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High-Risk Life Science Research

At Case Western Reserve University, we are committed to fostering innovative scientific discovery while maintaining the highest standards of safety, biosecurity, and regulatory compliance. To protect public health, safety, and national security, CWRU administers institutional oversight for research posing high-consequence biological risks.

In accordance with the USG Policy for Stopping High-Risk Life Sciences Research (issued July 2026), the university is transitioning from a list-based agent review to a comprehensive, risk-based oversight framework. This framework will govern two primary areas of high-risk life sciences research: Dangerous Gain-of-Function (DGOF) research and International Research of Concern (IROC).

Dangerous Gain-of-Function Research

The United States Government prohibits federal funding for research that meets the definition of Dangerous Gain-of-Function (DGOF). Research with a biological agent that could potentially result in one or more high-risk experimental outcomes and could result in significant negative societal consequences may be considered for federal funding following thorough institutional and federal review.

Definition
DGOF is defined as research involving any biological agent that seeks, achieves, or carries a substantial risk of achieving one or more high-risk outcomes that could result in significant, negative societal consequences. Potential DGOF means that, while not intended, a DGOF outcome could occur with a non-trivial likelihood.

High-Risk Outcomes of Concern

  • Enhancing Virulence: Increasing the harmful consequences or pathogenicity of the agent.
  • Evading Countermeasures: Disrupting immune responses, creating resistance to treatments/vaccines, or facilitating detection evasion.
  • Improving Transmission: Increasing stability, transmissibility, or ease of dissemination.
  • Altering Biology: Expanding the host range or increasing human susceptibility.
  • Reconstitution: Generating or reviving eradicated or extinct pathogens.

International Research of Concern (IROC)

To safeguard research integrity and protect sensitive scientific knowledge, the new policy introduces strict boundaries on international collaborations and geographic research environments.

Definition
International Research of Concern (IROC) covers life sciences research that meets either of the following criteria:

  1. Restricted Collaborations: Research conducted in a designated country of concern, or research involving foreign institutions or individuals of concern.
  2. Inadequate Local Oversight: Research conducted outside of the United States in a country or jurisdiction that lacks adequate regulatory oversight and biosafety controls, thereby posing an implicit threat to public health or national security.

Investigator Requirements: What PIs Must Do

Compliance is a shared responsibility. PIs must actively evaluate their research portfolios against these risk-based standards.

  1. SELF-ASSESS: Evaluate research for DGOF outcomes or IROC.
  2. DISCLOSE: Flag potential DGOF/IROC during SpartaGrants submission (after implementation).
  3. COOPERATE: Participate in IRE reviews & draft mitigation plans when potential DGOF is proposed.
  4. REPORT: Immediately report unexpected experimental outcomes.

Roadmap to Implementation (January 16, 2027)

CWRU is actively preparing for this transition. Our ongoing compliance and alignment efforts include:

  • Administrative Integration: The Office of Research and Technology Management (ORTM) is currently updating SpartaGrants and proposal submission workflows to embed the new triage questions seamlessly into the pre-award phase.
  • IRE Restructuring: CWRU’s Institutional Review Entity (IRE) is updating its review charter, drafting standard operating procedures, and establishing formal protocols to evaluate risk-benefit profiles under the new risk-based standards.
  • Education and Outreach: We are developing targeted training modules to guide faculty through the new self-assessment tools before the January 16, 2027, deadline.

For questions regarding potential DGOF or IROC in your current or proposed research, contact the Biosafety Office at biosafety@case.edu.

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