Ethics Committee Laboratory: 1. Institution and Standard Operative Procedures

Abstract

This article – the first of a series of ad hoc contributions that are to be published in “Medicina e Morale” – examines the practical problems concerining the Ethics Committee (EC) setting and activity, as it comes from the specific guidelines of the European Union (International Conference on Harmonisation – Good Clinical Practice, ICH-GCP) and from their acknowledgement and regulatory requirements in Italy by means of Health Ministry decrees.

First of all, the Authors analyse the ECs role in reviewing and approving trial protocols of new pharmacological products and medical devices. Then, they deal with ECs institution and legitimacy according to regulations in force and give detailed information on the principal “duties” ECs have to accomplish, namely the preparation or revision of their institutional code and their internal articles of Standard Operative Procedures (SOP). This information is not only based on the ordinances mentioned above, but also on various international guidelines about this topic.

Concerning the EC statute, some fundamental elements are pointed out: 1. Reference principles; 2. Committee functions; 3. Internal structure (members). Concerning the SOP, the main points concern several procedures: 1. Meetings, positions and alternation of the EC members; 2. Approval requests form to be submitted to the EC; examination of the requests; decision making; 5. EC approval/opinion communication; 6. Clinical trails continuous reviewing; documentation filing and access; SOP reviewing and possible enclosures.

In the appendix, the article presents two facsimiles of EC statute and SOP, that may be used by real ECs as models for drawing up these documents and adapting them to their local context.