Volume 17 - Supplement of 11th Annual Iranian Congress of Medical Ethics
IJMEHM 2024, 17 - Supplement of 11th Annual Iranian Congress of Medical Ethics : 1-2 |
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Hekmatian F, Hashemi A, Hoveida Manesh S, Saeedi Tehrani S. Evaluation of Participants' Awareness of Informed Consent Forms in Clinical Trials at Iran University of Medical Sciences in 2020. IJMEHM 2024; 17 (S1) :1-2
URL: http://ijme.tums.ac.ir/article-1-7106-en.html
URL: http://ijme.tums.ac.ir/article-1-7106-en.html
1- Department of Medical Ethics, School of Medicine, Iran University of Medical Sciences
2- Assistant Professor of Medical Education, Educational Development Center, Iran University of Medical Sciences
3- Assistant Professor of Community Medicine, Burn Research Center, Iran University of Medical Sciences
4- Assistant Professor of Medical Ethics, Department of Medical Ethics, School of Medicine, Iran University of Medical Sciences
2- Assistant Professor of Medical Education, Educational Development Center, Iran University of Medical Sciences
3- Assistant Professor of Community Medicine, Burn Research Center, Iran University of Medical Sciences
4- Assistant Professor of Medical Ethics, Department of Medical Ethics, School of Medicine, Iran University of Medical Sciences
Abstract: (458 Views)
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.
Type of Study: Oral Presentation |
Subject:
Health Ethics Congress (11th) - Oral Presentation
Received: 2025/10/29 | Revised: 2026/01/12 | Accepted: 2024/12/22 | Published: 2024/12/22
Received: 2025/10/29 | Revised: 2026/01/12 | Accepted: 2024/12/22 | Published: 2024/12/22
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