Guidelines for Ethics Committees

The objective of these guidelines and recommendations is to establish a greater
degree of scientific efficacy and procedural responsibility in the practices of Ethics
Committees (ECs) in Europe. The document is intended as a basis upon which ECs
can develop their own specific written procedures for their functions within
biomedical research. In this regard, the document establishes minimum guidelines and
recommendations for ECs to use in defining or revising standard operating
procedures.

The purpose of an EC is to safeguard the welfare and the rights of human subjects in
biomedical research studies, taking into account the scientific procedure and the
concerns of the local community.

ECs provide timely, comprehensive, and independent reviews of the ethics of
proposed studies, acting in accordance with the Declaration of Helsinki and following
international standards for Good Clinical Practice.

ECs are responsible for acting with due regard to the requirements of relevant
regulatory agencies, applicable laws, and in good faith with respect to both applicants
and the community.

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Guidelines and Recommendations for European Ethics Committees