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Compliance of final reports of approved clinical trials with ethical standards in the Hamadan University of Medical Sciences
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Ali Poormohammadi   , Salman Khazaei , Mohammad Khazaei , Erfan Ayubi * 1, Fateme Karbin , Reza Mohammadi |
| 1- , aubi65@gmail.com |
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Abstract: (166 Views) |
Background and Objectives
Education and research should be accompanied by moral values in the Quran and Islamic texts. Researchers in each field should be familiar with the values and ethical standards of that field. Compliance with ethical values and standards is very important in clinical trial studies. The purpose of this study is to determine the extent of compliance with ethical standards in research governing clinical trials in the final report of approved projects of Hamadan University of Medical Sciences during the years 2020-2021.
Materials and Methods
The final report of 34 clinical trial studies was reviewed through the standard clinical trial evaluation checklist. The checklist evaluates the status of the study regarding issues such as financial sponsors and costs, ethical approval, obtaining permission from relevant institutions, participants' health and safety, obtaining informed consent, and moral ownership of the results of the study.
Results
The results of this study showed that the state of estimating the cost of conducting experiments (88.2%), mentioning research sponsors (85.3%) and mentioning the necessary licenses of the Food and Drug Organization for eligible projects (79.4%) were less respected, respectively. Mentioning the entry and exit criteria were observed in all cases. Coordination with the attending physician in the clinical trial plans, registration of the trial in the Iranian clinical trial center and adherence to the contents of the plan were observed in 94.1%, 88.2% and 88.2% of the cases, respectively.
Conclusions
In the conducted clinical trials, the method of ethical approval, adherence to the study protocol, and the principles of informed consent have been properly observed, but the information related to costs and sponsors of the study can be reported more fully. Researchers of clinical trial studies should pay enough attention to issues such as clarifying costs and study sponsors, in addition to how to implement and report the results.
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| Keywords: Clinical trial, ethics in research, ethical considerations, Ethical values in the Quran and Islamic texts, Hamadan University of Medical Sciences |
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Editorial: Research |
Subject:
Ethics and health
Received: 2024/04/30 | Accepted: 2024/05/11
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