge: Polity Press.
• Schuklenk U, Aschcroft R. International research ethics. Bioethics 2000;14:158-72.
• Solbakk, J.H. (2011). In the ruins of Babel: Pitfalls on the way towards a universal language for research ethics and benefit sharing, Cambridge Quarterly of Health Care Ethics, 20: 341-355.
• Sreenivasan G. Justice, Inequality, and Health. Stanford Encyclopedia  of Philosophy, 2014, 20 pp.
• Tindana P, Kass N, Akweongo p. The Informed Consent Process in a Rural African Setting: A Case Study of the Kassena-Nankana District of Northern Ghana; IRB Ethics and Human research 2006; 28:1-6.
• Wertheimer, A. (2008). Exploitation in clinical research. In S. Hawkins & E. J. Emanuel (Eds.). Exploitation and developing countries. The ethics of clinical research (pp. 63¨C104). Princeton 2008.

Reports

• International Bioethics Committee. Draft preliminary report on traditional medicine and its ethical implications. UNESCO, Paris 2010.
• Leach B, Paluzzi JE, Monderi P. Prescription for healthy development: increasing access to medicines. N Millenium Project. Task force on HIV/AIDS, Malaria, TB and Access to Essential Medicines. Working Group on Asccess to Essential Medicines, 2005.
• Matsoso P, Auton M, Banoo S, Fomundam H, Leng H, & Noazin S. (2005). How does the regulatory framework affect incentives for research and development? study commissioned for the Commission on Intellectual Property Rights, Innovation and Public Health (CIPIH): World Health Organization; 2005. Accessible at: http://www.who.int/intellectualproperty/studies/Study5. Pdf).
• Nuffield Council on Bioethics. (2002). The ethics of research related to healthcare in developing countries. London: Nuffield Council on Bioethics Ed.
• WHO Traditional Medicine Strategy 2002-2005, Geneva 2005.

Declarations and guidelines

• Animal experimentation guidelines. International Association for Assessment and Accreditaion of Laboratory Animal Care.
• WMA Declaration of Helsinki
• UNESCO Universal Declaration on Bioethics and Human Rights
• Vancouver Guidelines on authorship
• The Nuremberg Code
• CIOMS International Guidelines for Biomedical Research
• WHO Operational Guidelines for RECs
• ICHGCP Guidelines
• The Belmont Report
• The Oviedo Convention on Biomedicine and Human Rights