Principal Investigator Responsibility for Flagging Research with Dual-Use or Pandemic Risk.

The new United States Government Policy for Oversight of Dual-Use Research of Concern and Pathogens with Enhanced Pandemic Potential places primary responsibility on the proposing principal investigator to flag potential need for special review. This approach may carry significant risks, given that investigators have incentives to downplay the types of risks the policy aims to address, compounded by substantial opposition to the policy from many virologists. However, this commentary argues that such an approach is much more consistent with proven models of research oversight for protecting human subjects and animals and may be essential in the long run. It identifies the need for several independent but potentially mutually reinforcing preconditions for success-which will require creativity and investment not fully specified in the regulations: researcher training on dual-use and population-level biosafety risks, effective institutional-level support for and scrutiny of investigator evaluation, cultural change, checks and balances, and speedy evaluation of low-risk research.