ABSTRACT
The modern conception of research ethics as an ongoing academic and regulatory concern gained traction following the revelations of the Nuremberg trials. Knowledge of the gruesome experiments undertaken by Nazi doctors like Dr Josef Mengele led to the first international guidelines stipulating basic ethics standards for research involving human participants (the Nuremberg Code: Trials of War Criminals before the Nuremberg Military Tribunals under Control Council Law No. 10 [1949]). Subsequent scandals – including, for instance, the Tuskegee syphilis study in the US – led to further, and improved, ethics guidelines such as the World Medical Association’s Declaration of Helsinki (World Medical Association 2008) as well as national regulatory documents such as the landmark Belmont Report in the US (National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research 1979). Academic and policy analyses in research ethics are marked by reasonably clear dividing lines
between clinical and non-clinical investigations, as well as between research conducted in developed countries and research in developing countries. A few issues cut across these dividing lines, such as concerns about academic misconduct like the falsification of data, arguments about legitimate claims to authorship of a scientific publication, and plagiarism (ICMJE 2013). Most of the latter concerns have been successfully addressed in international guidance documents. The former have led to decades of continuing productive research undertaken by many academics working in the field of research ethics, itself an area of specialization within the field of bioethics. The bulk of this chapter will address concerns to do with the ethics of clinical research, but let us begin by looking briefly at authorship-related issues.
