Click to Submit by Email
Institutional Biosafety Committee
Office of Research Affairs, Research Administration Bldg.
University of Massachusetts Amherst
70 Butterfield Terrace, Amherst, MA 01003-9242
Telephone: (413) 545-5283; Fax: (413) 577-1728
Recombinant and Synthetic Nucleic Acid Molecules
Research Protocol Form
The University of Massachusetts Amherst is required by law to ensure that all research activities
involving recombinant and synthetic nucleic acid molecules are reviewed in accordance with the
NIH Guidelines. This includes unfunded projects, projects that are funded by an agency other
than NIH.
A registration must be submitted to the University of Massachusetts Amherst’s Institutional
Biosafety Committee (IBC) for review to ensure that all provisions of the NIH Guidelines will be
followed. Please complete and submit the attached Registration Form to Barbara Miller in the
Office of Research Affairs (413-545-0668) for review to determine the NIH review level.
Recombinant and synthetic nucleic acid research at UMass Amherst generally falls into one of
three NIH review levels – IIID (IBC review and approval required before the work starts), IIIE
(notify the IBC before the work starts, IBC review required) and IIIF (exempt from IBC
oversight). Please note that you need to submit a registration for review by the Biosafety
Officer even if you believe your research is review level IIIF. For IIIF registrations you will
need to report to the BSO any changes in your procedures that could change the review level.
For specific questions about managing recombinant and synthetic nucleic acid research please
contact the campus Biological Safety Services Manager at [email protected] at 413-5457293.
A registration may be approved for up to 5 years. A new registration renewal must be submitted
to extend the approval period.
General Instructions:
Please complete:
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•
•
•
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Page 2 Principal Investigator and Contact Information
Section 1. General Project Description
Section 2. Recombinant and synthetic nucleic acid molecules
Section 3. Dual Use Questionnaire
Section 4. Principal Investigator Certification
FOR OFFICE USE ONLY
Project Working Title: ________________________________________________
Registration number _______________________
PI __________________________
UMass at Amherst
Recombinant and Synthetic Nucleic Acid Molecules
Research Protocol Form
Date received _____________________
Page 1 of 11
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Principal Investigator and Contact Information
Responsible PI:
Name:
________________________
Department:
______________________________
Building:
______________________________
Lab Room Number(s):
________________________
Office Phone: ________________ Lab Phone: ________________
E-Mail:_________________________________
Home Phone: ____________________
Campus ID ________________________________
Provide the name and contact information for an alternate contact who can either answer
questions for the IBC or an EH&S Inspector and/or who will always be able to contact you.
Alternate Contact:
(A Senior Research Assistant, Lab Manager or Co-PI, who is informed of the lab’s research
protocols and safety and emergency response procedures)
Lab Contact
______________________________
Department:
______________________________
Building:
______________________________
Room Number:
______________________________
Office Phone: _____________
Lab Phone
__________________
E-Mail: ______________________ Home Phone: __________________
Campus ID ____________________________________
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Recombinant and Synthetic Nucleic Acid Molecules
Research Protocol Form
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Other Personnel Working on this Project
Name: ________________________
Campus ID_______________
Email: __________________________
Position (e.g. undergrad, grad student, postdoc, technician): _________________________
Name: ________________________
Campus ID_______________
Email: __________________________
Position (e.g. undergrad, grad student, postdoc, technician): _________________________
Name: ________________________
Campus ID_______________
Email: __________________________
Position (e.g. undergrad, grad student, postdoc, technician): _________________________
Name: ________________________
Campus ID_______________
Email: __________________________
Position (e.g. undergrad, grad student, postdoc, technician): _________________________
Name: ________________________
Campus ID_______________
Email: __________________________
Position (e.g. undergrad, grad student, postdoc, technician): _________________________
Name: ________________________
Campus ID_______________
Email: __________________________
Position (e.g. undergrad, grad student, postdoc, technician): _________________________
Name: ________________________
Campus ID_______________
Email: __________________________
Position (e.g. undergrad, grad student, postdoc, technician): _________________________
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Research Protocol Form
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Section 1. General Project Description
(to be completed for all applications)
Project Title:
______________________________________________________________________________
Project Period: __________ to ____________
Funding Agency: ______________________________________
General Description
Briefly describe the research proposed that involves the use of recombinant or synthetic
nucleic acid molecules. Please write your description so that non-scientists on the IBC can
understand how you propose to use these materials. Please avoid or define acronyms and
abbreviations. Be sure to describe the origin or source of the nucleic acid molecules and
the host – vector system you will use. Include a flow chart for complex projects.
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Recombinant and Synthetic Nucleic Acid Molecules
Research Protocol Form
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Section 2. Recombinant or synthetic nucleic acid molecules
Please identify any of the following that you intend to use in your research:
Yes
No
Does the work involve transfer of a drug resistance trait to an organism that does
not acquire it normally (Check "no" for standard drug resistance, e.g., ampicillin
into E. coli)?
Does the experiment involve genes coding for molecules toxic to vertebrates
(LD50 <100 nanograms / kg body wt)?
Will the recombinant or synthetic nucleic acids be used in human subjects (human
gene transfer experiments)?
Do the experiments involve human genes being cloned into non-pathogenic
prokaryotic or lower eukaryotic host-vector systems?
Will there be any large-scale experiments (i.e. requiring more than 10 liters of
culture)?
Will genes from one microbe be used to express in another?
Are any human or animal pathogens used either as the host organism or as a
vector?
Is there the introduction of recombinant or synthetic nucleic acid molecules into
Risk Group 2, 3, 4 or restricted agents as host-vector systems?
Is any DNA from Risk Group 2, 3, or 4 agents or restricted organisms cloned into
non-pathogenic prokaryotic or lower eukaryotic host-vector systems?
Do experiments involve recombinant or synthetic nucleic acid molecules and the
use of infectious animal or plant viruses in tissue culture systems or in animals?
Do experiments involve the use of defective animal or plant viruses in the
presence of helper virus in tissue culture systems or in animals?
Do any recombinant or synthetic nucleic acid molecules contain two-thirds or
more of any eukaryotic viral genome?
Do experiments involve whole animals?
Do experiments involve whole plants?
Do experiments involve influenza viruses?
Will you release recombinant or synthetic nucleic acid molecules into the
environment?
Will you be breeding transgenic animals to create novel genetically engineered
animals?
If you answered NO to all of the questions, your rDNA research may be exempt
from the NIH Guidelines i.e. not require full review by the Institutional Biosafety
Committee.
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Recombinant and Synthetic Nucleic Acid Molecules
Research Protocol Form
Page 5 of 11
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Section 2. (Continued) Recombinant or Synthetic Nucleic Acid
Molecules
To determine whether your project and host-vector system are exempt
under NIH Guidelines refer to the complete text of Section III Experiments Covered
by the NIH Guidelines:
http://oba.od.nih.gov/oba/rac/guidelines/nih_guidelines.htm#_Toc351276228
1. Where will project be carried out:
Laboratory
_____ Yes
Bldg________________ Room______
______No
Greenhouse
_____Yes
Name___________________
______ No
Animal Facility
_____Yes
Bldg_____________ Room______
______No
Environmental Release (Attach USDA application/permit)
_____Yes
Location__________________________
______ No
2. Experimental and/or project details involving recombinant or synthetic nucleic acid
molecules. If more space is needed for your reply, please create an attachment:
a.) Host strain(s) used, (include genus, species, and parent strains):
b.) Source of DNA/RNA sequences (include genus, species, gene name and abbr., function of the
gene):
c.) Recombinant or synthetic plasmid(s)/vectors used (include vector system and sources of
insert):
d.) Record selection markers used and their effect (cell lysis, antibiotic resistance, mutations):
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Research Protocol Form
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e.) Will there be any attempt to obtain expression of the foreign gene?
Yes
If yes, Please describe function and expected action of the gene.
No
f.) If whole plants are used, and the plants will be going to pollination/seed, how will they be
contained to avoid releases to the environment? Example: contained in growth chambers,
bagging the flowers, etc.
g.) Recombinant or synthetic nucleic acid waste must be autoclaved prior to disposal. Please
provide the building and room number for the autoclave that you will be using:
Provide the names and contact info for the persons that will be performing this duty (assure that
they have received Biosafety Training within the previous 12 months):
h.) Please describe surface and liquid decontamination methods and list the product(s) to be
used:
3. Provide a brief assessment of the possible risks involved. What potential hazards would these
constructs have? How probable is recombination leading to infectious virus vectors? Is the risk to
the investigator, the environment, both?
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Research Protocol Form
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Check the NIH review category that you consider applies to your project.
X
Level
III-A
Approval/Review
NIH Director, RAC,
IBC
NIH/OBA, IBC
Requirements
A drug resistant gene transferred into a (new)
microorganism.
The cloning of toxin molecules with LD50 < 100 ng/kg of
III-B
body weight.
Recombinant or synthetic nucleic acids (or DNA or RNA
III-C RAC, IRB, IBC
derived from recombinant or synthetic nucleic acids)
transferred into humans.
†
Recombinant or synthetic nucleic acid molecules
III-D IBC
transferred to or from whole animals, whole plants,
transgenic rodents, experiments involving >10 Liters of
culture, or agents listed in Risk Groups 1, 2, 3, or 4 (see
below) at the appropriate Biological Safety Level (BSL).
Experiments involving infectious viruses or defective
viruses in the presence of helper virus.
§
Recombinant or synthetic nucleic acid molecules
III-E IBC
involving no more than 2/3 eukaryotic virus agents, whole
plants, arthropods, or transgenic rodents.
Ɣ
BSO
Recombinant DNA not found in organisms or viruses,
III-F
single monochromal or viral DNA sources, or host DNA
transferred to the same host or related species.
†
Approval required before initiation.
§
Notify IBC when project is initiated. IBC approval still required.
Ɣ
Submission of registration form still required
Which Risk Group (RG) applies to the proposed project?
Check the NIH Risk Category that applies to your project.
X
Risk Group 1
Agents that are not associated with disease in healthy adult humans.
(often BSL-1)
Risk Group 2 Agents that are associated with human disease which is rarely serious
and for which preventive or therapeutic interventions are often available.
(often BSL-2)
Risk Group 3 Agents that are associated with serious or lethal human disease for which
preventive or therapeutic interventions may be available (high individual
risk but low community risk). (often BSL-3)
Risk Group 4 Agents that are likely to cause serious or lethal human disease for which
preventive or therapeutic interventions are not usually available (high
individual risk and high community risk). (often BSL-4)
λ
For a listing of agents, see “Appendix B – Classification of Human Etiologic Agents on the Basis of
Hazard” in the NIH Guidelines For Research Involving Recombinant DNA Molecules, April 2002.
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Recombinant and Synthetic Nucleic Acid Molecules
Research Protocol Form
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Section 3. Dual Use Research of Concern
Dual use research of concern is life sciences research that, based on current understanding, can
be reasonably anticipated to provide knowledge, information, products, or technologies that
could be directly misapplied to pose a significant threat with broad potential consequences to
public health and safety, agricultural crops and other plants, animals, the environment, material,
or national security.
Does your research involve any experiments that would:
1
2
3
4
5
6
7
8
Yes
Demonstrate how to render a vaccine ineffective or otherwise enhance
the susceptibility of a host population to the agent or toxin
Render a pathogen (≥ risk group 2) resistant to antibiotics or antivirals
where other effective and readily accessible treatments do not exist
Enhance a pathogen's virulence or render a non-pathogen
virulent
Increase a replication competent pathogen's transmissibility or ability to
disseminate
Alter a replication competent pathogen's host range or tropism
Enable a pathogen to evade diagnostic tests
Enable weaponization of pathogens and toxins
Generate or reconstitute an eradicated or extinct agent or toxin
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Research Protocol Form
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No
Section 4. Principal Investigator Certification
By submitting this form, I certify that I have read the following statements and agree to abide by
them and other UMass policies and procedures governing the use of recombinant DNA,
infectious agents and other biological materials, as outlined in this application and in the
following:
I will:
a) Ensure
that
listed
personnel
have
received
biological
safety
training
http://www.ehs.umass.edu/biological-safety-training in safe laboratory practices and the
procedures for this protocol before any work begins on this project, received follow-up
trainings as required by University policy, and that all personnel who could have
occupational exposure to bloodborne pathogens have received appropriate bloodborne
pathogen training.
b) Follow the health surveillance practices outlined by the biosafety officer for this protocol.
c) Report accidental exposures or releases to Judy LaDuc, Biological Safety Services Manager
(EH&S) at 413-545-7293. Any releases must be reported to the NIH, therefore I must notify
EH&S so that the appropriate action is taken.
d) Have myself or my staff report to UHS (or an Emergency Room) to be seen by medical staff
and inform EH&S at 413-545-2682 of any research-related accident or illness as soon as
possible after its occurrence.
e) Submit a request for approval to the IBC for any significant modifications to the study,
facilities or procedures. This request should be submitted to Hilary Woodcock
[email protected] and it will be reviewed by the Biological Safety Officer as well as
other members of the IBC as deemed necessary.
f) Comply with safety practices as described in the most recent version of the Biosafety in
Microbiological and Biomedical Laboratories2
http://www.cdc.gov/biosafety/publications/bmbl5/index.htm for work with pathogens.
g) Ensure that all proposed live vertebrate animal use has been approved by the UMass
Institutional Animal Care and Use (IACUC).
h) Ensure that all biohazardous waste and/or sharps waste is decontaminated and handled in
accordance with EH&S medical/biological waste guidelines
(http://www.ehs.umass.edu/biological-materials-and-biohazardousmedical-waste-disposalprogram). Recombinant DNA waste must be autoclaved prior to disposal. Animal carcasses
are frozen for at least two days then packaged in bio-boxes for incineration. Sharps
containers and bio-boxes are removed for incineration by completing the form on this
website: http://www.umass.cems.sr.unh.edu/CEMS/RequestRemoval
i) Comply with NIH requirements pertaining to the shipment and transfer of recombinant DNA
materials1.
j) Become familiar with, and abide by, all provisions of the most current NIH Guidelines1.
Appendix H – Shipment http://oba.od.nih.gov/rdna/nih_guidelines_oba.html .
k) Recognize that the Biological Safety Officer will review all NIH exempt projects.
l) Recognize that I must register any changes in projects including exempt work.
____________________________________________
Signature (for electronic submission type name)
UMass at Amherst
Recombinant and Synthetic Nucleic Acid Molecules
Research Protocol Form
Page 10 of 11
__________________
Date
form last revised 2/21/2013
1.
NIH recombinant DNA Guidelines http://oba.od.nih.gov/rdna/nih_guidelines_oba.html.
2.
CDC / NIH publication Biosafety in Microbiological and Biomedical Laboratories
http://www.cdc.gov/biosafety/publications/bmbl5/index.htm.
3.
OSHA Bloodborne Pathogen Standard:
http://www.osha.gov/pls/oshaweb/owadisp.show_document?p_table=STANDARDS&p_id=100
51
4.
Transgenic Animals and the Use of Recombinant DNA in Animals FAQs for Research Subject
to the NIH Guidelines:
http://oba.od.nih.gov/oba/ibc/FAQs/FAQs%20about%20Transgenic%20Animals%20and%20the
%20Use%20of%20Recombinant%20DNA%20in%20Animals.pdf
5.
Arthropod Containment Guidelines
http://online.liebertpub.com/doi/pdf/10.1089/153036603322163475 and
http://www.cdc.gov/biosafety/publications/bmbl5/BMBL5_appendixE.pdf
When completed, please return this form to:
Barbara Miller, Program Administrator,
Office of Research Affairs, Research Administration Building,
University of Massachusetts Amherst, 70 Butterfield Terrace
Amherst, MA 01003-9242
Telephone: (413) 545-0668
Fax: (413) 577-1728
Email: [email protected]
****For Institutional Biosafety Committee (IBC) Use Only****
Approve
NIH Level:
Approve with
Stipulations
III-A
III-B
Disapprove
III-C
III-D
Signature: ________________________________
Exempt from IBC
Oversight
III-E
III-F
Date: _____________________
Recombinant DNA/Infectious Agent Registration
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Recombinant and Synthetic Nucleic Acid Molecules
Research Protocol Form
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