Research Governance

Institute effective, risk-based oversight for all high-consequence biological research51 — regardless of funding source — in every jurisdiction that conducts it.

Last updated: October 1, 2026

5-year budget target

$75M

Pillar

Prevent

Five-Year Trajectory

2027

Launch pilot bio-audits, accident-reporting frameworks, and institutional adoption pilots for high-consequence biological research

2028

Scale bio-audits, accident reporting, pre-publication biorisk review, and institutional participation into routine practice

2029

Move from pilot research governance to institutionalized oversight, licensing, audit, and institutional adoption frameworks

2030

Ensure accountable public authorities and participating institutions oversee high-consequence biological research in major research nations

2031

Reach high-risk research oversight and bio-audit coverage targets

Current Status of the Field

Technology and Tools11,51

Bio-audit methods, accident-reporting systems, pre-publication review processes, and personnel reliability tools exist in partial form but require institution-specific implementation and evaluation.

Policy

Several jurisdictions are reassessing high-risk research oversight, but privately funded work, non-Select-Agent research, and publication-risk management remain unevenly covered. Some private life-science funders conduct prefunding biosecurity and biosafety reviews, but there are no standards and coverage is patchy. According to the Global Health Security Index,8 94% of countries lack national level oversight mechanisms for dual-use life science research.

Bottleneck

A key bottleneck is institutional uptake for internal oversight of high-consequence, dual-use bioscience research. This will require stronger incentives for institutions to implement biosecurity and biosafety best practices, including funding to build the necessary capacity as well as national legal requirements or funder-based requirements.

The Problem

Some of the most dangerous biological research in the world is conducted under inadequate oversight and with inadequate biosafety and biosecurity practices. In many jurisdictions, there are few binding requirements for privately funded high-risk research on non-Select Agents, accidents often go unreported, and there is no consistent independent verification of biosafety and biosecurity practices. At the same time, adoption cannot come only from biosecurity organizations pressing from outside the field: universities, research consortia, funders, journals, and professional societies must understand, support, and participate in the system for it to work. This leaves serious gaps in accountability, transparency, uptake, and risk management.

The Solution

A practical near-term path is to establish consistent approaches for identifying, reviewing, reporting, and independently verifying high-risk biological research while building adoption inside the life-sciences community. Pilot bio-audits, researcher licensing concepts, accident-reporting systems, institutional awareness campaigns, pre-funding biosecurity review, dedicated funding for building in biosecurity by design, and publication-stage risk-management practices can lower friction and create models for stronger governance over time, while preserving and accelerating low-risk beneficial research. Over time, this should support a genuinely risk-based system in which research posing extreme societal risk is prohibited, research posing severe societal risk is restricted except in rare cases of extraordinary benefit, and the vast majority of low-risk life science research faces streamlined oversight rather than unnecessary burden.

Objectives

Effective, risk-based oversight of high-consequence biological research is broadly implemented around the globe.
- ◇All facilities conducting high-risk biological research undergo independent verification of laboratory safety ("bio-audits")
- ◇Researchers conducting high-risk biological research are licensed or receive a seal of approval by a competent third party, verifying biosafety training and personnel reliability
- ◇Public and private funders of life science research conduct systematic pre-funding biosafety and biosecurity review.51–53
- ◇Research that could generate high-risk information hazards undergoes appropriate review and risk management before publication
- ◇Institutions conducting high-risk biological research universally monitor and report all accidents to an appropriate, transparent public authority in their jurisdiction
- ◇Biorisk is managed in countries around the world through accountable, modernized national public authorities, capable of enforcing risk-based safeguards across privately and publicly funded research
Life-sciences institutions adopt and participate in the governance system
- ◇Universities, research consortia, funders, journals, and professional societies integrate risk-based biorisk review into routine research governance
- ◇Institutional leaders, biosafety officers, principal investigators, and trainees receive practical guidance on when high-consequence work requires additional review
- ◇Research institutions participate in bio-audits, accident reporting, and pre-publication biorisk management as field-owned norms, not only externally imposed requirements
- ◇Public and private life science funders allocate at least 1% of their budget to building biosecurity and biosafety capacity, systems, and technical solutions.
Implement guardrails on the highest-risk categories of research across the globe
- ◇Research posing extreme societal risk is prohibited, including for example research that may enable the creation of mirror life and research to enhance the human-to-human transmissibility of pathogens, increase their virulence and/or enable evasion of medical countermeasures.
- ◇Research posing severe societal risk is restricted, except in rare cases when it can demonstrate extraordinary and commensurate societal benefit, with no viable alternative methodology, under extensive precautions.
- ◇Oversight requirements are streamlined and calibrated to minimize burden on the vast majority of low-risk life sciences research.
◆Red teaming: Misuse safeguards are routinely red-teamed to detect and address vulnerabilities, including synthesis screening, KYC, and AI model safeguards.

Urgent 2027 Milestone

Launch pilot bio-audits, establish frameworks for mandatory accident reporting and risk-based oversight, and recruit major life-science funders and institutions into adoption pilots.

Long-term Targets

High-risk research oversight coverage globally

90% by 2031

Pre-funding biosecurity review by major life science funders globally

90% by 2031

Bio-audit coverage

75% by 2031

High-risk publication biorisk management

90% by 2031

Red-teaming coverage

90% by 2031

Year-by-Year

2027 — Build the foundation

Philanthropy

•Fund pilots of independent bio-audit programs and development of accident-reporting and researcher-licensing frameworks
•Fund development of insider-threat mitigation frameworks, including centralized whistleblower programs for high-risk biological research
•Fund institutional adoption pilots with universities, research consortia, journals, and funders
•Support norms development for publication biorisk management and responsible research governance

Private Sector

•Participate in bio-audit pilots, accident reporting, and pre-publication biorisk review pilots as research institutions and consortia
•Adopt institutional best practices for research risk oversight

Government

•Develop bio-audit frameworks and support pilot programs
•Establish mandatory accident-reporting requirements and begin incorporating biorisk management into research funding requirements
•Partner with major life-sciences institutions on awareness, participation, and adoption pathways
•Begin development of stronger oversight mechanisms for high-consequence biological research
•Begin articulating prohibited and restricted categories of research, including mirror life and research to enhance human-to-human pathogen transmissibility

2028 — Pilots into operating systemsPrevent-level actions

Philanthropy

•Continue funding deployment of screening software and independent audit capacity across providers, including smaller and international firms
•Support implementation-focused KYC tools and verification infrastructure
•Continue funding separate AI-bio evaluation tracks for frontier LLMs, biological AI models, and autonomous-lab workflows
•Support broader bio-audit adoption, institutional awareness, and development of publication-risk-management norms
•Continue support for misuse-detection tooling and cross-provider threat-sharing systems

Private Sector

•Implement standardized synthesis screening and customer verification at scale
•Participate in split-order detection systems and submit to independent screening verification where possible
•Expand KYC adoption across high-risk vendors and service providers
•Make AI-bio evaluation and safeguard deployment routine across separate LLM, biological AI model, and autonomous-lab tracks
•Expand participation in bio-audits, accident reporting, pre-publication review, and institutional adoption pilots
•Routinely share threat signals and maintain misuse monitoring

Government

•Move from legislative or rulemaking activity to initial compliance and oversight in synthesis screening and KYC
•Support independent verification of AI biorisk evaluation and safeguard adoption through track-specific formal agreements or requirements
•Expand implementation of accident-reporting requirements, research-risk oversight, and institutional participation pathways
•Support law-enforcement pathways for escalating provider-generated threat signals

2029 — Scale and enforcePrevent-level actions

Philanthropy

•Support more advanced evasion-resistant and function-based screening R&D
•Support scaling of KYC tools and red-teaming across a broader set of high-risk service categories
•Support secure data infrastructure for high-risk biological AI training data and continued safeguard research across LLM, bio-AI-model, and autonomous-lab tracks
•Support global governance reform, institutional adoption, and continued capacity-building for bio-audits and risk-based research oversight
•Support public communication efforts that reinforce deterrence posture and accountability

Private Sector

•Submit to independent screening verification and deploy updated screening algorithms
•Extend KYC and more extensive customer vetting to newly covered categories such as CROs, cloud labs, repositories, and AI/bio tools
•Continue safeguard deployment for high-risk AI systems and participate in track-specific red-teaming
•Expand compliance with institutional risk-governance requirements, adoption programs, and misuse monitoring mandates

Government

•Enforce synthesis-screening compliance and audit requirements
•Regulate the secondary market for benchtop synthesis devices and broaden KYC requirements to additional high-risk categories
•Mandate safeguards for high-risk AI systems with biological capabilities across separate LLM, biological AI model, and autonomous-lab pathways
•Institutionalize accountable public oversight for high-consequence biological research, including licensing, institutional participation, and bio-audit frameworks
•Institute requirements for misuse monitoring and threat sharing for high-risk biological services

2030 — Achieve durable readinessPrevent-level actions

Philanthropy

•Focus remaining philanthropic capital on gap-closing, deterrence signaling, and ensuring high-risk systems actually perform under stress
•Support maturation of attribution capabilities and public communication around accountability
•Continue targeted support for jurisdictions, sectors, or institutions lagging in compliance, AIxBio safeguards, or research-governance adoption

Private Sector

•Achieve broad compliance with screening, KYC, safeguard, and misuse-monitoring requirements
•Maintain regular red-teaming, audit participation, and rapid remediation processes
•Support stronger bioforensic attribution capability through data-sharing and exercise participation

Government

•Ensure broad compliance and meaningful enforcement across screening, KYC, AIxBio safeguards, and research governance
•Verify that high-risk LLM, biological AI model, and autonomous-lab safeguards perform under stress
•Establish or strengthen attribution and accountability doctrine for biological attacks
•Exercise bioforensic and deterrence capabilities routinely

2031 — Maintain defensive advantagePrevent-level actions

Philanthropy

•Focus on closing residual gaps, supporting lagging geographies or sectors, and maintaining pressure for continuous improvement
•Continue support for frontier-risk research, AI-bio track-specific evaluation, institutional research-governance adoption, residual-risk assessment, and measurement refinement