US bioethics fall short of world standards

In their study of motion resistant pulse oximetry in neonates, Sahni et al¹ obtained approval from their institutional review board and consent from the parents of the infants involved. Nevertheless, the study fails the most basic principles of bioethics, and this calls into question the value of institutional review boards and points to a yawning chasm between American ethical practices and world ethical standards.

The recognised criteria for ethical experimentation are the Nuremberg Code (1947)² and the Declaration of Helsinki (1964) as amended.³ The Nuremberg Code requires the consent of the subject, which obviously could not be obtained in this case. The Declaration of Helsinki provides for the consent of the legal representatives of minor children in certain limited instances:

“For a research subject who is legally incompetent, physically or mentally incapable of giving consent or is a legally incompetent minor, the investigator must obtain informed consent from the legally authorized representative in accordance with applicable law. These groups should not be included in research unless the research is necessary to promote the health of the population represented and this research cannot instead be performed on legally competent persons.”³

This provision is inapplicable in this instance because this research did not promote the health of the population group represented and because this research easily could have been performed on legally competent adults.

Male neonatal non-therapeutic circumcision violates basic human rights to security of the person and to freedom from torture, inhuman, or degrading procedures. A recent study found that neonatal circumcision fails all ethical tests.⁴ Moreover, the Norwegian Council for Medical Ethics advised the Norwegian Medical Association that the circumcision of boys is not consistent with important principles of medical ethics, has no established medical benefit, and causes pain even with the use of local anaesthesia.⁵ Non-therapeutic circumcision of children violates articles 1, 2, and 20 of the European Convention on Human Rights and Biomedicine.⁶

The institutional review board must be more than a rubber stamp to approve whatever is proposed. Clearly, world ethical standards were not considered in this instance. It is time for American bioethics boards and committees to adopt world standards.