The Law and Ethics of Consent and Causation
Jerry Menikoff1, National University Of Singapore Singapore 1National University Of Singapore, Singapore Singapore
Abstract
What is the relationship between the ethical and legal standards for obtaining consent in the health care setting (either for treatment or participation in research)? In many countries, a successful lawsuit for failure to obtain consent requires a demonstration that the patient was harmed, and that the harm would not have occurred but for the failure to obtain appropriate consent.
In a prominent case from the U.S. involving a clinical trial randomizing premature infants to high and low levels of oxygen (SUPPORT), a court in 2015 dismissed a lawsuit against the researchers on grounds that there was a failure to show that the injuries were caused by participation in the trial. Prominent bioethicist John Lantos wrote in the New England Journal of Medicine (2015, 373:1393-1395) that this was “vindication” of the consent forms used in the study. The editors of that journal in an editorial backed up his conclusions, faulting the ethicists who had criticised the trial.
Properly evaluated, it is apparent from what the court said – and from an important subsequent opinion from the court not addressed by these two NEJM pieces – that the dismissal of the lawsuit was in no way a vindication of the ethics of consent obtained in the trial. These events demonstrate the importance of distinguishing between the legal and ethical aspects of informed consent when dealing with causation issues.
Biography
Before joining NUS, Jerry Menikoff ran the main U.S. regulatory agency protecting research subjects (OHRP). He led the process of revising the “Common Rule,” with many changes reflecting proposals he promoted for years (particularly improving consent forms, making consent forms public, and requiring one IRB for review of multi-centered research).