ABSTRACT
Ethics may be thought of as a discipline for dealing with what is good or bad, a set or system of moral values, or a guiding philosophy [1]. Ethics as a philosophy to guide the conduct of clinical trials is a must: from protocol development, to the recruitment of investigators and investigational sites, to the recruitment and treatment of volunteers who participate in the trials, to the monitoring of the trials, to the collection, computerization, and quality assurance of data collected in the trials, to the statistical analysis of the data collected, to the writing and compiling the regulatory dossier, and to the conduct of all who have any responsibility for the design, conduct, and reporting of clinical trials. In the absence of a commitment to ethics, there may be no barriers to prevent inefficient and useless trials from being conducted or to safeguard the health of participants. Having a philosophy of ethics and being bound by a code of ethics ensures that the rights, common decency, and health of clinical trial participants will be paramount, and that the results from clinical trials are presented and reported factually. The purpose of this chapter is to provide an overview of the evolution of
ethical considerations in clinical trials and to impress upon the reader the need for ethical conduct by all individuals with any responsibility in their design, conduct, analysis, and reporting. Toward this end, key milestones in the history and evolution of ethics in clinical research are identified and briefly discussed in Section 3.2. The role of independent review boards is discussed in Section 3.3. Who should practice clinical trial ethics within the context of protocol development, protocol conduct, biostatistical analysis, interpretation, and dissemination of results are presented in Section 3.4. Informed consent is also revisited in Section 3.5 by linking it to sample size determination and power, and arguing that power and sample size should also be included in the informed consent document. Common ethical principles across various codes and regulations are summarized in Section 3.6. Concluding remarks appear in Section 3.7.
