Estudios Clínicos y Preclínicos​ - Inglés

The Ethics Committee for Research involving medicinal products (IECm) of the Hospital Clínico San Carlos is a multidisciplinary group of professionals who, following international recommendations on research ethics and current legislation, have as their main functions to ensure the protection of the rights, safety, and well-being of people participating in research projects.

In order to fulfil these main functions, the IECm evaluates methodological, ethical, and legal aspects of any clinical trial or research project involving patients, health data, or biological samples derived from patients.

Functions

The Ethics Committee for Research involving medicinal products (IECm) shall perform the following functions

• To assess the methodological, ethical, and legal aspects of research projects, with or without medicinal products involving human beings, which are referred to them.
• To evaluate substantial modifications to previously authorised projects.
• Follow-up of the clinical trial from the start of the trial until receipt of the final report.

Additional functions of the Committee are as follows:

• To provide assistance to investigators upon request in protocol development, study design or conduct of the study.
• To be aware of all significant incidents that occur during the study, as well as the possible causes that could lead to its suspension.
• To assess whether the conduct of the trial interferes with the performance of normal care activities.

Composition

The IECm is made up of a president, vice-president, technical secretary, and currently 11 members, in addition to a group of consultants and experts from different specialities.