Waiver Of Consent vs Waiver Of Written Consent

By Niecy Duncan, Technical Implementations Manager

The cornerstone of ethical clinical research remains firmly rooted in informed consent. This article provides clarity on two often confused concepts in clinical research: Waiver of Consent and Waiver of Written Consent. While both relate to the informed consent process, they represent distinct regulatory pathways with significant implications for researchers and participants alike.

Misunderstanding these distinctions can lead to ethical and legal challenges, potentially jeopardizing the integrity of a clinical trial. This article offers a comprehensive overview of each concept, outlining the specific criteria and regulatory guidelines that govern their application.

Furthermore, we explore the rising prominence of Waiver of Written Consent in the context of modern, decentralized clinical trials and discuss how technology can facilitate a seamless and compliant consent process. By shedding light on these critical aspects of informed consent, this article aims to equip researchers with the knowledge necessary to conduct ethical and participant-centric clinical trials.