Good clinical research practice demands that all research complies with the highest ethical code. Unfortunately, however, there are multiple examples of human rights abuses and exploitation of vulnerable groups in medical research. These include atrocities committed by Nazi doctors in concentration camps; trials where antibiotics were deliberately withheld from syphilis patients to facilitate observational studies, and experiments on American prison inmates recruited via coercion. Modern medical ethics evolved in response to such events. It originates from the Nuremberg Code: ten doctrines issued by the jurists involved in the “Doctors Trial” at Nuremberg. These principles advocate for the autonomy of participants and informed consent. The field of ethics has progressed from this time with the publication and subsequent revision of landmark guidelines including the Helsinki Declaration, the Belmont report and the Georgetown mantra. The overarching principles of ethical research include respect for autonomy, beneficence, non-maleficence and justice.

The Declaration of Helsinki states that “research must be preceded by careful assessment of predictable risks in comparison with foreseeable benefits to the subject or to others.” The current norm is that all research involving patients, service users or volunteers (or their organs or tissues) is subject to independent review to ensure it meets a minimum ethical standard. Gaining approval from the relevant research ethics committee is a