Continuing review of ethics in clinical trials: a surveillance study in Iran

Abstract

This study was conducted to examine adherence to ethical principles during research and the necessity to conduct systematic and continuing review of ongoing research in Iran. All clinical trials approved by the Research Ethics Committee of Tehran University of Medical Sciences (TUMS) ongoing in 2007 (n = 21) were reviewed through receiving principal investigators’ (PIs) reports, as well as reviewing patient consent forms. Two questionnaires were sent to PIs, one to collect information about the study and the other to evaluate PIs’ perception and awareness about ethical codes of clinical trials. A representative of the TUMS research ethics committee was sent to the research site to fill a checklist by reviewing the obtained informed consent and fill the other checklist by interviewing a sample of participants regarding their perception of their volunteer participation in the clinical trial and receiving adequate information. Only in 66.7% of the surveyed trials the objectives of the trial had been explained in the informed consent, and in 38.6% of the trials it was mentioned in informed consent that participation is voluntary. Among participants, 34.7% (n = 26) were not aware they were enrolled in a research project, 29.3% (n = 22) had not understood the information they had received, 74.7% (n = 56) did not know they could refuse to participate and still receive care from their physician, and 58.7% did not realize they were free to drop out of the study at any time. The results point to the need for continuing review of clinical research, especially clinical trials, and the necessity for thorough assessment of patient consent forms during the process of approval in terms of their contents and their understandability.