Showing 4 results for Medical Research
Hamidreza Namazi,
Volume 5, Issue 1 (3-2012)
Abstract
In medical etiquette and ethics, benefit and harm assessment includes risk evaluation, rational risk, distinction between medical and non medical utilitarian considerations, individual and community benefit ratio, and issues of the like.
This article explores philosophical foundations of this issue. In philosophy, benefit/harm reduces to pleasure/pain and good/bad. Pleasure (spiritual and non-spiritual) is considered a subjective criterion for benefit, whereas applied ethics needs an objective criterion. To achieve such a criterion, we need a specific model for casuistry evaluation and a holistic and organic approach. This article advocates the public sphere model and presumes it is the missing link of ethical confusions and the solution to ethics lack of quantifiability. Public sphere sits between public authority and private sphere, and supervises them impartially. Benefit/harm evaluation components in medical research requires such sphere for clarity and distinction.
Mina Mobasher, Jamileh Mahdavinia, Kazem Zendehdel,
Volume 5, Issue 1 (3-2012)
Abstract
The Declaration of Helsinki, the most creditable ethical guideline for medical research on human subjects, has been updated 8 times since its establishment and the last revision was in 2008. Researchers, medical research subjects, authors, members of ethics committees, and editors of medical journals must be informed of the tenets of the Helsinki declaration in order to improve achievements of medical research and respect the rights of participants in medical research. In this study, the evolution of the Helsinki declaration is examined, and the provisions of the last version are compared with the previous version (2004). Finally, we made a practical interpretation of the last version, and discussed its differences from previous version. There are seven new paragraphs in the last version of the declaration. Four new paragraphs concern informed consent in areas of its being written and voluntary, renewed consent for using human materials, participants' right to revoke the consent, and exceptions from informed consent requirements. The other three new paragraphs focus on the research subjects' right to being informed of the declarations' provisions, vulnerable groups gaining benefit from research, and registration of randomized clinical trials. It is important for researchers to recognize international guidelines such as the Declaration of Helsinki, because it enables them to use correct scientific and ethical standards in medical research. In the last version of the Helsinki Declaration more emphasis was placed on informed consent and vulnerable groups than previous versions.
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.
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.
