Guías operacionales para comités de ética que evalúan investigación biomédica

All biomedical research involving human subjects has to comply with established international guidelines that require ethical and scientific review of the research, alongside informed consent. This book sets out operational guidelines for ethics committees in order to facilitate, support, and ensure quality of the ethical review of biomedical research in all countries around the world.

Targeted for use by national and local bodies, these guidelines define the role and constituents of an ethics committee, and detail the requirements for submitting an application for review. The review procedure, plus details of the decision making process are provided, together with necessary follow-up and documentation procedures.

A background section describes the events leading up to the production of the guidelines; the book also includes a glossary, list of supporting documents and list of committee members.

See also: complementary guideline "Surveying and evaluating ethical review practices"