Disclosure to the Reader of Institutional Review Board Approval and Informed Consent

The Declaration of Helsinki provides rules for the ethical conduct of studies with human subjects by building on the foundation that a patient has a right to make an uncoerced, reasoned decision on whether or not to participate: to give informed consent. Many countries have mandated that institutional review boards (IRBs) or their equivalent ensure that the rules enshrined in the Declaration of Helsinki are followed in practice. See also pp 909, 925, and 927. The Declaration states: "Reports of experimentation not in accordance with the principles laid down in this Declaration should not be accepted for publication."1This statement implies that journals have a duty to confirm by the methods open to them that research was conducted according to ethical standards and suggests as well that they have a strong interest in promoting ethical research practices. Many journals seem to agree. For example, the International Committee of Medical