Biosafety

Protocol Submissions

research conference

Faculty, researchers and staff can electronically complete and submit protocols to the Institutional Biosafety Committee (IBC) via BiosafetyNet in the Appllications for Research Complliance (ARC) portal. Amendments also can be made by submitting protocol changes in BiosafetyNet. Other online submissions for electronic protocols include continuing reviews and three-year renewals. 

Research Integrity & Compliance no longer accepts new IBC protocols submitted on paper. IBC protocols that were originally approved on paper prior to December 31, 2017, will continue to use paper submissions for continuing reviews and amendments.

first protocol submission

ARC Account Registration

Prior to submitting your first electronic IBC protocol, you must request an ARC account unless you already have one.  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.

Request ARC Account

BiosafetyNet Application

Visit BioSafetyNet

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. 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.

The following guidance/training documents are available to familiarize yourself and assist in the BiosafetyNet process:

Notifications and Ability to Submit Follow-on Submission

Notifications (including notifications of approval letters and CR/Closure reminders) are sent by the ARC system to the PI, primary contact and PI proxies. There can only be one primary contact. 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 protocol 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 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 are approved either for a 3-year approval with annual CRs or for the life of the study with a five-year CR.

  1. Studies which are determined by the IBC to fall under III-A, III-B, III-C or III-D of the NIH guidelines (PDF) are approved for a for a 3-year term with a Continuing Review every year.

  2. 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 five years.

  3. 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) of the NIH guidelines 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 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.