Registration Document for Recombinant DNA Research
IMPORTANT: This form shall be used for Institutional Biosafety Committee (IBC) registration of research,
instruction and testing activities involving rDNA at a Risk Group 1, 2,3, & 4 or projects at a Biosafety Level 1, 2, 3
or 4.This registration document is based on the Guidelines for Research Involving Recombinant DNA Molecules
(NIH Guidelines, amended April 2002). Please review this document prior to filling out this registration form. To
obtain the most recent edition of the guidelines, visit the NIH website
(http://www4.od.nih.gov/oba/rac/guidelines/guidelines.html).
New submission
Teaching Purposes
Protocol # (to be
determined by the
IBC):
Grant Renewal
PI First Name:
PI Last Name:
College:
Department:
Building:
Office Room #
Office Phone #
Emergency Phone #
(home or cell-phone)
E-mail Address:
Lab Phone #
Building and Room (where project will take place):
Project Title (please use same
title as in Grant Application,
IRB, IACUC or Infectious
Materials Registration
Documents):
Project Period:
to
Funding/Granting
Agency:
1)
Briefly describe your study in non-scientific terms (Layman’s Terms, 1,000 words maximum):
2)
Insert a concise scientific summary and rationale for the proposed study. For example, the abstract from
a grant application may be used. (1,000 words maximum):
3)
List the names, telephone numbers, and e-mail addresses of those who may come into contact with the
agent(s) listed in this registration document (use additional paper if necessary):
Name:
Office Telephone #
Emergency Telephone #
(home or cell)
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Affiliation Status
E-mail Address:
4)
Where is this project carried out?
Laboratory
Greenhouse
Animal Facility
Environmental Release (please attach USDA application or
permit)
Other:
5)
Please classify and list the agents listed in this protocol in the appropriate Risk Group:
Risk Group One (RG-1): Agents that are not associated with disease in healthy humans.
a)
List all RG-1 agents used or stored in the laboratory:
Risk Group Two (RG-2): Agents that are associated with human disease which is rarely serious and for
which preventive or therapeutic interventions are often available.*
b) List all RG-2 agents used or stored in the laboratory:
Risk Group Three (RG-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).
c) List all RG-3 agents used or stored in the laboratory:
Risk Group Four (RG-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).
d) List all RG-4 agents used or stored in the laboratory:
*
Research with bloodborne pathogens (i.e. human tissue, blood, semen, vaginal fluid, breast milk, saliva, tears) or
environmental samples must be treated as RG2 or higher level agents.
**Currently, research with agents falling into RG3 or RG4 categories is not permitted at DePaul University due to the
absence of BSL-3&4 facilities necessary to conduct this type of research.
6)
Will this project involve the use of transgenic plant or animal* species?
Yes
No
If yes, please identify species:
*If using animals see item #14
7)
Will there be any attempt to transfer recombinant DNA molecules in vivo to plant or
animal* systems (other than tissue culture)?
If you are transfering into animal systems see item #14
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Yes
No
8)
Will this project, at some point, require the release of organisms containing
recombinant molecules into the environment?
Yes
No
9)
Will this project require large-scale fermentation (>10 liters) of organisms
containing recombinant DNA molecules?
Yes
No
10)
Which level of containment applies to the proposed project?
Biological Safety Level One (BSL-1): Work with agents not known to consistently cause disease in healthy
adults, animals and/or the environment.
Biological Safety Level Two (BSL-2): Work with agents associated with disease in humans, animals and/or the
environment. The route of exposure into the host is generally through ingestion, injection, absorption and/or
mucous membrane exposure.
Biological Safety Level Three (BSL-3)**: Work with indigenous and/or exotic agents capable of causing
serious or potentially lethal disease and present the potential of aerosol transmission. The most common route of
exposure is via the inhalation route, although exposure may be possible through ingestion, injection, absorption
and/or mucous membrane exposure.
Biological Safety Level Four (BSL-4)**: Work with dangerous or exotic agents which pose high risk of lifethreatening disease. The route of exposure may be unknown.
**DePaul University does not have facilities that comply with BSL-3 or BSL-4 requirements.
11)
Which of the six NIH categories
apply to the proposed project?
III-A
III-B
Refer to Section III of the NIH “Guidelines
for Research Involving Recombinant DNA
Molecules” to determine which category
applies to your research:
(http://oba.od.nih.gov/oba/rac/guide
lines_02/NIH_Guidelines_Apr_02.
htm#_Toc7261562).
12)
13)
Require IBC approval, RAC review and NIH Director
approval before initiation.
Require NIH/OBA and IBC approval before initiation.
III-D
Require IBC and Institutional Review Board approval
and RAC review before research participant
enrollment.
Require IBC approval before initiation.
III-E
Require IBC approval simultaneous with initiation.
III-F
Exempt experiments. (Although no registration is
required for exempt experiments, please complete this
entire form for IBC review.)
III-C
Yes
No
Yes
No
Does the project involve research animals?
Yes
No
a.
If “Yes,” do you have IACUC approval?
Yes
No
b.
If “Yes,” please provide protocol number :_________________
Does the project involve research human subjects?
a.
If “Yes,” do you have IRB approval?
b.
If “Yes,” please provide the protocol number :_______________
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Pending
Pending
14)
Recombinant DNA experiment and/or project details
a)
Source of DNA/RNA sequences (include
genus, species, gene name and abbreviation,
function of the gene):
b)
Plasmid(s)/vector(s) used:
c)
Host strain(s) (i.e. recipient) used, (include
genus and species, i.e. cloning in E. coli):
d)
Will there be any attempt to obtain expression
of the foreign gene?:
e)
Yes
No
If yes, identify the gene and gene functions:
Brief description of how recombinant DNA
would be manipulated at DePaul (cloning,
transfection, sequencing, etc.)
15)
Do you plan to receive, ship or transport any of the agents from Question #5 to
or from DePaul University? If so, please describe.
Yes
No
16)
Does the project require the use of a biological safety cabinet?
Yes
No
a.
If “Yes,” please provide the following information:
Location of cabinet (building and room #):
Last NSF certification date:
17)
18)
Please indicate the room(s) and location(s) where the aforementioned agents are:
(including teaching laboratories):
Building:
Room #
Building:
Room #
Building:
Room #
Building:
Room #
Please indicate how the agents will be stored.
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Used
Stored
19)
Please list who will have access to these agents.
For the following questions, please refer to established University Guidelines (Chemical hygiene
plan) or the CDC/NIH Biosafety in Microbiological and Biomedical Laboratories Guide (BMBL)
regarding appropriate laboratory practices. Using these as guides, provide specific information
relating to the agents you will be investigating. If you are using agents classified as BSL-2 then
Standard Operating Procedures (SOPs) will need to be developed for your laboratory which detail
the procedures performed with the agent, along with its risks, exposure controls, waste disposal,
spill and accident procedures, etc. . The SOP will need to be submitted with this registration. A
guide to how to write an SOP can be found at http://www.dehs.umn.edu/PDFs/writingSOP.pdf . If
your agent is BSL-2 you may answer the questions below by referring to specific sections of your
SOP.
20)
Identify potential exposure hazards during sample preparation and experimental manipulations (e.g.,
aerosol generation when transferring, mixing or centrifuging, use of sharps, waste disposal
considerations, etc.) and what safety practices are in place to deal with these potential hazards (e.g.,
gloves, safety goggles, biosafety cabinets, etc):
21)
Describe procedures for responding to an accidental spill and/or release (After calling Public Safety
773-325-7777 to notify them of the spill/release what steps will you take to address the accident e.g.
how will you clean up your agent?):
22)
Indicate any precautionary medical practices used by you or your research staff, and why these are
provided (e.g. are immunizations necessary to work with the agent (for example, HepB vaccination is
required by law for individuals working with human blood, tissue, etc.), should regular testing be
conducted i.e. if you’re working with HIV-based viruses, will researchers need yearly HIV
tests?):
23)
Please describe how laboratory personnel will be trained in the safe use of these agents (e.g. attending
yearly online trainings given by the Office of Risk Management and Environmental Health & Safety,
one-on-one training with regards to safety issues & practice in the laboratory, reading appropriate
sections of the BMBL?):
24)
Please describe how and where your agent will be disposed of (into red BIOHAZARD garbage bags,
etc.):
25)
Additional Information/Comments:
26)
Assurances : Please check the following assurances and sign below
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The information above is accurate and complete. I agree to conduct this research using the appropriate
biosafety level of containment and work practices.
I agree to comply with the requirements specified by the NIH Guide for Grants and Contracts
Pertaining to Shipment and Transfer of Recombinant DNA Materials.
http://grants.nih.gov/grants/policy/nihgps/nih_gps.pdf
I agree to accept responsibility to ensure that all laboratory workers involved in the project are
adequately trained.
All research personnel are familiar with and understand the potential biohazards and relevant biosafety
practices, protective equipment and techniques, and emergency procedures.
I agree to abide by all University Policies and Procedures as well as all of the provisions of the most
current NIH Recombinant DNA Guidelines
PI Printed Name:
Date:
PI Signature:
Title:
When completed, please return this document to the Research Protections Assistant, 1 E. Jackson Blvd.,
Chicago, IL, 60604. If sending through InterOffice Mail, send to Diana Alfaro at the Office of Research
Protections, Lytton Building, Suite 1030. Questions and concerns should be emailed to the Research
Protections Assistant, Diana Alfaro, at dalfaro@depaul.edu. If the matter needs immediate attention, please
call (312) 362-7592.
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