Informed Consent in Clinical Trials

Informed consent is a cornerstone and key ethical consideration in clinical trials. It is a critical component of any GCP guideline. Informed consent is the process of learning the key facts about a clinical trial before deciding whether or not to participate. Informed consent is not a one time event - it a continuing process throughout the study, providing information for participants.

Informed consent should help someone decide whether or not to participate. The doctors and nurses involved in the trial have to explain the details of the study to those participating in it.

Terminology

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Consent - The legally effective agreement of the subject (or a legally authorized representative) based on information that is given to the subject in an understandable language

Permission - Means the agreement of parent(s) or guardian to the participation of their child or ward in research.

ICH guidelines on informed consent

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According the ICH, the informed consent process should:

• Ensure that the declaration of Helsinki and the principles of GCP are adhered to
• Ensure that there is no coercion, of subjects to be on or stay on a study, at any time
• Ensure the subject's understanding of the information they are presented by you or your designees
• Ensure that the Informed Consent document is signed and dated by the subject or subject's legal representative

Informed Consent Document

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An informed consent document describes the rights of the study participants, and includes details about the study, such as its purpose, duration, required procedures, and key contacts.

Risks and potential benefits of the study are also described in the informed consent document. Clinical trial participants can decide whether or not to sign the document. Informed consent is not a contract, and the participant may withdraw from the trial at any time.

ComplianceOnline training on informed consent in clinical trials

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The ICF Process: Tips on Achieving Optimal compliance and Comprehension

This ICF process Webinar training teaches how to create an informed consent process for achieving optimal site compliance and subject comprehension. It also discusses how an inadequate ICF can affect data integrity and patient safety and/or well-being.

Are your Informed Consents in compliance with new FDA Regulations - An update on the informed consent process

This webinar discusses the steps to prepare an informed consent document under different situations.

Full Day Virtual Seminar: Clinical Research GCP training Course

This full day GCP training course provides comprehensive learning on the Good Clinical Practices of Research involving human subjects. It covers all key areas including recruiting study subjects, the Informed Consent process, Adverse Event Reporting and preventing protocol deviations.