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Gaceta Sanitaria

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PONS, J.M.V.. Experimental, innovative and standard procedures: ethics and sciencie in the introduction of medical technology. Gac Sanit [online]. 2003, vol.17, n.5, pp.422-429. ISSN 0213-9111.

The dividing lines between experimental, innovative and standard medical procedures are frequently blurred in current clinical practice. This is even more true in the fields of surgery and implantable devices. These differ substantially from pharmacological interventions, which are better regulated.  However, the character of the various medical interventions applied in human subjects should be ethically and scientifically delimited as clearly as possible. This task cannot be abandoned to personal discretion and criteria, which are currently used, especially in the field of surgical innovation.  External and independent review of the risk-benefit ratio of proposed innovations should enable specification of the particular features of a technique in the patient-doctor relationship, as well as the ethical and scientific requirements for more appropriate evaluation.

Keywords : Investigation; Innovation; Surgery; Health devices; Ethics.

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