Forms & Templates
New Protocols: Submission of protocols for the use of infectious agent(s), biological agent(s), Select Agent(s)/Toxin(s), and/or recombinant or synthetic nucleic acid molecules.
Changes to a Protocol: Amendments or Revisions to an IBC-approved protocol.
Continuing Reviews: Annual or five-year continuations for an IBC-approved protocol
ELECTRONIC INSTITUTIONAL Biosafety committee (IBC) Protocols
Faculty, researchers and staff can now electronically complete and submit to the IBC protocols online via the Electronic ICC (BiosafetyNet) system. BiosafetyNet is located within the Division of Research Integrity & Compliance (DRIC) Applications for Research Compliance (ARC) platform. We no longer accept any new IBC protocols submitted on paper.
BiosafetyNet can be accessed in the ARC system. Amendments can be made by submitting protocol changes in BiosafetyNet. Other online submissions for electronic protocols include continuing reviews and three year renewals.
NOTE: IBC protocols that were originally approved on paper prior to December 31, 2017, will continue to use paper submissions for continuing reviews and amendments.
Prior to submitting your first electronic IBC protocol you must first request an ARC account unless you already have one. This is a simple process:
- Go to the ARC Portal to request an ARC account.
- Questions regarding ARC registration can be directed to (813) 974-2880 or by email.
- Upon completing ARC registration, a new protocol to the IBC can be drafted.
Common IBC Application Format
In this system, there is one application that encompasses both infectious agents and rDNA. You no longer need to submit two different applications for infectious agents and rDNA.
Assistance in completing a BiosafetyNet smart form
Need Help? If you need help completing a BiosafetyNet application, or assistance in incorporating suggested revisions to your draft BiosafetyNet application, contact the Biosafety Office or contact us individually:
- Debra Howeth (email) – Telephone: (813) 974-5091
- Dylan Champer (email) – Telephone: (813) 974-9343
If you need technical assistance with logging in or locating the submission form, you may contact the ARC Help Desk by email or call (813) 974‐2880.
There are Help Texts (represented by blue question marks) throughout the common BiosafetyNet protocol to provide guidance, suggestions, and template responses that will assist you with your input.
The following guidance/training documents are available to familiarize yourself and assist in the BiosafetyNet process:
- USF BiosafetyNet Beginners Guide (PDF)
- Guidance document for PIs to assist in filling out protocol (PDF)
Primary contacts and PI proxies: notifications and ability to submit follow-on submission
In BiosafetyNet, notifications are sent out by ARC system. The notifications are sent to the PI, primary contact and PI proxies. This includes notifications of approval letters (Initial, CRs and Amendments) and CR/Closure reminders.
- Primary contacts: This should be the primary contact/liaison for the protocol. This person will receive all notifications from ARC about the protocol. There can only be one primary contact.
- PI proxy: A PI proxy can submit follow-on submissions such as CRs and amendments on behalf of the PI. There can be multiple PI proxies on the study.
CHANGES TO AN APPROVED IBC PROTOCOL
Faculty, researchers and staff must secure approval for any changes proposed to an approved IBC protocols prior to implementing any change. Any change proposed to an IBC-approved protocol must be within the scope of the original hypothesis.
Appropriate Formats for Proposing Changes to an Approved Protocol
Faculty, researchers and staff should use one of two formats for proposing amendments or revisions to an IBC-approved protocol.
- If the original application was drafted using the paper IBC applications, use the paper request forms provided below for proposing changes to an IBC-approved protocol.
- If the original protocol was drafted using the electronic IBC BiosafetyNet protocols, use the ARC system described below for proposing changes to an IBC-approved protocol.
Proposing Changes to an electronic IBC Protocol
The USF BiosafetyNet Amendment Submission Instructions for PIs and Coordinators (PDF) provides detailed instructions on creation and submission to the ARC system for proposing amendments to an existing electronic IBC protocol.
Proposing Changes to a paper IBC Protocol
Use the USF IBC Modification Request (MS Word) form to make proposed changes to a paper IBC protocol.
Continuing Reviews (CR)
IBC protocols are approved either for a 3-year approval with annual CRs or for the life of the study with a five-year CR.
- Studies which are determined by the IBC to fall under III-A, III-B, III-C or III-D
of the NIH guidelines are approved for a for a 3-year term with a Continuing Review every year.
- Studies which are determined by the IBC to fall under sections III-E (Experiments that Require Institutional Biosafety Committee Notice Simultaneous
with Initiation) or III-F (Exempt Experiments) of the NIH guidelines per IBC policy 8.2.3 are approved for the life of the research project with a Continuing Review every
- Studies which are determined by the IBC to be Human Gene Transfer (HGT) and fall under section III-C-1 (Experiments Involving the Deliberate Transfer of Recombinant or Synthetic Nucleic Acid Molecules, or DNA or RNA Derived from Recombinant or Synthetic Nucleic Acid Molecules, into One or More Human Research Participants) are approved for the period coinciding with the Institutional Review Board (IRB) Continuing Review Process.
For protocols under 1 and 2 above the USF BiosafetyNet Continuing Review Submission Instructions for PIs and Coordinators (PDF) provides detailed instructions on how to submit a CR in the ARC system for electronic IBC protocols.
For protocols under 3 above the USF BiosafetyNet HGT Continuing Review Submission Instructions for PIs and Coordinators (PDF) provides detailed instructions on how to submit a CR in the ARC system for electronic IBC protocols.
Other forms from our office
- BSL-2 Inspection Checklist (MS Word)
- BSL-3 Inspection Checklist (MS Word)
- Decontamination of Equipment Prior to Relocation or Closeout (MS Word)
- Decontamination Prior to Renovation/Maintenance in Active BSL-2 Labs (MS Word)
Toxin Record Form
- Toxin Record of Use Form (MS Word)