Ethics in human and animal studies

This chapter describes the basic principles of research ethics as they apply to biomedical research on human subjects and experimental animals. It builds on the more general introduction to ethics and scientific conduct presented in Chapter 2. It will first introduce two influential international regulatory documents on human biomedical research ethics and discuss specific problems raised when individuals are unable to give consent to participate in research projects, when placebos are used in randomized controlled trials, and when research involves vulnerable populations. It will also discuss the role of research ethics committees and how biomedical research on human subjects is regulated in most countries and at the international level. Although the details of regulatory protocols differ from country to country, the existence of long-standing international regulatory documents has resulted in significant harmonization of national regulations and an almost universal acceptance of certain principles of research ethics at the regulatory level.The controversial problems raised by research on embryos or fetuses will not be discussed, as this issue will be relevant to very few readers of this book, and the discussion would require an in-depth analysis of the moral status of embryos and fetuses.¹ The last part of the chapter will concern biomedical research on experimental animals, the justification of animal research, the obligation to minimize animal suffering, and the question of whether certain species require specific protections (see also Chapter 6). Summaries and key points are highlighted in boxes and a table.