Informed consent in clinical trials

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.

Purchasing Information

When you have completed your course order, Zenosis will finalise the setup of your course materials and contact you on the email address that you provide in your order. You can expect this process to be completed within one business day (using the UK business calendar) of completing your payment.
It is therefore essential that you use your real email address for your order, or indicate in the purchase notes the email address to be used for the course set-up, and check that any messages from Zenosis or grapl are not lost in your junk or spam folder.

You will have access to the course module(s) for a period of 180 days after your purchase is complete.

Detailed Course Information

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

Who will benefit from this course

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.

Module Outline
Research, Regulatory, Compliance
CPD Points
Course Study Time
Approx 15 minutes
USA, Europe, Other

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