Responsibilities and Ethics
Description
Ethics is more than just one part of Clinical Research. Ethics pervade every aspect of a trial, from the rationale in the first place through to the maintenance of data and its eventual destruction years after the publication of results. Ethical issues arise in the randomisation of subjects, the choice of outcome, the collection of data, access to that data, the analysis of the data, the reporting of results and the monitoring of the safety of participants. No Clinical Research can be conducted without a thorough and overarching ethical view of all that occurs.
Subject Code
CLRS90013
Credit Points
12.5 points
Objectives
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:
- Autonomy
- Justice
- Beneficence
- Malfeasance - 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
Description:
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
Pre-requisites and/or Co-requisites
For both the Professional Certificate and Graduate Certificate in Clinical Research the entry requirements are:
- An undergraduate degree or equivalent qualification in medicine, an allied health profession, nursing, science or social science which is recognised by the University as evidence of adequate preparation for the course PLUS
- Documented evidence of at least one year's full-time relevant professional work experience in a
medical, scientific or allied health environment.
All students will be required to meet the English Language requirements of the University.
Mode of Delivery
Intensive 4 day blocks
Student Commitment
Students should expect to undertake a minimum of 120 hours lectures, research, reading, writing etc to complete this subject successfully
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.
Subject Coordinator
Dr Deborah Zion
Venue
Venue: Hawthorn Campus
Dates
Dates: August 20, 21, 23 & 24 2012
Course Fee
Program Fees for 2012 are $2,350 per 12.5 point subject, making total costs as follows:
- The Professional Certificate - $4,700
- The Graduate Certificate - $9,400
The course fee includes:
- All course materials and assessment
- Access to on-line databases required
- Morning, afternoon tea and lunch on each day of teaching
For further information contact
Mary Georges 9810 3185 or m.georges@commercial.unimelb.edu.au
Application Process
Applications are managed by Student Services.