Leader: Dr D Zion

Offered

Alfred Hospital Second semester 2008 (Day)

Synopsis

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

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 accrues to those populations subsequent to research;

7. formulate some recommendations concerning potential responses to the issues raised during the unit.

Assessment

Oral presentation 30%
Written assignments 70%

Contact hours

2 contact hours per week