The second revision (1983) included seeking the consent of minors where possible. Subsequent revisions between 19 were relatively minor, so the 1975 version was effectively that which governed research over a quarter of a century of relative stability. Protocols now had to state explicitly that they adhered to the Declaration (Article I.12). The document was also made gender neutral and provisions were made for safeguarding animals. Any experimental manoeuvre was to be compared to the best available care as a comparator (Article II.2), and access to such care was assured (Article I.3). The duty to the individual was given primacy over that to society (Article I.5), and concepts of publication ethics were introduced (Article I.8). 'Legal guardian' was replaced with 'responsible relative'. Informed consent was developed further, made more prescriptive and partly moved from 'Medical Research Combined with Professional Care' into the first section (Basic Principles), with the burden of proof for not requiring consent being placed on the investigator to justify to the committee. In the United States regulations governing IRBs came into effect in 1981 and are now encapsulated in the Common Rule. The 1975 revision was almost twice the length of the original, and introduced the concept of oversight by an 'independent committee' (Article I.2) which became a system of Institutional Review Boards (IRB) in the US, and research ethics committees or ethical review boards in other countries (Riis 1977). Now doctors were asked to obtain consent 'if at all possible' and research was allowed without consent where a proxy consent, such as a legal guardian, was available (Article II.1). A notable change from the Nuremberg Code was a relaxation of the conditions of consent, which was 'absolutely essential' under Nuremberg. The Declaration more specifically addressed clinical research, reflecting changes in medical practice from the term 'Human Experimentation' used in the Nuremberg Code. The Declaration developed the ten principles first stated in the Nuremberg Code, and tied them to the Declaration of Geneva (1948), a statement of physician's ethical duties. Prior to the 1947 Nuremberg Code there was no generally accepted code of conduct governing the ethical aspects of human research, although some countries, notably Germany and Russia, had national policies. The Declaration is an important document in the history of research ethics as the first significant effort of the medical community to regulate research itself, and forms the basis of most subsequent documents. The Declaration was originally adopted in June 1964 in Helsinki, Finland, and has since undergone five revisions and two clarifications, growing considerably in length from 11 to 32 paragraphs.
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