IBC Protocol Submissions and Review
Before beginning, work with biohazardous materials for research protocols are registered, reviewed and approved by the Institutional Biosafety Committee (IBC). The Principal Investigator (PI) is responsible for initiating and supervising all potential biohazardous work. All submissions, regardless of type, are handled through the IRBNet electronic management system.
The Principal Investigator (PI) must have tenure, tenure track, emeritus status, or be research faculty with assigned research space at the University of South Alabama. The PI is responsible for all aspects of their research projects, including the actions of protocol personnel.
- Graduate Students
- Research assistants or associates
The above positions can only be listed as additional personnel on the protocol.
IBC policies and federal law require a committee review of all proposed activities related to using biohazardous materials at the University of South Alabama. Note: The information provided below is a limited list.
IBC approval must be obtained under the following circumstances before initiating research:
- The use of human/primate blood, bodily fluids, tissue samples, or cells from known at-risk sources.
- Commercially available cell lines and tissues of human/primate origin, that are classified as BSL-2 or higher by the ATCC and/or as Risk Group 2 or higher (NIH Guidelines and the BMBL).
- Recombinant or synthetic nucleic acids and viral vectors (adenovirus, retrovirus, herpes virus, etc.)
- Pure cultures of infectious microorganisms or materials containing such infectious agents.
- Environmental samples of soil, water, and plants suspected or known to harbor pathogens that pose a risk to people, animals, or the environment.
- Human Gene Therapy Trials (oncolytic viruses)
- Select Toxins and Agents
- Dual Use Research of Concern (DURC)
- Animal work that involves biological agents (bacteria, viruses, etc.) or toxins
- Does not present a significant risk to people, animals, or the environment.
- Experiments that do not involve extraction and manipulation of genetic materials (routine blood or urine tests).
- It cannot replicate nor generate nucleic acids that copy any living cell.
- If biological materials are in storage only (i.e., in a freezer) and are not part of active research. *IBC approval must be obtained before starting active research with stored materials. The materials may be added to an existing IBC protocol by amendment, or an original protocol may be needed.
*Note: We recommend investigators check with the IBC Administrator to ensure a protocol is not necessary.
Protocol applications, amendment forms, etc. are located under Forms and Templates in IRBNet. To help with the process of submitting a new application, download our Checklist for Submitting a New IBC project in IRBNet. This form is optional.
Levels of Review
- Protocol Pre-Review, the IBC Administrator, serves as a conduit between the reviewers and committee before
and after the IBC review. Pre-Review focuses on the required training of personnel, enrollment in the OHP (BSL3/ABSL3 workers),
grammatical and typographical errors, and compliance with institutional IBC policies
and guidelines. If applicable pre-review comments and/or suggestions are emailed to
the Principal Investigator before committee review.
Types of Protocol Review
- Full Committee Review is the standard process for new IBC submissions that fall under specific NIH guidelines
and must be reviewed by the IBC at a convened meeting. Suppose the protocol falls
under NIH guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules. In that case, a majority (quorum) of IBC committee members conduct an in-person
meeting. The protocol is shared with all committee members for review and discussion.
Following protocol review, the primary reviewer motions to the committee for one of
the following actions: Approve, Require Modifications (to secure approval) or Withhold Approval.
- Online Full Committee Review is a protocol that does not make use of recombinant DNA materials. A majority (quorum) of IBC committee members conducts a Full Committee review online through IRBNet.
- Chair Review the IBC chair reviews Biosafety Level 1 or exempt rDNA research. The Chair will notify
the Investigator in writing of the determination of their review. If the research
is not significantly modified, no additional action is required of the Investigator
or the IBC. *Note: If a new Investigator is conducting exempt BSL-1 research, a new laboratory
inspection is not necessary.
- IBC and work with other committees if there is a need for review by other compliance committees, such as IRB and IACUC, the IBC will work with the other committees to ensure those approvals are in place. IBC approval does not supersede or waive the requirement for independent review by other research compliance committees. To help expedite the review and approval process, reviews between committees are recommended in parallel. *Note: Any work begun before receiving IACUC or IRB approval violates federal law and jeopardizes all research.
- Approved once a project is approved by a majority vote (a quorum), the PI is notified by electronic letter that their project is approved, and research activities may begin.
- Modifications Required (to secure approval) a detailed memorandum is sent to the PI describing the required changes. The PI must address all comments and revise the protocol accordingly. The subsequently modified protocol is reviewed using the Designated Member Review (DMR) process. However, if during the DMR process, a member requests FCR of the revised protocol, the modified protocol will be reviewed at the next convened meeting.
- Withhold approval if a majority vote (a quorum) of members withholds approval, a detailed memorandum is sent to the PI that describes the changes required before approval can be granted. The PI can address the necessary changes and resubmit the protocol as a new submission. The protocol will be reviewed at the next convened meeting.
- Three Year IBC Renewal Investigators, who wish to continue their work beyond the third year of the protocol,
must submit a renewal form. At 30, 60, and 90 days, the Investigator will receive
an IRBNet email message about project expiration status. Three-year renewals are done
through IRBNet. Renewal forms are located under Forms and Templates in IRBNet.
- Amendments such as personnel changes, adding cell lines, protocol title, changes to approved
protocol sections and change of PI, etc. require an amendment. Once amendments are
submitted, the IBC administrator will determine if the amendment falls under administrative
review or full committee review.
- Protocol Closures normally the IBC Administrator reaches out to the Investigator before the protocol expires and inquires if the protocol should be closed or if the work will continue. The Investigator also has the option of letting the protocol expire naturally or request closure of the protocol by contacting the IBC Administrator.