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International Congress on Harmonization
The ICH is a regulatory body that brings together all the other minor regulatory bodies in the Europe and America that are in charge of regulating clinical research endeavors. The aim of this union is to have research activities coordinated and harmonized in order to avoid unnecessary duplication of research procedures (Levine, 2011). In the event that the latter occurrence happens, there will be losses in terms of resources, time, and human capacity. Therefore, there is a need to have all the work of the scientists guided by regulations that streamline them with the aim of coming up with distinct yet helpful results. This was the founding principle of ICH.
ICH Guidelines
ICH has four main guidelines on which their activities are directed. These include quality service guidelines, safety guidelines, multidisciplinary guidelines, as well as efficacy guidelines (ICH, 2014). These four guidelines, each spells out distinct procedures that must be undertaken for a sound research procedure to be attained. The provisions of each of the four guidelines mentioned above are discussed below.
Quality service guidelines
Under these guidelines, researchers are required to conduct research in a manner that meets acceptable standards of good quality and safety. How this contributes to harmonization of research makes all the research work be oriented towards achieving some similar set objectives....
ICH has also ensured that all research work is registered before being given the go-ahead to continue. It is through this process of registration that researchers get to be tamed on what not to do. This also acts as a way of protecting intellectual property. Under successful implementation, there will be perfection in the field of medical research since there will be no stealing of anyone's ideas.
Safety guidelines
Under these guidelines, the body enforces regulations to the effect of making sure that the research done meets the minimum safety standards recommended. Safety here will involve the proper treatment of the environment as well as the human life. The environment needs to be safeguarded by ensuring that the lives of individuals are not tampered with by any means and that the health status of the human beings will not be jeopardized by the outcome of the research. It also covers the safety of the researchers themselves. By enforcing this regulation, ICH ensures that there are no chances of hazards being reported from the research discourse. It is, therefore, of benefit to have a body in place.
Efficacy guidelines
The targets of these guidelines are procedural in nature. It covers the areas of design, safety, as well as reporting of the research findings. In this sense, the body strives to ensure that there is…
References
Levine, R. (2011). Ethics and Regulation of Clinical Research (2nd Ed.). Baltimore: Urban & Schwarzenberg.
Wertheimer, A. (2011). Rethinking The Ethics Of Clinical Research: Widening The Lens. New York: Oxford University Press.
International Conference on Harmonization (ICH), (Retrieved, 2014) http://www.ich.org/products/guidelines.html.
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