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An introduction to the ethical implications of research involving human participants and the procedures in place for governance of this research. The one-day course covers:
· Oversight of research: why do we need it?
Research ethics and governance: a historical perspective. Nuremburg, Helsinki Declaration, Belmont, CIOMS, Ethical guidelines for HIV vaccine research.
· Ethical research - the National Guidelines
The role of AHEC and HRECs. Ethical oversight of research - how it works and what is expected of researchers - shortfalls in current system.
· R esearch from the participants’ perspective
Thinking about the broader implications of research involving people.
· Good research conduct - what is it?
Guidelines and definitions - examples of research misconduct.
· National and international standards for the conduct of clinical trials.
International Committee on Harmonization Good Clinical Practice.
· Human Research Ethics Applications - hints and common mistakes.
Pearls of wisdom from the horse’s mouth.
· Reviewing research protocols and preparing HREC applications
Recruitment, consent forms, patient information - spot the issues and troubleshooting!
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