Replacing Institutional Review Boards with Strict Liability
Biorisk, Epistemic Institutions, Values and Reflective Process
Institutional Review Boards (IRBs) regulate biomedical and social science research. As a result of their risk-averse nature, important biomedical research is slowed or deterred entirely; eg, the UK human challenge trial was delayed by several months because of a protracted ethics review process and an enrollment delay in a thrombolytics trial cost thousands of lives. In the US, a plausible challenge to IRB legality can be mounted on First Amendment grounds. We would be interested in funding a civil rights challenge to IRB legality, with the eventual goal of FDA guidance on control groups and strict liability replacing IRBs as a means of research regulation. This would have substantial overlap with our project idea of rapid countermeasure development to new pathogens.
Replacing Institutional Review Boards with Strict Liability
Biorisk, Epistemic Institutions, Values and Reflective Process
Institutional Review Boards (IRBs) regulate biomedical and social science research. As a result of their risk-averse nature, important biomedical research is slowed or deterred entirely; eg, the UK human challenge trial was delayed by several months because of a protracted ethics review process and an enrollment delay in a thrombolytics trial cost thousands of lives. In the US, a plausible challenge to IRB legality can be mounted on First Amendment grounds. We would be interested in funding a civil rights challenge to IRB legality, with the eventual goal of FDA guidance on control groups and strict liability replacing IRBs as a means of research regulation. This would have substantial overlap with our project idea of rapid countermeasure development to new pathogens.