Department of Medical Ethics, School of Medicine ,Iran University of Medical Sciences, Tehran, Iran , sbiroudian@gmail.com
Abstract: (16 Views)
Ethical standards in clinical trials are essential to safeguard human participants and ensure scientific credibility. Despite global frameworks such as the Declaration of Helsinki and national reforms in Iran, evidence suggests ongoing ethical deficiencies in trial documentation and conduct. The objective of this study is to systematically examine and evaluate the ethical issues that arise in clinical trials. This analysis aims to identify common ethical challenges, assess current guidelines and regulatory frameworks, and propose recommendations to enhance the ethical conduct of clinical research. By providing a comprehensive overview, the study seeks to promote greater awareness and understanding of ethical considerations among researchers, participants, and policymakers involved in clinical trials. This retrospective descriptive study analyzed all clinical trial proposals approved by Guilan University of Medical Sciences between January 2018 and December 2022. Using a structured checklist, data were extracted on investigator demographics, faculty affiliation, clinical discipline, inclusion of informed consent forms, use of placebo, and treatment deprivation. A total of 219 proposals were reviewed. Only 137 (62.5%) of trials included an informed consent form, 26 (11.9%) used a placebo, and 11 (5%) involved deprivation from standard treatment, highlighting notable gaps in ethical documentation. Most studies were submitted in 2018, 64 (29.2%), and were affiliated with the Faculty of Medicine, 146 (66.7%). Male researchers were the majority, 119 (54.3%). Nursing, anesthesiology, and obstetrics & gynecology were the most active fields. Ethical documentation varied significantly across disciplines. Despite national-level improvements in Iran’s research ethics infrastructure, considerable gaps remain at the institutional level. Targeted efforts are needed to enhance ethical training, strengthen review processes, and ensure consistent adherence to international standards across all disciplines
Type of Study:
Research |
Subject:
General Received: 2025/07/12 | Accepted: 2025/11/15 | Published: 2025/11/30