Ethical Review Process by Ethics Committees

1. Authority, Role and Mandate of Research Ethics Committees (RECs)

1.2. Composition and Operational Aspects

RECs are multi-disciplinary committees, drawing on the strengths of their members with varied backgrounds. The goal of a diversified membership is to ensure that RECs can collectively conduct a thorough and independent ethics evaluation of research projects.

Although specific requirements vary greatly across Europe, for a typical composition of REC membership is:
  • At least 5 members who collectively have the qualifications and experience required to ensure proper review of the ethical, scientific, medical and financial aspects of a trial.
  • At least one lay person, from a diverse educational (social sciences, law, etc.) and social background, as well as ensuring gender balance.
In many countries, it is further required that there be three non-scientific members: one legal, one ethicist and one representing the community.

REC members should be appointed for a fixed term by the recognised authority according to an established procedure. The REC may choose to invite outside experts who are not members to assist on particular aspects (often scientific) of a project.