Note: This is an archived Handbook entry from 2009. Search for this in the current handbook
|Dates & Locations:|| |
This subject has the following teaching availabilities in 2009:For information about these dates, click here.
|Time Commitment:||Contact Hours: 24 hours of lectures/seminars/workshops |
Total Time Commitment: Not available
|Recommended Background Knowledge:||None|
|Non Allowed Subjects:||None|
|Core Participation Requirements:||
For the purposes of considering request for Reasonable Adjustments under the Disability Standards for Education (Cwth 2005), and Student Support and Engagement Policy, academic requirements for this subject are articulated in the Subject Overview, Learning Outcomes, Assessment and Generic Skills sections of this entry.
It is University policy to take all reasonable steps to minimise the impact of disability upon academic study, and reasonable adjustments will be made to enhance a student's participation in the University's programs. Students who feel their disability may impact on meeting the requirements of this subject are encouraged to discuss this matter with a Faculty Student Adviser and Student Equity and Disability Support: http://services.unimelb.edu.au/disability
|Subject Overview:||Topics covered include: |
Structure of Informed Consent documents
Meaning of Informed in the context of blinding and randomisation to allocated treatments.
Basic human rights in experimental settings
The human being as an experimental subject and unit of analysis
Data monitoring and safety committees
Exercises in complex ethical situations
Ethics committees structure; membership; terms of reference
Assessment of ethics applications (mock exercise)
Cultural differences in ethical viewpoints
Ethics under adverse conditions or under duress
Ethical responses to unlawful collection of data or specimens
Ethical issues of individual or volunteered experiments on the dying
|Assessment:||Two assignments each of 2000 words (100%). Students will review an ethics proposal, identifying major concerns and problems within that proposal. Students will prepare an ethics application for a project within their workplace or other appropriate setting, detailing all major ethical issues that arise and their management.|
|Breadth Options:|| |
This subject is not available as a breadth subject.
|Fees Information:||Subject EFTSL, Level, Discipline & Census Date|
|Generic Skills:||Students who successfully complete this subject will be able to: |
Demonstrate an sound understanding of the basic concepts in human ethics, including the principles of:
Understand the need for integrity in both research and researchers
Understand the need to protect human rights in research
Appreciate the requirement for informed consent
Appreciate both sides of the risk-benefit tension
Understand the impact of different cultural perspectives on ethical issues
Graduate Certificate in Clinical Research |
Graduate Diploma in Clinical Research
Master of Clinical Research
Professional Certificate in Clinical Research
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