Download risk assessment of genetic modification work

Part A version CT2 191202
RISK ASSESSMENT OF GENETIC MODIFICATION WORK
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PROJECT ADMINISTRATION DETAILS
TITLE
Royal Free Genetic Modification Committee Notification Reference Number
Please write number assigned by Secretary or leave blank
RF
Employer on whose premises the project will take place
UC & RF Medical School RFC
Royal Free NHS Trust
Anthony Nolan Trust
GM99
GM773
GM772
Will any part of this work be conducted at another centre?
If yes, please give details:Places were the project work is to be conducted
DEPARTMENT
LIST LOCATION(S) WHERE THE GMO WILL BE HANDLED AND STORED
Room(s)
Type of room
Date inspected
PERSONNEL
PROJECT PROPOSER
e-mail
telephone
ADMINISTRATION CONTACT
e-mail
telephone
PROJECT STAFF
Please asterisk the person with day-to-day laboratory responsibility for the project.
NAME
GMO experience(yrs)
Micro-organism experience(yrs)
LIST ANY ADDITIONAL COMPLIANCE DETAILS FOR THIS PROJECT
E.g. Home Office Licence, GTAC submission, Local Ethics Committee Approval date & no.
BIOLOGICAL MATERIAL- Please give details of all the following
VECTORS
HOSTS
GENE SEQUENCES/FUNCTION
CLINICAL TRIALS
Is this project a clinical trial?
If 'NO' proceed to Part A (risk assessment of GM work)
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Part A version CT2 191202
TO BE COMPLETED FOR CLINICAL TRIALS ONLY
Will a GM drug be administered to
 patients?
 volunteers?
Specify room number, room name and location where the GM drug will be:
i) Stored
Has the Assistant Biological Safety Officer inspected this room?
Date of inspection
How is the product stored and is access to the product restricted?
i) Prepared for patient administration
Has the Assistant Biological Safety Officer inspected this room?
Date of inspection
Has a date been arranged for a dummy run observed by the Assistant Biological
Safety Officer?
If yes please give date:Permission will be subject to completion of a satisfactory dummy run and resolution of all
issues arising.
What is required to prepare the GM drug for administration and for containment of
aerosol production?
Is the preparation / storage area adjacent to the patient administration area?
Please specify any
 transport arrangements with respect to containment of the GM drug
 emergency spillage procedures
 emergency procedure if there is a breach of containment
Does Personal Protective Equipment (e.g. gloves, mask and eye protection) need to
be used?
If yes please give details:Who will prepare the GM drug?
Name
Title / Position
Qualifications / training relevant to procedures involving GM material
Details of preparation of the GM drug
Who will administer the GM drug?
Name
Title / Position
Qualifications / training relevant to procedures involving GM material
Details of administration of the GM drug
Will the GM drug be shed from the patient / volunteer and has a risk assessment
been carried out for waste disposal?
It is the responsibility of the Project Proposer to ensure that the training of staff
involved in the administration of substances to human subjects and the facilities
and protocols used for reconstitution and administration of these substances, are
approved by the Medicines Control Agency.
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Part A version CT2 191202
RISK ASSESSMENT OF GENETIC MODIFICATION WORK
PART A
Title of project
Overview of the project
This should cover the following points:
 the scientific goals of the project
 an overview of the different types of GMM that will be constructed
 a detailed description of the most hazardous GMM. Details should be provided of any
disabling mutations in the recipient micro-organism and there should be a
consideration of whether the inserted gene might endow the modified micro-organism
with harmful properties
 implications of the use of sharps and the possible production of aerosols
 any mechanism by which the vector could cause harm to humans or the environment?
Does the work involve a recipient micro-organism that is inherently safe AND is the
gene being cloned non-harmful? Please give details and justifications.
Examples of inherently safe recipient micro-organisms which, depending on the nature of
the insert, would in most cases be expected to form the basis of extremely safe GMMs are
as follows:
 E coli K12
 Defective retrovirus produced from packaging line in which the helper genes are
located in two separate blocks of DNA (thus eliminating the possibility of a reversion to
replication competence by a single recombination event).
 E1 deleted adenovirus
The types of gene which when cloned into particular recipient micro-organisms might give
rise to a harmful phenotype can be divided into two types.
First the gene might encode a product that could act directly to cause harmful effects e.g.
a gene encoding a toxin, cytokine, oncogene, growth factor, receptor or hormone.
Second the gene might encode a product that could act alongside the existing
characteristics of the recipient micro-organism so as to endow the GMM with altered
pathogenic properties e.g. a pathogenicity gene or an engineered viral envelope gene with
an altered receptor binding capacity.
If the GMM meets BOTH of the above criteria, you may believe that you have
sufficient information at this stage to classify the project as Class 1, as defined in
the Contained Use Regulations 200. In order to do this you should be confident that
even in the event of a total breach of containment the genetically modified organism
would be no or negligible risk to human health or the environment.
Please give details of Human Health Risk Assessment with appropriate justifications
Please give details of Environmental Risk Assessment with appropriate justifications
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Part A version CT2 191202
Please fill in details of waste inactivation procedures
This should cover the following points:
 Name and concentration of disinfectant used for discard pots and spillages.
 Contact time and level of kill (this need not be precise, e.g. 'approximately 4 logs
reduction in viability' or 'below detectable level' is acceptable).
 Sterilisation with an autoclave: length of sterilisation cycle (min) and temperature.
 SPILLAGE: are written guidelines in place, give details and the title of document.
If you are assigning the work to CLASS 1 according to the above streamlined procedures,
sign the form below and submit the original, plus 30 copies with envelopes (or 10 copies
for routine Class 1 submission from a Principal Investigator with an existing approved GM
project at the Royal Free Campus)
to:The Secretary
Genetic Modification Advisory Committee
Medical School Administration
Royal Free Campus.
Telephone contact X 4358
ACGM CLASS AND LABORATORY CONTAINMENT LEVEL

Please state final ACGM class to which you assigned the project:
Will the laboratory for be used for any project with a higher laboratory containment level?
If so please give details:

Please state the final laboratory containment level at which you will be working:
Work should not commence until you have formal consent in writing that your application
has been successfully reviewed and states you can begin work. The Chairman will give
this via the Committee Secretary.
If you have any uncertainty as to whether the proposal meets the above criteria you should
obtain a continuation form B and undertake a more detailed risk assessment.
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Part A version CT2 191202
SIGNATORIES FOR THE PROJECT
Signature of Proposer:
Please print name
Date
Signature of GMSO:
Please print name
Date
Signature of Head of Department:
Please print name
Date
Please list any additional material supplied with your application proposal here:
Part A Version CT2 19/12/02
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