Showing 10 results for Research Ethics
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.
Farzaneh Zahedi, Bagher Larijani,
Volume 5, Issue 1 (3-2012)
Abstract
Research ethics, as one of the main issues of modern bioethics, has attracted the interest of scientists and ethicists in various areas of science and technology around the world. Research Ethics Committees (RECs) have been established to improve putting ethics into practice in the field of research. RECs, fortunately, have received a great deal of attention in different countries, and their mission, goals, and tasks have been described in many national and international guidelines. Ethical guidelines for biomedical research and RECs administrative regulations have been developed in Iran too. The need for special training courses for capacitating members has been emphasized in both international guides and our national administrative regulations for RECs. In this brief article, we present suggestions concerning course presentation and contents, which are provided by international assemblies. In view of the fact that many RECs in our country do not have specific plans for their members' primary training and continuing education, there seems to be a need for fundamental changes in the educational prerequisites for membership in this important organization.
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.
Fateme Fadaei, Ladan Naz Zahedi, Zahra Farahani, Nazafarin Ghasemzadeh,
Volume 9, Issue 3 (10-2016)
Abstract
The Declaration of Helsinki is one of the most important international documents in medical research ethics on human subjects which has been revised 7 times and the last revision was in 2013. Researchers must be informed of the principle of Helsinki declaration and the latest changes in order to respect the rights of participants in medical research. In this study, the last version of the declaration are compared with the previous version (2008). The evaluation of the changes and challenges of the final revision can be helpful in modification of the ethical codes of our country. The 2013 version included a number of important changes; it has been categorized into more clear and detailed sections. So this version has a better structure and more practical as well. The 2013 version places more emphasis on vulnerable groups and includes a separate section on the compensation and treatment of injuries due to research. The revised version of the Declaration of Helsinki also emphasizes obtaining of the informed consent (even in researches on material or data contained in biobanks) and post-trial access.
Amirhossein Mardani, Maryam Nakhoda, Ehsan Shamsi Goshki, Alireza Noruzi,
Volume 10, Issue 0 (3-2017)
Abstract
Substantial concerns about the research integrity in Iran have caused research misconducts to be issue for studies. But adequate recognition about causal factors is a necessary part of clear and explicit policy in order to manage the research misconducts and supply the research integrity. This study attempted investigating the available evidence on the reported research misconducts in the Iranian research and its causal factors. Therefore, 30 studies on the Iranian research misconducts were studied. The detected factors to research misconducts based on the reported evidence included: 1. Structural factors such as publication pressure, scientific promotion policies, research funding and job preservation; 2. Organizational factors such as research environment, regulatory-control activities on research and teaching research activities; 3. Personal factors such as research skills, degree orientation, financial benefits, understanding and moral judgment. The analytical model of causal factors was designed. Therewith, cultural and situational factors have received less attention in the literature and they have major focus on the obvious types of research misconduct (data fabrication, Falsification and Plagiarism), especially plagiarism.
Jila Sadighi, Nazila Nikravan Fard, Zahra Hatami, Ehsan Shamsi Gooshki,
Volume 13, Issue 0 (3-2020)
Abstract
More than two decades have passed since the establishment of research ethics committees in Iran. With many years of experience of research ethics committees, Iran Ministry of Health and Medical Education revised previous regulations and developed “Regulation on the Establishment, Leveling, and Duties of the Biomedical Research Ethics Committees”. Following publish and notification of “Regulation on the Establishment, Leveling, and Duties of the Biomedical Research Ethics Committees” in 2014, research ethics committees formed in national, academic, and organizational levels. In this regard, due to cooperation of the Iran Ministry of Health and Medical Education with the Iran Ministry of Science, Research and Technology, “the single article of the Act for Prevention and Combating Fraud in Scientific Publications” was approved in the Parliament of Iran in 2017; its executive bylaw was notified for implementation by the Cabinet of Ministers in 2019 and accordingly research ethics committees found a legal status in Iran. For promotion and update of the mentioned regulation and adaption to the Act, the secretariat of the national ethics committee proposed revised version of the regulation after obtaining opinions of stakeholders and several expert meetings. Then the new regulation entitled “Regulation on the Establishment, Procedures, and Duties of the Research Ethics Committees” was approved by the Iran National Committee for Ethics in Biomedical Research and the High Council of Medical Ethics of Iran in 2021. Structure of the committees in the new regulation includes “the National Committee for Ethics in Biomedical Research”, “Regional Research Ethics Committee”, “Institutional Research Ethics Committee”, “Biomedical Research Ethics Committee”, and “Specialized Committee”. This article introduces this new regulation.
Mahshad Noroozi, Ehsan Shamsi Gooshki, Saeedeh Saeedi Tehrani, Fatemeh Bahmani, Mina Forouzandeh, Saeed Biroudian, Nazila Nikravan Fard, Mahshad Goharimehr, Akram Hashemi,
Volume 16, Issue 1 (3-2023)
Abstract
The research activities of developing countries have increased over the last two decades. The expansion and decentralization of ethics committees necessitates appropriate performance evaluation. In 2023, a cross-sectional study was carried out on the Iranian research ethics Committees using the checklist called "Research Ethics Committee Self-Assessment Tool". The checklist was translated into Persian and revised based on the opinions of research ethics experts and the approved “regulation of establishment, grading, and description of duties for research ethics committees”. The electronic checklist was sent to the senior members of 269 research ethics committees. After gathering the data, it was analyzed using SPSS software. The response rate was 83%. The average overall score was 152.11 ± 25.173, or 69.14% of the maximum. The two sections (including continuing review (monitoring) and committee resources received less than 50% of the average score. The 138 research ethics committee scores were excellent and 85 committees were in the good range. The findings revealed that average scores are influenced by activity years, the number of monthly meetings, the presence of an approved annual budget, an approved quality improvement program, and having specific administrative staff. Completing the self-evaluation tool can raise the National Committee authorities' awareness about the adherence of the research ethics committees to the imperative standards. It can also lead to each committee's awareness of its strengths and challenges. Revision of national regulations governing the establishment, grading, and description of committee duties and then future self-evaluation can facilitate upgrading and improving the performance of ethics committees.
Amirhossein Mardani, Maryam Nakhoda, Ehsan Shamsi Gooshki,
Volume 17, Issue 0 (12-2024)
Abstract
Research misconduct cases reviewed by ethics committees serve as a valuable source of data for managing potential future misconduct. This study examines the reported cases within closed research misconduct files of the National Committee for Ethics in Biomedical Research of Iran, aiming to identify common manifestations of misconduct and influential factors across various activities within the research system. Documentation from 100 closed cases reviewed by the National Committee for Ethics in Biomedical Research during 2016 and 2017 was analyzed. A documentary research method and qualitative content analysis were employed. Using a directional analysis approach, the manifestations and factors contributing to misconduct in each case were extracted and categorized. Subsequently, causal relationships between the reported factors were defined. Twenty-one manifestations of research misconduct were identified, most of which involved undesirable micro-level activities, particularly the failure to adhere to ethical standards in research publication. Although negative impacts were observed at the meso level, including issues with research oversight, training in research standards and skills, journal management structures, and administrative and financial structures within universities, macro-level activities and deficiencies in research system performance—such as inadequate investment and financial resource allocation—were not addressed. Twelve causal relationships contributing to research misconduct were identified, highlighting how inadequate performance across different levels of the research system—including administrative structures for research approval and funding, research infrastructure, research evaluation, training, journal management, and oversight mechanisms—can interact and exacerbate misconduct. A key finding was the insufficient reporting of reasons for research misconduct in case documentation. Ethics committees appear to lack significant focus on analyzing the underlying causes of misconduct. Detailed and precise reporting of misconduct reasons, alongside independent studies, would provide decision-makers with valuable insights for preventing future occurrences.
Zahra Kazempour, Hasan Ashrafi-Rizi, Mohammadreza Hashemian,
Volume 17, Issue 1 (3-2024)
Abstract
The ethics of reviewing scientific works is a crucial aspect of research ethics in the field of health, where the outcomes significantly impact prevention, diagnosis, treatment, rehabilitation, and management, highlighting the importance of the quality of research results. Accordingly, this study aimed to develop a charter for the ethical peer review of scientific works in the field of health. The significance of this commentary lies in that researchers’ and reviewers’ adherence to ethical principles can contribute to enhancing the quality of scientific works aimed at prevention, diagnosis, treatment, rehabilitation, and management in the field of health. This charter can serve as a framework for scientific work review systems, assisting research managers in identifying the ethical components essential for reviewing scientific works in the field of health to develop effective research policies and plans. Moreover, it would help reviewers and practitioners at journals, research centers, and institutes, facilitating accurate, fair, and unbiased reviews of scientific works in the field of health.
Soudabeh Mehdizadeh, Ehsan Shamsi Gooshki,
Volume 18, Issue 1 (3-2025)
Abstract
The Declaration of Helsinki, as a fundamental document of ethics in medical research involving human participants, has been periodically revised since its adoption in accordance with theoretical and scientific advancements, emerging ethical issues in research, and the experiences gained over time. In the latest revision completed in 2024, significant changes and amendments have been made. This study examined the changes and revisions made in the latest version of the declaration in comparison to its previous version from 2013. Fundamental revisions in the recent update include a requirement for adherence to ethical principles in research not only by physicians but also by other researchers, the replacement of “subject” with “participant,” and the emphasis on the voluntary nature of informed consent. Attention to environmental sustainability, precise design to prevent research waste, and a focus on scientific integrity are among the other amendments in the new revision of this declaration. Other modifications and revisions made in the recent edition include the promotion of individual and public health as the ultimate purpose of research, the provision of sufficient resources for research ethics committees and strengthening their independence, the importance of local ethical review, consideration of the preferences and values of participants who are unable to provide voluntary and informed consent, and the necessity of adhering to the ethical principles of the declaration during public health crises and emergencies. Given the changes made, it is recommended that the national ethical guidelines for medical research involving human participants in Iran be revised based on the 2024 revisions.
