90 - More Than a Checkbox: The Ethics of Dual-Use Research Policy Implementation in the Context of Institutional Compliance

Background:  In discussions involving Dual Use Research of Concern or research with Pathogens with Enhanced Pandemic Potential, the debate is often superficially limited to whether or not to do the research itself. In this paper, we argue that a lesser-discussed issue arises when questioning how to best implement DURC research policy and establishing and appraising mechanisms to ensure meaningful and comprehensive review structures.

Methods:  We have analyzed the 2024 DURC Oversight policy in situation with the history and implementation of similar oversight bodies – such as Institutional Review Boards. We also explored this policy in terms of governmental reach and authority through historical literature and policy review. Our goal is to not only assess the practicality for institutional adoption, but also gauge each structure for comprehensive review from the Institutional Review Entity – and not a review limited to a checkbox at a feasibility level.

Conclusion:  Our hope is for the Institutional Review Entity put forth by this policy to become an independent, educational, professional working body, but this calls for major institutional and field-specific buy-in and in-earnest governmental support. We argue that this will be a long-term process and the field will need to be built and trained over a number of years.

Limitations: The limitations of this argument and these recommendations is that they are based off of a new policy that is not yet active. The recommendations are based off of historical opinions from NSABB and other public DURC and PEPP research ventures.

Discussion:  In giving a one-year implementation date, the Institutional Review Entity will require a strategic yet meteoric build up of training and education. We argue that ensuring the proper design and composition of the Institutional Review Entity, as well as providing for the relevant government and institutional provisions, will make an immense impact on the review process and uptake of the reviews themselves. We submit that in order to have the best chance at a comprehensive and meaningful review process, the authority of the backing of the IRE will need the force of at least a rule congruent with the federal authority of The Common Rule to ensure a review process that is thorough, fair, and taken seriously in the field.