NIH Guidelines

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.

 

Please use the links below to learn more about the NIH Guidelines.

 

The most recent version of the NIH Guidelines and additional information can be found on the NIH OBA website (click link to access NIH webpage).

 

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What are rDNA and SNA?

Who must follow the NIH Guidelines (regulatory requirements)?

Do I need to register my research?

What is the registration and approval processes for rDNA/SNA work?

What experiments are covered by the NIH Guidelines (includes examples)?

What are my responsibilities and the responsibilities of MIT?

Who is our Institution Biosafety Committee (IBC)?

What are some additional important sections of Guidelines I should consider?

 

What are recombinant DNA (rDNA) and Synthetic Nucleic Acids (SNA)?

 

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

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Who must follow the NIH Guidelines (regulatory requirements)?

 

  • 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 if their institution receives any funding
    • MIT receives funding so all PI’s are required to follow the Guidelines while working with rDNA/SNA
  • The City of Cambridge requires all rDNA/SNA research to be registered, even research that would otherwise be exempt from the NIH Guidelines (experiments falling under section III-F)
  • The Committee on Assessment of Biohazards & Embryonic Stem Cell Research Oversight (CAB/ESCRO) serves as the Institutional Biosafety Committee (IBC) for MIT and sets institutional policies for rDNA/SNA work; registration is extended to additional biological research beyond rDNA/SNA research

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Do I need to register my research?

 

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What is the registration and approval processes for rDNA/SNA work?

 

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.

In addition, 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).  The BRR is a document that describes the important regulatory and safety information for the biological research performed by your lab.  Below is a condensed discussion of the registration process at MIT. 

It’s important to note that new registrations or amendments to existing registrations that fall under Category III-D or above (or require BL2+ containment) cannot be given administrative approval and must have full CAB/ESCRO review and approval before the research can start.  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.

For a full discussion of the registration process, please visit the CAB/ESCRO website.

 

 

*Administrative approval is given at discretion of the Deputy Director of EHS Biosafety Program

**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

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What experiments are covered by the NIH Guidelines?

 

Below is a discussion of what types of experiments would fall under the NIH Guidelines.  In general, most rDNA/SNA research at MIT falls under Categories III-D, III-E, and 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 diagrams for an overview.  For more information, please see Section III of the NIH Guidelines.

 

 

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What are my responsibilities and the responsibilities of others at MIT?

 

The NIH Guidelines outline the role and responsibilities of those involved in rDNA/SNA research.  Please use the links below to learn more about your responsibilities and the responsibilities of others at MIT.  For full details, please see Section IV of the NIH Guidelines.

 

Principal Investigator (PI)

Researcher

Biosafety Officer (BSO)

Institutional Biosafety Committee (CAB/ESCRO)

Institute (MIT)

 

Principal Investigator (PI)

 

Section IV-B-7 of the NIH Guidelines outlines in full detail the responsibilities of the PI; below is a summary of important points:

 

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Researchers

The NIH Guidelines do not explicitly refer to the responsibilities of researchers who are not Primary Investigators.  However, researchers should be aware of the responsibility their PI has under the NIH Guidelines and work to ensure these responsibilities are being met.  MIT has the following additional expectations of researchers:

 

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Biosafety Officer (BSO)

Section IV-B-3 of the NIH Guidelines outlines in full detail the responsibilities of the BSO; below is a summary of important points:

 

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IBC (CAB/ESCRO)

Section IV-B-2 of the NIH Guidelines outlines in full detail the responsibilities of the IBC; below is a summary of important points:

 

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Institution (MIT)

Section IV-B outlines in full detail the responsibilities of MIT (as the Institution); below is a summary of important points:

 

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Who is our Institutional Biosafety Committee (IBC)?

 

The Committee on the Assessment of Biohazards & Embryonic Stem Cell Research Oversight (CAB/ESCRO) serves as the IBC for MIT.  The CAB/ESCRO is an Institutional Board and the members are approved by the MIT President.  The following types of member serve on the CAB/ESCRO:

  • MIT Faculty
  • Members of Cambridge community:
    • Required by the NIH Guidelines
    • Generally non-scientific members (“lay people”)
    • Not affiliated with MIT
    • Work or live in Cambridge
    • Represent interests of the community (Cambridge)
  • Occupational Health
  • Animal specialist (DCM)
  • Technical Staff representative
  • Post doc representative
  • Grad Student representative
  • Director of EHS
  • Institution Biosafety Officer (Deputy Director of EHS Biosafety)

For more information, please visit the CAB/ESCRO website (please click link).

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Additional important sections of Guidelines?

 

The NIH Guidelines also include over 90 pages of additional information on biosafety and biological research.  This information is organized in a series of appendices:

  • Appendix A: This section 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:  B defines bacterial Risk Groups (RG1-4) and organisms which would fall under each Risk Group
    • Risk Group (RG) differs from Biosafety Level (BL or BSL)
    • RG is based on the characteristics of the organism that define the risk posed by the organism
    • BL (or BSL) describes the containment and safety features needed in order to work safely with different organisms. 
    • RG and BL often correlate (i.e. often you would handle a RG2 organism under BL2/BSL2 containment), but they are distinct concepts and do not always match; some circumstances allow specific RG3 organism to be handled under BL2/BSL2 containment if there is small volume and minimal aerosol risk
  • 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
    • This section includes over 100 specific examples
  • 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 Gene Therapy Policy Conferences which are called to discuss human subject research/clinical research using rDNA/SNA
  • Appendix M discusses points to consider for Human subject research with rDNA/SNA
  • Appendix P discusses containment for plant work involving rDNA/SNA
  • Appendix Q discusses containment for animal work involving rDNA/SNA

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