The International Congress on Harmonization's four main guidelines

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.

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 the field of medicine. Researchers have to register their research work with the regulatory bodies before commencing. For the same reasons as ICH, the government is keen on enforcing safety and quality standards as well as safeguarding the intellectual property rights.

The importance of ICH

The international Congress on Harmonization plays a central role in ensuring a smooth process in the field of clinical research. In its absence, imperfection in the clinical research field would be a common thing where researchers would be stealing each other's work and defective drugs being availed to the market. The body also does well in its role of registering research works. This helps in ensuring that the medical fraternity attains some order such that it is possible to assess performance (Wertheimer, 2011). Regulation also ensures that revenue collection as well as funding of the research becomes predictable, which is good for budgeting.