Best practices for biological research at the MIT is guided by the Committee on Assessment of Biohazards and Embryonic Stem Cell Research Oversight (CAB/ESCRO), the Biosafety Program, and the National Institute of Health (NIH).
At MIT, all biological research falling under CAB/ESCRO purview must be registered. Open the accordion below to see if your research requires registration.
CAB/ESCRO was formed in January of 1975 to ensure the safe and responsible conduct of biological research at MIT. It functions as the mechanism for local oversight of biological research and meets the requirements of the following funding and regulatory agencies.
Learn more about CAB/ESCRO Guidelines and Policies
Research falling into any of the following categories must be registered with the CAB/ESCRO:
- Research involving recombinant DNA (rDNA) or synthetic nucleic acid technologies
- All uses of microorganisms including viral vectors
- Human and non-human primate materials, cells, and tissues
- Human embryonic stem (hES) cells and induced pluripotent stem (iPS) cells
- Select agents and toxins
- Toxins of biological origin
- Prions
- Nanoparticle-based delivery systems for nucleic acids, proteins, drugs, or biological sensors
- Use of any of the biological materials listed above in animals or humans
- All academic courses with laboratory components that utilize biological materials
The Biosafety Program (BSP) provides administrative support and biosafety expertise to the CAB/ESCRO. BSP is available to assist principal investigators and researchers with the registration of their biological research, performance of research risk assessments, compliance with CAB/ESCRO-required laboratory inspections, and completion of laboratory safety trainings. The Associate Director for BSP serves as the Institutional Biosafety Officer and contact person for the CAB/ESCRO.
Because research often requires registration with multiple committees on campus, BSP collaborates with the MIT Committee on Animal Care (CAC – MIT’s IACUC) and Committee on the Use of Humans as Experimental Subjects (COUHES – MIT’s IRB) to assure research projects receive the appropriate oversight. Keep in mind that a particular project may require registration and approval from more than one committee.
NIH Guidelines
The NIH Guidelines are a set of best practices adopted by the National Institutes of Health (NIH) in 1976. They define how to conduct research with recombinant DNA (rDNA) or synthetic nucleic acids (SNA) in a safe and responsible manner. The NIH Guidelines were developed to protect both the researchers working with this material and the environment from being contaminated by recombinant material or organisms.
Any organization receiving funding from the NIH is expected to follow the requirements listed in the NIH Guidelines. Since MIT receives funding as an Institution, all researchers at MIT are expected and required to abide by the NIH Guidelines while conducting biological research, even if their individual grant or lab does not receive funding from the NIH. Failure to abide by the NIH Guidelines can result in suspension or termination of funding.
Any institution that receives funding from the NIH or a Federal Source is expected to follow the NIH Guidelines when conducting research with rDNA/SNA. Primary Investigator’s (PI’s) that do not receive grant money from the NIH or another US Federal Government Source are not exempt from the Guidelines since MIT as in Institute receives funding from the NIH.
The NIH defines rDNA/synthetic nucleic acids (SNA) as:
- Molecules that are constructed by joining nucleic acid molecules and that can replicate in a living cell (rDNA)
- Nucleic acid molecules that are chemically or by other means synthesized or amplified, including those that are chemically or otherwise modified but can base pair with naturally occurring nucleic acid molecules (SNA)
- Molecules that result from the replication of those described above
In general, this includes any researcher involving:
- Plasmids introduced into bacteria, living cells, animals, or plants
- Viral vectors introduced to bacteria, living cells, or animals
- Genetically modified microorganisms or cell lines (regardless of whether the material was modified by the researchers or already received in a modified form)
- Genetically modified plants or animals
- Nanotechnology used to deliver rDNA/SNA to living cells or animals
Registration requirements are based on what is involved in your research.
Biological research that falls under NIH Guidelines including:
- Plasmids put into a living organism or cell
- Viruses or viral vectors
- Genetically modified microorganisms or cell lines
- Transgenic animals/insects/plants; Or making transgenic animals/insects/plants
- Nanoparticles attached to rDNA/SNA put into cells or organisms
In addition to registration, all research involving rDNA/SNA going into humans requires COUHES and NIH RAC approval.
Biological research that is exempt from the NIH Guidelines but still requires registration due to MIT Institutional Policies and Cambridge Department of Public Health including:
- Wild type animals/insects, plants, microorganisms, or cell lines/tissue
- Oligonucleotides used outside living organisms
- Biological toxins (toxins from living organisms) or prions
In addition to registration, animal work will require a CAC protocol and human samples may require a COUHES Protocol.
If your research does not involve biological material, no registration is required. This includes:
- Environmental soil or water samples
- Proteins (except prions or biological toxins) purchased from a vendor and used outside of living organisms
- Chemicals or nanoparticles without a biological rDNA, or SNA component
The NIH Guidelines require that most work involving rDNA or SNA require registration with, review by, and approval from the Institutional Biosafety Committee (IBC) of the organization planning to conduct the research.
All biological research at MIT, regardless of whether or not it includes rDNA/SNA, must be registered, reviewed, and approved by our IBC (the CAB/ESCRO). This is done through the biological research registration (BRR), a document that describes the important regulatory and safety information for the biological research performed by your lab.
CAB/ESCRO review can result in:
- Fully approved
- Approved pending additional information or increased containment
- Not approved – Reasons for non-approval will be given; PI can resubmit the registration with changes made to address the CAB/ESCRO concerns
The CAB/ESCRO meets 8 times a year, so research review and approval could take up to a month or more. Always contact your DLC Biosafety Officer as soon as possible when you have a new project involving rDNA/SNA.
Learn more about the CAB/ESCRO Registration Process
Section III of the NIH Guidelines discusses the types of experiments that are covered and which category they fall under. The category has an impact on the review and approval process. In general, most rDNA/SNA research at MIT falls under Categories III-D, III-E, or III-F. Remember, even experiments that would be exempt by the NIH Guidelines (category III-F) still require registration with the CAB/ESCRO due to City of Cambridge Public Health requirements. Please consult the list below or the BRR Categories & Experiments Table for an overview.
Categories III-D to III-F (most common research)
Definition
- Modifying pathogens or work with DNA from pathogens
- DNA/RNA virus work
- Viral vectors
- Modifying animals or microorganisms going into animals
- Modifying weeds, exotic plants, or plant pathogens
- Certain influenza studies
- Large scale GMO research (>10L volume)
Examples
- Cloning GFP plasmid into P. aeruginosa
- CrispR-Cas9 modification of H. pylori
- Using modified P. falciparum purchased from ATCC
- Cloning S. typhimurum genes into E. coli BL21
- Packaging a 3rd generation lentiviral vector in HEK cells
- Using GFP to make fluorescent mice
- Injecting modified HeLa cells into mice
- Feeding mice L. reuturi containing GFP
- Growing 11L of E. coli K12 with YFP
- Generating a new novel strain of influenza by combining fragments from different seasonal strains
Approvals for amendments
- EHS Biosafety
- CAB/ESCRO
- Project initiation
Definition
- Eukaryotic virus work (<2/3 of viral genome) in tissue culture at BL1 containment
- Modifying domestic, non-weed plants or non-pathogenic organisms in plants
- Transgenic mouse work at BL1 containment
- Anything else not covered by Categories IIIA-D or III-F
Examples
- Modifying Arabidopsis
- Adding B. subtilis with GFP to the soil of spinach
- Creating transgenic mice requiring only BL1 containment
- Cloning GFP in E. coli BL21
Approvals for amendments
- EHS Biosafety
- Administrative approval*
- Project initiation
- CAB/ESCRO
- Project continuation
Definition
- Material that can’t replicate in living cells or can’t enter living cells
- Low risk material already found in nature
- Transposons found in nature
- Work with specific non-pathogenic organisms
Examples
- Agents containing less than 1/2 of any eukaryotic virus propagated & maintained in cells in tissue culture
- GMO of E. coli K-12, S. cerevisiae, S. uvarum, K. lactis, or B. subtilis strains
Approvals for amendments
- EHS Biosafety
- Administrative approval*
- Project initiation
- CAB/ESCRO
- Project continuation
*Administrative approval can give be given at discretion of Institutional Biosafety Officer.
Categories III-A to III-C (less common experiments that require additional approval)
Definition
- Making a pathogen resistant to an antibiotic used as a primary method to treat the infection
Examples
- Making Staphylococcus aureus resistant to doxycycline
- Making Clostridium difficile resistant to vancomycin
Approval process
- EHS Biosafety
- CAB/ESCRO
- NIH review
- Project initiation
Definition
- Adding toxin genes into an organism
- Specific experiments considered “Major Actions” by the NIH
Examples
- Cloning botulinum toxin into Escherichia coli BL21Cloning tetanus toxin into Staphylococcus aureus
- Please see the NIH guidelines for specific examples of Major Actions.
Approval process
- EHS Biosafety
- CAB/ESCRO
- NIH review
- Project initiation
Definition
- Gene therapy or clinical studies with recombinant material in human subjects
Examples
- Initiating a clinical research experiment to test the efficacy of a retroviral vector targeting a specific disease
- Introducing CRISPR-Cas9 to human patients to target a cancer gene
Approval process
- EHS Biosafety
- CAB/ESCRO and COUHES
- NIH review
- Project initiation
The following provides a summary of responsibilities for those involved in rDNA/SNA research. Full details on roles and responsibilities are available in Section IV of the NIH Guidelines.
The principal investigator (PI) is ultimately responsible for full compliance with the NIH Guidelines in the conduct of rDNA/SNA research.
- Ultimately responsible for full compliance with NIH Guidelines
- Be trained in good microbiological techniques
- Follow safety procedures for spills & exposures
- Set the initial biosafety level
- Select lab practices & techniques, register with IBC, and communicate throughout project
- Train & supervise staff in safe practices and accident/emergency response procedures
- Comply with shipping requirements
- Investigate & report any significant problems, violations, or accidents/illnesses to BSO, IBC, NIH, or DCM as appropriate
- Correct mistakes/conditions that could result in release of rDNA/SNA into environment
Researcher’s responsibilities are not specifically outlined in NIH Guidelines, though researchers should be familiar with responsibilities of their PI.
MIT Requires the following from researchers:
- Work with PI to ensure researcher material and experiments are approved on Biological Research Registration (BRR)
- Complete all required biosafety and lab-specific training
- Follow established microbiological practices of lab
- Become familiar with a process prior to working with biological material
- Report significant safety concerns to PI or EHS
- Abide by Institutional policies
- Serve as a member of the IBC
- Perform periodic safety inspections
- Report to the IBC and the Institution
- Develop emergency plans for spills, exposures, and investigating lab accidents or illnesses
- Provide advice on laboratory security
- Provide technical advice to PI and IBC on research safety procedures
Additional MIT-specific functions of the BSO:
- Serve as the link between the IBC and the PI
- Provide biosafety training
- Perform registration pre-review prior to submission to IBC
CAB/ESCRO (MIT IBC)
Review the rDNA/SNA research of institution for compliance with NIH Guidelines including:
- Periodically review rDNA/SNA research at institution for compliance
- Approve biosafety levels
- Assess facilities, procedures, practices, and training/expertise of personnel
- Notify PI of results of the IBC’s review and approval
- Adopt emergency plans for spills and exposures
- Report or ensure reporting of any significant problems, violations, or significant research-related accidents or illnesses
Additional MIT-Specific Responsibilities fulfilled by CAB/ESCRO:
- Oversee all biological research conducted at MIT
- Develop and implement institutional policies for biosafety
- Serve as the Institutional Review Entity (IRE) for dual use research of concern (DURC)
- Serve as the Embryonic Stem Cell Research Oversight (ESCRO)
- Establish and implement policies that ensure safe conduct of rDNA/SNA research and compliance with the NIH Guidelines
- Establish an Institutional Biosafety Committee (IBC)
- Appoint an institutional Biological Safety Officer
- Appoint specific expert members to the IBC as necessary
- Assist Principal Investigators (PI) to ensure compliance with NIH Guidelines
- Ensure appropriate training available for PI, reseachers, staff, and IBC
- Determine need for health surveillance programs
- Report or ensure reporting of any significant problems, violations, or research-related accidents and illnesses
The NIH Guidelines also include over 90 pages of additional information on biosafety and biological research.
NIH Guidelines Appendices
- Appendix A: contains a list of organisms that exchange DNA by known physiological methods; this section can be used to determine if an experiment would fall under category III-F-6 (and thus be exempt from the NIH Guidelines)
- Appendix B: Defines bacterial Risk Groups (RG1-4) and organisms which would fall under each Risk Group
- Appendix C discusses experiments and organisms that would be exempt under section III-F-8; these are generally low-risk and well-defined organisms.
- Appendix D discusses Major Actions taken by the NIH (Category III-A experiments) – In general, these are decisions on containment and permissions given to specific researchers to do specific experiments with high level pathogens, release of genetically modified material into the environment, or rDNA/SNA used in clinical research trials
- Appendix E discusses examples of host-vector systems that are exempt by the NIH Guidelines category III-F-8; many of these organisms also fall under Appendix C
- Appendix F discusses information regarding cloning of vertebrate toxins
- Appendix G discusses containment and training requirements – This appendix forms the basis of what is required at each biosafety level (BL1-4); Physical containment, personal protective equipment, waste handling, and work practices are discussed
- Appendix H discusses shipping requirements for rDNA/SNA material
- Appendix I discusses setting containment levels for host-vector systems
- Appendix J discusses the Biotechnology Research Subcommittee; this is a group that considers Federal granting and research concerns and topics
- Appendix K discusses requirements for large scale research with rDNA/SNA which would fall under Category III-D-6
- Appendix L discusses containment for plant work involving rDNA/SNA
- Appendix M discusses containment for animal work involving rDNA/SNA
Best practices for biological research at the MIT is guided by the Committee on Assessment of Biohazards and Embryonic Stem Cell Research Oversight (CAB/ESCRO), the Biosafety Program, and the National Institute of Health (NIH).
At MIT, all biological research falling under CAB/ESCRO purview must be registered. Open the accordion below to see if your research requires registration.
CAB/ESCRO was formed in January of 1975 to ensure the safe and responsible conduct of biological research at MIT. It functions as the mechanism for local oversight of biological research and meets the requirements of the following funding and regulatory agencies.
Learn more about CAB/ESCRO Guidelines and Policies
Research falling into any of the following categories must be registered with the CAB/ESCRO:
- Research involving recombinant DNA (rDNA) or synthetic nucleic acid technologies
- All uses of microorganisms including viral vectors
- Human and non-human primate materials, cells, and tissues
- Human embryonic stem (hES) cells and induced pluripotent stem (iPS) cells
- Select agents and toxins
- Toxins of biological origin
- Prions
- Nanoparticle-based delivery systems for nucleic acids, proteins, drugs, or biological sensors
- Use of any of the biological materials listed above in animals or humans
- All academic courses with laboratory components that utilize biological materials
The Biosafety Program (BSP) provides administrative support and biosafety expertise to the CAB/ESCRO. BSP is available to assist principal investigators and researchers with the registration of their biological research, performance of research risk assessments, compliance with CAB/ESCRO-required laboratory inspections, and completion of laboratory safety trainings. The Associate Director for BSP serves as the Institutional Biosafety Officer and contact person for the CAB/ESCRO.
Because research often requires registration with multiple committees on campus, BSP collaborates with the MIT Committee on Animal Care (CAC – MIT’s IACUC) and Committee on the Use of Humans as Experimental Subjects (COUHES – MIT’s IRB) to assure research projects receive the appropriate oversight. Keep in mind that a particular project may require registration and approval from more than one committee.
NIH Guidelines
The NIH Guidelines are a set of best practices adopted by the National Institutes of Health (NIH) in 1976. They define how to conduct research with recombinant DNA (rDNA) or synthetic nucleic acids (SNA) in a safe and responsible manner. The NIH Guidelines were developed to protect both the researchers working with this material and the environment from being contaminated by recombinant material or organisms.
Any organization receiving funding from the NIH is expected to follow the requirements listed in the NIH Guidelines. Since MIT receives funding as an Institution, all researchers at MIT are expected and required to abide by the NIH Guidelines while conducting biological research, even if their individual grant or lab does not receive funding from the NIH. Failure to abide by the NIH Guidelines can result in suspension or termination of funding.
Any institution that receives funding from the NIH or a Federal Source is expected to follow the NIH Guidelines when conducting research with rDNA/SNA. Primary Investigator’s (PI’s) that do not receive grant money from the NIH or another US Federal Government Source are not exempt from the Guidelines since MIT as in Institute receives funding from the NIH.
The NIH defines rDNA/synthetic nucleic acids (SNA) as:
- Molecules that are constructed by joining nucleic acid molecules and that can replicate in a living cell (rDNA)
- Nucleic acid molecules that are chemically or by other means synthesized or amplified, including those that are chemically or otherwise modified but can base pair with naturally occurring nucleic acid molecules (SNA)
- Molecules that result from the replication of those described above
In general, this includes any researcher involving:
- Plasmids introduced into bacteria, living cells, animals, or plants
- Viral vectors introduced to bacteria, living cells, or animals
- Genetically modified microorganisms or cell lines (regardless of whether the material was modified by the researchers or already received in a modified form)
- Genetically modified plants or animals
- Nanotechnology used to deliver rDNA/SNA to living cells or animals
Registration requirements are based on what is involved in your research.
Biological research that falls under NIH Guidelines including:
- Plasmids put into a living organism or cell
- Viruses or viral vectors
- Genetically modified microorganisms or cell lines
- Transgenic animals/insects/plants; Or making transgenic animals/insects/plants
- Nanoparticles attached to rDNA/SNA put into cells or organisms
In addition to registration, all research involving rDNA/SNA going into humans requires COUHES and NIH RAC approval.
Biological research that is exempt from the NIH Guidelines but still requires registration due to MIT Institutional Policies and Cambridge Department of Public Health including:
- Wild type animals/insects, plants, microorganisms, or cell lines/tissue
- Oligonucleotides used outside living organisms
- Biological toxins (toxins from living organisms) or prions
In addition to registration, animal work will require a CAC protocol and human samples may require a COUHES Protocol.
If your research does not involve biological material, no registration is required. This includes:
- Environmental soil or water samples
- Proteins (except prions or biological toxins) purchased from a vendor and used outside of living organisms
- Chemicals or nanoparticles without a biological rDNA, or SNA component
The NIH Guidelines require that most work involving rDNA or SNA require registration with, review by, and approval from the Institutional Biosafety Committee (IBC) of the organization planning to conduct the research.
All biological research at MIT, regardless of whether or not it includes rDNA/SNA, must be registered, reviewed, and approved by our IBC (the CAB/ESCRO). This is done through the biological research registration (BRR), a document that describes the important regulatory and safety information for the biological research performed by your lab.
CAB/ESCRO review can result in:
- Fully approved
- Approved pending additional information or increased containment
- Not approved – Reasons for non-approval will be given; PI can resubmit the registration with changes made to address the CAB/ESCRO concerns
The CAB/ESCRO meets 8 times a year, so research review and approval could take up to a month or more. Always contact your DLC Biosafety Officer as soon as possible when you have a new project involving rDNA/SNA.
Learn more about the CAB/ESCRO Registration Process
Section III of the NIH Guidelines discusses the types of experiments that are covered and which category they fall under. The category has an impact on the review and approval process. In general, most rDNA/SNA research at MIT falls under Categories III-D, III-E, or III-F. Remember, even experiments that would be exempt by the NIH Guidelines (category III-F) still require registration with the CAB/ESCRO due to City of Cambridge Public Health requirements. Please consult the list below or the BRR Categories & Experiments Table for an overview.
Categories III-D to III-F (most common research)
Definition
- Modifying pathogens or work with DNA from pathogens
- DNA/RNA virus work
- Viral vectors
- Modifying animals or microorganisms going into animals
- Modifying weeds, exotic plants, or plant pathogens
- Certain influenza studies
- Large scale GMO research (>10L volume)
Examples
- Cloning GFP plasmid into P. aeruginosa
- CrispR-Cas9 modification of H. pylori
- Using modified P. falciparum purchased from ATCC
- Cloning S. typhimurum genes into E. coli BL21
- Packaging a 3rd generation lentiviral vector in HEK cells
- Using GFP to make fluorescent mice
- Injecting modified HeLa cells into mice
- Feeding mice L. reuturi containing GFP
- Growing 11L of E. coli K12 with YFP
- Generating a new novel strain of influenza by combining fragments from different seasonal strains
Approvals for amendments
- EHS Biosafety
- CAB/ESCRO
- Project initiation
Definition
- Eukaryotic virus work (<2/3 of viral genome) in tissue culture at BL1 containment
- Modifying domestic, non-weed plants or non-pathogenic organisms in plants
- Transgenic mouse work at BL1 containment
- Anything else not covered by Categories IIIA-D or III-F
Examples
- Modifying Arabidopsis
- Adding B. subtilis with GFP to the soil of spinach
- Creating transgenic mice requiring only BL1 containment
- Cloning GFP in E. coli BL21
Approvals for amendments
- EHS Biosafety
- Administrative approval*
- Project initiation
- CAB/ESCRO
- Project continuation
Definition
- Material that can’t replicate in living cells or can’t enter living cells
- Low risk material already found in nature
- Transposons found in nature
- Work with specific non-pathogenic organisms
Examples
- Agents containing less than 1/2 of any eukaryotic virus propagated & maintained in cells in tissue culture
- GMO of E. coli K-12, S. cerevisiae, S. uvarum, K. lactis, or B. subtilis strains
Approvals for amendments
- EHS Biosafety
- Administrative approval*
- Project initiation
- CAB/ESCRO
- Project continuation
*Administrative approval can give be given at discretion of Institutional Biosafety Officer.
Categories III-A to III-C (less common experiments that require additional approval)
Definition
- Making a pathogen resistant to an antibiotic used as a primary method to treat the infection
Examples
- Making Staphylococcus aureus resistant to doxycycline
- Making Clostridium difficile resistant to vancomycin
Approval process
- EHS Biosafety
- CAB/ESCRO
- NIH review
- Project initiation
Definition
- Adding toxin genes into an organism
- Specific experiments considered “Major Actions” by the NIH
Examples
- Cloning botulinum toxin into Escherichia coli BL21Cloning tetanus toxin into Staphylococcus aureus
- Please see the NIH guidelines for specific examples of Major Actions.
Approval process
- EHS Biosafety
- CAB/ESCRO
- NIH review
- Project initiation
Definition
- Gene therapy or clinical studies with recombinant material in human subjects
Examples
- Initiating a clinical research experiment to test the efficacy of a retroviral vector targeting a specific disease
- Introducing CRISPR-Cas9 to human patients to target a cancer gene
Approval process
- EHS Biosafety
- CAB/ESCRO and COUHES
- NIH review
- Project initiation
The following provides a summary of responsibilities for those involved in rDNA/SNA research. Full details on roles and responsibilities are available in Section IV of the NIH Guidelines.
The principal investigator (PI) is ultimately responsible for full compliance with the NIH Guidelines in the conduct of rDNA/SNA research.
- Ultimately responsible for full compliance with NIH Guidelines
- Be trained in good microbiological techniques
- Follow safety procedures for spills & exposures
- Set the initial biosafety level
- Select lab practices & techniques, register with IBC, and communicate throughout project
- Train & supervise staff in safe practices and accident/emergency response procedures
- Comply with shipping requirements
- Investigate & report any significant problems, violations, or accidents/illnesses to BSO, IBC, NIH, or DCM as appropriate
- Correct mistakes/conditions that could result in release of rDNA/SNA into environment
Researcher’s responsibilities are not specifically outlined in NIH Guidelines, though researchers should be familiar with responsibilities of their PI.
MIT Requires the following from researchers:
- Work with PI to ensure researcher material and experiments are approved on Biological Research Registration (BRR)
- Complete all required biosafety and lab-specific training
- Follow established microbiological practices of lab
- Become familiar with a process prior to working with biological material
- Report significant safety concerns to PI or EHS
- Abide by Institutional policies
- Serve as a member of the IBC
- Perform periodic safety inspections
- Report to the IBC and the Institution
- Develop emergency plans for spills, exposures, and investigating lab accidents or illnesses
- Provide advice on laboratory security
- Provide technical advice to PI and IBC on research safety procedures
Additional MIT-specific functions of the BSO:
- Serve as the link between the IBC and the PI
- Provide biosafety training
- Perform registration pre-review prior to submission to IBC
CAB/ESCRO (MIT IBC)
Review the rDNA/SNA research of institution for compliance with NIH Guidelines including:
- Periodically review rDNA/SNA research at institution for compliance
- Approve biosafety levels
- Assess facilities, procedures, practices, and training/expertise of personnel
- Notify PI of results of the IBC’s review and approval
- Adopt emergency plans for spills and exposures
- Report or ensure reporting of any significant problems, violations, or significant research-related accidents or illnesses
Additional MIT-Specific Responsibilities fulfilled by CAB/ESCRO:
- Oversee all biological research conducted at MIT
- Develop and implement institutional policies for biosafety
- Serve as the Institutional Review Entity (IRE) for dual use research of concern (DURC)
- Serve as the Embryonic Stem Cell Research Oversight (ESCRO)
- Establish and implement policies that ensure safe conduct of rDNA/SNA research and compliance with the NIH Guidelines
- Establish an Institutional Biosafety Committee (IBC)
- Appoint an institutional Biological Safety Officer
- Appoint specific expert members to the IBC as necessary
- Assist Principal Investigators (PI) to ensure compliance with NIH Guidelines
- Ensure appropriate training available for PI, reseachers, staff, and IBC
- Determine need for health surveillance programs
- Report or ensure reporting of any significant problems, violations, or research-related accidents and illnesses
The NIH Guidelines also include over 90 pages of additional information on biosafety and biological research.
NIH Guidelines Appendices
- Appendix A: contains a list of organisms that exchange DNA by known physiological methods; this section can be used to determine if an experiment would fall under category III-F-6 (and thus be exempt from the NIH Guidelines)
- Appendix B: Defines bacterial Risk Groups (RG1-4) and organisms which would fall under each Risk Group
- Appendix C discusses experiments and organisms that would be exempt under section III-F-8; these are generally low-risk and well-defined organisms.
- Appendix D discusses Major Actions taken by the NIH (Category III-A experiments) – In general, these are decisions on containment and permissions given to specific researchers to do specific experiments with high level pathogens, release of genetically modified material into the environment, or rDNA/SNA used in clinical research trials
- Appendix E discusses examples of host-vector systems that are exempt by the NIH Guidelines category III-F-8; many of these organisms also fall under Appendix C
- Appendix F discusses information regarding cloning of vertebrate toxins
- Appendix G discusses containment and training requirements – This appendix forms the basis of what is required at each biosafety level (BL1-4); Physical containment, personal protective equipment, waste handling, and work practices are discussed
- Appendix H discusses shipping requirements for rDNA/SNA material
- Appendix I discusses setting containment levels for host-vector systems
- Appendix J discusses the Biotechnology Research Subcommittee; this is a group that considers Federal granting and research concerns and topics
- Appendix K discusses requirements for large scale research with rDNA/SNA which would fall under Category III-D-6
- Appendix L discusses containment for plant work involving rDNA/SNA
- Appendix M discusses containment for animal work involving rDNA/SNA