Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 3.2 - Introduction

Document information
Reference	WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995
Validity area	WHO
Scope(s)	HM
Document name	WHO - Guidelines for GCP for trials on pharmaceutical products*
Version / Revision	1995
Status	Current
Document type	International guideline
Language(s)	EN
Description	World Health Organization WHO Technical Report Series, No. 850, 1995, Annex 3 Guidelines for good clinical practice (GCP) for trials on pharmaceutical products*
Official source	Official link
Restricted access	No
Submitted by	Florian Adragna
Contributors

Reference Details
Scope	HM
Document part	3.2 - Introduction
Language	EN
Original entry by	Florian Adragna
Contributors
Tags (EN)
Tags (original language)
Tags (FR)
Comment	Role of the ethics committee in trial oversight

Content

3.2 Ethics committee The role of the ethics committee (or other board responsible for reviewing the trial) is to ensure the protection of the rights and welfare of human subjects participating in clinical trials, as defined by the current revision of the Declaration of Helsinki and national and other relevant regulations, and to provide public reassurance, inter alia, by previewing trial protocols, etc. (see Section 2). The ethics committee should be constituted and operated so that its tasks can be executed free from bias and from any influence of those who are conducting the trial. The ethics committee should have documented policies and procedures as a basis for its work, which should be available to the public. These should set out the authority under which the committee is established, the number of members elected and their qualifications, a definition of what it will review and its authority to intervene and maintain records of its activities. The documents should also state how frequently the committee will meet and how it interacts with the investigator and/or sponsor. [...]