1. IBC APPLICATION REQUIRED (April 18, 2018)
Full Committee Review (FCR)
NIH Guidelines:
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

2. 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

3. 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

4. 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