When Robert Levine was asked by the
CIOMS to provide a definition of informed consent which would be "widely applicable to different countries and cultures," he wrote that "in recognition of the vastly different perspectives on the nature of 'person,' I cannot do this," and he warned against relying upon "any person situated in any culture to provide a universally applicable definition of informed consent." (124) UNESCO went so far as to conclude that "the need for consent to be 'informed' may be objectively impossible to achieve." (125)
Los grupos de poblaciones vulnerables son clasificados por las pautas del
CIOMS y definidos como individuos con una sustancial incapacidad para proteger sus propios intereses con la posibilidad de ser perjudicado fisica, psicologica o socialmente, dado por la disminucion o ausencia en su capacidad para tomar decisiones de manera voluntaria (Organizacion Panamericana de la Salud & Consejo de Organizaciones Internacionales de las Ciencias Medica, 2016).
Justamente con el animo de proteger a la poblacion vulnerable expuesta a participar en investigacion, el
CIOMS presenta una version actualizada, que recientemente ha entrado en vigencia (11).
According to the preliminarily established and posteriorly revised DILI classification criteria by the Council for International Organization of Medical Sciences (
CIOMS), DILI was classified into 3 types: liver cell type, intrahepatic cholestasis type and mixed type.
This research was classified as minimal risk in accordance with the regulations established by Resolution 8430, Ministry of Health of Colombia and
CIOMS [11, 12].
DRAP, as part of pharmacovigilance activity, had already introduced new Adverse Drugs Reaction reporting system and initiated through the ADR and
CIOMS forms on its website, for both healthcare professionals and Pharma Industry, he added.
Hoy se exige que no tan solo la investigacion deba conducirse respetando los principios y responsabilidades que establece la Declaracion de Singapur sobre la Integridad en la Investigacion (5), sino que tambien, cuando esta involucra a seres humanos, deba conducirse respetando los principios y normas de la pautas eticas internacionales de investigacion con seres humanos, tales como, por ejemplo, la Declaracion de Helsinki, las Pautas
CIOMS (6), las Normas Eticas de Investigacion de la OPS (7), entre otras.
The Council for International Organisations of Medical Sciences (
CIOMS) states that "all proposals to conduct research involving human subjects must be submitted for review and approval to one or more independent ethical and scientific review committees".1 Other regulatory bodies like the International Conference on Harmonisation (ICH), 2 the Council of Europe3 and the United Nations Educational, Scientific and Cultural Organisation (UNESCO)4 have also issued similar guidelines.