What is the Institutional Biological Safety Committee (IBC) and why do I need to register a protocol with them?

The IBC is a committee of faculty, university officials, and outside community members appointed by the President’s office at JMU to work with University to fulfill required federal, state and university mandates regarding Biosafety.

The federal regulations (see NIH Guidelines for Research Involving Recombinant DNA Molecules), require James Madison University to establish an IBC committee to approve and maintain documentation on all protocols involving recombinant DNA. 

Over time, many states and institutions have also chosen to assign their IBC's the responsibility of reviewing a variety of experimentation that involves hazardous agents.  To this end in order to keep the University prepared to deal with a natural disaster or other unforeseen circumstance and to better ensure the safety of the faculty, staff and students, JMU has asked our committee to help monitor any work that is performed using organisms, government specified toxins or select agents that may adversely affect plant, human or animal health regardless of whether it involves recombinant research.

What are some of the common types of research that must have a registration protocol with the IBC?

Research involving:

  • the production or use of recombinant DNA molecule including viral vectors and plasmids;
  • the production of synthetic nucleic acid molecules including those that are chemically or otherwise modified but can base pair with naturally occurring nucleic acid molecules
  • cell and organ cultures of human and mammalian origin, including well established cell lines, human embryonic stem cells, and pluripotent cells and their derivatives
  • De novo generation of transgenic plants or animals (using recombinant DNA technology to add foreign DNA or subtract a portion of the host's genome);
  • unfixed human tissues;
  • potential human or environmental toxins or select agents.
  • Plant pathogens or pests (arthropods, nematodes, weeds) that are regulated by state or federal policy or law. Consult the following web sites for up to date lists of regulated organisms.  See: USDA/APHIS - http://www.aphis.usda.gov/ppq/regpestlist
  • Pathogens that adversely affect human, animal or plant heal

I receive no funding from NIH. Do I still have to register my recombinant DNA protocol?

Yes.   Since the University receives funding from NIH grants, ALL recombinant DNA research, teaching and outreach activities involving recombinant or synthetic nucleic acid molecules or infectious agents conducted at or sponsored by James Madison University must be reviewed by the IBC.

I know my work is exempt from NIH registration. Why are you bothering me?

The IBC is tasked with maintaining an inventory of all recombinant DNA research at JMU. Registration with the committee ensures that someone else who is knowledgeable about your area of science and biosafety has examined your protocol for potential safety concerns and agrees with you that your protocol is exempt.  Also when the IBC is informed of new safety issues or changes of the NIH Guidelines that might affect you, we can more easily send these to you because of your protocol registration.

I am not registered and I think I should be what do I do to register my protocol?

The JMU IBC has two levels of protocol registration, exempt and non-exempt registration.  

Exempt protocol registration is required for any recombinant DNA experiment that is not expected to have any potential for human disease or potential environmental contamination.  A lot of what we do at JMU involves expressing non-toxic genes in K12 E. coli, yeast, drosophila, mouse…..  As long as the genes being expressed are determined to have no human or environmental risks these experiments simply need to be registered as exempt protocols.  The IBC is responsible for maintaining a record of these experiments.

Non-exempt registration is required for all experiments that have some risk for causing human disease or the possibility of potential environmental contamination.  Non-exempt registrants are required to fill out an on-line non-exempt protocol. 

If you are unsure whether your protocol is exempt start by filling out the exempt form and the committee can help you make a decision about your protocol’s status. 

How often do protocols need to be updated with the IBC?

There is no expiration date put on an exempt protocol as long as federal, state and university guidelines do not change but the committee will ask for occasional updates to ensure that have been no substantial changes have happened in your research.   Failure to submit a requested update may terminate an exempt protocol.

Non-exempt protocols must be resubmitted every three years. During those three years the committee will ask for yearly updates to ensure that no substantial changes have happened in your research. 

When leaving the University or ending a project, protocols should be terminated using the termination of protocol form. 

Will I be inspected?

Yes, because JMU accepts NIH grant funding and state funding, our institutional labs can and likely will be inspected by various accrediting, granting, and government agencies.   Additionally if you have a non-exempt protocol, the IBC is required to perform annual inspections of your lab to help ensure that researchers are aware of, and are meeting required BSL1 or BSL2 safety standards.   The P.I. of the lab is encouraged to be present for these inspections.  Inspection forms explaining more about the inspection process can be found on the IBC website.  Following the inspection, committee members in attendance will put together a list of any safety concerns to be sent to the P.I. to be addressed as soon as possible. 

How do I determine if I am working with a select agent or toxin covered by IBC?

Select agents are those agents and toxins that have been determined by the federal government to have the potential to pose a severe threat to public health and safety and are under special restrictions.

For a list of all these agents, please go to: http://www.cdc.gov/od/sap/docs/salist.pdf

How do I know what I need for Biosafety Level 2 research?

More information about what is needed to meet BSL2 requirements can be found at the Centers for Disease Control, the Biosafety in Microbiological and Biomedical Laboratories (BMBL), at http://www.cdc.gov/od/ohs/biosfty/bmbl5/bmbl5toc.htm.

How do you determine Risk Group and Biosafety Level Containment?

Risk groups are a classification system for disease-causing agents; the lower the risk – the lower the risk group class. The Biosafety Level refers to the physical and procedural barriers used to contain an disease-causing agent. Risk groups and biosafety containment levels are not proportional determinations.

The tables below give a brief summary of Risk Groups (RG) and Biosafety Levels (BSL). The IBC uses the following resources for guidance for determining the risk group and biosafety level:


Risk Group (NIH Guidelines)

Containment Level

Examples

RG1: Agents are NOT associated with disease in healthy adult humans.

BSL1:

  • Work is done on open bench top/special containment is not required

  • Standard microbiological practices

  • Biohazard signs to be posted

Escherichia coli K12 and its derivatives (DH5a, JM109)

pBluescript

PYAC4

lambda GT-11 vector

RG2: Agents are associated with human disease which is rarely serious (moderate risk).

BSL2:

All BSL-1 containment and practices PLUS:

  • Lab access is restricted when work is in progress

  • Personnel have specific training in handling of agents

  • Biological safety cabinets or other containment devices are used for potential aerosol generation procedures

  • Biohazard signs must be posted to include agent/contact information

  • Specific PPE requirements

Adenovirus - all types

All unfixed Human samples

Established Human cell lines (i.e., HEK 293)

Various potentially pathogenic bacteria

RG3: Agents are associated with serious or lethal human disease for which preventive or therapeutic interventions MAY be available (high risk).

BSL3:

  • The university currently does not approve any work at a level higher than BSL2.

NONE – no current usage of this risk group classification

RG4: Agents are likely to cause serious or lethal human disease for which preventive or therapeutic interventions are not usually available.

BSL4:

  • The university currently does not approve any work at a level higher than BSL2.

NONE – no current usage of this risk group classification

I have an active IBC approval for DNA recombinant work in my lab. Recently I submitted a new research proposal. Do I have to submit a new registration with the IBC or can I just modify the current protocol?

You will need to submit a new application with the IBC if the research project involves a substantial change to the currently approved protocol, such as a change in the biosafety containment level. A modification may be submitted for IBC review when changes are not considered to be substantial.

The IBC reserves the right to request a full renewal or a new application for any submitted modifications that are deemed to be substantial in nature.

How often does the IBC meet?

The frequency of IBC meetings is commensurate with the volume of protocols needing review, the nature and risks of the research, and the need for continuing oversight. The committee meets as needed (typically every month) and follows the guidelines provided by the NIH Office of Biotechnology Activities (OBA) involving research with recombinant DNA.

You are welcomed and encouraged to come to our meetings when your protocols are being reviewed to answer any questions from the committee that come up on the review of your protocol.

I have additional questions. Who do I contact?

Please contact the Office of Research Integrity at (540) 568-7025 or researchintegrity@jmu.edu

 

*Thank you to University of California Irvine’s IBC for inspiring us to start this questionnaire.

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