A Population Perspective on Ethical Compliance with Drug Trial Standards of Practice

Protection of individual rights and vulnerable groups is critical, and it is increasingly recognized that all countries wishing to engage with the international scientific community must set high standards, have robust regional ethical committees (RECs), and ensure genuine and complete compliance [1–3]. Despite raising concerns over the protection of subjects, over 90% of the included articles did not mention the reporting of REC approval [4]. These results are unexpected, because most journals request authors to report REC approval or ethical considerations. In views of this, Dr. Rosenberg’s paper [5] attempts to put forward the following approaches: to perfect local governmental regulations, to conduct preventive measures in the education of ethics issues for medical researchers, and to carry out the security mechanism of publishing reinforcement by journal editors. These are the most vital elements for genuine compliance of clinical trials. The protection of the rights, health, and safety of participants should be the primary concern in human drug trials. As publication is the final stage of most biomedical research, peer-review journals should play a greater role in safeguarding human subjects by controlling items relating to ethics. Just as every manuscript cover includes a list of authors, a statement on the ethical considerations of the participants should be included for every study trial. Papers including sensitive data that involve REC approval should not be submitted for publication. Should researchers claim that the study does not require REC review, the reasons for review exemption should be given and this decision must not be made by the researchers. Furthermore, scientific publications could serve an essential role in the propagation of ethics principles [6–7], and this appears to be happening with drug clinical trials in China. In addition, there are some good online ethics courses (including one by Stanford [8]), and a ‘train the trainers’ model built by overseas institutions in cooperation with China that could accelerate such capacity building. Inviting international input into the process would be helpful in building trust in the developing system and achieving good results. To some extent, making researchers aware of ethics considerations in research has been an add-on process. However, we believe that such consciousness should be maintained throughout initial training and the continuing practice of all staff connected with trials. Dr. Rosenberg has made a very good point on this issue, providing effective approaches for fulfillment, adding merit for increasing ethical compliance with drug trial standards of practice in China. Great appreciation should be expressed for Dr. Rosenberg’s earnest work.