The Ethical Committee Laboratory - 2. The information paper and the consent form to clinical trials

Abstract

This contribution falls into the set of articles about the Ethical Committee Laboratory and deals with the preparation and evaluation – by means of the ethical committee (EC) – of the information paper and the informed consent form (i.p. and i.c.f.) directed to individuals who are asked to enter a clinical trial.

As a matter of fact, these documents are necessary items of clinical trials protocols, which are often critically reviewed by the EC According to Italian current legislation, they are indeed the only part of a protocol that each EC can modify for its need, even in case of multicenter trials.

After a short introduction concerning the general aspects of the relation between ECs and informed consent, the main reference international documents for clinical trials ethics and Italian current legislation are presented, together with their instructions to trials operators and ECs for the i.p. and i.c.f. setup.

Then, after confronting the 1991 and the 1996 version of Good Clinical Practice (GCP) about our subject, and following the literature available, the article makes suggestions as to i.p./i.c.f. content and editing, that can contribute to the optimization of the documents setting.

As an appendix, it is offered a facsimile which may help the documents setting, with reference to the inclusion of both consent capable adults and minors or consent incapable subjects. Anyhow, the trial operator and the sponsor retain the task of improving and adapting the documents according to their creativity and the particular needs each protocol requires.