Prof. Jerry Menikoff1
1National University Of Singapore, Singapore, Singapore
Biography:
Before joining the faculty of the National University of Singapore Centre for Biomedical Ethics in 2023 as a Professor of Bioethics and senior fellow of the NUS Faculty of Law, Jerry Menikoff was the director of the main U.S. regulatory agency protecting research subjects in federally funded research (OHRP).
Abstract:
A major legal and ethical requirement for research consent is that a person be given appropriate information about the possible benefits of participation. All too commonly, however, consent forms provide a generic statement that “you may or may not benefit from participating in this study.” As has convincingly been argued, the rules were not intended to allow a boilerplate statement to fulfill this requirement. What prospective participants should be given is specific information about both the likelihood of benefiting and the type of possible benefits. Yet researchers commonly respond that they do not have that type of information, and the generic language is all they can provide.
A new drug for treating common forms of metastatic breast cancer, when it was announced in 2022 at a major medical meeting, led to a standing ovation – the first one in decades at such a meeting – because the improved survival was so unheard-of. What was that increase in survival? Six months, in comparison to the “extra few weeks” that would normally constitute success in a trial. Looking at online versions of consent forms for this type of research shows that it is rare for them to include any of this crucial information: that even if the trial is successful, the benefit is likely to be at best a few extra weeks of life. Consent forms failing to include long known realistic information about benefits thus can indeed be a cause of the unrealistic expectations that trial participants all too often have.
Presentation Slides PDF – Click here