Institutional Review Entity (IRE)
The Saint Louis University Institutional Review Entity (IRE) will oversee applicable life sciences research by conducting risk assessments and monitoring compliance with the United States Government Policy for Stopping High-Risk Life Sciences Research (USG Policy), issued July 20, 2026. Under SLU’s implementation process, all life sciences research proposals must be evaluated by the Principal Investigator and verified by SLU before submission.
The USG Policy, which becomes effective Jan. 16, 2027, establishes requirements addressing two principal categories of high-risk life sciences research: DGOF research and IROC. It also establishes a review pathway for research identified as potential DGOF research.
Research involving a biological agent that seeks, achieves, or has a substantial risk of achieving one or more outcomes specified in the USG Policy and that could result in significant negative societal consequences.
Research that could potentially result in a listed outcome and significant negative societal consequences.
Federally funded life sciences research conducted outside the United States that is prohibited or subject to additional review under the USG Policy, including research involving foreign countries of concern, foreign entities of concern, or locations where adequate oversight cannot be ensured.
Saint Louis University is developing institutional policies and procedures to support compliance with the United States Government Policy for Stopping High-Risk Life Sciences Research. This page will be updated as federal guidance and institutional requirements are finalized.
Questions related to the IRE may be directed to christopher.eickhoff@health.slu.edu.
Key Responsibilities
The USG Policy assigns responsibilities to PIs and research institutions:
PI Responsibilities
- Complete annual USG Policy training
- Evaluate proposed research for DGOF and potential DGOF, submit a written assessment, and receive IRE approval for each proposal prior to submission.
- Assess ongoing research, regardless of funding, for DGOF and potential DGOF (e.g., IRE review of IBC protocols)
SLU Responsibilities
- Establish an Institutional Review Entity (IRE)
- Designate an Institutional Contact for DGOF Research (ICDGOF)
- Verify the PI’s written DGOF/potential DGOF assessment before submission of a federally funded life sciences research proposal
- Establish processes to ensure compliance with the federal policy.
- Ensure that federally funded proposed and ongoing life sciences research is assessed as required by the USG Policy. Under SLU’s broader institutional process, applicable research will be screened regardless of funding source.
- Submit required reports and certifications to federal funding agencies.
Life Sciences Research Defined
USG Policy definition of “life sciences research”:
Research pertaining to the study or use of living organisms, viruses, or their products, including all disciplines, methodologies, and applications of biology (including biotechnology, genomics, proteomics, bioinformatics, and pharmaceutical and biomedical research and techniques).
This includes funding for building research capacity and infrastructure, including, but not limited to, construction or renovation of biosafety level 3 or 4 laboratory space (BSL-3 or BSL-4).
Training Requirements
Principal Investigators (PIs) must complete DGOF/IROC training before assessing their research and must complete refresher training annually thereafter. Training will be available through Workday Learning.
Research Proposal Review
For life sciences research proposals submitted on or after Jan. 16, 2027, federally funded proposals must be evaluated for DGOF, potential DGOF, and, when the proposed research will be conducted outside the United States, IROC. Under SLU’s implementation process, all life sciences research proposals must be screened by the PI and reviewed by the IRE before submission.
Projects identified as potential DGOF require additional review before funding may be awarded. This review includes a risk-benefit analysis, development of any required risk-mitigation measures, and review by the government-wide independent third-party review entity designated under the USG Policy.
IBC Protocol Review
Research involving biological agents that is described in current or pending IBC protocols must be assessed for DGOF and potential DGOF. Federally funded research conducted outside the United States must also be assessed for IROC. Current applicable IBC protocols must be reviewed by the IRE before Jan. 16, 2027.