Awareness of Clinical Research Coordinators Toward Ethics and Protection of Clinical Trial Patients.

Abstract

Clinical research coordinators (CRCs) play an important role in the protection of clinical trial participants and maintenance of ethical standards. However, limited data are available on the ethical cognition of CRCs. Understanding the knowledge, attitude, and practices (KAP) of CRCs toward ethics is essential to protect study participants and improve their compliance. We conducted a descriptive, cross-sectional, quantitative study at 20 hospitals in Anhui province of China. A self-administered questionnaire was completed by 435 CRCs conducting clinical trials. The good knowledge, positive attitude, and good practice rates were 55.2%, 59.3%, and 79.5% respectively. Most CRCs (99.1%) were aware of the participants' rights. Only 127 (29.2%) and 140 (32.2%) CRCs were aware of measures to protect participants' rights and ethical guidelines regarding trials, respectively. In total, 59.6% of CRCs stated that ethical review might delay the start of a clinical trial. Marital status (odds ratio [OR] 0.47, 95% confidence interval [CI] 0.27-0.83), CRC work experience (OR 0.11, 95% CI 0.02-0.75), and educational background (OR 0.31, 95% CI 0.13-0.76) affected the knowledge of CRCs regarding ethics. Some deficiencies were observed in the ethical knowledge and behavior of CRCs. Interventions to improve the ethical training of CRCs regarding study participant protection, international guidelines, and the role of ethical committees are essential when conducting clinical trials. Validated instruments should be constructed to assess the effectiveness of ethical training and measure the KAP of CRCs toward ethics.