CEIm – INCLIVA – Instituto de Investigación Sanitaria

Introduction

The Ethics Committee for Research with Medication (CEIm) of the Hospital Clínico Universitario de València was created to comply with Law 25/1990, of December 20, on Medicines. According to this law, all clinical trial projects involving medicines and healthcare products must be previously approved by a clinical research committee accredited by the competent authority.

Mission

The mission of the CEIm is to promote, favor, coordinate and improve the quality of clinical medical research on humans according with the current regulations.

Scope

The scope of action as the Ethics Committee for Research with Medication (CEIm) of the Hospital Clínico Universitario de València, as established in RD1090/2015, article 17.2.a, are clinical trials with medicines for the national territory. In addition, the CEIm evaluates clinical research with healthcare products, observational studies with medicines, research projects and studies for academic purposes.

The scope of action as the Ethics Committee for Research (ECR) of Hospital Clínico Universitario de València, will be the Valencia Clinical-Malvarrosa Health Department, which will include the following centers:

Hospital Clínico Universitario de València
Malvarrosa Hospital

In addition, they will also be centers that will receive the tutelage of the CEI of the Hospital Clínico Universitario de València:

University of Valencia
Any center/ promoter that previously requests the tutelage of our committee, subject to approval of the guardianship by the Committee.

Functions

The CEIm evaluates the methodological, ethic and legal aspects of clinical trial protocols and research projects. CEIm’s opinion on clinical trials with medicines and healthcare products and for observational studies with medicines, is valid for all the national territory (single opinion).
The CEIm evaluates the substantial modifications (changes) of the authorized clinical studies.
It also monitors the study from the beginning until receipt of the final report and should be aware of relevant incidents during the study and possible causes that could lead to its suspension.
As Ethics Committee for Research (ECR), it evaluates research projects, final degree projects and other types of studies.
In addition, it provides assistance to investigators who request it for protocol development, study design or conduct of the study.