04.05 Ethics in Clinical Trials

The atrocities of the Nazis on concentration camp inmates, such as cutting people and seeing how long they bled for, were investigated after World War II in Nuremberg Tribunal. The tribunal developed the Nuremberg Code, which is started the modern era of ethics. There are 4 main principles of modern ethics (Figure 4.3).

Figure 4.3 Principles of ethics (Copyright QUT, Sheila Doggrell)

Firstly, there is non-maleficence, which means to do no harm. The second aspect, is the reverse of this, it is beneficence, which is to do good. Combining non-maleficence and beneficence means that clinical trials have to maximize benefits and minimize harm to the patient. The third aspect of ethics in clinical trials is justice, which means that the benefits of research should be distributed fairly, not just to the rich and powerful. The fourth aspect is respect for person. This has three parts, Firstly, individuals be regarded as autonomous agents, and their opinions and choices respected, regardless of how daft or illogical they are. The second part is veracity, the truth must be told to participants. Participants have to be able to understand the clinical trial, and the benefits and risks, and these are provide in a Plain Language Statement, prior to consent being asked for. Finally, confidentiality, the participants name, details etc are to be kept confidential.

Ethics are policed by IRBs, Institutional Research Boards, which are also known as Ethics committee. This process involves peer review of proposed research. Peer review is independent review of the proposed clinical trial to determine whether the trial is appropriate. Universities often have ethics committees both for peer reviewing animal experiments and human experiments. For instance, QUT has a Human Research Ethics committee, an Animal Ethics committee and a Biosafety committee.