Generate a comprehensive risk assessment matrix for dual-use CRISPR gene editing research protocols requiring NIH Recombinant DNA Advisory Committee review

Protocol Document *

Research Classification * Select classification tier Tier 1 - Standard laboratory procedures with low risk Tier 2 - RG2 agents requiring enhanced containment Tier 3 - RG3 pathogens with significant dual-use potential Tier 4 - Gain-of-function research of concern Clinical trial involving human gene transfer Environmental release applications Animal models with human gene editing

Institutional Details *

Risk Categories * Select risk category Human health and pathogenicity enhancement Environmental release and ecosystem impact Agricultural security and food safety Biodefense and dual-use potential Gene drive ecological consequences Weaponization potential assessment Clinical translation safety protocols

Stakeholder Review Panel * Select review structure Single-site NIH RAC Review Committee Multi-site collaborative review panel FDA-NIH joint review protocol International deliberative process Private sector ethics board Government agency coordination panel Academic consortium review board

biosafety Level * Select containment level BSL-1 standard laboratory practices BSL-2 enhanced containment with PPE BSL-3 specialized ventilation and procedures BSL-4 maximum containment required Animal ABSL-2 with specialized caging Plant greenhouse containment level Clinical grade GMP facility

Regulatory Pathway * Select pathway expedited review for low-risk protocols Standard NIH RAC full committee review Parallel FDA IND and RAC review International harmonization pathway Emergency review fast-track Renewal/amendment of existing approval SARS-CoV-2 research special procedures

Risk Mitigation Requirements *

Output Format Specifications * Select format NIH RAC standard format with risk tables ISO 31000 compliant risk framework Clinical risk assessment report Institutional biosafety document Investigator brochure appendix Regulatory submission document Executive summary with technical appendices

Timeline Sensitivity * Select timeline requirement Standard 60-90 day review timeline Rush review 30-45 days Emergency review within 14 days Phase-gate with conditional approval International coordination required 120 days Pending grant award deadline Seasonal research window constraints

Additional Context Notes