Tuesday, August 12, 2014

White Paper: The Process of Informed Consent

Today, we feature a White Paper from the Association of Clinical Research Professionals looking at the importance of patients understanding the informed consent process.  As the paper points out, there has been no updates to the original informed consent policy since it was published in 1981.  The professionals participating in the clinical studies should make it their job to work with the patients so that they fully understand the complexities of the clinical trial.

In this white paper, the ACRP lays out the a guidance for the informed consent process.  It looks at: Environment, Assessment of Capacity to Consent, Presentation of the Elements of Informed Consent, Use of a Delayed Consent Procedure, Assessment of the Subject’s Comprehension, Documentation of Informed Consent and Ongoing Consent.

This fall at Partnerships in Clinical Trials Asia, we'll have a morning dedicated to patient recruitment, informed consent and care where we'll have a panel of experts from Cadilia Pharmaceuticals, Pfizer, Jiangsu Hengrui Medicine and The University of Hong Kong on hand to look at the informed consent process to better a patient's experience.  For more information on this session and the rest of the program, download the brochure.  If you'd like to join us in Shanghai, as a reader of this blog, when you register to join us an mention code XP1975BLOG, you can save 15% off the standard rate.

When it comes to the informed consent process for clinical trials, how involved should investigators be in the informed consent process?   And is this the common participation rate you see of investigators in clinical trials?

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