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Overview of the NIH Guidelines for Research Involving Recombinant DNA Molecules. This is an edited combination of Haverford College’s IBC training materials and training materials from the NIH; by Gretchen Hofmeister, April 2017. NIH Guidelines for Research Involving Recombinant DNA Molecules.
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Overview of the NIH Guidelines for Research Involving Recombinant DNA Molecules This is an edited combination of Haverford College’s IBC training materials and training materials from the NIH; by Gretchen Hofmeister, April 2017
NIH Guidelines for Research Involving Recombinant DNA Molecules • These guidelines specify practices for constructing and handling: • Recombinant DNA (rDNA) molecules • Organisms and viruses containing rDNA molecules • History: • Guidelines originally established in 1975 at the Asilomar Conference on Recombinant DNA • Established recommendations to perform rDNA experiments in a manner safe for researchers and the public • Revised as needed, most recently in April 2016
Why does Carleton need to oversee rDNA research? Carleton receives NSF funding for non-exempt projects involving rDNA research, therefore: • ALL researchers at Carleton must comply with the NIH Guidelines Even those not directly receiving NIH funding AND • Just one non-compliant researcher could jeopardize NIH grant funding for the entire college
How can Carleton and St. Olaf stay in compliance with the NIH Guidelines? • The NIH Office of Biotechnology Activities (OBA)fosters awareness of and adherence to the NIH Guidelines • OBA periodically conducts site visits to review how institutions follow the NIH Guidelines • Compliance with the NIH Guidelines is the responsibility of: • The Institution • The Institutional Biosafety Committee (IBC) • The Principal Investigator
The Institution’s Responsibilities • Provide training tools to researchers on the safe use of rDNA • Inform Principal Investigators of their responsibilities outlined in the guidelines • Form an Institutional Biosafety Committee (IBC)
Institutional Biosafety Committee (IBC) Responsibilities On behalf of the institution, the IBC is responsible for: • Reviewing rDNA research conducted at or sponsored by the institution • Setting containment levels • Notifying PI of the results of the IBC’s review and approval • Reporting significant problems or violations with the NIH guidelines to NIH/OBA • Developing emergency plans covering accidental spills and personnel contamination resulting from rDNA research
Institutional Biosafety Committee (IBC) • Functions to review, approve, and oversee projects in accordance with the responsibilities defined in NIH GuidelinesSection IV-B-2 • Committee membership requirements: • Individuals with expertise in rDNA technology • Individuals with expertise in human gene transfer* • Individual with expertise in plant containment* • Scientist with expertise in animal containment* • Biosafety officer¶ • Community members not affiliated with institution *when experiments involve plants, animals, or humans ¶For research at BL3 or BL4
What are rDNA molecules? • Definition of rDNA molecules: • Molecules constructed outside living cells by joining natural or synthetic DNA segments to DNA molecules that can replicate in a living cell • Synthetic DNA segments, likely to yield a potentially harmful polynucleotide or polypeptide, are considered equivalent to their natural DNA counterpart. • Examples: • Human gene transfer • Cloning plasmids • Viral or bacterial vectors • Transgenic animals • Genetically modified cell lines
NIH Guidelines – Section II • Safety Considerations • Risk assessments: (Appendix B) RG 1 RG 2 RG 3 RG 4
BSL1 BSL2 BSL3 BSL4 NIH Guidelines – Section II • Safety Considerations • Containment • Physical (Appendix G) • Practices • Equipment • Facilities • Biological (Appendix I) • Survival • Transmission
IBC, RAC, NIH Director IBC, OBA (in consult with experts) IBC, IRB, RAC IBC IBC (notification) Exempt Section III - Levels of Review RISK
Exempt rDNA Experiments • NIH Guidelines“Section III-F” covers exempt experiments • Registration with the IBC is not required • Exempt experiments are those involving rDNA molecules that: • III-F-1: are not in organisms or viruses • III-F-2: consist entirely of DNA from single nonchromosomal or viral DNA source • III-F-3: consist entirely of DNA from a prokaryotic host when propagated only in that host • III-F-4: consist entirely of DNA from an eukaryotic host when propagated only in that host (excluding DNA from viruses) • III-F-5: consist entirely of DNA from different species that exchange DNA by known physiological processes (list periodically updated in Appendices A-I through A-VI) • III-F-6: do not present significant risk to health or to the environment as determined by NIH Director with the advice of RAC
Training Requirements • All personnel who are listed on a registration document must complete training, including: • PI • Anyone directly involved in rDNA experiments • Registrations will not be approved until all training is complete • This module satisfies the knowledge portion of training on the NIH Guidelines • PI is responsible for “hands-on” training of personnel
Carleton’s rDNA Registration Review Process • Submit the completed and signed registration forms to the chair of the IBC (Associate Dean of the College) • A member of the IBC will review the registration form and contact you with any questions or necessary revisions • The IBC reviews registrations as needed • The IBC is not permitted to review registrations outside of a fully convened meeting SO • Please be sure to submit registrations in a timely fashion, allowing enough time for a full meeting of the IBC to be arranged and convened
Carleton’s rDNA Registration Review Process • If the IBC approves your registration, you will receive an approval letter with: • IBC registration number (ex. #11-805) • The biosafety level (BSL) required • The animal biosafety level (ABSL) required (if applicable) • Registrations must be renewed every 3 years • If your registration is for work requiring IBC approval BEFORE initiation (Sections III-A, III-B, III-C, III-D), you may not start work until an official approval letter has been received
Additional Resources to Foster NIH Guideline Understanding • Office of Biotechnology Activities website • NIH Guidelines • Office of Environmental Health and Radiation Safety’s (EHRS) website for Biological Safetyat U. Penn • St. Olaf College Biosafety Information • Contact Carleton or St. Olaf IBC members