Office of Sponsored Research and Programs
Frequently Asked Questions - Biosafety
Questions relating to the Institutional Biosafety Commitee:
- What type of research requires the Institutional Biosafety Committee (IBC) approval?
- Where do I find biosafety protocol forms?
- Who can be a Principal Investigator (PI) on an IBC protocol?
- Where can I find help with completing the protocol forms?
- What is Biosafety?
- What is a Biosafety level?
- Where is the IBC Office located?
- What research must be registered with the IBC?
- What are biohazardous materials?
- How do I determine what Risk group and/or Biosafety level my research is?
- What is the length of approval for biosafety protocols?
- What types of non-recombinant infectious agents and toxins must be reviewed by the IBC?
- What is Recombinant DNA?
- What do I do if I forgot to notify the IBC before modifying my recombinant DNA experiments?
- How does the IBC review protocols?
- What is reviewed by the committee?
- Does lab equipment need to be decontaminated prior to disposal, repair or servicing?
- What do I do if I change my research after my protocol is approved?
- Are there biohazardous training materials available to me?
- I have some lab equipment. How do I know if it must be collected as used electronics under the Universal waste law?
- What are the record-keeping requirements?
- I share a lab with an investigator who is registered with the IBC. Doesn’t that registration apply to my work in the shared lab?
- I have an active IBC approval for 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?
- Help! How do I modify my current protocol?
- How do I determine the appropriate risk group and/or Biosafety Level for my protocol application?
- Where can I find more information concerning Biosafety?
- Who are the members of Missouri State's IBC?
- This FAQ has not been completely helpful. Can I get additional help from the Office of Sponsored Research and Programs?
Common Acronyms and Abbreviations:
OSRP: Office of Sponsored Research and Programs
IBC: Institutional Biosafety Committee
IRB: Institutional Review Board
IACUC: Institutional Animal Care and Use Committee
OSHA: Occupational Safety & Health Administration (http://www.osha.gov/)
PI: Principal Investigator
DNA: Deoxyribonucleic acid
rDNA: Recombinant Deoxyribonucleic acid
NIH: National Institute of Health
DHHS: Department of Health and Human Services
MoDHSS: Missouri Department of Health and Senior Services
CDC: Centers for Disease Control and Prevention
Answers to above questions:
(Note: Links within the answers open a new window)
Research at the University of Chicago involving the use of biohazardous materials, including recombinant DNA, agents infectious to humans, animals or plants, and other genetically altered organisms and agents.
A principal investigator is a member of the academic staff or faculty who bears responsibility for the intellectual leadership of a project. The principal investigator accepts overall responsibility for directing the research; the financial oversight of the award's funding, as well as compliance with relevant University policies and sponsor terms and conditions of award. For more information see the University's Environmental Management Policy guideline.
You can call the Director of Environment Management at 417-836-8334 or the Office of Sponsored Research and Programs at 417-836-5972 (email: sponsoredresearch@missouristate.edu).
Biosafety is a term used to describe efforts to reduce and eliminate the potential risks resulting from biotechnology and its products. For the purposes of the Biosafety Protocol, this is based on the precautionary approach, whereby the lack of full scientific certainty should not be used as an excuse to postpone action when there is a threat of serious or irreversible damage. While developed countries that are at the center of the global biotechnology industry have established domestic biosafety regimes, many developing countries are only now starting to establish their own national systems.
Biosafety levels are combinations of laboratory practices and techniques, safety equipment, and laboratory facilities that create a laboratory condition under which particular microorganisms can be safely handled. Generally, work should be conducted at the biosafety level that is suggested by the CDC, NIH and the University Biosafety Committee.
The Office of Sponsored Research and Programs supports the work of the Institutional Biosfaety Committee and is located at Carrington Hall 407, the main administrative building of the university. The telephone number is 417-836-5972, fax number is 417-836-8818 and e-mail is SponsoredResearch@missouristate.edu.
Missouri State University’s policy regarding recombinant DNA activities requires that all Recombinant DNA research must be registered with the Institutional Biosafety (rDNA) Committee.
Biohazardous materials include recombinant DNA, agents infectious to humans, animals or plants (e.g. parasites, viruses, bacteria, fungi), and other genetically altered organisms and agents. Using these materials in laboratory or clinical requires the prior review and approval of the Institutional Biosafety Committee, and may require the review of the Institutional Animal Care and Use Committee (IACUC) or the Institutional Review Board (IRB).
See above for Biosafety level.
Risk Group: A critical step in planning the use of a biohazardous material is to make an initial determination regarding the appropriate level of risk associated with the agent and its proposed uses. It is the investigator's responsibility to make an initial risk assessment based on the Risk Group (RG) of an agent. Agents are classified into four Risk Groups (RGs) according to their relative pathogenicity for healthy adult humans by the following criteria:
- Risk Group 1 (RG1) agents are not associated with disease in healthy adult humans.
- Risk Group 2 (RG2) agents are associated with human disease which is rarely serious and for which preventive or therapeutic interventions are often available.
- Risk Group 3 (RG3) agents are associated with serious or lethal human disease for which preventive or therapeutic interventions may be available.
- Risk Group 4 (RG4) agents are likely to cause serious or lethal human disease for which preventive or therapeutic interventions are not usually available
IBC Protocols are approved for five years, but must be updated and reviewed annually through the annual surveys. Changes in the protocol must be made through submitting an amendment.
Infectious Agents are generally defined as risk group 2 agents and above (agents that can cause disease in healthy adult humans)
Use of Biologically Derived Toxins need only be reviewed by the IBC if the toxin is a select agent, or if the toxin is lethal for vertebrates at an LD of less than 100 nanograms per kilogram body weight.
The NIH Guidelines for Research Involving Recombinant DNA Molecules defines rDNA as either:
That means research projects involving the use of all recombinant plasmids/vectors/viruses, even though many are exempt, should be submitted to the IBC for review (exempt determination should be made by IBC).
- molecules that are constructed outside living cells by joining natural or synthetic DNA segments to DNA molecules that can replicate in a living cell, or
- molecules that result from the replication of those described in (i) above.
First determine whether the modification is “pre-approved” or not (see http://www.srp.missouristate.edu/23238.htm). For pre-approved changes, you must notify the IBC on the next annual review. If you forget to do this, please notify the IBC as soon as possible by submitting a new annual review/modification form. This will be noted by the IBC as a minor protocol deviation. If the modification is not pre-approved, you must notify the IBC immediately by submitting an annual renewal/modification form. When you submit the modification form and assure that you have included all changes to the registered project, this will reset your annual approval date.
The IBC review process involves the following steps:
The members will recommend one of the following possible actions:
- All protocols are received through the IBC where they are initially screened to ensure that applications are complete.
- Complete protocols are entered into the rDNA Database and a receipt email is sent to the investigator.
- Applications are distributed electronically to committee members.
a. Full approval
b. Approval pending IBC-rDNA-directed changes
c. Reconsideration
d. Discussion
- Recommendations and/or concerns from the committee are relayed to the investigator through the IBC.
- The IBC-rDNA will review all applications at a convened meeting of a quorum (>50% member attendance) and take one of the following possible actions:
a. Full approval
b. Approval pending IBC-rDNA-directed changes
c. Reconsideration
d. Disapproval
- The investigator is notified by the IBC of the outcome of the committee’s review.
The IBC review process considers the following points:
- Is the Biosafety Level appropriate to the research proposal?
- vectors and host systems used in the proposal
- safety
- environmental considerations
- Evaluation of facilities, procedures, practices, training of personnel
Yes. Equipment must be decontaminated with a tuberculocidal disinfectant such as 10% bleach solution (allow at least 15 minutes contact time). A "Biological Safety Notice" must be completed and affixed to the equipment prior to being discarded or serviced.
NOTE: Bleach is very corrosive to most metal surfaces, including stainless steel. Equipment should be wiped down with water or 70% ethanol to prevent pitting of the surface (after decontaminating with bleach).
An amendment must be submitted for review by the IBC prior to any change in research being conducted. This includes change in staff.
There are training videos on reserve at Sponsored Research and Programs (Carrington 407) or see the US Department of Labor website.
- I have some lab equipment. How do I know if it must be collected as used electronics under the Universal waste law?
If the equipment contains circuit boards or computer components and it was used to store or transfer data then it must be collected as universal waste. Or, if the equipment was used for entertainment purposes such as a radio, cell phone, palm pilot, etc. it must be collected.
Missouri State must maintain:
- An up to date list of individuals who are approved to handle and use select agents and toxins
- An accurate, current inventory of each select agent and toxin (name, characteristics, quantity, disposition, etc.)
- Inspection records
- Safety, security, and emergency response plans
- Training records
- Transfer documents and permits
- I share a lab with an investigator who is registered with the IBC. Doesn’t that registration apply to my work in the shared lab?
No – Each principal investigator is responsible for full compliance with the NIH Guidelines in the conduct of recombinant DNA research. Investigators may not “piggy-back” on the existing IBC registrations of other investigators.
- I have an active IBC approval for 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 an increase in the biosafety containment level. A modification may be submitted for IBC review when changes would not be considered to be substantial.
The IBC-rDNA reserves the right to request a full renewal or a new application for any submitted modifications that are deemed to be substantial in nature.
On the IBC-rDNA application there are two options for describing your modification.
- Type 1 modifications are clerical and do not involve the recombinant procedures or materials.
- Type 2 modifications involve changes to the originally approved protocol that do not substantially impact the overall biosafety.
Investigators are required to report new information to the IBC and to remain in communication with the IBC throughout the conduct of the project.
Risk groups are a classification system for etiological agents; the lower the risk – the lower the risk group class. Biosafety level refers to the physical and procedural barriers used to contain an etiological agent. Risk groups and biosafety containment levels are not proportional determinations.
The IBC-rDNA application provides additional information regarding risk groups and biosafety levels. If you are unsure of the proper determinations after reviewing the information in the application, please contact Office of Envirnomental Management at 417-836-8334 or Sponsored Research at 417-836-5972 or by email at sponsoredresearch@missouristate.edu.
Center for Disease Control and Prevention: http://www.cdc.gov/od/sap/index.htm.
See Information on Missouri State University IBC.
- This FAQ has not been completely helpful. Can I get additional help from the Office of Sponsored Research and Programs?
The Office of Sponsored Research and Programs will provide assistance when help is needed. You can contact the office at (417) 836-5972 or e-mail at sponsoredresearch@missouristate.edu.