*Note: The NIH has released an amended version of the NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules as of April 2024. These guidelines can be found here and include revisions specific to research involving Gene Drive Modified Organisms in contained research settings. Research at MTSU is in accordance with the original guidelines listed in the approved charter below and any updates provided by the amendment.

IBC CHARTER

Introduction

The Institutional Biosafety Committee (IBC) at Middle Tennessee State University (MTSU) oversees all research involving recombinant or synthetic nucleic acid molecules in accordance with the NIH Guidelines (April 2019). The IBC may also maintain oversight of other research areas involving biohazardous materials and biological agents as needed by the institution. The overarching mission of the IBC is to protect all lab personnel and the general community from any potential biohazardous exposures and ensure that federal and state guidelines pertaining to biohazardous materials are followed. The IBC is commissioned by the Vice Provost for Research within the Office of Research and Sponsored Programs (ORSP) and receives input and support from the Environmental Health and Safety (EH&S) office.

The information in this Charter is specific to research performed at MTSU. Teaching labs that use recombinant or synthetic nucleic acid molecules and/or potentially biohazardous materials are not under the purview of the IBC at this time. All teaching related labs are under the oversight of a teaching lab supervisor, the Department Chair, and EH&S.

Membership and Training

In accordance with the NIH Guidelines, the IBC must include at least five members. Collectively all members should have expertise in recombinant or synthetic nucleic acid technologies and have the ability to assess safety and potential risks concerning the use of these molecules in research. Among the five members, at least two members are not affiliated with MTSU and are assigned to represent the interests of the community as it relates to health and environmental protection. When experiments involving recombinant or synthetic nucleic acid molecules in plants or animals require prior approval before initiation, then the IBC will include at least one member with this specific expertise. Any research occurring at Biosafety Level 3 or 4 (BSL3 or BSL4) or involving large scale experiments (more than 10 liters) will require IBC membership to include a Biosafety Officer. However, at this time MTSU has no experiments performed at this level.

IBC members are appointed by the Vice Provost for Research for a term of three years. Members may maintain their IBC appointment beyond this term if they are willing to continue service in order to maintain the expertise and experience required by the NIH guidelines. In addition to having expertise in recombinant or synthetic nucleic acid technologies, all members of the IBC are offered training through the CITI training program on the NIH guidelines. The IBC Chair also meets with IBC members on an as-needed basis if additional training is requested.

Responsibilities of the IBC

In accordance with the NIH Guidelines, the responsibilities of the IBC are as follows:

1. Review and approve research conducted at or sponsored by MTSU that involves recombinant or synthetic nucleic acid molecules, or other biohazardous materials as required by the institution.
2. Assess containment levels for research projects submitted to the IBC and set containment levels for using recombinant or synthetic nucleic acid molecules in experiments involving plants or animals.
3. Assess facilities, procedures, practices, and training for all personnel involved in projects submitted to the IBC.
4. Communicate with the investigator the results of the IBC review and approval and if applicable explain the reasons for disapproval.
5. Lower containment levels for certain experiments described in Section III-D-2-a of the NIH guidelines if nonpathogenic prokaryotic or lower eukaryotic host-vector systems are employed.
6. Perform periodic reviews of research involving recombinant or synthetic nucleic acid molecule research to ensure compliance with the NIH guidelines.
7. Adopt emergency plans for accidental spills and exposures, including personnel contamination, that is a direct result of recombinant or synthetic nucleic acid research or other biohazardous research that falls under the oversight of the IBC.
8. Report problems or violations of the NIH guidelines to ORSP, EH&S, and the NIH Office of Science Policy (NIH OSP) within 30 days, unless investigator has already filed a report.

IBC meetings

Frequency of meetings

The IBC meets at least annually to review compliance related to 1) research involving recombinant or synthetic nucleic acid molecules and 2) any other research areas involving biohazardous materials and biological agents that the IBC has been given oversight. For review and approval of new or amended project protocols, the IBC will meet on an as-needed basis throughout the year. The IBC chair will prepare meeting agendas and send out meeting invitations. A member of EH&S will also be encouraged to attend each meeting, depending on the meeting agenda. Meetings are held in a virtual format over Zoom or Microsoft Teams and the public may attend these meetings by contacting ORSP at compliance@mtsu.edu.

Quorum and Voting

A quorum of more than half of voting members present is required to hold an IBC meeting. The quorum will be confirmed by the IBC chair prior to beginning the meeting and if a quorum is not present the meeting will be rescheduled. For experiments requiring an IBC member with expertise in a specific area such as plants or animals, the meeting will not be held unless that IBC member can be present. All IBC members are voting members.

Minutes

The ORSP Research Compliance Officer will be responsible for recording meeting minutes. The IBC chair will review and approve minutes before distribution to the IBC committee. Meeting minutes may be requested by the public through contacting ORSP at compliance@mtsu.edu. 

Conflict of Interest

If an IBC member has a project under review in which they will be engaged in or directly benefit financially from, they may not be involved in the review or approval process related to their project.

Institutional responsibilities

MTSU assumes responsibility for ensuring research involving recombinant or synthetic nucleic acid molecules is conducted at MTSU in compliance with the NIH guidelines. MTSU also assumes responsibility for ensuring any research that uses potentially biohazardous materials or biological agents receives proper oversight to reduce any risk to the researchers, environment, and broader community. To fulfill this responsibility, a combined effort between ORSP and EH&S is employed. As it relates to ORSP, this office has established the IBC, ensures that members have the adequate expertise needed for review of protocols, and establishes procedures used by the IBC for review and approval of IBC protocols. ORSP is also charged with filing annual reports of IBC membership and additional information to the NIH OSP. ORSP provides training to all IBC members and EH&S provides training and support to individual investigators and lab personnel.

Investigator responsibilities

In accordance with the NIH guidelines, the investigator should determine if their project requires IBC approval prior to initiation (Section III-A, III-B, III-C, III-D) or simultaneous with initiation (Section III-E). Some experiments using recombinant or synthetic nucleic acids are exempt from the NIH guidelines. These experiments are outlined in Section III-F and may be found in Appendix C.

While the investigator must make an initial determination of when to obtain IBC approval, a majority of experiments fall under Section III-D, which generally involves recombinant or synthetic nucleic acids with a BSL-2 or higher designation, or fall under Section III-E, which generally involves experiments that can be conducted at BSL-1 containment. If the project falls under Section III-A, III-B, III-C, or III-D the investigator will not initiate or modify research until the project protocol has been approved by the IBC. If the project falls under Section III-E, the investigator will submit an IBC protocol at the time the experiments are initiated.

Prior to initiating any experiments, the investigator overseeing research involving recombinant or synthetic nucleic acid molecules, or other potentially biohazardous agents under the purview of the IBC, is responsible for safety of laboratory staff and students. The investigator should make protocols that describe the potential biohazards and precautions available to all lab personnel. The investigator should instruct and train lab personnel in best practices and techniques for safety and how to deal with accidental biohazardous spills or exposures. The investigator should always inform lab personnel of reasoning behind any precautionary medical practices that are advised, such as vaccinations or serum collection.

During the conduct of the research, the investigator should supervise safety performance of all lab personnel to ensure safe practices are employed. The investigator should correct and supplement training of lab personnel to avoid the release of recombinant or synthetic nucleic acid molecules, or other potentially biohazardous agents, if any issues are witnessed. Additionally, the investigator should ensure the integrity of physical and biological containment systems used and report any significant problems with practices or procedures to the IBC.

Additional responsibilities of the investigator include:

1. Reporting significant problems or violations of the NIH guidelines to the IBC and/or the NIH OSP within 30 days of incident.
2. Complete regular training in good microbiological techniques and biosafety and ensure all lab personnel receive the required safety trainings (see “Training personnel in working with biohazardous materials” section below for more details).
3. Adhere to any IBC-approved emergency plans for handling biohazardous spills or exposures.
4. Follow all shipping requirements for recombinant or synthetic nucleic acid molecules (Appendix H, NIH guidelines).

The following resources should be reviewed by all investigators working with recombinant or synthetic nucleic acid molecules, or other potentially biohazardous materials:

NIH Guidelines April 2019

Lentiviral Vector Containment Guidelines 

NIH Laboratory Safety Monograph (covering accidental spill and exposure procedures)

Biosafety in Microbiological and Biomedical Laboratories

Training lab personnel in working with biohazardous materials or biological agents

While the investigator assumes the primary responsibility in providing adequate training in handling and limiting the exposure risk to biohazardous agents, the IBC will expect all personnel working with recombinant or synthetic nucleic acid molecules or other potentially biohazardous agents to have completed formal laboratory safety training. At MTSU, formal training and instruction of all personnel is done through the Safe Colleges training platform. Each department has a designated training coordinator (DTC) that can assign training to individuals as needed. The investigator should work with their departmental DTC to ensure that they and their lab personnel receive the appropriate training for the work that they perform. As it relates to research that falls under the NIH guidelines, each person working in the lab should minimally complete Biosafety training through the MTSU EH&S Safe Colleges training platform. For laboratory staff that plan to conduct research with human cell lines or animals, the Bloodborne Pathogen Exposure training should also be completed in addition to Biosafety training. Biosafety training and Bloodborne Pathogen Exposure training should be completed annually and refresher courses are assigned by the departmental DTC. In addition to these two primary training courses, the DTC will assign a set of core classes to be completed that includes a variety of topics concerning science lab safety, fire and explosion hazards, and personal protective equipment. These courses are meant to supplement training from the investigator and should not replace investigator responsibility in adequate training of laboratory personnel.

Protocol registration and review

All investigators requiring IBC project approval should complete a New IBC application within Cayuse Hazard Safety following the procedures outlined here. A new IBC protocol must be submitted every three years and updated annually as needed. Training videos for both researchers and IBC committee members on how to use Cayuse Hazard Safety are located here: IBC Hazard Safety Training videos. These videos cannot be downloaded and must be viewed online. If there is any issue in viewing these videos, please contact april.weissmiller@mtsu.edu for a private viewer link.

To submit an IBC protocol investigators should:

1. 1. Fill out the Cayuse User Request Form to add all personnel that will be working on the project. This includes the investigator, research staff, post-doctoral fellows, visiting students or faculty, undergraduate students, and graduate students.
   2. Access Cayuse Hazard Safety by signing into PipelineMT, scrolling down to the Employee Resources block on the Home Page, and choosing Cayuse.
   3. Once in Cayuse, under the “Products” tab at the top, click onto “Hazard Safety”. The logo for Hazard Safety should show on the top left side of the website. A role as “Researcher Staff Member” may give access to Animal Safety, so please always ensure the left side of the webpage says the correct Hazard Safety indicator.
   4. Follow the instructions with Cayuse Hazard Safety to complete a new or amended IBC protocol by clicking the icon that says “+ Start a New IBC Application”. For any issues filling out the protocol, refer to the training videos above or contact the IBC chair.
   5. Once a protocol is submitted, the IBC will review the protocol and provide comments and/or necessary changes within the protocol.
   6. The IBC will compile all comments and/or necessary changes and provide these to the investigator through a Cayuse-generated email. Please make sure to check non-focused email if using Outlook as Cayuse-generated emails may not fall in the “focused” folder.
   7. Within the Cayuse Hazard Safety account, review and respond to all comments made by the IBC and resubmit the IBC protocol for a final review.
   8. An IBC meeting will be called within one month of protocol submission to discuss the protocol. Upon approval, notification will be given through a Cayuse-generated email with the approval date. All protocols are approved for a three-year period.
   9. When it gets close to the expiration date of an approved protocol, a reminder to renew the protocol will be provided by a Cayuse-generated email. In order to renew, the investigator should follow the instructions within Cayuse to do so. If no renewal is submitted the protocol will expire on the expiration date.
   10. IBC protocols may be amended if new agents or personnel are added to the project. To amend an existing IBC protocol, complete an “IBC amendment” within Cayuse Hazard Safety. Amendments such as adding or removing personnel or adding or removing proposed activities within an approved protocol should be done annually as needed.
   11. Experiments that require IBC approval and involve human subjects or animal work must also gain approval from the IRB or the IACUC, respectively.

Audits and noncompliance procedures

Audits

Once an IBC protocol is initiated for review and approval, the investigator should contact EH&S to review the proposed biological hazards and research plan. A staff member within EH&S will assist with answering any questions related to the biosafety level designation proposed, go over procedures and requirements at MTSU for operating at that biosafety level, and will assist with appropriate signage and labelling of the rooms involved. Staff within EH&S may perform a biosafety audit at any time to ensure safety and compliance with the NIH guidelines and institutional policies on working with biohazardous materials or biological agents. Any audit will be scheduled with the investigator so that the investigator can be present during the visit. During the visit, EH&S staff and the investigator will go over biosafety procedures used in the laboratory and the spaces used for the research will be reviewed for proper labeling, signage, and contact information. EH&S staff will provide the investigator a summary of their visit within one week by email.

Teaching labs that use recombinant or synthetic nucleic acid molecules and/or additional biohazards are not required to obtain IBC approval at this time. However, the teaching lab supervisor must receive specific training from a EH&S staff member based on the proposed teaching activities. This training will include a review of the teaching activities to be executed, along with training in how to handle potentially biohazardous materials within the classroom including the use of personal protective equipment for all students, proper containment strategies, and disposal of biohazardous materials. Teaching labs and activities performed within teaching lab space may be audited at any time by EH&S to ensure safety and compliance.

Noncompliance

To receive and continue any NIH funding for recombinant or synthetic nucleic acid molecule research, the NIH guidelines will be enforced and regularly reviewed for compliance by the IBC, ORSP, and EH&S.

As it relates to research involving recombinant or synthetic nucleic acids there are specific consequences for not complying with the NIH guidelines including:

1. Suspension, termination, or limitation of NIH-funding for the non-compliant research or any other research involving recombinant or synthetic nucleic acid molecules conducted at MTSU
2. Requirement for prior approval by the NIH of any projects related to recombinant or synthetic nucleic acid molecules

However, at the institutional level, noncompliance extends beyond research involving recombinant or synthetic nucleic acids to include all research involving biohazardous materials and/or biological agents performed at MTSU. Information concerning noncompliance can be brought forward by any person through contacting the IBC chair (April.weissmiller@mtsu.edu) ORSP (compliance@mtsu.edu) or EH&S (jim.rowland@mtsu.edu). Following report of a noncompliance issue, an investigation will be performed, and corrective action taken. The investigation will include determining if the research has an active IBC protocol and/or is actively supported by a funding agency, confirming the training completed by all laboratory personnel, discussing the nature of the incident with the laboratory personnel and investigator, and determining the severity of the noncompliance issue.

Consequences at the institutional level will depend on the severity of the case under investigation. Minor noncompliance issues are those that result from unintentional errors, inadequate training, or misunderstanding of procedures and are isolated incidences. Major noncompliance issues are those that result from a serious oversight or exposure that poses a risk to the health and safety of the environment, humans, animals, or plants. Continued noncompliance related to unintentional errors or inadequate training will also be considered a major noncompliance issue.

If the incident is determined to be a minor noncompliance issue, all efforts will be made to allow research to continue without pause. EH&S will provide a notification in writing to the investigator that summarizes the results of the investigation. EH&S and/or the IBC Chair will meet with the investigator to develop a plan of action for correcting and preventing any future incidences. The plan of action will be documented by EH&S and provided to the investigator. This plan will include at a minimum mandatory re-training of all laboratory personnel in best practices when working with biohazardous materials or biological agents. Follow-up will occur with the investigator no later than six months following the plan agreement to ensure the laboratory is in compliance with federal and institutional regulations.

If the incident is determined to be a major noncompliance issue, a decision on whether to immediately halt the impacted research while under investigation will be decided on by EH&S, ORSP, and the IBC chair. EH&S will provide a notification in writing that summarizes the results of the investigation to the investigator, department chair, college dean, and ORSP. If the impacted research is under the oversight of the IBC, the committee will meet to review the noncompliance issue and results of the investigation while also deciding the length of research suspension. The IBC can recommend additional actions to be enforced by EH&S, including but not limited to terminating or suspending the use of biohazardous materials in the investigator’s research, requiring more frequent audits of the research facilities and personnel, or requiring changes to protocols or procedures used by the laboratory. As with minor noncompliance issues, a plan of action will be created for the investigator with consultation from EH&S and the IBC chair with follow up no later than six months following plan agreement. If the incident is a significant violation of the NIH guidelines a complete report of the incident will be submitted to the NIH OSP within 30 days of the incident.

For all minor and major noncompliance investigations, the investigator may communicate concerns and/or disagreements over the investigation proceedings or resulting consequences imposed on the research in writing to EH&S or the IBC chair. These concerns will be discussed and a response in writing will be provided to the investigator with the outcome of the discussion.

Approval and review of IBC Charter

The IBC Charter is reviewed every three years by EH&S, ORSP, and the IBC. Final approval is granted by majority vote from voting members of the IBC.