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The Essence of Subject and Specimen Protection in Clinical Trials

Updated on June 27, 2017

Protection of subjects and specimen taking part or being used in clinical research is not a choice, but mandatory for practitioners in the field. This protection should be in terms of their rights and more critical from harm. The reason why clinical researchers must be keen on protecting their subjects owes to the fact that such people or animals are vulnerable to harm that may be caused by the trials. This is more particular when the trials happen to go wrong or cause adverse effects other than the ones that were intended. It should be considered that what is being conducted is simply a trial and that the effectiveness or workability of that particular process or intended intervention has not yet been proven. Therefore, the operation is under uncertainty. In such a case, proper protocols, regulations, standards and all the necessary requirement must be strictly be adhered to. In accordance to the National Health Institute (2013), clinical researchers must place much emphasis on the safety of those taking part in clinical trials. In this respect, each clinical trial must be guided by scientific oversight, and the right of patients in the whole process must be protected to their fullest. Hence, quality assurance, improvement and performance improvement are intended to protect the safety and rights of subjects in clinical trials.

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