Introduction to Quality Practices in Biomedical Research
The world’s population is facing serious health challenges in the form of newly emerging diseases or disease patterns e.g. avian influenza, severe acute respiratory syndrome (SARS), transmissible spongiform encephalopathy , human immunodeficiency virus (HIV), Ebola, and multidrug resistant diseases or organisms such as malaria. There are increasing difficulties in treating ‘old’ diseases such as trypanosomiasis, onchocerciasis, diabetes, hypertension and cancer. The problem is worsened by the changing age distribution in populations, greater population movements that promote transmission of diseases, new practices in land use, agriculture and forestry, and changing world climate, to name but a few. As a result, there is increased demand for new drugs and new principles for treatment, based on new knowledge about the causes and mechanisms of diseases, and for new methods of vector control.
The search for these commodities and principles increases the need for scientific researchers and research programmes. With the continued restrictions in available funding, it is essential that basic scientific research as a whole, and especially in all fields connected with health issues, be conducted in a proper fashion using processes that minimize waste of resources and reduce the need for costly confirmation and repetition of work already performed. Today, research facilities in many universities, hospitals, government institutions and industries are used for basic scientific studies relevant to the discovery and development of new strategies for fighting disease including products with potential usefulness in health care. Data from these activities need to be reliable to ensure a solid basis for deciding whether to invest in further development of a strategy or product. Since the activities fall outside regulatory scope, i.e. they are not covered by, for example, the Organization for Economic Co-operation and Development (OECD) Principles of Good Laboratory Practice (GLP), a need for guidance on quality practices in these areas has been recognized.
This is why this handbook was commissioned. It should not be surprising, therefore, to find that some controversies in the scientific literature could probably have been resolved earlier, more easily and better if the practical experimental conditions had been fully described, or if the supportive data had been properly collected. It must be stressed here that the quality practices for biomedical research described in this document do not address the scientific content of a research programme or proposal, but are concerned with the way the research work is organized and planned, performed, recorded, reported, archived, monitored and published. Figure 1 sketches the main steps in this process. Usually biomedical research is first outlined in a research proposal and then described more fully in individual study plans or protocols explaining why and how the experimental work will be undertaken. It is clear that if the basic underlying conditions of the experimental set-up are unclear or poorly documented, and if the raw data are incomplete, there may be fundamental doubts about the validity of the knowledge obtained and its contribution to science. The application and use of sound scientific principles in the conduct of basic exploratory and discovery studies, coupled with an attention to good quality practices.
Journal of Biochemistry & Biotechnology