Biosafety Program

Forms & Templates

New Protocols: Submission of protocols for the use of infectious agent(s), and/or recombinant or synthetic nucleic acid molecules. 

Changes to a Protocol: Amendments to an IBC-approved protocol.

Continuing Reviews: Limited to IBC protocols that describe the administration of rDNA to human research subjects.

ELECTRONIC INSTITUTIONAL Biosafety committee (IBC) Protocols

At USF, faculty, researchers, and staff submit their IBC protocols electronically through a web-based platform, BiosafetyNet, located within the Research Integrity & Compliance (RIC) Applications for Research Compliance (ARC) platform.

ARC Account

An ARC Account is required to submit your electronic IBC protocol. Your ARC account will be used for all the USF research compliance groups (IBC, IACUC and IRB) all of which are electronic/web-based. If you do not have an ARC account, you need to request 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 Protocol Format

In this system, there is one protocol that encompasses both infectious agents and rDNA.

Assistance in completing a BiosafetyNet smart form

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:

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:

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.

Proposing Changes to an Electronic IBC Protocol

The USF BiosafetyNet Amendment Submission Instructions for PIs and Coordinators provides detailed instructions on creation and submission to the ARC system for proposing amendments to an existing electronic IBC protocol. 

Continuing Reviews (CR)

IBC protocols which are determined by the IBC to be Human Gene Transfer (HGT) as described in the NIH Guidelines 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.

A guidance document to assist in the submission of CR is available: 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

LAB Inspections

Decontamination Forms

Toxin Record Form