Reviewing Clinical Trials: A Guide For The Ethics Committee

This article is part of the network’s archive of useful research information. This article is closed to new comments due to inactivity.  We welcome new content which can be done by submitting an article for review or take part in discussions in an open topic or submit a blog post to take your discussions online.

This guidance article aims to provide a fully comprehensive, pragmatic guide for researchers of all roles, but especially ethics reviewers, to explain the details of each type of ethics review. The article is available in English, Spanish, Portuguese and Chinese, and has been kindly provided by www.ctmagnifier.org.

You can download the ethics guide in each language by clicking on the links on the right hand side of the screen.

Authored by Dr. Johan Karlberg, Founder and Director, Clinical Trial Magnifier Ltd. and co-edited by Dr. Marjorie Speers, Ph.D., President and CEO of AAHRPP, Reviewing Clinical Trials: A Guide for the Ethics Committee was sponsored by Pfizer to help familiarize new ethics committee members about the fundamentals of clinical trials, the importance of human participant protection, and compliance of good clinical practice (GCP). The author-editors reviewed the content of the manual with a group of international research ethics experts.

Idea of Ethics Guide
The idea for this manual came from Pfizer in the US, which provided the Clinical Trials Centre at The University of Hong Kong, Hong Kong SAR, PR China with a nonbinding grant for its development. The general project layout protocol was accepted by Pfizer in July 2009.
Although the publication is entitled Reviewing Clinical Trials: A Guide for the Ethics Committee, it was developed mindfully to be relevant and useful to all other categories of professionals entering the clinical trial research area. We highly recommend anyone, whether a novice in the clinical trials research area or experienced, wishing to learn more about the basic modern concepts of human research ethics and clinical trial research methodology to study this manual. The audience can equally be professionals acting as investigators, research nurses, research support staff, ethics committee administrators, contract and budget development administrative staff, monitors, project managers, biostatisticians, clinical data managers, regulators or inspectors.

This guidance article aims to provide a fully comprehensive, pragmatic guide for researchers of all roles, but especially ethics reviewers, to explain the details of each type of ethics review. The article is available in English, Spanish, Portuguese and Chinese, and has been kindly provided by www.ctmagnifier.org.