Background: Ethical consideration is a basic requirement for design of randomized clinical trials. The purpose of this study was to assess whether reports of Iranian dental clinical trials complied with the requirements of the ethical principles of human research.
Methods: In this retrospective observational study electronic search was performed to identify all dental clinical trials published between 2001 and 2011. Each trial report was assessed for inclusion of a statement that 17 items about research ethics.
Results: Totally 242 papers were identified, of which 15.3%, stated that ethical approval had been obtained and 50.4% of the trial reports indicated that informed consent had been obtained. The mean ethical score for the mentioned studies was 7/68 out of 17.
Conclusions: Most Iranian dental clinical trial reports failed to consider important ethical principles. The reporting of the ethical issues associated with these trials could be improved further not only by the instructions to authors, but also by Journal editors refusing to publish trials that do not comply.
Keywords: Ethics, Clinical Trials, Journal, Dental, Iran
Every research is inevitably associated with ethical considerations and with advances in science, observance of ethical guidelines becomes ever-increasingly important (1,2). A wide range of medical ethics theories have been applied to hu-man research studies (3). Use of human subjects in medical research has a long history; however, since late 1960s serious attention has been focused on ethical issues in such studies (4). Scientific and ethical standards in relation to biomedical research on human subjects are rooted in international protocols, which have been designed according to accurate evaluations of human ethical needs to facilitate and support ethical considerations world-wide (5). Some of the most famous ethical proto-cols include the International Nuremberg Code, Helsinki Declaration, Belmont Report and ICP and GCP (Good Clinical Practice) (6-8). Strict observance of these protocols helps preserve dig-nity, rights and health of the participants in hu-man research studies.
Several ethical issues have been implicated in the ethical aspects of interventional research studies. RCTs (Randomized Clinical Trials) are the gold standard of such research studies and are generally the best method to evaluate the effect of a new medication or a new treatment modality (9-11). Based on what was discussed above, it appears necessary to minimize injuries inflicted on subjects and patients during RCTs (12). Various new therapeutic techniques are widely introduced and used in dentistry and RCTs are required to confirm these treatment modalities (13). Human rights and ethical considerations in research studies in the field of oral health are consistent with other human studies and the principles are based on international agreements; some of these principles include respect for the dignity of all the humans, respect for the principle of participation by one's own volition, respect for the confidentiality of personal information, attempt to reduce damages and injuries and increase benefits as far as possible and the scientific authenticity of the study (14). The most important ethical codes in clinical trials include the necessity to gain ap-proval of the protocol from the ethics committee (15) and to obtain informed consent from the subjects (16,17), participation by free will of the subjects, infliction of no extra costs on or wasting of the time of the subjects, confidentiality of per-sonal information, absence of any risks for the subjects, allowance for compensation of any inad-vertent damages and injuries to the participants during the study, permission to voluntarily drop out of the study, no use of only available popula-tions for the purpose of the study, infliction of no pain and stress on the patients during their routine daily lives (18). …