Mandatory readings (all available on Fronter):
- Lesson 1: History of Medical Research Ethics, Codes and Guidelines
- Lesson 2: Informed consent
- Lesson 3: Involvement and protection of vulnerable populations in research
- Lesson 4: Confidentiality, protection of privacy and genetic research
- Lesson 5: Risk Benefit to participants in research
- Lesson 6: Review by the Research Ethics Committee
- Lesson 7: Research Misconduct
Optional readings (all available on Fronter):
Benatar, S.R. (2002). Reflections and recommendations on research ethics in developing countries. Social Sience and Medicine 54; 1131-1141.
Beynum, W. (1988). Reflection on the History of Human Experimentation, in S.F. Spikler, I. Alon, A. de Vries, and H.T Engelhardt (eds ): The Use of Human beings in research: 29-46.1988 by Kluwer Academic Publishers.
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), 17–27.
Carse, A. L., & Little, M. O. (2008). Exploitation and the enterprise of medical research. In J. Hawkins & E. Emanuel (Eds.), Exploitation.
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.
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), 24–37.
Macklin, R. (2003). Bioethics, vulnerability, and protection. Bioethics 17(5–6): 472–486.
Macklin, R. (2004). Double standards in medical research in developing countries (pp. 99–130). Cambridge: Cambridge University Press 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, 443–454).
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.
Rothman, David J. (1987). Ethics and Human Experimentation: Henry Beecher Revisited." The New England Journal of Medicine. Vol. 317, No. 19.
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.
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.
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.
Weijer C, Emanuel E. Ethics: protecting communities in biomedical research. Science. 2000;289: 1142–1144.
Wertheimer, A. (2008). Exploitation on clinical research. In S. Hawkins & E. J. Emanuel (Eds.). Exploitation and developing countries. The ethics of clinical research (pp. 63–104). Princeton 2008.
Declarations and guidelines:
- Animal experimentation guidelines (International Association for Assessment and Accreditation 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
Videos:
4 videos on research ethics which has been made by Associate Professor Jens Erik Paulsen in collaboration with Viva Combs Thorsen, Jan Helge Solbakk and Ronny Fagereng. Available at: http://www.med-utv.uio.no/elaring/fag/med-etikk/etikk_0909/index.shtml
- Video 1: What does good research mean?
- Video 2: Autonomy
- Video 3: Vulnerability
- Video 4: Science ethics