GENETICALLY MODIFIED ORGANISMS (DELIBERATE RELEASE) REGULATIONS 2002
As noted under Regulation 11 and Schedule 2
LOCAL ENVIRONMENTAL RISK ASSESSMENT FOR DELIBERATE RELEASE PROJECTS (TRIALS)
(QM_OHSD_SE014_April 2013)

Assessing the risks posed to human health (to workers and others who may be affected, *excluding clinical trial patients / subjects) and the environment by the deliberate release of genetically modified organisms (other than genetically modified higher plants) in a trial site (e.g. involving gene therapy trials, lower plant crop trials) within Queen Mary University of London and/or Barts Health Trust premises and/or other areas within their control. 

Introduction And Guidance
The local environmental risk assessment is subjective to, and must be read in conjunction with, the CONSENT TO RELEASE application made to the Secretary of State (administered by DEFRA) for this specific Deliberate Release trial and the REVIEW issued by the Government Advisory Body (Advisory Committee on Releases to the Environment, ACRE) for this specific Deliberate Release trial. 
Where applicable, the page number and section of the CONSENT TO RELEASE and applicable REVIEW should be referred to. Applicable local Standard Operating Protocols (SOP’s) should form part of the local risk assessment. The form can be lengthened as required (it is in rich text format, rtf).
There is no legal requirement for any Genetic Modification Safety Committee (GMSC) involvement for applications for Deliberate Release Consent. However, this local environmental risk assessment can be reviewed by the Queen Mary University of London GMSC to ensure best practice and standards for work with Genetically Modified organisms (*non-patient safety related) are achieved.
Further guidance on Deliberate Release Clinical Trials is available at:

http://www.defra.gov.uk/environment/quality/gm/    http://www.defra.gov.uk/acre/publications/   http://www.hse.gov.uk/biosafety/gmo/acgm/acgmcomp/part6.pdf 

*Please note the College GMSC cannot provide patient safety and/or ethical approval related advice and assistance. This aspect is controlled nationally by the Health Research Authority (HRA) under the ‘IRAS’ process. Appropriate College / Trust Officers should be contacted for patient safety and/or ethical approval related procedures, advice and assistance.

The CONSENT TO RELEASE and REVIEW documentation is in the public domain, due to publication by DEFRA on their website. However, Local (College / Trust) policy, procedures and names / contact details will not necessarily be publicly available, so this completed document should be kept confidential and restricted to those who will work in the trial project, to senior / line management and regulatory overseers / authorities.

Local Environmental Risk Assessment
		
Item	Information 
(add text and/or embed electronic files; box will expand upon typing)	
1.	The name and address of the applicant of the CONSENT TO RELEASE application:		
2.	DEFRA Reference and Consent Date (if consent not given, state expected consent date):		
3.	Reference and Date of REVIEW issued by the Government Advisory Body for Deliberate Release trials (ACRE):		
4.	Is this a multi-centre Project: 	Yes / No.	
5.	Note the page number in the CONSENT TO RELEASE application where Queen Mary University of London and/or Barts Health Trust site is authorised for the Deliberate Release clinical trial:		
6.	The name and address, contact details (telephone, email) of the Local Principal Investigator, their qualifications and experience:		
7.	The name and address, contact details (telephone, email) of the coordinating local Clinical Research Associate, their qualifications and experience:		
8.	Other staff responsible for carrying out the work under this project (names, qualifications and experience):		
9.	Location where the Deliberate Release clinical trial is to be conducted (ward number, building, campus / hospital site address) and other locations where stocks / shed material may be stored / handled (e.g. pharmacy, linen wash room, patients’ homes; for patients homes only - note ‘patients homes’, do not note any addresses)		
10.	Brief Description of the genetically modified organism(s) in relation to the Deliberate Release clinical trial (parent organism, genetic modification(s) made: genes deleted / inserted):		

11.	General purpose and brief details of the Deliberate Release clinical trial:		
12.	Deliberate Release clinical trial schedule and regime in relation to the Queen Mary University of London and/or Barts Health Trust site (use the following sub-headings; Standard Operating Protocols (SOP’s) can be referred to and attached to this risk assessment):		
12.1	Foreseen dates of Deliberate Release:		
12.2	Frequency and duration of Deliberate Release:		
12.3	Training for workers and preparation for the Deliberate Release trial identified; give brief description or note applicable SOP:		
12.4	Clinical methods used for Deliberate Release identified; give brief description or note applicable SOP:		
12.5	Quantity of genetically modified organisms to be released during Deliberate Release trial (in total and during each release):		
12.6	Worker protection methods and arrangements identified during release; give brief description or note applicable SOP:		
12.7	Environment (site) protection methods and arrangements identified during release; give brief description or note applicable SOP:		
12.8	Post-release worker and site protective methods identified to prevent uncontrolled release; give brief description or note applicable SOP:		
12.9	Waste disposal and inactivation methods (decontamination methods such as disinfection) required; give brief description or note applicable SOP: 		
12.10	Worker occupational health surveillance / monitoring (if assessed as necessary) identified; give brief description or note applicable SOP:		
12.11	Other affected persons health surveillance / monitoring (if assessed as necessary) identified; give brief description or note applicable SOP:		
12.12	Facilities and arrangements for receipt, transport and storage identified; give brief description or note applicable SOP:		

12.13	Emergency protocol/s to control accidental / unexpected release drawn up; give brief description or note applicable SOP:		
13.	In line with the CONSENT TO RELEASE application and REVIEW and local risk assessment, is the Deliberate Release clinical trial likely to pose negligible or no risk to workers and other affected persons:  
If your assessment answers No, concerns should be noted below and raised with the Trial Sponsor (named in 1) before the trial commences:
	
Yes / No (delete as appropriate).	
14.	In line with the CONSENT TO RELEASE application and REVIEW and local risk assessment, is the Deliberate Release clinical trial likely to pose negligible or no risk to the environment: 
If your assessment answers No, concerns should be noted below and raised with the Trial Sponsor (named in 1) before the trial commences:
	Yes / No (delete as appropriate).

15.	LOCAL RISK ASSESSMENT PREPARED BY:

Name	………………………………………

Position	………………………………………

Date	………………………………………

Signature	………………………………………

There is no legal requirement for any GMSC involvement with applications for Deliberate Release Consent. However, the local environmental risk assessment can be reviewed by the Queen Mary University of London GMSC to ensure best practice and standards for work with Genetically Modified Organisms are achieved.

If the Local Principal Investigator needs the Queen Mary University of London GMSC to review this local environmental risk assessment and assist with the preparations and arrangements in terms of GMO safety*, please send the risk assessment to:

Dr Mark Ariyanayagam
(Biological Safety Adviser and GMSC BSO)
Occupational Health and Safety Directorate
Queen Mary University of London
Mile End Road
London, E1 4NS
Email m.r.ariyanayagam@qmul.ac.uk
Telephone 020 7882 8378

*Please note the BSO and GMSC cannot provide patient safety and/or ethical approval related advice and assistance. This is provided nationally by the Health Research Authority (HRA) under the ‘IRAS’ process. Appropriate College / Trust Officers should be contacted for patient safety and/or ethical approval related advice and assistance.

16.	GMSC Review (GMSC use only)
Local Risk Assessment - Date Reviewed by GMSC:

Note advice and assistance required for GMO work safety:

Schedule for advice and assistance drawn up (attach) and date sent to Local Principal Investigator / Clinical Research Associate: