IngentaConnect Protecting patients rights, ensuring safety and quality assurance...

Authors: Chiang, C-Y.¹; Glaziou, P.²; Enarson, D.A.¹; Cobelens, F.³; Lew, W-J.⁴

Source: The International Journal of Tuberculosis and Lung Disease, Volume 13, Number 1, January 2009 , pp. 27-31(5)

Publisher: International Union Against Tuberculosis and Lung Disease

Abstract:

The conduct of biomedical studies is guided by statements of internationally recognised principles of human rights. The first principle of the Nuremberg Code was the centrality of voluntary participation of subjects with informed consent. All prevalence surveys should be reviewed by the appropriate ethics review committees. Each potential survey participant should be adequately informed of the aims, methods and sources of funding of the survey, any possible conflicts of interest, the institutional affiliations of the researchers, the anticipated benefits and potential risks of the study, and any discomfort it may entail. Attention should be paid to safety in each component of the survey. Test procedures that require particular attention are chest radiography (CXR) and bacteriological examination. Quality assurance should be applied to all aspects of research and, in particular, to any measurements undertaken, including CXR assessments, laboratory examinations and questionnaire and data management. Furthermore, to ensure comparability of data from different surveys, it is important to apply the same survey design and methodology and to use the same reporting format.

Keywords: patient rights; safety; quality assurance; prevalence survey

Document Type: Invited paper

Affiliations: 1: International Union Against Tuberculosis and Lung Disease, Paris, France 2: World Health Organization Regional Office for the Western Pacific, Manila, The Philippines 3: Royal Netherlands Tuberculosis Association (KNCV), The Hague, The Netherlands 4: Korean Institute of Tuberculosis, Korean National Tuberculosis Association, Seoul, Korea

Protecting patients' rights, ensuring safety and quality assurance in tuberculosis prevalence surveys [Educational series. Serialised guidelines. Assessing tuberculosis prevalence through population-based surveys. Number 5 in the series]