Office of Responsible Research Practices
The Ohio State University

Frequently Asked Questions

Biosafety Research

Submissions to the IBC

If I need to ship materials, do I need to register my shipment or obtain permits?

Your shipment may require permits from the Center for Disease Control (CDC), Department of Commerce (DOC) and/or United States Department of Agriculture (USDA). In addition, you will need to obtain certification.

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What are Biosafety Levels (BSL)?

A fundamental objective of any biosafety program is the “containment” of potentially harmful biological agents. The term “containment” is used in describing safe methods, facilities and equipment for managing infectious materials in the laboratory environment where they are being handled or maintained. The purpose of containment is to reduce or eliminate exposure of laboratory workers, other persons, and the outside environment to potentially hazardous agents. The use of vaccines may provide an increased level of personal protection. The risk assessment of the work to be done with a specific agent will determine the appropriate combination of these elements. Four “Biosafety Levels ((BSL) have been developed. No BSL4 work is conducted at Ohio State.

  • BSL-1: Suitable for work involving well characterized agents not known to cause disease in healthy adult humans and of minimal potential hazard to laboratory personnel and the environment.
  • BSL-2: Suitable for work involving agents of moderate potential hazard to personnel and the environment.
  • BSL-3: Suitable for work with infectious agents which may cause serious or potentially lethal disease as a result of exposure by the inhalation route.

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What are Risk Group (RG) levels?

In many countries, including the United States, infectious agents are categorized in risk groups based on their relative risk. Depending on the country and/or organization, this classification system might take the following factors into consideration:

  • Pathogenicity of the organism
  • Mode of transmission and host range
  • Availability of effective preventive measures (e.g., vaccines)
  • Availability of effective treatment (e.g., antibiotics)
  • Other factors

Risk group classifications are primarily used in the research environment as part of a comprehensive biosafety risk assessment. There are four (4) risk group designations:

  • (1) Risk Group 1 (RG1) agents are not associated with disease in healthy adult humans.
  • (2) Risk Group 2 (RG2) agents are associated with human disease which is rarely serious and for which preventive or therapeutic interventions are often available.
  • (3) Risk Group 3 (RG3) agents are associated with serious or lethal human disease for which preventive or therapeutic interventions may be available.
  • (4) Risk Group 4 (RG4) agents are likely to cause serious or lethal human disease for which preventive or therapeutic interventions are not usually available.

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Why do I need my laboratory inspected and how can I have my lab inspected?

The Ohio State University provides compliance assurances to the National Institutes of Health. One of these assurances is that laboratory inspections will be conducted periodically for all research involving recombinant DNA and/or biohazards.

Contact Tina Bogac, Institutional Biosafety Officer, or your Environmental Health & Safety Representative to set up an inspection at 614-292-1284.

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How do I obtain IBC approval for research conducted at multiple locations?

Research conducted at each location must undergo location-specific institutional (e.g., IBC) research risk reviews and grant approval. Grant approval is often dependent on IBC approval.

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How much time is required to have my submission reviewed and approved?

New applications, responses to deferrals, and any amendments calling for significant changes to approved research require convened committee review and will be discussed at the subsequent monthly meeting. Investigators will receive a response to these submissions within 10 business days of the meeting. All other submissions including exempt applications may be reviewed administratively; approval typically occurs within five business days.

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What are the deadlines for submissions?

Deadlines for new applications, responses to deferrals, and any amendments calling for significant changes to approved research are listed on our Meeting Dates page. All other submissions including exempt applications are administratively reviewed/approved on a rolling basis.

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Why was I contacted about my PA-005 request?

One or more of the boxes checked on the PA-005 application indicated that your research may require IBC review and approval before any funding could be transferred. You do not need to take action if the work described in your PA-005 application is already IBC approved.

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