Lack of Informed Consent and Absence of Ethical Committee Approval are the Major Ethical Issues for Clinical Studies in Thesis Researches for Postgraduate Students in Pharmacy College at Baghdad University

Objective: Evaluating some ethical issues in the researches of postgraduate students that submitted to Baghdad University – college of pharmacy – clinical pharmacy department. Methods: All thesis researches of postgraduate students that involve clinical studies on human beings, that submitted within three years period ( from 2011 till 2014) to Baghdad University, College of Pharmacy – Clinical Pharmacy department, were retrospectively reviewed by direct access to the library of Pharmacy college at Baghdad University. A set of questions were prepared in questionnaire format was used to evaluate ethical issues in postgraduate student researches through careful reading for the methodology of each one of these researches. Results: This study showed that there is a significant absence (64.5%) of ethical committee approval for researches of postgraduate students that submitted to clinical pharmacy department in College of pharmacy/ Baghdad University. The ethical committee of Pharmacy College played a minor role for approval of clinical pharmacy department postgraduate students (12.9%). There is a significant absence (54.9%) of patient informed consent in the researches of postgraduate students. Additionally there is a non significant correlation between ethical committee approval for the research and the presence of patient informed consent. More than 77% of researches for postgraduate students in the form of randomized controlled clinical trial, at which the majority (61%) were open label trials. Furthermore, this study found that research funding and conflict of interest were not disclosed in any research for postgraduate students, besides the absence of any details about protection of patient privacy and confidentiality. Conclusions: there are many ethical problems with the clinical researches of postgraduate students in Iraq. The role of ethical committee approval for researches is poor and without sufficient follow up for these researches. Informed consent was absent in most researches. Additionally there is a non disclosure for any information regarding research conflict of interest, funding, or patient privacy and confidentiality protection.

Author(s): Ehab Mudher Mikhael

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