Basic ethical, professional and legal principles of biomedical research

Objectives This study attempted to ascertain and explain current basic legal principles for biomedical research involving human subjects, to compare these legal principles with research ethics and professional guidelines, and to explore briefly the relationship between ethics, professional guidelines, and the law. Methods A broad empirical and comparative analysis was carried out of international (European) and national law (primarily Norwegian) as it currently stands according to primary and valid sources of law (legal science or jurisprudence). Results The following 10 basic legal principles of international law were identified and explained: human primacy, informed consent, absence of alternatives, risks and benefits, scientific quality, confidentiality, freedom of research, openness and publication of results, advance examination, and personal responsibility. By and large, these principles concur with national law. For the most part, the legal principles concur with professional guidelines, and both are founded upon common values and ethical reflections (research ethics). Conclusions Current regulation of biomedical research is centered around a few basic principles. The exact number, order, and wording are of less importance in this principal context. The extent of concurrence between ethics, professional guidelines, and the law suggest an anticipated and desirable intimate and interactive relationship. More can, however, be done at the international and national level to harmonize, simplify, and enunciate current regulations clearly, for example, through a holistic approach centered around the basics. This approach may enhance the knowledge, understanding, and observance of applicable regulations.