Protocol Development and Submission

The IBC requires registration of the research by submission of a New Protocol Form.  No covered work activities can be initiated without submission of a New Protocol Form.

The Office of Research has an online research administration system, NUgrant, for submission of the majority of paperwork related to lab research at UNL.  All new protocol submissions to the IBC are handled through the NUgrant system.

NUgrant Research Administration System

Below are instructions for logging into NUgrant and entering your project details.  The initial steps are briefly outlined here:

You can login to NUgrant at http://nugrant.unl.edu.  Your username and password are the same as the one used for Blackboard (My.UNL), if you have trouble logging in, please use the link under the login dialog for assistance.  Once logged in, click on the "add new" link next to the IBC Protocols heading on the left side of the screen.

IBC protocols logo

This will open a blank form for you to edit.  Ths form is user friendly and completing it is straightforward, just input the requested information.  The IBC is encouraging investigators to consolidate multiple projects into one (1) IBC protocol when possible.  For some questions you will be able to copy and paste information from grants or other documents into this form.  Although, in many cases there is additional information requested, which must be provided to continue with the form.

More detailed instructions can be found in the following documents:

NUgrant IBC Protocol Form Instructions
NUgrant IBC Protocol Form Instructions for Field Collection & Wild Animal Sampling Procedures


Protocol Review

The IBC approval process begins witht he PI completing all required documentation and supporting material necessary for thorough review by the IBC and Biosafety Officer (BSO).  Documentation and supporting materials consist of the following items:
  • A completed NUgrant IBC New Protocol form, and;
  • A lab-specific biosafety manual (see EHS SOP, Preparing a Laboratory Biosafety Manual).
  • Completion of required training (see the Training Needs Assessment document) by all personnel listed in the protocol.  http://ehs.unl.edu/onlinetraining

     At a minimum you must take the Core Training including Emergency Preparedness and Injury, Illness and Prevention.  Chemical Safety, NIH Guidelines Training, Bloodborne Pathogens, Biosafety Basics, and/or Biosafety in the BSL-2 Laboratory may also be required based on the research you will be doing. 
     
  • Satisfactory completion of a Pre-approval audit by the EHS Biosafety Staff.
Protocols requiring review by the full committee must be complete no less than two (2) weeks prior to the next scheduled meeting (including revisions requested by the BSO during the pre-review process).  In some cases, a longer period may be necessary to allow the scheduling and completion of a pre-approval audit by the BSO.  PIs are encouraged to communicate with the BSO early in their planning stages.


Approved Protocols and Protocol Maintenance

Protocols approved by the IBC are valid indefinitely contingent on the PI following the requirements for protocol maintenance described in the UNL Biosafety Guidelines.  
 
Amendments
 
  • Major Changes
Major changes/modifications to the work described in the protocol (e.g., changes in host vector systems, new transgenes, factors affecting the final risk assessment, adding transgenic animals, etc.) will require submittal of a Protocol Amendment Form to the IBC for review and approval prior to initiation of the change.  Review of major change protocol amendments will be the same as for New Protocol Forms.
 
  • Minor Changes
Minor changes to a protocol are reviewed by the BSO and can be approved without full committee review only if they involve one of the following:
 
  • Changes to Personnel
  • Changes to Facilities (facility inspection by the BSO is required)
  • Changes to Funding
  • Changes to Decontamination/Disinfection/Disposal Procedures
 
Annual Updates
 
  • Every year on the anniversary of protocol approval the PI will be notified by email to login to the NUgrant system and submit an Annual Update Form.  Reminders will be sent 30 days, two weeks before the anniversary date, on the anniversary date and every week after that until the form is submitted or the protocol is suspended or terminated.
     
  • Submission of an Annual Update Form is a condition of continued protocol approval and failure to submit annual update forms or amendments in a timely manner may result in the IBC taking action to suspend or withdraw approval of the protocol until the requested information/documents are received.