GM Project Approval Process – How it Works
1. Decide if your work concerns:
GM animals, GM human viruses or viral vectors, GM microorganisms other than viruses
(but including cell cultures), GM plant viruses, GM plants
2. Download the appropriate Risk Assessment form and also the School/Department GM
Project Submission form: http://www.cardiff.ac.uk/osheu/safety/biological/index.html
3. Fill in the form electronically and e-mail it to your School/Department Biological Safety
Officer (BSO). They will check it over for you and suggest any changes required. (After
feedback and the inclusion of any amendments move on to points 4 and 5).
4. Print off a hard-copy, attach a signature form
which the project supervisor has signed and send
it via the internal mail to your School/Dept
Biological Safety Officer
5. Send an electronic copy to:
Dr Rachel Coombe
(CoombeRA@cf.ac.uk) or
Mrs Heather Lam (LamH@cf.ac.uk)
The BSO will sign it and send it on to the HOS/HOD
HOS/HOD will sign it off and send it on to OSHEU
For Class 1 Projects
Forms will be circulated to GM committee members
The reviewing/approval process will take
approximately 1 month to complete. The
premises will be inspected for suitability.
Subject to the committee being satisfied with the
risk assessment and the premises having been
deemed satisfactory, approval will be given for
work to go ahead. Risk assessments will be signed
– off by the chairman of the committee.
For Class 2/3 Projects
Risk assessment will be reviewed at next
meeting (Projects originally submitted as Class
1 may be upgraded to Class 2 by the committee
and will therefore require review at meeting)
6. Containment level 2 projects and
above will require HSE notification
(additional notification form and cost)
7. For all projects download GM worker registration forms from
http://www.cardiff.ac.uk/osheu/safety/biological/index.html print out, fill in, sign and send
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to: Dr. Rachel Coombe at OSHEU via the internal
mail
[For completion by word processor. To view the guidance provided in
the Comments boxes select View/Comment or View/Markup]
Genetic Modification Safety Committee [GMSC]
Proposal and Risk Assessment for Work with Genetically Modified
Human and Animal Viruses and Viral Vectors
You should take note of the information provided in the Comments boxes and
consult the HSE document “ACGM Compendium of Guidance”
http://www.hse.gov.uk/hthdir/noframes/acgmcomp/acgmcomp.htm.
Hard copies may also be obtained from OSHEU on request.
Date of Application:
Project Number:
Title of Project:
:
Person responsible/Supervisor:
Is this part of a Connected Programme of Work?
Email:
Yes
No
Titles of other projects in the Programme:
Department:
Location of work (Building & Room No.)
Proposed Final Activity Class
1
2
3
Containment Level Required by
GMSC
1 2 3
Signature of Chairman:
Date:
Date Notified to HSE (if required): Date of HSE reply:
HSE Reference number :
Laboratory/facility approved for
the required Containment Level
Signature of inspecting
Biological Safety Adviser:
Date:
2
Section 1 Personnel
Person responsible/Supervisor details
Briefly indicate your experience of working with microorganisms and
genetically modified organisms and any training you have received
Table 1
Names of other workers
on the project (if known)
Qualifications
3
Experience/Training
Section 2 Project
Description of the project, including the methods to be used and the
purpose of the genetic modification
Will you cultivate on a large scale (e.g. 10 or more litres per culture)?
Yes
No
Table 2
Host(s)
Vector(s)
Source of
nucleic acid
insert (e.g.
species)
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Description of DNA to
be inserted (including
brief explanation of
function)
Section 3 Risk Assessment
NB: This section should include in each of the answers to the questions
sufficient detail to justify your assessments of Level of Risk. Insufficient detail
is likely to result in delays in the overall application process
Level of risk can be estimated using the matrix given in Appendix 1
Section 3A: Risk to Human Health
3A.1 Characteristics of the host virus or viral vector and any hazards
associated with it
Is the viral vector disabled?
Yes
No
Explanation:
3A.2 Describe the origin of the virus, the mechanism of attenuation, and its
stability in both the parent viral vector and the recombinant vector
3A.3 Indicate the probability of reversion to the wildtype
3A.4 Is the viral vector replication competent?
Yes
No
Explanation:
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3A.5 Are all potential routes of transmission of the virus known, e.g. those
that may occur during a laboratory accident?
Yes
No
3A.6 What are the known routes and will they deliver the virus or its products
to tissues where it may be biologically active?
3A.7 Is there potential for the transmission of the naked nucleic acid?
Yes
No
Explanation:
3A.8 Does the viral vector infect humans or human cells in vitro?
Yes
No
Explanation:
Level of Risk:
3A.9 Source and characteristics of the inserted gene product and any
hazards arising directly from its use
Describe the nature of the inserted genes and the properties of the final
genetically modified viral vector
3A.10 Does the insert code for a protein with known or suspected
physiological, pathological and/or pharmacological effect?
Yes
No
Explanation:
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3A.11 Will the viral vector contain any natural or inserted oncogene and/or
oncogenic sequences
Yes
No
Explanation:
Level of Risk:
3A.12 Hazards arising from the alteration of existing pathogenic traits
Is there reason to suspect that the tissue tropism or host range of the
recombinant virus will be any different from that of the parent vector or virus?
Yes
No
Explanation:
3A.13 Is there reason to suspect that the recombinant virus may have altered
susceptibility to host defence mechanisms?
Yes
No
Explanation:
e.g.
Will normal immune status be compromised by the recombinant virus
Yes
No
Explanation:
3A.14 Is there a suitable vaccine to protect against the recombinant virus?
Yes
No
Yes
No
Explanation:
If Yes, will it be given?
If No, give reasons for not doing so:
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3A.15 Is the recombinant virus likely to have any effect upon an
immunocompromised host beyond those normally expected with the parent
virus
Yes
No
Explanation:
3A.16 Will viral susceptibility to anti-viral drugs (if available) be affected by the
genetic modification?
Yes
No
Explanation and any significance:
3A.17 Could the route of transmission of the recombinant virus be altered?
Yes
No
Explanation and any predicted effects of the recombinant viruses in tissues
which it would not normally infect:
Level of Risk:
3A.18 Potential hazard of harmful sequences within the virus being
transferred to related viruses
Level of Risk:
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3A.19 The overall likelihood that, in the event of exposure, the GM virus
could cause harm to human health
Level of Risk:
3A.20 Assign the provisional containment level which is adequate to
protect against hazards to human health
: Tick required box
1
2
3
Section 3B: Assessment for Environmental Harm
Note: If the answer to a question is Yes, provide appropriate details
3B.1 What is the capacity of the GMM to survive, establish,
disseminate with and/or displace other organisms?
Is there reason to suspect that the recombinant virus may have
enhanced environmental survival factors; e.g. enhanced tolerance to
UV, temperature, desiccation etc?
Yes
No
Explanation and significance:
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3B.2 Are all potential routes of transmission or escape of the virus to
the environment known e.g. following a laboratory accident?
Yes
No
Explanation:
3B.3 Will the recombinant virus or its products gain access to
organisms in which effects may be manifested?
Yes
No
Explanation and any significance:
Level of risk:
3B.4 What is its ability to cause harm to organisms other than
humans?
Is the host pathogenic to organisms other than humans?
Yes
No
Explanation:
3B.5 Does the insert code for a protein[s] with known or suspected
inhibitory, detrimental, or other physiologically active effect on any
organisms other than humans?
Yes
No
Explanation:
3B.6 Is there a potential for harmful effects of gene expression on other
organisms?
Yes
No
Explanation:
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3B.7 Will the recombinant virus alter infectivity or interactions with host
defence mechanisms?
Yes
No
If yes, answer the remaining questions in this section:
[1] Will the normal status of host defence systems be compromised by
the recombinant virus?
Yes
No
Explanation:
[2] Is the recombinant virus likely to have enhanced effects on a
weakened host or one lacking normal vigour beyond those
normally expected with the parent virus?
Yes
No
Explanation:
[3] Will viral susceptibility to control agents be affected by genetic
modification?
Yes
No
Explanation and significance:
[4] Will the insert cause changes in the host range of the virus?
Yes
No
Explanation:
[5] Is there reason to suspect that the tissue tropism of the recombinant
virus in host organisms will be different from that of the
unmodified virus?
Yes
No
Explanation:
Level of risk:
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3B.8 What is the potential for transfer of genetic material between the
GMM and other organisms?
Level of risk:
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Section 4 Control Measures Monitoring, and Inactivation
Provide details of the control measures to be used to protect human
health and the environment and the means by which their use and
effectiveness will be monitored. .
Are any of the procedures likely to generate aerosols? Yes
Will a safety cabinet be used? Yes
No
No
Will any procedures use sharps? Yes
No
If Yes, state control measures to be used and means of disposal:
Will liquid waste be autoclaved
or disinfected
?
If Disinfected:
Product Name
Generic Chemical Name:
Expected degree of kill
How validated
Solid waste to be autoclaved
disposed of as clinical waste
Details of any other control measures to be used:
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Section 5: Emergency Planning
Does your project require an emergency action plan?
Yes
No
If Yes, does your School emergency action plan provide adequate
protection in case of accidental release?
Yes
No
If No, give details of specific extra safety measures which will be applied
to the project
To print this current application/risk assessment form without the Comment
boxes by go to File/Print/Print what/ and replacing the, “document showing
markup” with the “document” selection).
Please ensure you have printed off the ‘School / Department GM Project
Submission Form’ from the OSHEU website and obtained the necessary
signatures.
Attach the signed ‘School / Department GM Project Submission Form’ to the
project proposal/risk assessment form and send them by internal mail to:
Heather Lam – OSHEU, 47 Park Place. You will also need to send an
electronic copy of this current form (without attached signature form) to
LamH@cf.ac.uk. Both electronic and hard copies are required for efficient
processing of your proposal.
THE PROJECT PROPOSAL/RISK ASSESSMENT WILL NOT BE REVIEWED BY
THE GMSC UNTIL OSHEU HAS RECEIVED BOTH THE ELECTRONIC AND HARD
COPY VERSIONS OF THE DOCUMENT.
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Review of Risk Assessment
NB: This risk assessment must be subjected to regular review by the
supervisor and also be reviewed if project circumstances change significantly.
The GMSC will request an annual review as part of this requirement.
Appendix 1: Matrix for estimation of level of risk
[Consequence x likelihood = risk of causing harm]
Likelihood of Hazard
Consequence
of Hazard
High
Medium
Low
Negligible
Severe
High
High
Medium
Effectively
Zero
Medium
High
Medium
Medium/Low
Effectively
Zero
Low
Medium/Low Low
Low
Effectively
Zero
Negligible
Effectively
Zero
Effectively
Zero
Effectively
Zero
Effectively
Zero
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