Reporting of Ethical Considerations Associated with Clinical Trials Published in Iranian Dental Journals between 2001 and 2011

Nader Navabi, Arash Shahravan, Ali Modaberi, Nader Navabi, Arash Shahravan, Ali Modaberi

Abstract

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: Clinical Trials; Dental; Ethics; Iran; Journal.

Figures

Fig. 1:
Fig. 1:
Frequency of 17 Ethical Items observed in 242 Articles

  1. q1-Have the subjects participated in the study voluntarily?

  2. q2-Have the participants completed and signed consent forms?

  3. q3-Has the study protocol imposed any extra costs on or has it wasted the time of the participants?

  4. q4-Have the participants received any gifts, free medicines or …… for their participation?

  5. q5-Has the personal information of the participants and the results been kept confidential through out the study?

  6. q6-Does the study have any ethical codes?

  7. q7-Have the tests been safe for the subjects?

  8. q8-Has compensation of any possibly inadvertent injuries to the subjects been considered?

  9. q9-Have the participants been free to drop out of the study at their own volition?

  10. q10-Have only available populations been included in the study, i.e. mentally retarded subjects, prisoners, patients referring to treatment centers or the health care system professional personnel?

  11. q11-Has the study implicated itself in discussions of sensitive issues?

  12. q12-Has the study resulted in pain or discomfort (even minor) in the subjects?

  13. q13-Has the study led to the induction of stress in the daily lives of participants?

  14. q14-Has the participation of the subjects in the study involved gaining permission from a guardian?

  15. q15-Has the protocol of the study necessitated long and repetitive measurements?

  16. q16-Have invalid and dubious sources have been used to carry out the study?

  17. q17-Was it ethically acceptable to administer a placebo?

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