Protecting Participants in Clinical Trials Through Research Ethics Review

Abstract

International standards require research involving humans to undergo ethics review by a research ethics committee. Such committees apply local, national, and international policies and regulations in order to ensure the protection of human participants and ensure that research projects have undergone independent scientific review. The committees themselves exist within universities and hospitals or at a national level. However, delicate issues emerge whenever governance arrangements do not ensure the adequate independence of the process and the avoidance of conflicts of interests or when research participants are used primarily for the advancement of science or when commercial benefits are privileged over the betterment of public health advancement. All the elements of the decisional process of an ethics review system must be independent from the organizational structures that have interest in the outcome of the ethics review. International research may raise the issues of shopping for lower national standards and taking advantage of the vulnerable and less adequate national systems of protection. The exportation of research activities that would not be compliant with the regulations of a developed country, which often is the main beneficiary of the research activity, to a developing country where the regulatory requirements are less stringent is called “ethics dumping” and is morally objectionable. We give examples of inadequacies of review and propose safeguards to ensure the adequate balance of interests, including education, improvement of health literacy, and the development of appropriate, transparent, accountable, and robust oversight mechanisms.