Informed consent

Consumers learn about the legal nature and the elements of informed consent. They examine and explore the risks and costs associated with decision making, and appraise scenarios that may not fulfill the requirements of valid, competent and voluntary consent.

By the end of this module, you will be able to:

• Describe what constitutes informed consent.
• Describe personal decision-making in relation to informed consent for clinical trials.
• Identify flaws in informed consent process.
• Explain how people are informed about clinical trials research.

Learning activity: what is informed consent?

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Learning activity: what do we know about the consent process?

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Reference:

• The adequacy of consent forms for informing patients entering clinical trials. 1995, I Olver et al.

Learning activity: a pathway for communication and decision making

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References:

• Strategic Physician Communication and Oncology Clinical Trials. 1999, Terrence L. Albrecht et al.
• Seeking informed consent to cancer clinical trials: describing current practice 2004, R. F. Brown et al.

Learning activity: informed consent pathway example

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Reference:

• Surgery alone versus chemoradiotherapy followed by surgery for resectable cancer of the oesophagus: a randomised controlled phase III trial. 2005, Bryan H. Burmeister et al.