Any faculty or staff member planning to utilize biologically hazardous materials for research and/or teaching activities on campus must complete a Biosafety Protocol Application (BPA) found on the IBC Forms and Documents page, and submit one electronic copy to biosafety@uwsp.edu. 

Biological materials subject to review by the IBC include: 

1. Recombinant and synthetic NA (and RNA) including purchase, creation, or use of transgenic plants and animals.

2. Biohazardous agents, including bloodborne pathogens (e.g. bacteria, viruses, fungi, protozoa, prions, see NIH guidelines Appendix B and OSHA list of biological agents).
   

3. Human and non-human primate source material (e.g. blood, body secretions and tissues, primary and established cell lines).

4. Select agents and biologically derived toxins (including strain and amounts exempted from the Select Agent regulations).

5. Any material requiring a CDC import license or a USDA permit.
   

UWSP does not have facilities available to conduct activities at Biosafety Level 3 or 4. 

Research in the following categories does NOT require a BPA:

1. The activities use only commercially available deregulated transgenic crops.

2. The activities involve only the in vitro use of nucleic acids (i.e., PCR, synthetic double stranded RNA) and does not involve the cloning and propagation of recombinant DNA in cells. For clarification, nucleic acids that are not and cannot be replicated inside organisms, cells, or viruses are not considered recDNA. Commonly encountered examples of synthetic DNA not considered to be recDNA include polymerase chain reaction (PCR) products, synthetic oligonucleotides/primers, and complementary DNA (cDNA) obtained by reverse transcription of RNA
   

Training requirements for faculty, staff, and students based on project type can be found on the IBC Training page. 

1. Submission of the BPA: The BPA form is available from the UWSP IBC website. If your work is exempt, you must complete parts 1 and 2 of the BPA. If your work is non-exempt, you must complete all applicable sections of the BPA.

2. Initial Application Review by the IBC: Initial review of applications will be conducted by the IBC chair, or another member of the IBC designated by the IBC chair. The initial review will determine what level of review (full committee, designated member, or administrative) is necessary for the protocol based on the activities and whether the NIH Guidelines apply. The PI will be contacted by IBC staff to clarify any questions from the initial reviewer. A primary reviewer(s) will be assigned by the chair. The reviewers will use the respective checklists from the IBC for consideration of the applications.

The IBC will conduct an initial laboratory assessment at the time of IBC Application submission. However, if a lab has completed (and remedied) a lab inspection within the last 12 months prior to submission, the PI may use that report. Lab assessments will be conducted by the Biological Safety Officer and will focus on safe work practices. An example of a Laboratory Assessment Checklist is located on the Forms and Documents page and may be given to PI's in advance. Lab assessments may be used as a resource for PI's ahead of inspections.  Lab assessments will be conducted on an 18-month interval, unless the IBC requests a more frequent schedule for a specific project.  The BSO also provides a comprehensive biological/chemical lab safety at the same time, as the Chemical Hygiene Officer. 

3. IBC Coordination of Review with other Institutional Oversight Committees (IACUC or IRB): Order of review is not prescribed in the NIH Guidelines. UWSP requests that research or teaching activities that require IBC review and additional institutional oversight (i.e. IACUC or IBC review) submit the applications simultaneously. Approval of the protocol by the IBC will be contingent upon approval by the additional oversight committee(s).

4. Procedure for Full Committee Review

• Required for non-exempt protocols.
• IBC administration confirms a meeting date when a quorum can be present, prepares the meeting agenda, and distributes the materials to the IBC two weeks prior to the meeting. The PI may be requested to be present to explain the proposed research and answer any questions. The primary reviewer will present their findings to the committee.
• IBC members who have a conflict of interest with the presented protocol may be present to answer questions but will abstain from voting.
• Members will be physically present, however, in rare circumstances teleconference or videoconference in real time may be utilized. If a protocol involving plants is on the agenda, the member with plant expertise will be present or submit their review comments in advance. If a protocol involving animals is on the agenda, the member with animal expertise will be present or submit their review comments in advance. The biosafety officer will be present or submit any review comments or concerns in advance.
• Minutes of meetings are recorded and will include any dissenting views and resolution through vote. The minutes are shared with the committee following the meeting.

5. Designated Member Review: may be used for evaluation of exempt protocol applications or when changes to existing protocols are made. The IBC Chair or an IBC member delegated by the chair (i.e., primary reviewer) may verify that the changes have been made satisfactorily. If the IBC uses designated member review subsequent to full committee review, the approval date is the date that the designated IBC member(s) were satisfied with the revisions made.

6. Administrative Review: may be used to verify minor points of order or clarifications requested when determined through vote by the full IBC to be administrative in nature with no impact on biosafety. This review can be conducted by the IBC Administrator or IBC Chair. Examples of minor points of order/clarification include but are not limited to: typographical or grammatical errors, funding source information, linking IRB or IACUC protocols, contact information, addition of personnel and verification of training, or verification of biosafety cabinet certification, etc.). If the IBC uses Administrative Review subsequent to Full Committee Review, the approval date is the date that the full committee approved the study pending the minor points of order/clarification.

7. IBC Actions

Review by the IBC will result in one of the following:

• Approval-work may begin subject to NIH requirements.
• A request to modify the protocol to secure approval-the submitter will make the requested changes in consultation with the chair who will determine the subsequent level of review.
• Deferment or tabling of the protocol-it will be on the agenda for the next meeting of the IBC.
• Withhold approval.
• The PI will be notified in writing by IBC Administration of the determination made by the IBC.
  

If approval is withheld, the IBC must provide the rationale in writing and give the PI an opportunity to respond or appeal the findings. The PI has the right to appeal the decision, within two weeks of notification from IBC that approval has been withheld. The appeal should be initiated by submitting a letter to the IBC Chair (biosafety@uwsp.edu) addressing relevant issues. The appeal will be discussed by the full committee. Any decision to reverse a non-approved protocol requires a vote by the full committee.

Protocols may be approved for a maximum period of 3 years. The PI will be informed in writing of the IBC's review decision. The Department Chair or supervisor will be copied electronically on the correspondence.

The approval date is the date the Full Committee approves the changes. If the IBC uses administrative review subsequent to full committee review, the approval date is the date that the full committee approved the study pending the minor points of order/clarification.

Any member of the IBC may, at any time, request to see the revised protocol and/or call for Full Committee Review

1. If a PI would like to report a change in laboratory personnel (excluding changes in PI), a new Personnel Training Form must be completed and submitted.

2. If a PI would like to amend their active protocol, they must submit revised BPA to biosafety@uwsp.edu. The "Modification Form" box should be selected on the coversheet.

3. Depending on the type of modification requested, the modification may be reviewed through administrative review, designated member review, or full IBC review.

1. Modifications allowable under administrative review must have no impact on biosafety. Administrative changes may include typographical or grammatical errors, funding source information, linking IRB or IACUC protocols, contact information, or verification of biosafety cabinet certification, etc.

2. The IBC Chair, an IBC member delegated by the chair (designated reviewer) may review modifications to protocol that they determine are minor in nature. For example, a change in room where the work is conducted.

3. Significant changes to protocols that may have an impact on biosafety, must be reviewed by the Full Committee.

The PI will be notified in writing by IBC Administration of the determination made by the IBC. Changes may not be implemented until a modification request has been approved by the IBC

Principal Investigators will be notified approximately 60 and 30 days prior to their protocol expiration date. At this time, the PI must decide whether they wish to request an IBC renewal or to close the project. Principal Investigators who plan to renew their project must review and update their protocol and re-submit a BPA form selecting the 3-year renewal on the application prior to the protocol expiration date. The IBC will conduct a de novo review of the renewal BPA following the review procedures described in Part B. The PI will be notified in writing of the determination made by the IBC.

If a PI wishes to close their protocol they must submit a Closure Form to biosafety@uwsp.edu.

Any incident that has the potential to adversely affect researcher or public health and safety must be reported to the IBC and potentially to the Office of Science Policy (OSP) depending on the nature of the incident.  Incidents that are immediately reportable to IBC include:

• Personnel exposure (skin puncture with needle containing rDNA)
• Spill of high risk recombinant materials occuring outside a biosafety cabinet
• Loss of Containment/Failure to follow approved containment conditions
• Loss of improper disposition of transgenic animal
• Failure to obtain IBC approval before procedure(s) commenced
• Incidents that are reportable to the IBC within 72 hours include: 
• Minor spill of low-risk with no breach of containment and properly cleaned/decontaminated

If  you have a reportable incident, please submit an IBC Incident Report Form  to biosafety@uwsp.edu and notify administration at 346-3799. Forms can be found under the IBC Forms and Documents page. The IBC is responsible for reporting incidents involving recombinant materials to OSP.