Course Summary

Informed consent in clinical research is an ethical and regulatory requirement. A research subject must enter a study voluntarily, be informed about risks and benefits, and understand the difference between investigation and treatment. Subjects must not be coerced into enrolment, nor must they be enticed by exaggerated claims of benefit. Before they can enrol, all potential subjects must agree, in writing, to participate. In addition to ethical and regulatory imperatives, the potential for litigation by subjects further highlights the importance of rigorous adherence to informed consent principles. In this short course we set out the principles and requirements and provide examples of practical issues confronting healthcare professionals and subjects.

Who will benefit from this module?

This course provides essential learning for clinical research associates, project managers and other employees of companies sponsoring clinical research, as well as all healthcare professionals involved in conducting clinical trials. Anyone who needs to develop an understanding of the importance of Good Clinical Practice and its application should take this course.

Learning Objectives

• Discuss the ethical principles underlying requirements for informed consent of trial subjects
• Describe the consent process
• Specify information to be provided in discussion between healthcare professional and subject, in the informed consent form, and in any supporting document
• Discuss practical issues for healthcare professionals and subjects regarding informed consent
• Describe circumstances in which third parties may act as proxies for prospective subjects in the informed consent process

Module Outline

Key topics covered in this module include:

• Informed consent principles
• The consent process
• The informed consent form
• Informed consent issues in practice
• Informed consent
• Proxies

Assessment - Multiple-choice assessment.