Institutional Biosafety Committee (IBC) LSUHSC-Shreveport

Biosafety Committee Members: Title Department Voting Member Michelle Arnold, Ph.D. Assistant Professor Microbiology & Immunology Voting Jason Bodily, Ph.D. Lynda Britton, Ph.D. Professor SAHP Jessica Esparza, Ph.D. Forensic DNA Analyst NLA Criminalistics Lab/Community Rep Edward Glasscock, Ph.D. Anatomy Ron Klein, Ph.D. - Vice Chairman Associate Professor Pharmacology David McGee, Ph.D. - Chairman Sumi Miriyala, Ph.D. Hyung Nam, Ph.D. Annella Nelson, M.B.A. Director Office for Sponsored Programs & Technology Transfer Non-Voting Mani Panchatcharam, Ph.D. Hugh Price, Jr., D.V.M. Animal Resources Brent Reed, Ph.D. Biochemistry Xinggui Shen, Ph.D. Instructor Pathology Michael Stroud Safety Officer Safety Office Suzie Golas- Secretary Coordinator Office of Research Pat Wojtkiewicz, Ph.D. Xiuping Yu, Ph.D.

Purpose of the IBC According to NIH Guidelines for Research Involving Recombinant DNA Molecules Section IV, the Institution shall establish an Institutional Biosafety Committee whose responsibilities include specifying practices for constructing and handling recombinant DNA molecules. However, this committee need not be restricted to recombinant DNA. Its responsibilities may include organisms and viruses containing recombinant DNA molecules and other chemical and biological hazards.

Responsibility of the IBC The Institutional Biosafety Committee (IBC) is responsible for reviewing, approving, and overseeing all projects performed at LSUHSC which involve biological materials that are a potential hazard to investigators or research subjects. The IBC meets on the 2nd Thursday of each month. If there are no new protocols or revisions to be reviewed, an email meeting will take place.

Role & Responsibility of the Principal Investigator (PI) The Principal Investigator (PI) must gain the approval of the Institutional Biosafety Committee to proceed with research that utilizes infectious agents/biohazards, chemical agents and recombinant DNA. The PI is responsible for notifying the IBC of any changes to their protocol. PIs can have only one active protocol at a time. If a PI needs to add or make a change to their protocol, they may submit a memo to the committee requesting the change. If the scope of the research is changing, then the PI must submit a new protocol and request to terminate the other. For any kind of lab activity, the PI is primarily responsible.

What is a Recombinant DNA? NIH Guidelines for Research Involving Recombinant DNA Section 1-B (i) molecules that are constructed outside living cells by joining natural or synthetic DNA segments to DNA molecules that can replicate in a living cell, or (ii) molecules that result from the replication of those described in (i) above.

Select Agents & Toxins The Public Health Security and Bioterrorism Preparedness and Response Act of 2002, Subtitle A of Public Law 107–188 requires the Department of Health and Human Services (HHS) to establish and regulate a list of biological agents and toxins that have the potential to pose a severe threat to public health and safety. For a complete list of select agents and toxins, please visit http://www.selectagents.gov/Select%20Agents%20and%20Toxins%20List.html. Select Agent Exclusions The HHS regulations in 42 CFR Part 73 and 9 CFR Part 121 establish a procedure by which an attenuated strain of a select biological agent or toxin that does not pose a severe threat to public health and safety, animal health, or animal products may be excluded from the list of select biological agents and toxins. For a complete list of excluded select agents and toxins, please visit http://www.selectagents.gov/Select%20Agents%20and%20Toxins%20Exclusions.html. Permissible Toxin Amounts The following toxins are not regulated if the amount under the control of a principal investigator, treating physician or veterinarian, or commercial manufacturer or distributor does not exceed, at any time, the amounts indicated in the table. http://www.selectagents.gov/Permissible%20Toxin%20Amounts.html National Select Agent Registry. Select Agent and Toxins. http://www.selectagents.gov/Select%20Agents%20and%20Toxins.html

Biosafety Levels LSUHSC-S IBC follows the NIH Guidelines for Research Involving Recombinant DNA when selecting a Biosafety Level (BSL) for each protocol. BSL 1 BSL 2 BSL 3* BSL 4 The description of each category can be found in the NIH Guidelines for Research Involving Recombinant DNA which is located on the IBC website. *The use of BSL 3 is performed within conjunction with CDC and the Safety Office. Michael Stroud and the IBC Chairman are on the BSL 3 committee.

Biosafety Submissions All submissions are due to the Office for Sponsored Programs & Technology Transfer (OSPTT) the first Tuesday of the month. The Assurance Committee Calendar can be located on the OSPTT website. All forms can be found on the following IBC webpage: http://www.lsuhscshreveport.edu/Research/assurancecommittees/institutionalbiosafetycommittee/index The Coordinator processes all submissions and will send to the chairperson for review. The chairperson will present the submissions at the next IBC meeting. The committee will then vote to Approve, Disapprove, Contingent Approval, or Table the submission. After the meeting, the Coordinator will send out a notice by email and a signed copy by campus mail to the PI and copying the Department Business Managers notifying them of the committee decision and any revisions that need to be submitted.

Biosafety Submissions – New Protocols New protocols are submitted to the Office of Research for initial review. The Coordinator assigns the protocol an IBC number (B00-000) and then sends the protocol to two committee reviewers for review. The reviewers will present their reviews at the next meeting where the committee will vote to Approve, Contingent Approval, Table, or Disapprove. If revisions are not received within 6 months of the original review, the committee will vote to Administratively Withdraw the protocol.

Biosafety Submissions - New Protocol Revisions Revisions are made in the protocol with a memo stating the revisions made and are submitted to the Office of Research for initial review. The Coordinator sends the protocol to the original two committee reviewers for review. The reviewers will present their reviews at the next meeting where the committee will vote to Approve, Contingent Approval, Table, or Disapprove.

Biosafety Submissions – Chemical Hygiene Plans (CHP) Chemical Hygiene Plans (CHP) are submitted to the Safety Office for review and approval. CHP’s are required when submitting a new protocol and an annual update. All new protocols and annual updates will be Tabled if their CHP is not submitted.

Biosafety Submissions – Annual Update Annual Updates are due each year for all active protocols. A biological inventory is required to be submitted with the annual update each year. Reminder emails with the form are sent to the PI’s and Business Managers 30 days prior to their assigned month’s due date. The due dates are assigned by the first letter of the PI’s last name Month Alphabet Letter January A February B March C – D April E – G May H – J June K – L July M August N – P September Q – R October S November T – V December W - Z

Biosafety Submissions – Annual Update continued If an annual update is not received, the PI will be listed as a Non-Responder until their update is received. The Coordinator will send out reminders by email and campus mail to the PI and copying the Department Business Managers requesting the update. If the annual update is not received within 3 months from the due date or if revisions are needed and not received within 3 months of the signed IBC letter, the committee will vote to Administratively Terminate the protocol.

Biosafety Submissions – Other Changes to an active protocol: Any changes to an active protocol (ie: add/delete biohazard(s), PI change, personnel change, etc) must be submitted by the deadline in either memo form or by email to the Coordinator. Request to terminate protocol: A PI can request to terminate their protocol at any time. The PI can either submit a memo or email requesting the terminate of their protocol or they can submit an annual update form with the appropriate box checked. Request to withdraw new protocol: A PI can request to withdraw their new protocol submission. The PI can submit a memo requesting the withdrawal of their new protocol.

Bloodborne Pathogen & Laboratory Safety Training Training is mandatory within 90 days of hire for all personnel that work in or around laboratories and is required for all personnel that have not previously passed the training sessions. Personnel are required to take refresher training according to the following schedule: Bloodborne Pathogen - every year Laboratory/Chemical Safety - every two years Biological Safety - ever two years. All Biosafety & Laboratory Training is done online through Collaborative Institutional Training Initiative (CITI). To complete the necessary training online please visit: https://www.citiprogram.org/index.cfm?pageID=14 If you would prefer to have live training by one of our Safety Officers, please contact the Office of Safety Services at ext: 3.3450.

IBC Compliance Compliance with NIH Institution Compliance LSUHSC-S IBC is a registered member of the National Institutes of Health Office of Biotechnology Activities (NIH OBA). The IBC is responsible for providing an annual report to OBA for compliance purposes. The current approval date is March 22, 2017. NIH Guidelines for Research Involving Recombinant DNA Molecules Sections I-D-1 & I-D-2: Non-compliance may result in: (i) suspension, limitation, or termination of financial assistance for the noncompliant NIH-funded research project and of NIH funds for other recombinant DNA research at the institution, or (ii) a requirement for prior NIH approval of any or all recombinant DNA projects at the institution. PI Compliance Failing to comply with the IBC can result in the suspension, limitation, or termination of any grant that the PI has been awarded or applied for. Failing to comply can also result in the suspension, limitation, or termination of any Animal Care & Use Committee protocol.

Frequently Asked Questions: Q: Can I submit the IBC forms electronically? A: Yes, however we still need the signed hardcopy. Q: What is a biological inventory? A: A biological inventory is a list of all cell lines, plasmids, viruses, toxins, and etc that are being used or stored in the PI’s lab. A biological inventory is required with all annual update and Chemical Hygiene Plan submissions. Q: What is Recombinant DNA? A: NIH Guidelines for Research Involving Recombinant DNA Section 1-B (i) molecules that are constructed outside living cells by joining natural or synthetic DNA segments to DNA molecules that can replicate in a living cell, or (ii) molecules that result from the replication of those described in (i) above. Q: My grant submission is requesting the institution’s IBC Assurance number. What is our institution’s IBC Assurance number? A: Our institution is registered with NIH OBA. The IBC Assurance number that we receive is the approval date of our annual report to NIH OBA. Our current approval is March 22, 2017. Anytime you need this date for submitting a grant, please contact the IBC Coordinator at shvbiosafety@lsuhsc.edu or check the IBC website for the correct date.

Important Contact Information David McGee, Ph.D. – IBC chairperson Associate Professor in Department of Microbiology & Immunology email: dmcgee@lsuhsc.edu ext: 5-8138 Michael Stroud – Biosafety Officer Office of Safety Services email: mstrou@lsuhsc.edu ext: 5-4753 Suzie Golas– IBC Coordinator Office of Research email: shvbiosafety@lsuhsc.edu ext: 5-4109