Ethics-Governance: Article: eMJA: Loblay & Chalmers, Ethics committees: is reform in order?

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eMJA: Loblay & Chalmers, Ethics committees: is reform in order? Ethics committees: is reform in order? Ethical review of multicentre studies is necessarily complex, but the system is improving MJA 1999; 170: 9-10. The introduction by the National Health and Medical Research Council (NHMRC) of the requirement for ethical approval of all grant applications in 1973 marked the beginning of the present institutional ethics committee (IEC) system in Australia. This ended the "closed shop" research era, reflecting a wider community demand for more open government, greater public accountability, expanded civil liberties and respect for human rights. It also came at a time when public confidence in "experts" was declining, when complex new technologies were being introduced, and when details of grossly unethical research, such as the Tuskegee syphilis study in the USA, were revealed.1 Until the early 1990s, most research involving humans was conducted within individual institutions; this was reflected in the NHMRC Statement on human experimentation and supplementary notes,2 where emphasis was placed on institutional responsibility for ethical oversight. Only passing reference was made to the possibility of multicentre research, with the stipulation that an IEC shall "give its own consideration to projects that involve research in more than one institution", accompanied by a footnote indicating that "An IEC is free to discuss a project with other IECs if it chooses, with due regard to confidentiality." In 1991, in response to perceived bureaucratic delays within the Therapeutic Goods Administration in its centralised approval process for clinical trials, the Baume Report recommended decentralisation of the system, with IECs assuming responsibility for evaluating study design and safety as well as ethical aspects.3 Despite initial uncertainties and difficulties, the clinical trials notification system has proved enormously popular. Full Article: http://www.mja.com.au/public/issues/jan4/loblay/loblay.html


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