Ethical and legal standards in biology and biomedicine research

Authors

  • Núria Terribas Universitat de Vic-Central de Catalunya

Keywords:

research ethics, ethics committees, informed consent, riskbenefit, confidentiality.

Abstract

Over the last few decades, a growing concern with the need for the ethical supervision of research in biology and biomedicine, and in particular of research involving human beings, has led to the development of documents, guidelines and regulations at both the national and the international level. This has probably been driven by our historical experiences, and it has made such research one of the most highly regulated fields of knowledge, with an extensive array of supervisory instruments, as is evidenced both at the European level and in the Spanish context. The background to this has always been the need to protect people’s rights (and those of animals), to respect their independence and personal dignity, and to ensure that the work of investigators in the pursuit of knowledge and the validation of working hypotheses is characterized by honesty. Research ethics committees – operating in a variety of forms and contexts – have shown themselves to be an essential means of delivering such ethical supervision, but one that requires the provision of the necessary resources if they are to perform their job well. Every day, research pushes back the boundaries of knowledge and becomes more complex, and this poses a constant ethical challenge to societies and to states, a challenge that requires them to agree on the criteria that govern such activities.

Keywords: research ethics, ethics committees, informed consent, riskbenefit,
confidentiality.

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