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Biosafety and IBC

The Institutional Biosafety Committee (IBC) at 黑料社区 was established under the NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules (NIH Guidelines) to provide local review and oversight of nearly all forms of research utilizing recombinant or synthetic nucleic acid molecules. The IBC also provides review and oversight of experimentation that involves infectious agents and other potentially hazardous biological materials.

Application and Review Process

Application

Prior to beginning research or acquiring/purchasing agents, researchers are required to submit an application to the Office of Research and Innovation for review by the Institutional Biosafety Committee. 黑料社区 is currently utilizing Cayuse for application submission. After logging into Cayuse, please select "Hazard Safety" from the Products Dropdown menu to navigate to the Hazard Safety application. You will then have the ability to start a new application for IBC review. Please note that this application of Cayuse has a separate login from the Cayuse Proposal Submission Site. If you have any questions, please contact the Office of Research and Innovation at biosafety@miamioh.edu for additional assistance.

 

Initial Review

Once an application has been submitted, the Office of Research and Innovation will distribute the application to the Institutional Biosafety Committee for review. ORI will make a determination, based upon the information included in the application, regarding the training required of each researcher listed on the application. This information will be communicated directly with each researcher. ORI and the Environmental Health and Safety Office will perform a joint inspection of the lab space(s) identified on the application to ensure that the space is adequate to perform experiments with the agents identified in the application.

Revisions

After reviewing the application, additional clarification or information may be needed from the Primary Investigator. ORI will contact the PI directly regarding any requests for additional information. The PI shall respond to each comment directly from the information provided by ORI and make revisions to their application based upon the IBC reviewer’s comments via biosafety@miamioh.edu. The revisions will be provided to the IBC by ORI.

Final Review and Decision

The application and any revisions will be reviewed by the IBC at a convened meeting. A formal vote will occur so long as a quorum is present. Once a decision has been made by the IBC to approve, conditionally approve, or deny the application, ORI will communicate with the PI the decision rendered.

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黑料社区 Institutional Biosafety Committee (IBC)

The NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules (NIH Guidelines) requires, as a condition of NIH funding, shall appoint an IBC consisting of no fewer than five members and meet the requirements as outlined below:

  • The members must collectively have experience and expertise in recombinant or synthetic nucleic acid molecule technology and have the capability to assess the safety of recombinant or synthetic nucleic acid molecule research and to identify any potential risk to public health or the environment.
  • At least one individual with expertise in plant, plant pathogen, or plant pest containment principles when experiments outlined in Appendix L - Physical and Biological Containment for Recombinant or Synthetic Nucleic Acid Molecule Research Involving Plants require IBC approval.
  • At least one scientist with expertise in animal containment principles when experiments outlined in Appendix M - Physical and Biological Containment for Recombinant or Synthetic Nucleic Acid Molecule Research Involving Animals, required IBC approval.
  • At least two members shall not be affiliated with the institution (apart from their membership on the Institutional Biosafety Committee) and who represent the interest of the surrounding community with respect to health and protection of the environment

Functions of the IBC

The 黑料社区 IBC provides local review and oversight of nearly all forms of research utilizing recombinant or synthetic nucleic acid molecules and provides review and oversight for experimentation that involves infectious agents and other potentially hazardous biological materials. This review includes (but is not limited to):

  • An independent assessment of the containment levels required by the NIH Guidelines for the proposed research;
  • Assessment of the facilities, procedures, practices, and training and expertise of personnel involved in recombinant or synthetic nucleic acid molecule research

IBC Meeting Minutes

The meeting minutes are listed chronologically by each calendar year and are formatted based upon the guidance provided by National Institutes of Health in the "” and in Notice NOT-OD-25-082 "

 Researchers conducting a laboratory experiment involving the preparation of samples, with one pouring a liquid into a container while the other observes.

IBC Meeting Minutes

 

 

 

 

 

Training Requirements

The Office of Research and Innovation is responsible for ensuring that the appropriate research-specific training is provided to all researchers. The Principal Investigator listed on the application (or approved protocol) is responsible for ensuring that each researcher completes the training assigned by the Office of Research and Innovation. In addition, the Principal Investigator is responsible for training all researchers regarding the specific experimentation and lab procedures listed in each application (or approved protocol).

Once an application has been submitted for review, the Office of Research and Innovation will determine the training requirements for each researcher listed on the application. The required training is determined based upon the research described. The training must be completed by each researcher and the PI. A copy of each training completion certificate must be emailed to biosafety@MiamiOH.edu upon completion. Please note that an application cannot change to approved status until each researcher and PI complete the assigned training. The Office of Research and Innovation staff will contact each researcher listed on an application regarding their assigned training modules.

If you experience an accessibility barrier while completing CITI training, please contact our office at ori@miamioh.edu. 

The Office of Research and Innovation offers training, at no cost, to all researchers listed on application. Assigned training modules may include (but are not limited to): Basic Introduction to Biosafety, NIH Recombinant DNA Guidelines, and OSHA Bloodborne Pathogens.

The Office of Research and Innovation may assign training to researchers developed by the CDC, such as “Fundamentals of Working Safely in a Biological Safety Cabinet (BSC)”. This training is free to all researchers.

The Office of Research and Innovation may assign training to researchers developed by the University of Cincinnati, when the proposed research includes viral vectors. This training is free to all researchers.

Personnel Updates

The Office of Research and Innovation will contact you throughout the calendar year regarding personnel updates on your active protocol. It is the responsibility of the Principal Investigator to notify the Office of Research and Innovation regarding any personnel changes as they occur. Please email biosafety@MiamiOH.edu with any personnel change requests.

Dual Use Research of Concern

“The NIH defines Dual Use Research of Concern (DURC) as “life sciences research that, based on current understanding, can be reasonably anticipated to provide knowledge, information, products, or technologies that could be directly misapplied to pose a significant threat with broad potential consequences to public health and safety, agricultural crops and other plants, animals, the environment, materiel, or national security. The United States Government’s oversight of DURC is aimed at preserving the benefits of life sciences research while minimizing the risk of misuse of the knowledge, information, products, or technologies provided by such research.” 

The NIH has created a short video that can be accessed at the link below with additional information regarding DURC.

FAQs

Do I need to submit an application for IBC review?

Principal Investigators and course instructors are required to submit an application to the Office of Research and Innovation for IBC review if their research and/or teaching labs utilize recombinant or synthetic nucleic acid molecules, infectious agents, or other potentially hazardous biological materials. This may include RG-1 agents.

I do not receive NIH funding. Do I have to submit an application for IBC review?

Yes. Per Section I-D of the NIH Guidelines, “as a condition for NIH funding of recombinant or synthetic nucleic acid molecule research, institutes shall ensure that such research conducted at or sponsored by the institution, irrespective of the source of funding, shall comply with the NIH Guidelines."

My research may be listed under Section III-F - Exempt Experiments in the NIH Guidelines. Do I have to submit an application for IBC review?

Yes. The 黑料社区 IBC does not allow self-exemption from the NIH Guidelines. The IBC must review your application before making this determination.

I have completed all of the assigned training but all of the personnel listed on my application have not. Can the application still be approved by the IBC?

You may receive conditional approval from the IBC pending the completion of training. Your application will not be approved until all researchers have completed all assigned training.

I have been assigned training. Do I have to provide funding for it?

No. All training assigned by the Office of Research and Innovation is free to researchers. Instructions to access the training are provided at the time of assignment by the Office of Research and Innovation.

What biosafety levels are permitted at 黑料社区?

BSL-1, BSL-2, and BSL-2+. 黑料社区 prohibits agents that require BSL-3 and BSL-4 containment.

How often do I need to renew my application?

The expiration date of each protocol is three years after the date of initial approval.

How often will my lab space(s) be inspected?

The lab space(s) listed in your application will be inspected initially during the IBC review process. Once your protocol is approved, your lab space(s) will be inspected at least once annually. All lab inspections will be scheduled with the PI.

Do I need a Material Transfer Agreement (MTA) for biological materials I receive from other academic institutions?

Yes. Please contact the Office of Research and Innovation for additional information.

Additional Resources

Contact Us

For any questions or to report non-compliance with protocols, please email biosafety@MiamiOH.edu

Joseph Carlin
Institutional Biosafety Committee Chair

Joseph Carlin

Pearson Hall, 48
Oxford, OH 45056