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Journal: International Journal of Advanced Research (Vol.9, No. 01)

Publication Date:

Authors : ; ;

Page : 1079-1086

Keywords : Ethical issues in clinical trials Good Clinical Practice Training (GCP) Risk mitigations Risk based quality management Ethical culture in clinical trials Regulatory challenges;

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Purpose: To identify ethical issues and risks involved in clinical trials and develop a conceptual model of identified issues in patient safety in clinical trials. Methodology: The review comprises of qualitative meta-analysis of available literature to identify potential ethical issues involved in the field of clinical trials. Findings: Our review identifies gaps in following core areas: 1) Research vs. Practice; 2) Inform Consent; 3) Ethical Oversight. Existing literature shows gaps in the true definition of research and does not clarify points of difference to clinical care. Existing guidelines are still confusing about the requirement of inform consent, in which cases it is mandatory and in which cases it should be waived off. There are indiscripencies, how much information should be provided in the inform consent disclosure. Is ethical oversight required in all research studies and if so at what level. We will build a streamline ethical argumentation to identify gaps in the existing literature, evaluate existing guidelines, analyze the contents to reach a conclusion and put forward recommendations for quality improvement. Conclusions: For the definition of research and its difference with clinical practice, decision should be taken in the best interest of the patient whether it is patient care or it is research.For ethical overview oversight, we suggest concept of proportionate review. Inform consent should be seeked in all researches but if becomes a barrier in patient care then waiver should be granted for the well-being of the patient. All information should be disclosed to the research participants so that they make an informed decision for their participation.

Last modified: 2021-02-24 19:05:44