International Congress on Harmonization

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. Therefore, in the event that duplication arises, the regulatory body will intervene to remedy the situation. 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 some order in the manner in which research is done, and findings are reported. It has set procedures through which reporting of findings is presented. It has also incorporated the use of set laws that recommend how research procedures ought to be.

The benefit that such imposition of order in procedures brings is that it helps in the assessment of the success and compliance to the regulations. It becomes easy to assess and approve compliance where it is due in a procedure that follows some definite order. Where there is no particular order suggested, it becomes nearly impossible to have an assessment done. The coming in of ICH to the field of clinical research is, therefore, important in this regard.

Multidisciplinary guidelines This section of the regulations caters for all the other guideline procedures that do not fall under any of the above-mentioned ones. It is through this regulation that issues of the technical nature are served. ICH, in this case, intervenes to ensure that there are no technical faults in the research procedure. This being a scientific research field that is being regulated, varied technical terminologies, and procedures shall have to be regulated.

In this way, ICH has set up panels that are in charge of all the unique regulatory tasks that fall under this category. Current ethical standards in clinical research In the United States, clinical research is guided by ethical standards that govern best practices, as well as orient actions of the researchers towards achievement of the set standards. Similar to the objectives of ICH, the American regulatory bodies emphasize on safety, respect for intellectual property, and the need for order in the course of research.

There are procedures that have been instituted by the federal laws that prohibit unlicensed research in.