Institutional Biosafety Committee (IBC)

Structure

The MU-IBC is federally registered with NIH Office of Science Policy (OSP) and is empowered by the Provost to review all research protocols, particularly those involving nucleic acids or potentially biohazardous materials to be conducted at or supported by Marian University. In addition to its traditional roles within the NIH OSP structure, the MU-IBC also reviews research that may be subject to other local, state, or federal safety regulations.

Committee Organization

The chair of the IBC reports to the Provost. The MU-IBC is comprised of at least five members representing distinct areas of expertise, two of which are not affiliated with Marian University. These members are appointed by the Provost in accordance with Section IV-B-2 of the NIH Guidelines Additional information regarding the roles and responsibilities of the committee may be found in the MU-IBC Bylaws Apr 2021.

What research needs to be reviewed?

All researchers engaging in laboratory activities must complete an IBC Pre-Submission form (please see Submitting a Protocol to the IBC below). Full protocol review may additionally be required for any activities that include, but are not limited to:

• Potentially biohazardous materials
• Potentially infectious agents
• Use of any Biosafety Level 2 or greater non-recombinant biological material
• Viral vectors or plasmid vectors
• All use of recombinant DNA (rDNA) or synthetic nucleic acid molecules
• Transgenic/Knock-in/Knock-Out animals
• Genetically modified plants
• Transactive or infectious proteins
• Prion proteins
• Biohazards (e.g.: human or non-human tissues or fluids)
• Microorganisms
• Select agents or toxins

Compliance

It is the responsibility of the MU-IBC to address non-compliance with University policies and procedures. Thus, the IBC is empowered to inspect laboratories, procedure areas, animal housing areas, and sequester research or training records. The full process for identifying and addressing non-compliance can be found in the MU-IBC Bylaws, but include corrective actions to achieve compliance, additional education, oversight, or suspending or terminating individual protocols or research activities.

General Workflow

Figure 1. IBC General Workflow. PIs will submit their pre-submission form for evaluation. Based on the information presented, the chair may request more information before sending it on to one of three possible review types. For research that falls within the NIH Guidelines, this will require a full protocol submission and Full Committee Review (FCR). Protocols that are exempt from NIH Guidelines but may utilize Risk Group 2 (RG2) or Biosafety Level 2 (BL2) materials will also be sent for FCR. Protocols that are exempt and do not utilize any procedures or materials that are considered biohazardous may be sent for FCR or Designated Member Review (DMR), depending on the nature of the experiments. Not all protocols can be approved as drafted, and some modifications and revisions may be required before approval.

New Protocols

You may not begin research until your IBC protocol has been approved.

1. Download the MU IBC Pre-Submission Evaluation 2021 and email the completed form to IBC@marian.edu. The form consists of three main parts:

• Contact information for the Principal Investigator and any users
• Brief description of the research protocol including goals, agents used, and procedures conducted both in vitro and in vivo. It must include a description of any recombinant approach, biohazardous, or infectious agent used. This description is used to determine exemption status and detailed descriptions will facilitate the rapid assignment of your protocol.
• Research parameters, including funding, all included investigators and their safety training, and the research locations.
• Selection of all appropriate sections of the NIH Guidelines Section III designations that apply to the proposed research.

Please note – all forms must be submitted electronically using your Marian credentials. If you do not have a Marian email address, or if you have any questions, please contact the committee at IBC@marian.edu.

2. The IBC chair will conduct an initial screen to determine what level of review your protocol requires. You will be contacted by the IBC and notified that your research:

• Requires additional information. You will be notified that additional information is needed to determine the appropriate protocol review requirements.
• Fulfills the criteria for exemption from NIH Guidelines and is in the lowest risk group (RG) and biosafety level (BL). In most cases, this will be approved by a designated member review (DMR), usually by the chairperson. Pending any necessary safety training (please see below), you may proceed with your study. Exemption is limited to the materials, procedures, containment, locations, and safety practices outlined in the submission. Additional or modified procedures and materials must be submitted to the IBC prior to beginning any work.
• Requires full committee review (FCR). Any research subject to NIH Guidelines must complete FCR. In some cases, the proposed research may be exempt from NIH Guidelines but the nature of the research, typically RG2/BL2, necessitates additional review under OSHA, BMBL, or ISDH standards. You will be asked to complete the MU IBC Full Application 2021 form and submit this via email to IBC@marian.edu. Please note – all forms must be submitted electronically. During the review process, the IBC may request additional information and/or modifications. In some cases, additional oversight and review by the NIH Director, Recombinant DNA Advisory Committee (RAC), and/or Office of Biotechnology Activities (OBA) may be required. You are welcome to attend the meeting during which your protocol is reviewed. You will be notified by the IBC chair when your protocol is approved, at which point you may commence research activities. Protocols are valid for three years from the date of approval.

3. Complete and submit requisite safety training.

• All researchers at Marian University, including the Principle Investigator and any other faculty, staff, or students working with the PI must complete the required  CITI training course(s) (please see “Laboratory Safety and Training” below). After review of the pre-submission, the IBC will communicate which, if any, CITI courses are required for the initiation of research. The courses must be recertified every three years.
• It is the PI’s responsibility to ensure that all members of the lab have complete and current training protocols on file.

  Renewals

Renewals

It is Marian University policy that no work can begin until approved by the IBC. If you wish to renew a previously approved protocol that has no modifications, you may request a renewal of your active protocol.

4. Update any existing information in your approved protocol documents using track changes. 

5. Submit your renewal via email to IBC@marian.edu.

6. Complete or renew any required safety training.

• All researchers at Marian University, including the Principle Investigator and any other faculty, staff, or students working with the PI must complete the required CITI training course(s) (please see below). The courses must be recertified every three years.
• It is the PI’s responsibility to ensure that all members of the lab have complete and current training protocols on file.

  Please note – renewal protocols must still undergo the review process outlined above.

Amendments

Research is limited to the materials, procedures, containment, locations, and safety practices in the approved protocol. Any changes must be approved prior to beginning any work. It is Marian University's policy that only approved work may be conducted.

7. Download the appropriate amendment form: either a MU IBC Protocol Amendment Form - Brief or MU IBC Protocol Amendment Form - Substantive amendment.

• Brief – this abbreviated form will be to update any funding, personnel, or research locations.
• Substantive – this form will be used to update any changes in procedures, materials, or oversight.

8. Complete and submit the form via email to IBC@marian.edu.

9. Complete or renew any required safety training.

• All researchers at Marian University, including the Principle Investigator and any other faculty, staff, or students working with the PI must complete the required CITI training course(s) (please see below). The courses must be recertified every three years.
• It is the PI’s responsibility to ensure that all members of the lab have complete and current training protocols on file.
  Please note – amendment protocols must still undergo the review process outlined above.
  

   

Laboratory Safety

All research and teaching activities supported by Marian University must comply with the NIH Guidelines, the Biosafety in Microbiological and Biomedical Laboratories (BMBL), the OSHA Bloodborne Pathogen Standard, the ISDH infectious waste standards, and other applicable federal, state, and local laws or regulations governing the use of biohazardous materials and recombinant or synthetic nucleic acid molecules. Additional safety, security, and training protocols may be required depending on the nature of your research.

Training

It is the responsibility of the PI to ensure that all laboratory personnel is trained and follow the practices and techniques required to ensure safety and compliance.

In addition to the CITI Training (below) specific policies and practices may be required for certain research activities and facilities. This will be communicated through the protocol review process. If you have questions, you may direct them to IBC@marian.edu.

Incident Reports

Any person, including any University employee, student, volunteer, or member of the general public, may report concerns involving the use of biohazardous materials and/or recombinant or synthetic nucleic acid molecules. Such concerns may be reported  using this anonymous link, or by contacting the IBC at IBC@marian.edu directly.

Marian University has an institutional subscription to the online Collaborative Institutional Training Initiative (CITI) program. This federally-run training is mandatory for all researchers that work with or have laboratory access to recombinant or synthetic nucleic acid molecules, biological materials, and other potentially biohazardous agents. This requirement includes students, staff, or faculty conducting research in specific laboratory spaces regardless of personal use. Completion of the CITI program fulfills the federal government's requirements for training outlined in the NIH Guidelines.

1. Navigate to the CITI Program website at www.citiprogram.org
   1. If you have never registered before (you do not have a CITI Program username) please go to and register an account in the system. Click on the "Register" button under "Create an account" from the homepage. Select Marian University – Indianapolis and from the dynamic drop-down list and follow the prompts to create your account. Please note that there are two 'Marian University's listed in the drop-down list. We are 'Marian University – Indianapolis' – the other school is in Wisconsin.
   2. If you already have a CITI Program username associated with a different institution, please log into your account. Go to Main Menu, and follow the "Click here to affiliate with another institution" link. Type and locate your institution via the dynamic drop down list. Researchers who have completed CITI training at another institution and can produce their completion certificate validated from within the past three years do not need to complete the course until their previous certificate expires.
   3. New Learner Instructions are  available here.
2. Complete the required safety and training protocols. These may vary depending on the nature of the research. For compliance with MU-IBC regulations, these may include, but are not limited to:
   1. Biosafety/Biosecurity - Group 1: Biomedical Lab Researcher (required for all research in biology laboratory spaces)
   2. Biosafety/Biosecurity - Group 8: Laboratory Chemical Safety (required for all research in biology and chemistry laboratory spaces)
   3. Biosafety/Biosecurity - Group 3: rDNA Investigators (required for all research in labs where rDNA protocols are ongoing)
   4. Activities Involving Vertebrate Animals – Group 1: All Researchers (for researchers working with transgenic animals or non-human primate tissues)
   5. Responsible Conduct of Research – Biomedical and Clinical Researchers
   6. Optional/Elective Courses - There are additional course options that may not be required but can supplement and document training that pertains to your areas of interest and investigation.

      Once you have completed the required modules, you will receive a completion report that will also be reported to the IBC Chair. If additional training modules are required, this will be communicated by the IBC. No research protocols will be approved by the IBC unless all of the researchers involved, including faculty, staff, and students have completed CITI training. Your completion certificate will be valid for three years, when a refresher course will be required. Questions regarding required training and processes may be directed to IBC@marian.edu.

Applications should be submitted no less than 3 Months prior to the intended start date for any research. The IBC meets biannually, with additional meetings scheduled as needed. Meeting dates and times can be found on the Marian University Events calendar. Investigators are encouraged to submit their protocols early to allow time for the IBC to convene special review meetings as needed. Questions about the process or help in preparing the application are welcomed at IBC@marian.edu.

Does my research need a protocol?

Any research conducted in Marian University laboratory spaces requires an IBC Pre-Submission form, especially any research involving recombinant or synthetic nucleic acids, biological materials, microorganisms, or potentially biohazardous chemicals or materials. This includes nearly all laboratory research at Marian University. The nature and the scope of the research will determine if a full protocol is required. Please see "Submitting a Protocol to the IBC" for detailed instructions.

How long does it take to approve a protocol?

The length of the protocol approval process can vary, depending on the biosafety oversight required. Investigators are recommended to submit their protocols at least 3 months prior to any anticipated start date. However, for protocols requiring significant oversight or revision, this process could be longer. PIs are strongly encouraged to initiate the review process as early as possible to avoid any delays in their work.

What if my protocol is not approved?

No research can be conducted without an approved IBC protocol. While not all proposed experiments can be approved as written, the MU-IBC will work directly with investigators to revise their protocols or identify alternatives for experiments that cannot be safely conducted at this time. This process may be time-consuming, so PIs are strongly encouraged to submit their protocols well in advance of any planned research activities.

Can I attend the IBC meetings?

IBC meetings are closed to the general public but PIs may attend the meetings where their research is being discussed. However, the committee may limit attendance to the relevant portions of the meeting, and PIs must adhere to the confidentiality and conflicts of interest policies of the committee.

How long is an IBC protocol valid?

An approved protocol is valid for three years from the time of approval. However, any new materials, procedures, containment, locations, and safety practices will require an amendment or new protocol prior to beginning any work. Additionally, you will need to submit an annual update of the laboratory personnel covered by your protocol.

My research is exempt. Do I still need to complete CITI training?

CITI training is required for all researchers who have access to potential biosafety risks. Even researchers working under exempt protocols may be required to complete specific CITI training, depending on the nature and location of their research. These requirements are communicated directly to the investigator through the IBC Pre-Submission process.

Where do I find the appropriate CITI training?

The specific requirements may vary depending on the nature and location of your research and will be communicated directly to the investigator through the IBC Pre-Submission process. However, the majority of the core CITI training can be found under the Biosafety/Biosecurity suite (Question 3, Groups 1 and 8):

I am a Marian University investigator, but I am conducting my research at another institution. Do I need a protocol?

Yes. Marian University requires all affiliated investigators whose research falls under its purview to maintain current IBC protocols. In many cases, submission of the approved protocol from the partner institution may suffice. Please contact the chairperson at IBC@marian.edu for approval of outside protocols. Please note, collaborative institutions may also require protocols for their facilities in addition to an approved MU-IBC protocol.

I have a collaborator not affiliated with Marian University that will be working in our facilities. Does this individual need an IBC protocol?

No. Your collaborators can be included in your protocol by submitting an amendment (please see “Submitting a Protocol to the IBC”) to the IBC. However, the PI will be responsible for all safety, training, and protocol requirements.

Should students working in my lab be listed on my IBC protocol?

All individuals working on a protocol, including faculty, staff, and students, should be included. This can be updated at any time using the amendment process (please see “Submitting a Protocol to the IBC”).

I have submitted my pre-submission form. What happens next?

Your submission will be reviewed by the chair. You will be notified by email what next steps are required, depending on the nature of your protocol.

I do not have a Marian email address. How do I submit my protocol?

Currently, only investigators with an active Marian email address can access the digital submission system. If you are not affiliated with Marian or are waiting on institutional credentials, please contact IBC@marian.edu and we will help guide you through an alternative submission process.          

When is the next IBC meeting?

IBC meetings will be posted to the University calendar at events.marian.edu.

I still have more questions. How can I get help?

Please feel free to email IBC@marian.edu with any questions.