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  6. U.S. Government Policy for Stopping High-risk Life Sciences Research

U.S. Government Policy for Stopping High-risk Life Sciences Research

U.S. Government Policy for Stopping High-Risk Life Sciences Research

Stop and Report

The Stopping Policy: what researchers and institutions must do

If federally funded life sciences work may be, or may become, dangerous gain-of-function research, it must stop and be reported.
1
Who is Covered
Researchers and institutions receiving federal life sciences funding must evaluate all proposed and ongoing projects, not only those already considered high risk.
Institutions must develop mechanisms to identify dangerous gain-of-function research (DGOFR), potential DGOFR, and international research of concern (IROC) across all life sciences research, regardless of funding source.
2
When Work Must Stop
Potential dangerous gain-of-function research (DGOF)
If funded research not previously reviewed by the government-wide review body later meets, or could meet, the "potential DGOF" definition, the principal investigator (PI) must halt the work and notify the institution and funding agency.
DGOF
If research may meet the DGOF definition itself, it must stop immediately, with notice given within 24 hours.
3
It is Continuous, Not One-Time
Before proposal submission
PIs must assess and attest to their research's classification.
As the work changes
PIs must keep re-evaluating the classification.
When aims, key personnel, or institutional arrangements change
These changes must be reported to the funder.
4
Funding Implications Depending On Category of Review
Research categories have different review requirements and funding implications.
DGOFR
Federal funding prohibited
Potential DGOFR
Independent Third-Party Review Board (ITPRB) review required prior to federal funding
IROC: Country/Entity of Concern
Federal funding prohibited
Other Risky International Research
Risk-based review required
5
What Institutions Must Have In Place
  • A designated Institutional Contact for DGOF (ICDGOF)
  • An Institutional Review Entity (IRE) of at least five members with life-sciences expertise
  • Institutional review and oversight processes
  • Attestation, certification, and record keeping mechanisms
  • Annual researcher training and documentation of compliance
  • Annual reporting of identified non-federally funded DGOF or potential-DGOF research
6
Why It Matters
  • Loss of funding, including immediate revocation of federal funding
  • Multi-Year Funding Blacklist: Noncompliant institutions face up to five years of complete ineligibility for any federal life sciences funding.
  • Potential False Claims Act exposure
  • Applies to violations of oversight, tracking, and reporting obligations or applicable agency regulations
Source: COGR, "The Stopping Policy: What Changes for Research Institutions" infographic, with additional policy summary content.