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Biological Project Registration Form (BPRF)
Institutional Biosafety Committee (IBC)
Ȧ
This form is available at: HYPERLINK "http://www.ric.edu/biosafety" http://www.ric.edu/biosafety
REFER TO THE INSTITUTIONAL REVIEW BOARD FOR RESEARCH CONDUCTED WITH HUMANS. DO NOT USE THIS FORM.
Use of biological agents, including recombinant DNA, unfixed human or non-human primate materials (blood, cells, tissues), unfixed prokaryotic or eukaryotic cells, transgenic plants or animals, animals known to be reservoirs of zoonotic diseases, and Select Agents, must be reviewed and approved by the Ȧ Institutional Biosafety Committee prior to using the biological agents.
This form can be filled out to register activities to be performed under a specific grant or contract (specific project registration) or for research activities performed regularly as part of multiple funded or non-funded projects (general procedures).
If the research involves use of live vertebrate animals, an IACUC project number must be provided or statement that the protocol is pending review (list date of anticipated review).
For grant-funded projects, the original research description or abstract from the proposal must be attached. If the project is not supported by grant funds, a brief description of the research activities that will be conducted during the project must be attached to the form.
If this form is not submitted through the IBC website, PI may email the completed Biological Project Registration Form the Ȧ IBC Chair at HYPERLINK "mailto:ibcchair@ric.edu?subject=Ȧ%20IBC%20Project%20Registration%20form" ibcchair@ric.edu. Incomplete forms will not be reviewed.
The IBC will review submissions within 30 days of receipt. Projects are approved for three years, but are to be renewed each year with a declaration that the project protocols are the same as was approved, including changes in personnel and their competencies.
Changes in project activities such as use of additional biological agents, significant procedural changes, or modifications that increase the risk of the activities must be approved by the IBC before the changes are made. PIs wanting to modify a current BPRF may submit a memo to the IBC Chair describing the changes. The IBC will respond within 14 days of receipt of a project change description. The PI is required to notify the IBC Chair (by e-mail) when a project is completed or is no longer active.
Complete Sections 1, 2, 3, 4
Include a brief description of the research activities or provide the original grant proposal description/abstract
Attach SDS or spec sheet (if available) for biological materials used in this project
If PI does not certify that research activities are limited to the experimental activities/use of biological materials described in 4A, 4B, 4C, 4D, the project is NOT EXEMPT and the remainder of the form must be completed
Available resources to assist in completing this form:
HYPERLINK "http://osp.od.nih.gov/office-biotechnology-activities/biosafety/nih-guidelines" http://osp.od.nih.gov/office-biotechnology-activities/biosafety/nih-guidelines
HYPERLINK "http://www.cdc.gov/biosafety/publications/bmbl5/index.htm" http://www.cdc.gov/biosafety/publications/bmbl5/index.htm
HYPERLINK "http://www.selectagents.gov/index.html" http://www.selectagents.gov/index.html
1. GENERAL INFORMATION
& N e w p r o j e c t & P r o j e c t r e g i s t r a t i o n r e n e w a l I D _ _ _ _ _ _ _ _ _ _ _ _ _
& S p e c i f i c G r a n t t i t l e :
P r o j e c t t i t l e :
F u n d i n g a g e n c y G r a n t n u m b e r ( i f a p p l i c a b l e )
& P r o j e c t t i t l e ( n o t g r a n t - s p e c i f i c ) :
& G e n e r i c P r o c e d u r e :
P r i n c i p a l I n v e s t i g a t o r i n f o r m a t i o n
N a m e
T i t l e
D e p a r t m e n t
O f f i c e l o c a t i o n
O f f i c e t e l e p h o n e
E - m a i l
2 . B I O L O G I C A L M A T E R I A L S I N F O R M A T I O N
B i o l o g i c a l m a t e r i a l s / a c t i v i t y ( c h e c k a l l t h a t a p p l y )
& R e c o m b i n a n t o r s y n t h e t i c n u c l e i c a c i d m o l e c u l e s
& T r a n s g e n i c p l a n t s o r a n i m a l s
& C R I S P R / C a s 9 o r o t h e r g e n e e d i t i n g t e c h n o l o g y
& V i r a l n u c l e i c a c i d s
& U n f i x e d / l i v e p r o k a r y o t i c c e l l s
& U n f i x e d / l i v e e u k a r y o t i c c e l l s
& U n f i x e d / l i v e h u m a n o r n o n - h u m a n p r i m a t e f l u i d s , c e l l s , t i s s u e s
& A n i m a l s t h a t a r e k n o w n r e s e r v o i r s o f z o o n o t i c d i s e a s e s ( H Y P E R L I N K " h t t p s : / / w w w . c d c . g o v / n c e z i d / s t o r i e s - f e a t u r e s / b r o w s e / s u b j e c t s / z o o n o t i c - d i s e a s e s . h t m l " h t t p s : / / w w w . c d c . g o v / n c e z i d / s t o r i e s - f e a t u r e s / b r o w s e / s u b j e c t s / z o o n o t i c - d i s e a s e s . h t m l )
& S e l e c t a g e n t s ( H Y P E R L I N K " h t t p s : / / w w w . s e l e c t a g e n t s . g o v / ) " h t t p s : / / w w w . s e l e c t a g e n t s . g o v / )
& O t h e r p o t e n t i a l l y b i o h a z a r d o u s m a t e r i a l , s p e c i f y _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _
B i o s a f e t y c o n t a i n m e n t l e v e l , r e c D N A r i s k g r o u p , o r b i o h a z a r d ( c h e c k a l l t h a t a p p l y )
& B L 1 & B L 2 ( s e e : H Y P E R L I N K " h t t p s : / / w w w . c d c . g o v / b i o s a f e t y / p u b l i c a t i o n s / b m b l 5 / i n d e x . h t m " h t t p s : / / w w w . c d c . g o v / b i o s a f e t y / p u b l i c a t i o n s / b m b l 5 / i n d e x . h t m )
& R G 1 & R G 2 ( r i s k g r o u p d a t a b a s e : H Y P E R L I N K " h t t p s : / / m y . a b s a . o r g / t i k i - i n d e x . p h p ? p a g e = R i s k g r o u p s _ _ ) " h t t p s : / / m y . a b s a . o r g / t i k i - i n d e x . p h p ? p a g e = R i s k g r o u p s _ _ )
& S e l e c t a g e n t ( HYPERLINK "https://www.selectagents.gov/)" https://www.selectagents.gov/)
Principal investigator laboratory experience with the biological material(s) or containment level listed in 2A and/or 2B
Years _________ Experience with methodology in this registration _________
Context _________________________________________
3. EXPERIENCE AND TRAINING
Plan for training of personnel working with the biological material(s) or containment level listed in 2A and/or 2B
& D i r e c t t r a i n i n g b y R I C F a c u l t y
& T r a i n i n g a t a n o t h e r i n s t i t u t i o n
& P r e v i o u s t r a i n i n g , d e s c r i b e _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _
& O t h e r , s p e c i f y _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _
4 . D E T E R M I N A T I O N O F E X E M P T A C T I V I T I E S
I f t h e r e s e a r c h a c t i v i t i e s a r e l i m i t e d t o t h e experimental activities/use of biological materials that fall into the activities described below, the project is exempt. For additional details on this list, consult:
HYPERLINK "https://osp.od.nih.gov/wp-content/uploads/NIH_Guidelines.html" https://osp.od.nih.gov/wp-content/uploads/NIH_Guidelines.html
HYPERLINK "https://osp.od.nih.gov/wp-content/uploads/2013/12/Experiments_that_are_Exempt_from_the_NIH_Guidelines.pdf" https://osp.od.nih.gov/wp-content/uploads/2013/12/Experiments_that_are_Exempt_from_the_NIH_Guidelines.pdf
HYPERLINK "https://osp.od.nih.gov/biotechnology/faqs-about-experiments-that-are-exempt-from-the-nih-guidelines/" https://osp.od.nih.gov/biotechnology/faqs-about-experiments-that-are-exempt-from-the-nih-guidelines/
Recombinant or synthetic nucleic acid molecules that:
Can neither replicate nor generate nucleic acids that can replicate in any living cell (e.g., oligonucleotides or other synthetic nucleic acids that do not contain an origin of replication or contain elements known to interact with either DNA or RNA polymerase)
Are not designed to integrate into DNA
Do not produce a toxin that is lethal for vertebrates at an LD50 < 100 ng/kg BW
Are not in organisms, cells, or viruses and that have not been modified or manipulated (e.g., encapsulated into synthetic or natural vehicles) to render them capable of penetrating cellular membranes
Consists solely of the exact recombinant or synthetic nucleic acid sequence from a single source that exists contemporaneously in nature
Consists entirely of nucleic acids from a prokaryotic host, including its indigenous plasmids or viruses when propagated only in that host (or a closely related strain), or when transferred to another host by well-established physiological means
Consists entirely of nucleic acids from a eukaryotic host including its chloroplasts, mitochondria, or plasmids (but excluding viruses) when propagated only in that host (or a closely related strain)
Consists entirely of DNA segments from different species that exchange DNA by known physiological processes, though one or more of the segments may be a synthetic equivalent
Are genomic DNA molecules that have acquired a transposable element, provided the transposable element does not contain any recombinant and/or synthetic DNA
Do not present a significant risk to health or the environment
Biological materials classified as biosafety level 1 (BL1) or risk group 1 (RG1) that are not known to cause disease in healthy adults
Research or production activities involving viable organisms containing recombinant or synthetic nucleic acid molecules in LESS THAN 10 liters of culture
Select agent toxins of biological origin are NOT used
Although these experiments are exempt, it is recommended that they be performed at the appropriate biosafety level for the host or recombinant/synthetic organism (see these publications: HYPERLINK "https://www.cdc.gov/biosafety/publications/index.htm" https://www.cdc.gov/biosafety/publications/index.htm)
By typing name, title, and date in the box below, the principal investigator certifies that the project described in this registration application form is limited to the activities listed above. This exempt status does not exempt proper training of personnel involved in the project or authorize the use of BL2 facilities and resources. The IBC Chair will confirm the EXEMPT status and assign a project number.
Name (First, MI, Last)Title/rankDate 5. LABORATORY INFORMATION/TRAINING
Please list any abbreviations used in this registration form:
I s t h i s p r o j e c t p a r t o f a c o u r s e o r t e a c h i n g l a b ? & Y E S & N O
L i s t A L L L a b o r a t o r i e s , f a c i l i t i e s , a n r e s o u r c e s t h a t w i l l b e u s e d d u r i n g t h i s r e s e a r c h p r o j e c t a n d t h e c o r r e s p o n d i n g b i o s a f e t y l e v e l o f t h e m a t e r i a l s t h a t w i l l b e i n t h o s e l o c a t i o n s . N o t e t h at some materials and activities may require additional containment if being transported to different locations on or off campus.
Check box if applicableBuilding/Room/Other locale Biosafety LevelBiological Safety CabinetHuman Materials usedMicroscopeCryogenic storage
Will animals be used for this project? & N O & Y E S , p r o v i d e I A C U C P r o t o c o l _ _ _ _ _ _ _ _ _ _
W i l l m i x e d w a s t e ( h a z a r d o u s c h e m i c a l / b i o l o g i c a l ) b e g e n e r a t e d ? & N O & Y E S , i n d i c a t e h o w t h e w a s t e w i l l b e d e c o n t a m i n a t e d a n d d i s p o s e d
L i s t a l l l a b o r a t o r y p e r s o n n e l w o r k i n g o n t h i s p r o j e c t , i n c l u d i n g PI, and their training.
NOTE: THIS LIST MUST BE UPDATED IN THE INSTANCE OF A CHANGE IN PERSONNEL WITH AN E-MAIL OR WRITTEN MESSAGE TO THE IBC Chair.
NAMEROLE ON PROJECTEXPERIENCETRAINING
If someone other than the PI will be training any personnel participating in this protocol, list their name, credetials, and contact information below with a brief explanation as to why the PI is not personally training those listed above:
NAMEROLE ON PROJECTCREDENTIALSREASON FOR TRAINING 6. USE OF RECOMBINANT OR SYNTHETIC NUCLEIC ACIDS
If applicable, list the source of gene, insert, or clone in expression constructs
Source of DNA/RNA/probeDescribe InsertCRISPR/Cas9 or gene editing?Proteins expressed?Encoding a Toxin?DNA from USDA-regulated plant, animal, insect**If yes, and the regulated organism is grown or stored at Ȧ, please include a copy of the USDA permit. (USDA HYPERLINK "http://www.aphis.usda.gov/brs/index.html"http://www.aphis.usda.gov/brs/index.html)
COMMENTS:
If applicable, list the vectors or host cells to be used with the material listed in 5A and/or 5B; this includes viral vectors; specificfy if sgRNA and Cas9 in separate loci in CRISPR experiments
Vector designationSourceRecipient bacterial strainsHost cell linesPromoter typePackaging cell linesCOMMENTS:
Use in animals, plants or insectsFor transgenic or knockout organisms, describe the transgene and vectorTransgene Recipient CRISPR/Cas9 or similar gene editingExpected phenotype (for example, immunodeficient, enhanced disease susceptibility, early disease onset or resistance, etc.)Use of recombinant or synthetic nucleic acids in animals or plants
COMMENTS:
CRISPR/Cas9 or similar gene editing experiments:
If gene editing is performed, list the life stage of the organism:Describe the containment of the organism with edited gene(s) or is the locale outside its habitable range? Barriers?Will this organism reproduce? Can it reproduce with wild strains? If yes, reiterate containment protocol. Are the sgRNA and Cas9 in separate loci?Expected phenotype (for example, immunodeficient, enhanced disease susceptibility, early disease onset or resistance, etc.):Describe any additional molecules not completely described in the tables above
Large-scale research or production activities involving viable organisms containing recombinant or synthetic nucleic acid molecules grown in m o r e t h a n 1 0 l i t e r s o f c u l t u r e a t o n e t i m e & N O & Y E S , i d e n t i f y c u l t u r e r o o m a n d t y p e o f e q u i p m e n t u s e d
7 . U S E O F I N F E C T I O U S B I O L O G I C A L A G E N T S
L i s t a g e n t s / m i c r o o r g a n i s m s t o b e u s e d i n t h e p r o j e c t , t h e C D C - d e s i g n a t e d b i o s a f e t y l e v e l , a n d i n f e c t i o n p o t e ntial (note that no agents higher than BL2 are authorized for use at Ȧ)
Agent/microorganism (species, strain)SourceCDC Biosafety LevelHuman pathogenPathogenic to other animalsPlant pathogen
If agent can infect humans, list infectious dose information
Experimental procedures
Describe procedures involving use of infectious agent (indicate culture volume, maximum concentration). How and at what stage of the experiment is the infectious agent inactivated or lysed?
Will e x p e r i m e n t s r e s u l t i n a c q u i s i t i o n o f n e w c h a r a c t e r i s t i c s s u c h a s e n h a n c e d v i r u l e n c e , i n f e c t i v i t y , d r u g r e s i s t a n c e , o r c h a n g e i n h o s t r a n g e ? & N O & Y E S , e x p l a i n
C o n t a i n m e n t a n d d e c o n t a m i n a t i o n p r o c e d u r e s
D e s c r i b e p r o t e c t i v e e q u i p m e n t r e q u i r e d t o m i n i m ize exposure of laboratory personnel during all procedures requiring handling or manipulation of infectious agent
List procedures for decontamination of work surfaces, instruments, equipment, liquid containing infectious materials and glassware
List disposal procedures for contaminated sharps, contaminated solid waste, tissues, pipette tips, etc.
If using viral vectors, describe the method used to test for replication-competent virus
8. USE OF HUMAN AND NON-HUMAN PRIMATE MATERIALS
List materials and handling of human and non-human primate materials
Type (blood, bone, sputum, cells)Source Prior treatment (fixation, heat treatment, etc.)Storage & ContainmentOther information If agent is infectious, list infectious dose information
Experimental procedures
Describe procedures involving use of these materials
List precautions and PPE that will be used to minimize laboratory worker exposure
Containment and decontamination procedures
Describe how the materials will be contained to minimize distribution of potentially infectious agents in the laboratory workspace
List procedures for decontamination of work surfaces, instruments, equipment, liquid containing potentially infectious materials and glassware
List disposal procedures for contaminated sharps, contaminated solid waste, tissues, pipette tips, etc.
Is there a bloodborne pathogen exposure control plan in place? & N O & Y E S , i n c l u d e d o c u m e n t a t i o n ( s e e f o r m o r e i n f o r m a t i o n H Y P E R L I N K " h t t p : / / w w w . c d c . g o v / n i o s h / t o p i c s / b b p / " h t t p : / / w w w . c d c . g o v / n i o s h / t o p i c s / b b p / )
9 . O C C U P A T I O N A L M E D I C I N E ( U s u a l l y n o t a p p l i c a b l e t o r e s e a r c h a t R I C ; s e e I B C B i o s a f e t y M a n u a l A p p e n d i x I )
S o m e r e s e a r c h p r o t o c o l s r a t e d a s B L 2 m a y i n v o l v e a n e e d f o r s e r v i c e s f r o m a n o c c u p a t i o n a l m e d i c a l p r o v i d e r .
A r e p r e - p r o j e c t s e r u m s a m p l e s , i m m u n i z a t i o n o r m e d i c a l m o n i t o r i n g o r s u r v e i l l a n c e a d v i s a b l e ?
& N O & Y E S , d e s c r i b e t h e n e e d
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W i l l b i o l o g i c a l t o x i n s b e u s e d o r s y n t h e s i z e d & N O & Y E S , d e s c r i b e s t o r a g e a n d s e c u r i t y p r o c e d u r e s
T h e f o l l o w i n g t o x i n s a r e n o t r e g u l a t e d i f t h e a m o u n t u n d e r t h e c o n t r o l o f a p r i ncipal investigator does not exceed, at any time, the amounts listed below [73.3(d)(7)]. RETRIEVED 1/26/18 FROM:
HYPERLINK "https://www.selectagents.gov/PermissibleToxinAmounts.html" https://www.selectagents.gov/PermissibleToxinAmounts.html (updated March 2017)
ToxinRegulatory Threshold Quantity Expected QuantityAbrin1000 mgShort, paralytic alpha conotoxins100 mgDiacetoxyscirpenol (DAS)10,000 mgRicin1000 mgSaxitoxin500 mgTetrodotoxin500 mgBotulinum neurotoxins1.0 mgStaphylococcal enterotoxins (subtypes A, B, C, D, E)100 mgT-2 toxin10,000 mgDescribe any select agent toxin used in the project if is not listed above:
See HYPERLINK "https://www.selectagents.gov/SelectAgentsandToxinsList.html" https://www.selectagents.gov/SelectAgentsandToxinsList.html
SKIP THIS SECTION IF THERE HAVE BEEN NO INCIDENTS WITH BIOLOGICAL MATERIALS UNDER YOUR SUPERVISION AND AUTHORITY
11. INCIDENTS WITH BIOLOGICAL MATERIALS
Incidents involving RG2 and BL2 activities must be repo r t e d . I n c i d e n t s i n c l u d e a n i n j u r y - c a u s i n g a c c i d e n t , a l a r g e v o l u m e s p i l l , o r o t h e r s i g n i f i c a n t e v e n t .
H a s a n i n c i d e n t o c c u r r e d ? & N O & Y E S
R e p o r t d a t e W h e r e w a s r e p o r t f i l e d ? D e s c r i b e i n c i d e n t D e s c r i b e w h e t h e r a p r o c e d u r e o r p r a c t i c e w a s c h a n g e d t o avoid the incident from reoccurring
12. CERTIFICATION BY THE PRINCIPAL INVESTIGATOR
By entering name, title/rank, and date below, the principal investigator:
Certifies that the information contained in this application is accurate and complete.
Agrees to abide by the provisions of the current NIH Guidelines, the NIH Guide for Grants and Contracts, other specific NIH instructions pertaining to the proposed research, federal, state, and local regulations, and the provisions of Ȧ IBC.
Assures that
No non-exempt recombinant or synthetic nucleic acid research subject to the NIH Guidelines will be started before review and approved by the Ȧ IBC.
All appropriate biosafety level laboratory techniques will be implemented in the research
Compliance with all shipping requirements for biological materials
Laboratory workers will be provided copies of approved protocols that describe the potential biohazards and the precautions to be taken
The PI will train researchers in good microbiological practices and techniques required to ensure safety for this project, in the procedures for dealing with accidents, and in waste management procedures
All personnel will be supervised and work errors and conditions that could result in breaches of the NIH Guidelines will be adequately addressed
Name (First, MI, Last)Title/rankDate
Ȧ IBC USE ONLY
MARK STATUSBiosafety/risk levelApproved EXEMPT - APPROVAL #Approved NON-EXEMPT - APPROVAL #Conditional approval, pending response to information requestNot approved, subject to re-review pending response to information requestRejected (see comments below)
Additional Information requestedDate of request ____________
Renewal dateComments
IBC Chair Date
Other, if necessary Date
Other, if necessary Date
Approval Date: Renewal Date:Project ID:
PAGE 1
PAGE 9 Ȧ IBC Biological Research Project Form January 2017 v. 5.0
INSTRUCTIONS
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