How to Register Protocols Involving Biohazardous Material
Work involving biohazardous material must be registered with the IBC committee.
1. Complete the IBC Registration Form and additional sections relevant to the work.
2. Email the completed sections to labsafe@gmu.edu
3. Registrations must be submitted to labsafe@gmu.edu three (3) weeks prior to the meeting to provide sufficient time for review.
Modifications to Existing Protocols
Updates and changes in personnel, material, or project scope to an existing registration must be reviewed and approved by the IBC. Minor administrative changes such as the addition or removal of personnel can be approved outside of the full committee review. Significant modifications will require full committee review. To submit a modification to an existing protocol, submit Section G to labsafe@gmu.edu.
IBC Review
The IBC meets on the 1st Friday of the month to review submitted registrations. A review has four (4) possible outcomes:
• Full Approval: The registration is fully approved, no additional actions are required.
• Prerequisite Approval: The registration is approved with required conditions/actions applied. PIs are given 30 days to respond to IBC questions/concerns. If the PI does not address these questions/concerns within 60 days, the Chair will contact the PI. The Chair will bring delinquent registrations to the IBC, as necessary.
• Deferred: The Biosafety Officer (BSO) will work with the PI to answer questions or concerns of the committee with the goal of reviewing the project at the next month’s meeting.
• Tabled: No additional actions are required.
Administrative Review
The BSO and the Chair conduct the administrative review which are projects involving BSL-1 work with Risk Group 1, agents that are exempt from NIH Guidelines, and any updates and renewals of these projects, updates to other approved registrations that do not change the scope or scale of the project (i.e., addition or removal of personnel)
• The BSO reviews the registration and contacts the PI to resolve any questions or concerns.
• The BSO forwards the registration to the Chair for review and discussion.
• When the BSO and Chair are satisfied with the registrations, the registration is approved.
Three Year Renewal
All approved IBC registrations must be renewed every three (3) years.
How to Complete the IBC Registration Form
Complete Section A of the Form:
• Part 1 – Contact Information: Provide current contact information for the Principal Investigator (PI) or course coordinator responsible for the protocol.
• Part 2 – Co-PI/ Collaborator Information: Provide contact information for any collaborators or Co-PIs involved in the project; this excludes any laboratory personnel or students associated with the laboratory.
• Part 3 – Protocol Information: Provide a concise title for the protocol. Indicate whether the protocol is new, a renewal, or a modification. Indicate whether the protocol is research, instructional, or other. List building and laboratory locations where work will be conducted or material will be stored. Indicate whether any other committees on or off campus are reviewing this work.
• Part 4 – Protocol Description:
o In Question 1, provide a description of the protocol that will assist the IBC inunderstand the objective and type of work that will be performed. The purpose and summary should be understandable to those members of the committee without a science background.
o In Question 2, provide additional background about how the work will be conducted. This too should be clear and easily understood by nonscientific IBC members. Be specific by explaining in detail experimental procedures to be conducted. Additional items that will aid committee members during the review process: e.g., specific vector and plasmid information, cell lines, ATCC product description, etc., can be attached via a separate file.
• Part 5 – Materials: Indicate Yes, No, or Unsure for each of the questions listed in this section; answers will explain which additional sections must be filled out for your registration.
• Part 6 – Procedural Hazards and Controls: Indicate the types of manipulations that will be performed. For each type of manipulation indicated, provide a brief description of controls in place to contain the risk.
• Part 7 – Personal Protective Equipment: Check all personal protective equipment (PPE) that will be used. If other forms of PPE will be used, describe these in the “Other” category.
• Part 8 – Disinfection/ Decontamination/ Waste Disposal: Include the type and concentration of disinfectant that will be used to decontaminate surfaces, waste products, and spills of material. List the methods employed to render waste ready for disposal.
• Part 9 – Shipping and Transfer: Answer yes, no, or unsure to questions regarding the shipment and transfer of material.
• Part 10 – Laboratory personnel: Provide a list of personnel who will be working on the project and a description of their current laboratory and protocol-specific experience. It is not necessary to attach a resume or Curriculum Vitae, however, provide sufficient information to allow the IBC to understand the level of ability of those conducting the work.
• Part 11 – Laboratory Information: Indicate recordkeeping practices and laboratory security.
• Part 12 – PI Acknowledgement of Responsibility: Read the Acknowledgement of Responsibility and check the box to indicate that you have read and accept the responsibilities outlined in this section.
Complete Section B for Registrations Involving Infectious Agents
• Part 1 – Agents Involved in the Protocol: Indicate all infectious agents used in the protocol. Include the strain and source of infectious material. If the source is not commercial, such as ATCC or BEI, provide additional information about the source. If the source is commercial, indicate “N/A” in the “Source Information” column.
• Part 2 – Agent Information: Provide additional information about infectious agents, what strains are being used in the protocol, what the environmental stability of the pathogen or stability outside the host is, what the host range is, and what the routes of transmission are.
• Part 3 – Exposure Information: Include what disease the pathogen may cause, if the disease is communicable, and the infectious dose, if known. Describe the symptoms and the incubation period. Additionally, describe what host factors may contribute to the onset of symptoms.
• Part 4 – Manipulations: Indicate the maximum volumes and concentrations that will be used in the protocol for each pathogen strain. Indicate yes, no, or unsure to questions regarding how the pathogen will be manipulated, whether it will be attenuated, and if any manipulations will increase the risk of working with these agents. Indicate if you intend to inactivate any pathogens;.Describe the method of inactivation and provide documentation for its effectiveness.
• Part 5 – Identifying Dual Use Research of Concern: All research with Dual Use Research of Concern (DURC) potential at George Mason University will be reviewed by the IBC. Complete this part of the form in order to identify if the registration falls under DURC criteria. Indicate yes, no, or unsure to questions regarding the experiments and the agents used in the protocol.
• Part 6 –Dual Use Research of Concern – Benefits and Risks of Research: Identify what type of knowledge, information, technology, or products are expected to be generated through the research. Describe if this research or the research methods used are new or have performed before, where they have been done, how accessible are the results and if they have previously been shared.
Describe the potential benefits of the research being done, any problems the results of the research could provide solutions to, and how soon these benefits could become available.
Answer Yes, No, or Unsure to questions regarding risks this research may pose: Describe the accessibility of the knowledge, information, or technologies and products from research that may be misused; how feasible it is for one to misuse this knowledge, information, or technologies and products from research; and the potential consequences of misuse, should it occur.
Analyze, when considering the benefits and risks in relation to one another, whether the potential benefits of research are such that proceeding with research is a responsible decision. Consider that implementing a risk mitigation plan may effectively reduce the likelihood of misuse and the risks associated with research. This is the case for the vast majority of cases of DURC.
• Part 7 – Dual Use Research of Concern – Risk Mitigation Plan: Describe mitigation strategies that could reduce or eliminate the risk of: the accessibility of knowledge, information, technologies, and products from research that could be misused; how feasible it is for one to misuse this knowledge, information, or technologies and products from research; the potential consequences of misuse, should it occur; and any other potential risks posed by conducting research. This will aid in developing a risk mitigation plan.
Complete Section C for Protocols Involving Human or Nonhuman Primate Material
• Part 1 – Cell Lines: Indicate proposed cell lines to be used and the tissue type, origin and source of the cell line. Also, indicate whether any cell lines are fixed and the method of fixation, as well as if the cell lines will be altered in any other way.
• Part 2 – Tissue, Bodily Fluids, and Other Samples: Indicate any other potentially-infectious materials (OPIM). Indicate fixation methods, if any. Indicate origin of the material (what organism it is obtained from).
Complete Section D for Protocols Involving Recombinant or Synthetic Nucleic Acids
• Part 1 – Recombinant DNA and Vectors: Indicate yes, no, or unsure to the questions about the usage of recombinant deoxyribonucleic acid (DNA), ribonucleic acid (RNA), or DNA-based vectors. List and describe any recombinant DNA used. Describe the function of this recombinant DNA, what organism it is from; the commercial source, and any addition information that will help the IBC assess the protocol. Are any of the recombinant DNA listed oncogenes; if so, describe the types. List the plasmids and viral vectors that will be used. For vectors that may pose risk to humans or animals, include a description which assists the IBC in performing a risk assessment. If the recombinant DNA and expressed proteins will result in infectious organisms, complete Section B. Complete Section B, if resistant traits will be introduced to a pathogen. Indicate yes, no or unsure to the question about transgenic animal use; if so, complete Section F.
• Part 2 – Viral work: Indicate yes, no or unsure to the questions about viral work. Describe in detail the viral vectors, any helper viruses, and note whether they are replication competent.
• Part 3 – General Information: Indicate yes, no or unsure to the questions regarding some of the general information about your protocol. This part of the form will help categorize your registration under the NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules. https://osp.od.nih.gov/wp-content/uploads/2013/06/NIH_Guidelines.pdf
Complete Section E for Protocols Involving Biologically-Derived Toxins
• Part 1 – Toxins Involved in the Protocol: Describe toxins that will be used and indicate if they are currently in your possession within the laboratory. Indicate if the toxin is on the Select Agent list; the information can be found at https://www.selectagents.gov/selectagentsandtoxinslist.html.
• Part 2 – Toxin Information: Indicate permissible amounts of toxin used (https://www.selectagents.gov/SelectAgentsandToxinsExclusions.html). Include maximum quantity and maximum volume and concentration.
• Part 3 – Health information: Describe how the toxin(s) could target organs and indicate the LD50. Provide information on availability of an antidote, and whether it is available onsite. Describe the toxin’s specific exposure response procedure.
Complete Section F for Protocols Involving Animals
NOTE: This section is not meant to mimic IACUC protocol submissions. Rather, in this section the IBC is requesting a description of animal work involving infectious or potentially-infectious material, recombinant or synthetic nucleic acids, transgenic animals, biologically-derived toxins, and/or field-caught animals. Describe the risk to the laboratory personnel and how the risk will be mitigated.
If you are filling out this section, the IACUC protocol must be submitted as well.
• Part 1 – General Information: Indicate the type of animals used; include strain and genotype, as well as the source from where they were obtained. Also indicate the CAS#.
• Part 2 – Zoonotic Diseases: Identify and list any zoonotic diseases that may be associated with the animals used. Indicate yes or no to animals being screened prior to acquiring or during the study. Describe the controls in place to prevent occupational exposure.
• Part 3 – Experimental Manipulations: Indicate yes or no to whether animals will be infected with pathogens Indicate the method of administration of the infectious agent, maximum concentration and dose of the pathogens, and how the animals will be restrained during the procedure.
Indicate yes or no regarding whether potentially-infectious materials will be administered to the animals. Include the material, method of administration, and a brief description of it. Discuss the method of restraint for the animals.
Indicate yes or no regarding whether the toxins will be administered to the animals. Describe the toxin, how it will be administered to the animal, and the maximum concentration and dose that will be used in the protocol. Specify what the toxin will be resuspended in or the vehicle to deliver the toxin. Include the method of animal restraint.
Indicate yes or no regarding whether viral vectors will be administered to the animals. Specify the method of delivery, maximum concentration, and dose. Indicate yes, no or unsure regarding whether animals contain genetic information that could result in the production of a replication competent infectious virus.
Indicate yes or no regarding whether recombinant DNA or synthetic nucleic acids will be administered to the animals. Describe the material used; specify the method of administration and the maximum dose. Describe how the material will be resuspended or a vehicle to deliver the material to the animal.
Indicate yes or no regarding whether any drugs, chemicals, or any other treatment will be administered to the animals. Describe the material used, the method of administration, and specify the maximum dose and concentration.
• Part 4 – Experimental Procedures: Indicate yes or no regarding whether surgery will be performed on the animals. If yes, describe the type of surgery and if a biosafety cabinet or downdraft table will be used.
Indicate yes or no regarding whether samples will be collected from live animals. Describe in detail the type of samples, the collection method, and the instruments used to collect the samples. Include a detailed description of how samples will be processed post-collection; and how the animals are restrained during sample collection.
Indicate yes or no regarding whether necropsy and postmortem tissue collection will be performed. Describe in detail the samples collected and the collection method, and what instruments are used. Include how the collected samples will be processed (homogenized, fixed, frozen, etc.).
List and describe all procedures performed on the animal other than previously described (e.g., imaging). Indicate the procedure; include the method of restraint, and provide a detailed description of procedure. Attach appropriate approved standard operating procedures (SOP) to support and facilitate the IBC review.
- Part 5 – Shedding: Indicate yes or no regarding whether animals are able to shed material they were exposed to (infectious or other). Summarize if the material will shed and how long it will be viable outside its host. Include all environmental factors affecting the persistence of viability of shed material in the immediate environment, such as humidity.