IRBNet Specifics

This page is dedicated to IRBNet specifics for IBC (Institutional Biosafety Committee) submissions. For help with general IRBNet navigation, such as creating a new project, accessing required materials, etc., please refer to our IRBNet Basics/Pro guidance here

Frequently Asked Questions (FAQs)

The IBC meets as necessary. There are no submission deadlines because of the infrequency of IBC meetings.

Any work that falls under Section III-A, B, C, D, or E of the NIH Guidelines, involves the use of infectious organisms included in Risk Groups 3 and 4, or the use of Select Agents and Toxins will a require review by a convened committee.

The process after FCR depends on committee review and votes. Protocols can be either Approved, Modifications Required, or Withhold Approval. If the project is approved, the Investigator receives an electronic letter via IRBNet stating their protocol is approved, and research activities can begin (provided you are not waiting on IACUC approval). If the project requires modifications, a letter is sent via IRBNet to the Investigator. The letter details the information required to secure IBC approval. If Withhold Approval is the outcome, the Investigator is notified via IRBNet through a letter. If approval is withheld, the  Investigator has the option to submit a new protocol. The new submission would be reviewed at the next FCR meeting.  For additional guidance with general IRBNet navigation, such as submitting a follow-up response and accessing Board Documents, please refer to our IRBNet Basics/Pro guidance here.

 Responses to the committee are addressed by letter from the Investigator. Once the investigator has addressed all committee comments by letter and has attached all revised documents, the Investigator submits their follow-up response through IRBNet in a NEW package. For additional guidance on submitting a new package, please refer to our IRBNet Basics page.

Yes. Regardless of the funding source, all recombinant DNA research must be reviewed by the IBC. The University of South Alabama receives funding from NIH grants; ALL recombinant DNA research conducted at the University must comply with NIH Guidelines and Institutional policies.

Any modification to a protocol (personnel changes, additional cell lines, procedure, etc.) requires an amendment. Amendments occur post-approval of the protocol. Amendment submissions are created as a New package. The amendment can be reviewed administratively for minor changes. For significant changes that go beyond the scope of administrative review, an FCR review is required. For additional guidance on How to Create a New Package In IRBNet, please refer to our IRBNet Pro section.
IBC protocols are approved for three years. Three-year renewals are submitted at least sixty (60) days before the expiration date.

Research projects that use similar biohazards in a similar manner do not require separate registrations. However, if the research project involves a substantial change to the current and approved protocol, an amendment or a new IBC protocol application may be applicable.

No. Protocols are approved for three (3) years only. The approval date of a modification does not alter the protocol's original approval date.

Yes. Wherever you see a Save and Exit button or Save the form, click on it. You can return to your existing project at any time to complete the documents. For additional guidance on Accessing an Existing Project, please refer to our IRBNet Basics here.

The Investigator can let the protocol expire naturally, or a request to have the protocol closed can be submitted.  To request protocol closure, please get in touch with the IBC office.

Yes. Regardless of protocol status, the PI will always have access to their protocol (s).

No. IBC approvals only cover the specific research project that was reviewed by the IBC, not the shared space.

Yes. All new labs must be inspected prior to the start of any research activities. New laboratories are inspected two weeks post-approval of the protocol.  Download examples below for guidance on new laboratory inspections. If you need additional guidance or have questions, please get in touch with the IBC office.

Download our New Lab Inspection guidance [downloadable forms]

Exposure Control Plan Example               

Exposure Control Training Log      

Laboratory Signage Information Sheet 

Laboratory Door Sign (laminate)

Biohazardous Waste Liquid Log

Liquid Waste Log

Biosafety spill kits for USA Investigators must contain the following items:

  • PPE such as gloves, lab coat, safety goggles
  • Broom/dustpan and Tongs (plastic)
  • Absorbent paper towels
  • Red Biohazard bags
  • Appropriate Disinfectants like 10% bleach and/or other decontaminate appropriate for agent in use.

To find out how and where to get a spill kit; contact the Office of Safety and Environmental Compliance at 251-460-7070.

You will notice we use acronyms often or we use two different words, but both have the same meaning. Below are some abbreviations and words with their definition and/or meaning.

IBC: Institutional Biosafety Committee

NIH: National Institutes of Health

BSO: Biological Safety Officer

Proposal: can be called protocol or project

PI: Principal Investigator/Investigator/Researcher  

OSPT: Office of Science Technology Policy

RO: Responsible Official

BMBL: Biosafety in Microbiological and Biomedical Laboratories       

SEC: Safety and Environmental Compliance

BSL: Biosafety Level

FCR: Full Committee Review

DMR: Designated Member Review

HGT: Human Gene Therapy

ECP: Exposure Control Plan

USDA: United States Department of Agriculture

ARO: Alternate Responsible Official

   

 

Have questions not addressed on the FAQ page? Please get in touch with the IBC office by email or call (251) 341-4913