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Clinical trials on healthy volunteers: review of ethical considerations and a critique of acceptable risk
Alireza Parsapoor, Fariba Asghari,
Volume 5, Issue 1 (3-2012)
Abstract
Healthy volunteers are the first group who take part in experimental studies on the efficacy of new drugs. Parallel with expanding the boundaries of medical science, medical research has shown rapid growth which has caused new and critical ethical challenges in medical research.A clinical trial is one of the essential methods in clinical research and a very challenging method from the ethical viewpoint.Recruiting healthy volunteer participants is necessary in clinical trials of drugs, and it requires special and careful ethical considerations. Although recruiting healthy volunteers is not limited to clinical trials, we have focused our discussion on ethical issues of research on healthy volunteers in this kind of study. In this paper, ethical challenges of involving healthy volunteers in clinical trials have been discussed in four domains of risk-benefit assessment, fair subject recruitment, incentives, and informed consent. The authors believe and argue that using the daily life risks standard as the acceptable risk for healthy volunteers is impractical. We suggest defining a reasonable risk that is acceptable to the research ethics committee. The ethical committee, as a jury, can then evaluate the public acceptance of the risks.
A survey on the rate of observance of research ethics in approved proposals at Urmia University of Medical Sciences (2003 - 2008)
Nazafarin Ghasemzadeh , Nazila Nikravan Fard , Mohammad Hossein Rahimi Rad , Sara Mousavipour , Fatemeh Faramarzi Razini ,
Volume 6, Issue 2 (5-2013)
Abstract

Considering the importance of medicine and the ever-increasing developments in medical research, the implementation of such research according to the ethical principles and criteria of creditable national and international declarations is of great significance. According to these declarations, the researcher has the highest responsibility to observe the rights and safety of participants. The present study intends to survey the rate of observance of research ethics in proposals approved at Urmia University of Medical Sciences between the years 2003 and 2008. Three hundred and twenty four research proposals that had been approved between 2003 and 2008 were evaluated retrospectively. Related checklists (self- constructed ones and World Health Organization checklists) were completed for each project, a statistical analysis of the results was done by SPSS software, and descriptive statistics were subsequently extracted.  A summary of the most important results is as follows: In 85.5% of the proposals, the ethical considerations part was completed. In 68.4% of the cases the participants were aware of participating in the study and in 67.9% of the cases the informed consent of participants was obtained, 50.9% of which was in written form. Among clinical trials, in 80% of the proposals informed consent was obtained, 85% of which was written. Out of 60 clinical trials, 37 projects (62%) were confirmed by the ethics committee. Considering the results obtained in this study, principles of research ethics were applied more closely in this study compared to similar studies in Iran. It seems this is due to the establishment and launch of regional ethics committees in 2003 and afterwards. However, in order to bring these measures closer to current standards, holding educational workshops for honorable members of scientific boards and students is recommended. Moreover, more accurate supervision of ethics committees, especially in clinical trials and animal experimentations, seems to be beneficial.


Evaluation of Participants' Awareness of Informed Consent Forms in Clinical Trials at Iran University of Medical Sciences in 2020
Fatemeh Hekmatian, Akram Hashemi, Soodabeh Hoveida Manesh, Saeedeh Saeedi Tehrani,
Volume 17, Issue 0 (12-2024)
Abstract
Obtaining informed consent is a fundamental ethical and legal right of participants in clinical trials. It ensures that individuals are adequately informed about the research, including its nature, potential risks and benefits, and their role in the study. This knowledge empowers participants to make informed decisions about their involvement. This study aimed to evaluate the awareness of participants regarding the information provided in informed consent forms (ICFs) for clinical trials conducted at Iran University of Medical Sciences (IUMS) in 2020. This study evaluated the accuracy of the content of ICFs of registered clinical trials and assessed participants' understanding of the information presented. ICFs were reviewed using a ministerial checklist. Participants were subsequently contacted to assess their comprehension of key aspects of the trial as outlined in the ICF. Analysis revealed a discrepancy between the information presented in the ICFs and participants' actual understanding. Despite adequate coverage of certain aspects, such as the research nature of the interventions (98.2%) and the mention of specific benefits (92.7%), significant gaps were observed in participants' comprehension of crucial information. Notably, lower levels of understanding were observed regarding the possibility of invasive interventions (25.7%), the random assignment of participants to study groups and the potential use of placebos (44%), and the possibility of not personally benefiting from the research outcomes (44%). Additionally, only 47.7% of participants reported understanding the confidentiality of their information. These findings highlight the need for improvements in the process of obtaining informed consent. While researchers may adequately address the overall research objectives and potential benefits, crucial aspects such as the potential for invasiveness, randomization procedures, and the possibility of no direct personal benefit may not be adequately communicated to participants. Enhancing participant understanding of these critical aspects is crucial for ensuring truly informed consent and upholding ethical research practices.

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