EPM5023

International research bioethics ( 6 points, SCA Band 2, 0.125 EFTSL)

Leader: B Loff

Offered:
Clayton Second semester 2005 (Day)
MMS-ALFRED Second semester 2005 (Day)

Synopsis: Builds awareness of key bioethical issues in research and in international collaborative health research. The history of rules guiding research & essential components of ethical review process. Geopolitical purposes, 10/90 disequilibrium, relationship between research parties including host & sponsor countries, multilateral organisations & pharmaceutical companies, trial design & community / potential participants, informed consent, placebo controlled trials, justice issues including benefit access & capacity building. Different international & national guidelines reveiwed.

Objectives: On completion of this unit, students should be able to: 1. demonstrate an understanding of the key ethical issues in research; 2. show familiarity with the historical development of ethical review of medical research in its geopolitical context; 3. show familiarity with current international and national guidelines for medical research; 4. identify the substantive issues and controversies that arise when medical research sponsored by an industrialised country is conducted in a developing country; 5. demonstrate an understanding of the complexities that arise when research is conducted in resource poor settings or in settings where civil rights are compromised and in environments without functioning ethical review mechanisms; 6. demonstrate some insights into why so little of the research conducted in resource poor settings is relevant to the needs of those populations and why little benefit accures to those populations subsequent to research; and 7. formulate some recommendations concerning potential responses to the issues raised during the unit.

Assessment: Oral presentation + Written assignment

Contact Hours: 2 contact hours per week