ICH is an abbreviation for International Council on Harmonization for Technical Requirements; an initiative started in 1990. It was formulated by Europe, the United States, and Japan, and covers 17 wealthy nations. The body sets the regulations for the planning, execution, recording, and reporting the clinical trials that involve the use of human beings as subjects. The rules are meant to provide assurance that the tests conducted are consistent with the participants’ rights, safety, and comfort. However, the definition of this has a deficiency. The rules are not applicable to the practice itself but to how the trial is conducted (Grimes et.al, 2005).
Not all countries have adhered to the standards as they are not legally bound. However, most people funding these trials require for these nations to conduct the tests by the norm ethical codes supporting the GCP. A study carried out by Mueller et.al (2007) analyses whether the practice and guidelines are applied rigorously in other countries. The primary focus was Gambia located in the Sub-Saharan area. The research indicates that over 90% of participants for a trial were not aware they were subjects of a test and were not aware of existing side effects or the withdrawal criteria (Mueller et.al, 2007). The primary barrier affecting this was illiteracy. 45% of mothers also volunteered their children for a free pneumococcal vaccine without knowing the purpose of the study (Mueller et.al, 2007). Other barriers include information overload, the presence of vulnerable participants, and complexities of trials such as costs, finding a viable group, and logistics challenges.
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Therefore, unless there is a strict form of supervision from relevant bodies, most developing countries are not strict on following the ICH of GCP. It is advisable for organizations conducting research and using humans as test subjects to adhere to the ethical codes. By doing so, they eliminate the possibility of bringing harm to the innocent subject, abide by the law, and also increase the chance of getting valid data and result through transparency.
References
Grimes, D., Hubacher, D., Nanda, K., Schulz, K., Moher, D., Altman, D. (2005). The good
clinical practice guideline: A bronze standard for clinical research. Lancet, 366(9480), 172–174.
Mueller, J., Scheflenberg, D., Owens, S. (2007). Third-World barriers: Getting past consent
and ethical issues endemic in underserved populations to ensure quality GCP. Applied Clinical Trials, 16(10), 58–64.
