IBC APPLICATION REQUIRED (April 18, 2018) Full Committee Review (FCR) NIH Guidelines: https://osp.od.nih.gov/wp-content/uploads/NIH_Guidelines.html#_Toc446948316 Designated Member Review (DMR) Biosafety Review (Bio) Administrative Review New NIH Guidelines IIIA- IIID Risk Group (RG)2 , RG3 and RG4 agents and materials potentially infected with RG2, RG3 and RG4 Non human primate materials including fluids/tissues/organs Animals/Arthropods that are natural reservoirs/vectors of zoonotic diseases Use of Botulinum neurotoxin at any amount Use of Select toxin above permissible amount NIH Guidelines IIIE (with approval at IBC meeting) Use of Select Toxin, (except Botulinum neurotoxin) below permissible amount Primary human materials including tissues and organs NIH Guidelines IIIF Human blood, bodily fluid Established human and non human primate cells only Non-rDNA at BSL1 Addition/Removal of personnel Change in Faculty Sponsor Change in Funding Removal of location (Consult with Biosafety) Change in PI Renewal Use of exempt Select Toxin except Botulinum neurotoxin Modification All applications above that fall under different NIH Guidelines (IIIA- IIID) All modifications (except changes in location, personnel, number of subjects enrolled, statistical analysis) in HGT application (IIIC) All modification involving RG 3 and RG4 Change in procedures/materials/host/agent that result in higher risk ( eg. purchasing lentivirus from outside vendor versus growing lentivirus in the lab, using aerosol transmissible pathogen versus bloodborne pathogen, using modified agent that is amphotrophic versus ecotrophic, using sheep for heart transplant versus mice) IIIE (with approval at IBC meeting) that is different from approved application Primary human materials that might have different risk from currently approved ones IIID that meets the following criteria 1) currently approved under the same applicable guideline 2) has the same risk (eg. Adding different reporter gene in Lentiviral vector, carrying out same experiments in mice versus rats, adding RG2s that have the same risk as currently approved ones) 3) has same NIH guidelines requirements Addition of new location

PI receives IBC approval Full Committee Review (FCR) PI submits application, **PI resubmits application IBC admin. assigns application to Biosafety Biosafety prereview and IBC walkthrough IBC administrator sends prereview comments to PI (if needed) PI resubmits application IBC admin. assigns IBC application and walkthrough report to IBC members IBC meeting IBC review and outcome - Full Approval - Subcommittee review - Administrative review - **Resubmission PI receives IBC approval (Average number of days 18) IBC admin. requests more information for subcommittee/Administrative review IBC admin. or subcommittee confirms all issues are addressed (Average number of days 30 or less) If no prereview comments Submission deadline, Day 1 Subcommittee review/ Administrative review Full Approval * All days are business days

PI receives IBC approval Designated Member Review (DMR) PI submits application (*Day 1) IBC admin. assigns application to 1 IBC member and Biosafety IBC and Biosafety prereview and IBC walkthrough IBC administrator sends prereview comments to PI (if needed) PI resubmits application IBC/ Biosafety/IBC administrator confirms all issues are addressed PI receives IBC approval (Average number of days 18 ) On-going (no submission deadline) If no prereview comments * All days are business days

PI receives IBC approval Biosafety Review PI submits application (*Day 1) IBC admin. assigns application to Biosafety Biosafety prereview and IBC walkthrough IBC administrator sends prereview comments to PI (if needed) PI resubmits application Biosafety/IBC administrator confirms all issues are addressed PI receives IBC approval (Average number of days 11 ) On-going (no submission deadline) If no prereview comments * All days are business days