Ethics in Health Research
After this unit, students should be able to: 1. Define the basic principles of moral foundations of bioethics. 2. Analyze ethical questions underlying a research involving human beings. 3. Understand the elements that comprise the informed consent. 4. Write an informed consent adequate to the research design. 5. Write an ethically adequate research protocol, suitable for submission to an Ethics Committee.
Weekly - 5
Total - 16
English and Portuguese
• Beauchamp T, Childress J (2009) Principles of Biomedical Ethics. 6th Edition. New York: Oxford University Press. • Jennings B, Steinbock B, Gostin L Bayer R (eds.) (2006) Public Health Ethics: Theory, Policy, and Practice. New York: Oxford University Press. • Marshall, Patricia A. Ethical challenges in study design and informed consent for health research in resource-poor settings. Special Topics in Social, Economic and Behavioural (SEB) Research report series; No. 5). WHO. 2007. • Ethical and Policy Issues in Research Involving Human Participants. National Bioethics Advisory Commission. Bethesda, USA. 2001.(http://bioethics.georgetown.edu/nbac/human/oversumm.html)
We will present moral theories and ethical concepts in lectures and debate in plenary sessions their application to specific cases.
The assessment will consist in an individual written assignment. The assignment will consist in writing the ethical and legal implications chapter of a research protocol. Students can write this chapter for a study they want to conduct otherwise, a study will be provided by the teacher.
I. Historical evolution of Bioethics: Code of Nuremberg, Helsinki Declaration, Belmont report, Common Rule, International Conference on Harmonization. II. Moral Theory: utilitarism and Kantianism and their applicatication to biomedical research. III. Ethical Concepts: - Moral Status (problem and theories, practical guidelines, vulnerable populations). - Respect for autonomy: nature of autonomy, capacity of autonomous choice, meaning and justification of informed consent, disclosure, understanding and voluntariness). - Non maleficience (concept, distinctions and rules governing nontreatment, optional treatments and obligatory treatments, protecting incompetent patients). - Beneficience (concept, obligatory beneficience and ideal beneficience, balance between benefits, costs and risks). - Justice (concept, fair opportunity and unfair discrimination, vulnerability and exploitation, national and global policy and the right to health care). IV. Informed consent: concepts, principles, modalities and basic elements, utilization of data and record keeping, the process of submitting a research protocol to the ethics committee. V. Conflict of interest: concept and implications for research using humans.
Programs where the course is taught: