726902943
th
All researchers must complete an assessment of ethical and risk factors relating to any research project to be undertaken, whether funded by internal or external funds (except undergraduate and taught postgraduate research projects), before the commencement of the research work. The completed assessment forms must be submitted to the ITT Dublin Research Ethics Committee for approval.
A re-assessment of ethical and risk factors must be undertaken by researchers in any research project where any significant change in the direction or focus of the ongoing research project is intended.
Particular attention must be given to any research involving potential risk to the researcher(s) and/or subject(s), raises ethical issues or involves pharmaceutical preparations and/or research on pregnant women, persons under the age of 18, persons with physical or mental disabilities, other vulnerable categories or members of ethnic or minority groups, or work involving animals.
Note: a) When submitting the Assessment of Ethics and/or Risk in Research Form , attach a copy of the research application to the form. b) This should be submitted at the time of proposal submission and again if a significant change in the direction or focus of the ongoing research project is intended. c) No research work should commence before the proposal has been approved by the Research Ethics
Committee. d) Research funds will not be released and the registration of postgraduate research students will not normally be processed until the proposal has been approved by the Research Ethics Committee.
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1. Project Title:
Completed forms should be returned to: Research Ethics Committee
2. Applicant Details (Use Block Capitals):
Name:
Dept. & School:
Present appointment:
Contact details: Tel : E-mail :
3. Collaborating researchers / Institutions / Organisations:
Name:
Dept. & School:
Present appointment:
Contact details:
4. Source of Funding:
Tel : E-mail :
Agency : Amount : €
5. Has this research project already received approval from another research ethics committee?
Tick one only: Yes : . NO : .
If Yes, attach relevant details and/ documentation
Has the proposal been submitted to, and been rejected by any other research ethics committee?
Yes : . NO : .
If Yes, attach relevant details and/ documentation
6. Insurance

Normally, ITT Dublin insurance covers standard research activity.
 Are there any unusual or exceptional risks or insurance issues to which ITT Dublin’s insurance company should be alerted? If so, please list the issues: (use a separate sheet if necessary)

No contract should be entered into for clinical/medical (including drug testing) or surgical trials/tests on human subjects until written confirmation has been received from the ITT Dublin’s insurers that the
relevant insurance cover is in place.
p.t.o. →
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7. RESEARCH ETHICS DECLARATION All applicants for research funds, whether directly or indirectly through ITT Dublin, are obliged to complete and sign the Ethics Declaration Form. Please tick the appropriate box below.
If you believe that that there are nil or minimal risks and/or ethical issues involved in your research project, please tick here. .
If you believe that there are significant risks and/or ethical issues involved in your research, please tick here. .
8. Risks and/or Ethical issues: Do any of the following categories of risk and/or ethical issues arise during the course of your research? Please tick YES or NO , as appropriate, in the boxes below and complete the relevant forms (2 to 14) below.
Risks and/or Ethical issues: Yes No

Impact on human subject(s) and/or researcher(s) [Form 2]

Consent and advice form provided to subjects prior to their participation in the research [Form 3]
 Consent form for research involving ‘less powerful’ subjects, minors, or those under
18 years [Form 4]

Neonatal material [Form 5]

Conflict of interest [Form 6]

Drugs and medical devices [Form 7]

Animal welfare [Form 8]

General risk assessment [Form 9]

Hazardous chemical risk assessment [Form 10]

Biological agents risk assessment [Form 11]

Risks relating to generation or use of genetically modified organisms [Form 12]

Ionising radiation [Form 13]

Field work risk assessment [Form 14]
If other risk and/or ethical issues are identified please provide a written submission which outlines the issues and the manner in which they are being addressed. p.t.o. →
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9. RESEARCH ETHICS DECLARATION continued:
In accordance with the ITT Dublin Code of Good Research Practice, I declare that the information provided in this form is true to the best of my knowledge and judgement.
I will advise the Research Ethics Committee of any adverse or unforeseen circumstances or changes in the research which might concern or affect any risks or ethical issues, including if the project fails to start or is abandoned.
Signature of applicant 1: Date:
Signature of applicant 2:
Signature of applicant 3
Checklist
Please ensure the following, if appropriate, are attached:
Documents to be attached
Date:
Date:
Tick if attached


Research Proposal

Letters (to subjects, parents/guardians, GPs, etc)

Questionnaire(s)

Advertisement/Poster

Ethical clearance from other ethical research committees
Other (please specify)
Tick if not appropriate
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FORM 2
SUBJECTS AND/OR RESEARCHERS
1. Researcher’s Name: (use block capitals) 1a. Title:
2. School/Department/Centre: 2a. Location of Work
3. Title of Study:
4. Please specify the types of subjects involved in this study and indicate the number of each type;
Type of Subject:
 healthy subjects
 in-patients
 clinic attendees
 minors
Number Type of Subject:
Others – specify: a) b) c)
Number
5. With regard to subjects to be involved in the research:

How will subjects be recruited for the study? (use an additional sheet if needed)

Is written consent to be obtained? If YES, complete the Form 3

Are subjects under the age of 18 to be included? If YES, complete the Form 4
Yes
Yes
No
No

Is human neonatal material to be used in this study? If YES, complete the Form 5
No

Will any payments be made to subjects? If YES give details:
Yes No

Is any proportion of this payment being paid by a commercially sponsored organization and if so by whom?

If controls are to be included please state how they are to be selected.
Yes No
NB. Names of Student Subjects receiving payment in commercially sponsored research must be notified to the Research Ethics Committee (attach list). p.t.o. →
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FORM 2 continued
SUBJECTS AND/OR RESEARCHERS
6. Specify the number of subjects to be used in this project, the selection criteria and the exclusion criteria to be used. Number: .
7. Specify whether any of the following procedures are involved: ( Tick yes or no as necessary ) a) Any invasive procedures b) Physical contact c) Any procedure that may cause mental distress
8. Outline the procedures involved in your study

Are samples to be taken?
If YES, indicate:
Yes
Yes
Yes
Yes
No
No
No
No a) Types of sample to be taken: b) Frequency of samples: c) Amount of sample: d) Is this part of the person’s normal treatment? Yes No
9.
If Radiological Investigations are part of the procedure indicate the number and frequency of exposures and total calculated dosage
 Number of exposures: 
Frequency:

Total dosage:
10 . Identify the procedures which may cause discomfort or distress and the degree of discomfort or distress likely to be endured by the subjects. a) b) c)
11.
What are the potential risks within the project, if any, for the investigator, subjects, the environment and/or participants, and the precautions being taken to meet them?
Add an additional sheet if necessary. You will also need to complete the relevant forms identified in
Section 8 of Form 1
-
ASSESSMENT FORM FOR ETHICS AND/OR RISK IN RESEARCH a) b) c)
12. In accordance with the ITT Dublin Code of Good Research Practice, I declare that the information provided in this form is true to the best of my knowledge and judgement.
Signature of applicant 1:
Signature of applicant 2:
Signature of applicant 3:
Date:
Date:
Date:
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FORM 3
CONSENT FORM FOR RESEARCH SUBJECTS
(other than ‘less powerful’ subjects or those under 18 years – See Form 4)
1. Researcher’s Name: (use block capitals) 1a. Title:
2. School/Department/Centre: 2a. Location of Work
3. Title of Study:
4.
In what way, if any does the proposed study benefit the individual subject? [Please type here]
5 . Is the subject able to give their own assent i.e. a consenting adult over 18 years of age?
If no, complete FORM 4 for ‘less powerful’ subjects or those under 18 years.
Yes
6.
If YES, what form of consent will be sought? Tick as needed
Please attach a copy of the relevant forms to be used
Verbal:
Written:
7.
Are the risks of the investigation judged to be minimal or nil?
Witnessed:
Other:
Yes
No
No
8.
Please attach the necessary risk assessment forms ( indicate which forms are attached )
Form 9 Form 10 Form 11 Form 12 Form 13 Form 14
9. In accordance with the ITT Dublin Code of Good Research Practice, I declare that the information provided in this form is true to the best of my knowledge and judgement.
Signature of applicant 1: Date:
Signature of applicant 2:
Signature of applicant 3:
Date:
Date:
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FORM 4
CONSENT FORM FOR RESEARCH INVOLVING
‘LESS POWERFUL’ SUBJECTS OR THOSE UNDER 18 YRS
1. Researcher’s Name: (use block capitals) 1a. Title:
2a. Location of Work 2. School/Department/Centre:
3. Title of Study:
4.
In what way, if any does the proposed study benefit the individual subject? [Please type here]
5 . Has parent's/guardian's consent to be obtained? Yes
Verbal:
No
6.
If YES, what form of consent was/will be obtained?
Tick as needed
Please attach a copy of the relevant forms to be used
Written:
Witnessed:
7.
Will the child's or young person's assent be sought?
7.
Are the risks of the investigation judged to be minimal or nil?
Other:
Yes
Yes
No
No
8.
Please attach the necessary risk assessment forms ( indicate which forms are attached )
Form 9 Form 10 Form 11 Form 12 Form 13 Form 14
9. In accordance with the ITT Dublin Code of Good Research Practice, I declare that the information provided in this form is true to the best of my knowledge and judgement.
Signature of applicant 1:
Signature of applicant 2:
Signature of applicant 3:
Date:
Date:
Date:
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FORM 5
RESEARCH INVOLVING HUMAN NEONETAL MATERIAL
1. Researcher’s Name: (use block capitals) 1a. Title:
2. School/Department/Centre:
3. Title of Study:
2a. Location of Work [Please type here]
4.
Specify the nature of the neonatal material involved and the quantity required
[Please type here]
5.
If the material required is other than from suction terminations please state:
 How soon after the delivery of the fetus materials will need to be obtained (this form covers spontaneous or therapeutic abortion up to 20 weeks gestation)
 Where and how the material will be obtained
Type here:
Type here:
 The way in which parental consent will be obtained (this must be discussed with the consultant responsible for the women whose fetuses are sought for research)
Attach a copy of the consent form and any other relevant material
Type here:
5 . Has parent's/guardian's consent to be obtained?
6.
If YES, what form of consent was/will be obtained?
Tick as needed
Please attach a copy of the relevant forms to be used
Yes
Verbal:
Written:
7.
Will the child's or young person's assent be sought?
7.
Are the risks of the investigation judged to be minimal or nil?
No
Witnessed:
Other specify :
Yes
Yes
No
No
8.
Please attach the necessary risk assessment forms ( indicate which forms are attached )
Form 9 Form 10 Form 11 Form 12 Form 13 Form 14 p.t.o. →
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FORM 5 continued
RESEARCH INVOLVING HUMAN NEONETAL MATERIAL
9. Signature
In submitting this application you are required to certify that:
 you are not involved in the management of the women whose foetuses will be used for research
 no dissection of the foetus or experiments on the foetus or foetal material will occur in the operating theatre or place of delivery
 there is no monetary exchange for foetuses or foetal material
I acknowledge and agree to observe the above conditions:
Signature of applicant 1: Date:
Signature of applicant 2: Date:
Signature of applicant 3:
Signature of Consultant:
Hospital:
Date:
Date:
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FORM 6 edit
CONFLICT OF INTEREST
1. Researcher’s Name: (use block capitals) 1a. Title:
2. School/Department/Centre: 2a. Location of Work
3. Title of Study:
4.
Specify any financial, material or non-material benefit or other direct interest to you or your
Department/School/Faculty arising from this study. A full declaration should be included in this space, or on an attached sheet.
 Note: ‘Material benefits’ are benefits which may derive from the research or which are provided by way of inducement to participate.
[Please type here]
5. Please identify any conflicts of interest a) b) c) d)
6. Outline how the conflicts of interest identified will be managed with respect to best practice, confidentiality agreements and reporting of results ( use additional sheets if needed)
7. In accordance with the ITT Dublin Code of Good Research Practice, I declare that the information provided in this form is true to the best of my knowledge and judgement.
Signature of applicant 1: Date:
Signature of applicant 2:
Signature of applicant 3:
Date:
Date:
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FORM 7
DRUGS AND MEDICAL DEVICES
Please refer to the Irish Medical Board web page for more information www.imb.ie/
1. Researcher’s Name: (use block capitals) 1a. Title:
2. School/Department/Centre: 2a. Location of Work
3. Title of Study:
4 . Is the study initiated/sponsored by a pharmaceutical or other industrial company? Yes
5 . Does the study involve pre-marketing use of a drug/appliance or a new use for a marketed product?
Yes
6. What is the regulatory status of the drug?

Does the drug or device have a product license for the purpose for which it is to be used?

Is any drug or device being supplied by a company with a Clinical Trial Licence issued by the Irish Medical Board?
Yes
Yes
If Yes, give specific details and attach copies of the appropriate certificate).
7.
Details of the drug use or medical device

Approved Name

Strength

Dosage & Frequency

Route
8.
Who will administer the drug or fit the device?
9.
Have arrangements for dispensing drugs/devices been agreed?
No
No
No
No
10. In accordance with the ITT Dublin Code of Good Research Practice, I declare that the information provided in this form is true to the best of my knowledge and judgement.
Signature of applicant 1:
Signature of applicant 2:
Signature of applicant 3:
Date:
Date:
Date:
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FORM 8
FOR RESEARCH INVOLVING WORK WITH ANIMALS
Note: In Ireland, scientific research and experimental activity on live animals may only be performed where no alternative procedure is available and under licence from the Minister for Health and Children under the
Cruelty to Animals Act, 1876 as amended by the European Communities (Amendment to Cruelty to
Animals Act, 1876) Regulations, 1994.
Application forms for a licence to perform procedures on live animals may be obtained from: The Public
Health Division, Department of Health, Hawkins House, Dublin 2. Telephone: 714711 Ext: 2538
1. Researcher’s Name: (use block capitals) 1a. Title:
2. School/Department/Centre: 2a. Location of Work
3. Title of Study:
4. How does the proposed project make an original contribution to scientific knowledge?
5. Have the proposed protocols undergone peer review?

If YES, by whom?
Yes No
6.
How is the work to be funded?
7.
Is the use of animals essential?
8. Justify why animals should be used Type here:
Yes No
9. Could the objective of the experiment be achieved using alternative techniques?

If yes, please explain why these techniques are not being used:
10. Description of proposed procedures: Tick as appropriate

Behavioural/Stress

Surgical

Dermatological

Nutritional/Metabolic

Pharmacodynamic

Pharmacokinetic

Diagnostic/Forensic

Immunological

Pathological

Climatic


Physiological
Toxicological

Drug Testing
Yes

Tumour Induction

Other (please specify)
No p.t.o. →
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FORM 8 continued
FOR RESEARCH INVOLVING WORK WITH ANIMALS
11.
Identify the principal techniques to be used: Tick as appropriate

Inhalation

Interruption of function

Removal of tissues / organs

Parenteral administration

Drug testing / manufacture

Oral administration

Fitting prosthesis

Isolation of organs

Implants

Surgery

Serum production

Other (please specify)
12.
Categorize the anticipated severity of pain and suffering for the animals to be used?

Mild:

Moderate:

Severe:

Explain how the degrees of severity of pain and suffering are to be minimised and how are side effects to be alleviated.
13. Will the animals be sacrificed during the course of the experiment? Yes
Yes 14. Have you had previous experience in the conduct of experiments on live animals?

Give details:
15. Will the person conducting the experiment receive adequate training?

Give details:
Yes
No
No
No
16. Do you have a relevant current license for animal experiments?

If YES, have there been any conditions attached to the license? Attach a copy of the license to this form

Is the person conducting the experiments covered by this license?

Where and in what condition will the animals be maintained?
Yes
Yes
Yes
No
No
No

Detail methods for the handling and disposal of animals with reference to environmental and public health issues.
17. In accordance with the ITT Dublin Code of Good Research Practice, I declare that the information provided in this form is true to the best of my knowledge and judgement.
Signature of applicant 1: Date:
Signature of applicant 2:
Signature of applicant 3:
Date:
Date:
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FORM 9
GENERAL RISK ASSESSMENT
The purpose of a risk assessment is to identify possible causes of harm and measures needed to avoid these before an accident occurs.
A hazard is anything with the potential to cause harm. The risk is the likelihood that someone will be harmed by the hazard and the severity of the harm caused. A high risk is one which is very likely to occur and/or may cause death or serious injury/illness. A low risk is extremely unlikely and/or would result in trivial or no injury/illness. A medium risk is in between these two.
By carrying out a risk assessment, you can direct attention and resources where they are most needed to prevent injuries or ill health. Deal with higher risks first.
There are five steps to carry out a risk assessment:
1 . Identify the hazards: Contact your Head of Department for documentation on ITT Dublin health and safety policies in your area. Information on general health and safety issues may be obtained from the Health and Safety Authority web page www.hsa.ie/ and www.hsa.ie/osh/regs.htm
2 . Identify who might be harmed and how : Think about the people directly involved and also others who may be affected. Look at how the work is actually done, rather than how it should be done or how you think it is done. Inexperienced people or those with health problems or who are pregnant may be at greater risk and need extra protection.
3 . Evaluate the risks and consider how the risk of harm can be removed or reduced: Consider whether existing measures give adequate protection and what more should be done to reduce risks.
This may have to be done in stages. Is it possible to get rid of the risk altogether, without introducing worse risks instead?
4. Record your findings - on the risk assessment form overleaf. Include arrangements for emergency procedures such as fire fighting or first aid if needed. Keep a copy of your assessment but don’t just fill in the form and forget it. The assessment should form the basis of safe working practices and local rules - make sure everyone knows about the risks and how to avoid them.
5. Review and revise your assessment where necessary - you must do this when there are significant changes in materials, equipment, work methods, location or people involved.
Assessments must also be reviewed if there are accidents, near misses or complaints associated with the work. It is also good practice to review assessments annually. If no changes are needed, sign and date the review box on the form.
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Form 9: General Risk Assessment Sheet
Researcher’s Name: (use block capitals)
School/Department/Centre:
Title:
Location of Work
Title of Study:
Description of Work
Give brief details of task, materials and equipment, frequency and duration. Continue on separate sheet if necessary or attach method statement, protocol etc.
1 2 3 4 5
REF HAZARD/CONSEQUENCE
(i) Type of hazard e.g. lifting & carrying; repetitive movements; heat or cold; sharp edges; working at heights; noise; electrical, chemical, biological.
(ii) Injuries that could occur and how?
(iii) Who is at risk?
CONTROLS
Safe work practices, personal protective equipment, signs, warnings, alarms, training, etc.
Frequency Risk
(high / medium / low)
(iv) Physical or mental conditions that may alter the risk? e.g. pregnancy; illness (specify); disability
(specify); height, etc.
Continuation sheet p.t.
o. →
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Form 9: General Risk Assessment Sheet - Continuation Sheet:
Researcher’s Name: (use block capitals)
School/Department/Centre:
Title of Study:
1
REF
2
HAZARD/CONSEQUENCE
Assessment completed by: Print Name:
Approved by Head of Dept./School Print Name:
Title:
Location of Work [Please type here]
Signature:
Signature:
3
CONTROLS.
4
Frequency
Date:
Date:
5
Risk
(Hi/Med/Lo)
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FORM 10
HAZARDOUS CHEMICALS RISK ASSESSMENT
The purpose of a risk assessment is to identify possible causes of harm and measures needed to avoid these before an accident occurs.
A hazard is anything with the potential to cause harm. The risk is the likelihood that someone will be harmed by the hazard and the severity of the harm caused. A high risk is one which is very likely to occur and/or may cause death or serious injury/illness. A low risk is extremely unlikely and/or would result in trivial or no injury/illness. A medium risk is in between these two. By carrying out a risk assessment, you can direct attention and resources where they are most needed to prevent injuries or ill health.
There are five steps to carry out a chemicals risk assessment:
1 . Identify the hazards - check labels and the MSDS (Material Safety Data Sheet) which suppliers provide with all chemicals. Check reaction products, intermediates and associated equipment hazards, at all stages including preparation, storage and disposal.
Contact your School Safety Officer and/or Head of School for documentation on Health and Safety policies. Information on general health and safety issues may be obtained from the Health and Safety Authority web page www.hsa.ie/ .
2 . Identify who might be harmed and how - think about the people directly involved and also others who may be affected. Look at how the work is actually done, rather than how it should be done or how you think it is done. Inexperienced people or those with health problems or who are pregnant may be at greater risk and need extra protection.
3 . Evaluate the risks and consider how risks of harm can be reduced – do existing measures give adequate protection and what more should be done to reduce risk? Is it possible to eliminate the risk altogether by using a different chemical or process?
4. Record your findings - on the risk assessment form overleaf. Include instructions for the arrangements that have been put in place for the safe disposal of waste and emergency procedures, including fire fighting and first aid. A copy of your assessment form should be kept near to where the work is being done, and everyone involved should be familiar with the contents. Ideally, the assessment should be included in practical scripts, laboratory and research protocols. The assessment should form the basis of safe working practices and local rules. Don’t just fill in the form and forget it - make sure everyone in your team or class knows about the risks and how to avoid them.
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5. Review and revise your assessment where necessary - you should do this when there are significant changes in materials, equipment, work methods, location or people involved. Assessments should also be reviewed if there are accidents, near misses or complaints associated with the work.
If work also involves biological agents, completed FORM 11 - BIOLOGICAL AGENT RISK
ASSESSMENT
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FORM 10: Chemical Risk Assessment Sheet
Researcher’s Name: (use block capitals)
School/Department/Centre:
Title:
Location of Work
Title of Study:
Description of Work
Give brief details of task, materials and equipment, frequency and duration. Continue on separate sheet if necessary or attach method statement, protocol etc.
1 2 3 4 5
REF CONTROLS Frequency Risk HAZARD/CONSEQUENCE
(i) Hazards of chemicals used, mixtures, products, intermediates etc. e.g. toxic by inhalation or ingestion; skin irritant; corrosive; flammable; explosive; carcinogenic; radioactive.
Safe work practices, personal protective equipment, signs, warnings, alarms, training, etc.
(high / medium / low)
(ii) Injuries that could occur and how?
(iii) Who is at risk?
(iv) Physical or mental conditions that may alter the risk? e.g. pregnancy; illness (specify); disability (specify); height, etc.
Continuation sheet p.t.o. →
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FORM 10: Chemical Risk Assessment Sheet - Continuation Sheet:
Researcher’s Name: (use block capitals)
School/Department/Centre:
Title of Study:
1
REF
2
HAZARD/CONSEQUENCE
Assessment completed by: Print Name:
Approved by Head of Dept./School Print Name:
Title:
Location of Work
Signature:
Signature:
3
CONTROLS.
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4
Frequency
Date:
Date:
5
Risk
(Hi/Med/Lo)
21

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FORM 11
BIOLOGICAL AGENT RISK ASSESSMENT
If work also involves hazardous chemicals e.g. disinfectants, attach a completed FORM 10 -
Chemical Risk Assessment.
If work involves genetically modified organisms complete a FORM 12 – ‘Work Involving
Genetically Modified Organisms Risk Assessment ’ instead of the Biological Agent Risk
Assessment Form.
A biological agent is any micro-organism, including those which have been genetically modified, a cell culture or a human endoparasite, which may be able to provoke any infection, allergy, toxicity or other risk to human health. It includes bacteria, viruses, fungi and parasites.
The possible transmission of a biological agent through use of human and/or animal material and incidental exposure e.g. work with soil, stagnant water, should be taken into account.
The purpose of this risk assessment is to identify possible causes of harm and measures needed to avoid them - before an accident occurs. By carrying out a risk assessment, you can direct attention and resources where they are most needed to prevent injuries or ill health.
A hazard is anything with the potential to cause harm. Risk is the likelihood that someone will be harmed by the hazard and the severity of the harm caused. A high risk is one which is very likely to occur and/or may cause death or serious injury/illness. A low risk is extremely unlikely and/or would result in trivial or no injury/illness. A medium risk is in between these two.
There are five steps to carry out a risk assessment :
1 . Identify the hazards : Check suppliers’ information, journals and the list of biological agents classified by the Health and Safety Authority (www.hsa.ie/ see legislation).
Consider how the agents cause illness e.g. inhaled spore or dust, skin contact, via cuts or mucus membranes. Think about hazards at all stages including preparation, storage and disposal.
2 . Identify who might be harmed and how : Think about the people directly involved and also others who may be affected. Look at how the work is actually done, rather than how it should be done or how you think it is done. Inexperienced people or those with health problems or who are pregnant may be at greater risk and need extra protection.
3 . Evaluate the risks and consider how the risk of harm can be reduced: Consider whether existing measures give adequate protection and what more should be done to
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726902943 reduce risks. Is it possible to get rid of the risk altogether by using a different agent or process?
4. Record your findings on the risk assessment form overleaf. Include instructions for safe disposal of waste and emergency procedures, including decontamination and first aid. A copy of your assessment form should be kept near to where the work is being done, and everyone involved should be familiar with the contents. Ideally, the assessment should part of practical scripts, laboratory and research protocols. The assessment should form the basis of safe working practices and local rules. Don’t just fill in the form and forget it; make sure everyone in the team knows about the risks and how to avoid them.
5. Review and revise your assessment where necessary - you should do this when there are significant changes in materials, equipment, work methods, location or people involved. Assessments should also be reviewed if there are accidents, near misses or complaints associated with the work.
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FORM 11: Biological Risk Assessment Sheet
Researcher’s Name: (use block capitals)
School/Department/Centre:
Title:
Location of Work
Title of Study:
Description of Work
Give brief details of task, materials and equipment, frequency and duration. Continue on separate sheet if necessary or attach method statement, protocol etc.
1 2 3 4 5
REF Frequency HAZARD/CONSEQUENCE
Hazards of biological used, blood borne infection; skin sensitisation; sensitisation by inhalation; toxic by ingestion or inhalation, products, intermediates etc.
CONTROLS
Laboratory containment level - specify level (1-4):
Injuries that could occur and how?
Who is at risk?
Physical or mental conditions that may alter the risk? e.g. pregnancy; illness (specify); disability (specify); height, etc.
Safe work practices, personal protective equipment (ppe), signs, warnings, alarms, training, etc.
Environmental controls (specify types): exhaust ventilation; safety or fume cupboards; limited access to work area; protective clothing; respiratory protection; information; supervision
Arrangements for disinfection and disposal methods of samples, contaminated materials, sharps etc.
Risk
(high / medium / low)
Conti nuation sheet p.t.o. →
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FORM 11: Biological Risk Assessment Sheet - Continuation Sheet:
Researcher’s Name: (use block capitals)
School/Department/Centre:
Title of Study:
1
REF
2
HAZARD/CONSEQUENCE
Assessment completed by: Print Name:
Approved by Head of Dept./School Print Name:
Title:
Location of Work
Signature:
Signature:
3
CONTROLS.
13/04/2020
4
Frequency
Date:
Date:
5
Risk
(Hi/Med/Lo)
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FORM 12
RISK ASSESSMENT OF WORK INVOLVING GENETICALLY MODIFIED ORGANISMS
This risk assessment form incorporates a biological agents risk assessment, so you do not have to complete a separate FORM 11 Biological Agents Risk Assessment.
If work also involves hazardous chemical, e.g. disinfectants, a form 10 hazardous chemicals risk assessment must also be completed.
The purpose of this form is to provide the required notification of an intention to work with genetically modified organisms and to complete an assessment of the risks associated with this work. This assessment must include risks arising from both the modified and the un-modified biological agents to be used in the work. It must also include an assessment of the risk to the environment as well as the risk to human health.
A biological agent means “any micro-organism, including those which have been genetically modified, a cell culture and a human endoparasite, which may be able to provoke any infection, allergy toxici ty or other risk to human health”. This includes bacteria, viruses, fungi and parasites. The possible transmission of a biological agent through the usage of human and/or animal material and incidental exposure e.g. work with soil, stagnant water, should be taken into account.
A genetically modified organism (GMO) is any organism (cellular or non-cellular) including bacteria, viruses, fungi, plant and animal cells in which the genetic material has been altered in a way that does not occur naturally by mating and/or natural recombination. Three examples
(amongst others) of techniques covered by this definition are:

Recombinant DNA techniques using viral or bacterial vectors

The direct introduction of DNA into an organism, e.g. by micro-injection

Cell fusion or hybridisation
The submission of a risk assessment Form 10 (iv) for ‘Work involving genetically modified organism’ to the Research Ethics Committee is for consideration of the ethical aspects of the work involved. Researchers should ensure that they formally submit work to a competent government authority in compliance with current regulations (see below)
Submission to a Competent Authority
Researchers should note that they are obliged to register all operations with GMO’s with the relevant authority.
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The commencement of a GMO contained use operation (bacteria, plants, or animals) prior to the
1 st January 1995 constitutes an existing use and a notification of existing use must be submitted to the competent authority in accordance with Article 14 of the GMO Regulations, S.I. No. 345 of
1994.
Where the contained use commenced on January 1 st 1995 or anytime thereafter, a notification of first time use must be submitted in accordance with Article 16 of the GMO Regulations, 1994.
Researchers should also note that Genetically Modified Micro-organisms (GMM) are classified as Group I GMM or Group II GMM in accordance with GMO Regulations S.I. No. 348 of 1996.
The type of operation must be classified as Type A (Research & development) or Type (B)
(Commercial) –more precise definitions are provided under Article 3 of the GMO Regulations
1994.
Risk Assessment
The purpose of a risk assessment is to identify possible causes of harm and the measures needed to avoid these – before an accident occurs.
A hazard is anything with the potential to cause harm. The risk is the likelihood that harm will be incurred and the severity of the harm caused. A high risk is one that is very likely to occur and/or has serious consequences (death, serious injury/illness, significant harm to the environment). A low risk is extremely unlikely and/or would result in trivial or no injury/illness/harm to the environment. A medium risk is in between these two.
By carrying out a risk assessment, you can direct attention and resources where they are most needed to prevent harm.
There are five steps to carry out in a risk assessment:
1. Identify the hazards check suppliers’ information, journals and the list of biological agents classified by the Health and Safety Authority ( www.hsa.ie/ see legislation above). Consider how the agents cause illness e.g. inhaled spore or dust, skin contact, via cuts or mucus membranes. Think about hazards at all stages including preparation, storage and disposal.
Contact your School Safety Officer and/or Head of School for documentation on Health and
Safety policies. Information on general health and safety issues may be obtained from the
Health and Safety Authority web page www.hsa.ie/ . These sites contain information on the
Safety, Health and Welfare at Work Act, 1989 including the Safety. Health and Welfare at
Work (Biological Agents) Regulations, 1994.
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2. Identify who might be harmed and how - think about the people directly involved and also others who may be affected. Look at how the work is actually done, rather than how it should be done or how you think it is done. Inexperienced people or those with health problems or who are pregnant may be at greater risk and need extra protection.
3. Evaluate the risks and consider how the risk of harm can be reduced - consider whether existing measures give adequate protection and what more should be done to reduce risks.
Is it possible to get rid of the risk altogether by using a different agent or process?
4. Record your findings - on the risk assessment form overleaf. Include instructions for safe disposal of waste and emergency procedures, including decontamination and first aid. A copy of your assessment form should be kept near to where the work is being done, and everyone involved should be familiar with the contents. Ideally, the assessment should be included in practical scripts, laboratory and research protocols. The assessment should form the basis of safe working practices and local rules. Don’t just fill in the form and forget it - make sure everyone in your team or class knows about the risks and how to avoid them.
5. Review and revise your assessment where necessary - you should do this when there are significant changes in materials, equipment, work methods, location or people involved.
Assessments should also be reviewed if there are accidents, near misses or complaints associated with the work.
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Information Sources: Table 1 EU legislation
Directive/
Regulation
Purpose
Directive
90/219/EEC
Directive
90/220/EEC
Directive
Directive
90/679/EEC
Regulates the contained use of
GMM s
Regulates the deliberate release of GMO's into the environment for: i. R&D purposes-Field
Trials ii. Placing GMO products on the market
Regulates biological agents in the workplace
Directive
94/55/EC
Regulation
258/97/EC
Regulates the transportation of certain GMO's
Regulates Novel Foods &
Novel Food Ingredients- including GMO's
Competent Authority
EPA
EPA
Department of Environment &
Local Government are responsible for certain functions, e.g. decisions to place GMO's on the market under Article 21 of this
Directive.
Health and Safety Authority
(HSA)
Department of Enterprise
Trade & Employment
Department of Health &
Children
Regulation
1139/98/EC
2309/93/EEC
Directive
91/414/EEC
Regulates the labelling of certain foodstuffs produced from GMO's
Regulates GMO's for medicinal and veterinary use
Regulates the use of plant protection products
Department of Health &
Children
Irish Medicines Board (IMB)
Pesticide Control Service of the Department of Agriculture
& Food
Aspects regulated
Contained use of Genetically Modified Micro-organisms (GMM's), also GM animals & GM plants.
Environmental assessment for the cultivation and importation of
GMO's in the EU;
Animal feed aspects - feeding of ‘live’ GMO's to animals;
Human health aspects (including toxicity and allergenicity), related to the cultivation of GM crops in the EU.
Workplace contact
Transportation
Foods and food ingredients containing or consisting of GMO's;
Foods and food ingredients produced from, but not containing
GMO's, for example, oil from GM soybeans.
Labelling of foods derived from GM soybean and GM maize (Ciba maize).
Regulates medicinal & veterinary products including those products which contain or consist of GMO's.
Regulates the use of herbicides, insecticides & fungicides etc. on crops including GM crops.
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Table 2 EU Legislation in preparation
Directive
Seed for cultivation
Purpose
The proposed Directive will amend current Directives relating to seed
Animal feed The proposed Directive will amend current Directives relating to animal feed
ALSO CONTACT:

Environmental Protection Agency: http://www.epa.ie/

Department of the Environment & Local Government
Competent Authority
Department of
Agriculture & Food will be responsible
Department of Agriculture &
Food will be responsible
Aspects regulated
Regulates GM seed to be placed on catalogues for use in agriculture.
Regulates animal feeding stuffs containing or consisting of GMO's and feed derived from GMO's.

Irish Medicines Board http://www.imb.ie

Health and Safety Authority http://www.hsa.ie

Food Safety Authority of Ireland http://www.fsai.ie/

The Department of Arts, Culture, Gaeltacht and the Islands - http://www.environ.ie/

Department of Health & Children - http://www.doh.ie

Department of Agriculture and Food- http://www.irlgov.ie

Pesticide Control Service-DAF- http://www.irlgov.ie/daff/

Department of Enterprise, Trade and Employment- http://www.irlgov.ie/ealga/

EU Commission Sites: http://europa.eu.int/comm/dg11/abc.htm
 http://europa.eu.int/comm/dg24/ http://www.entemp.ie
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FORM 12: Genetically Modified Organism (GMO) Risk Assessment Sheet
Researcher’s Name: (use block capitals)
School/Department/Centre:
Title of Study:
Title:
Location of Work
Description of Work
Give brief details of task, materials and equipment, frequency and duration. Continue on separate sheet if necessary or attach method statement, protocol etc.
Compliance with GMO Regulations
 Has the relevant Competent Authority been notified of the work with the GMO? Tick one only
If yes:
 Name of Competent Authority:
 Has the work been approved by Competent Authority?
Tick one only
 If not yet approved, what is the expected date of approval? Give Date :
 What is the expected start date of the work with the GMO? Give Date :
Copies of documentation indicating approval for commencement of work should be supplied with this form.
If no:
 Name of Competent Authority to which the application is to be made:
 Has the work been approved by Competent Authority?
Tick one only
 When is the submission to be made? Give Date :
 What is the expected approval date? Give Date :
 What is the expected start date of the work with the GMO? Give Date :
The Research Ethics Committee must be notified when the approval for commencement of work becomes available.
Yes
Yes
Yes
No
No
No
Continuation sheet 1 p.t.o. →
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FORM 12:
Researcher’s Name: (use block capitals) Title:
School/Department/Centre:
Title of Study:
Location of Work
Classification of Genetically Modified Organism
Name(s) of organism(s): Group
I or II
Characteristics
Capacity to survive, establish, disseminate and/or displace other organisms / plants / animals
Pathogenicity to plants and/or animals
Potential for transfer of genetic material between GMO and other organisms
Products of gene expression that could be toxic to other organisms/plants/animals
Phenotypic and genetic stability
Potential to cause other harm to target or non-target organisms/plants/animals (specify what sort of harm)
Capacity to survive, establish, disseminate and/or displace other organisms / plants / animals
Pathogenicity to plants and/or animals
Potential for transfer of genetic material between GMO and other organisms
Products of gene expression that could be toxic to other organisms/plants/animals
Phenotypic and genetic stability
Potential to cause other harm to target or non-target organisms/plants/animals (specify what sort of harm)
Continuation sheet 2 p.t.o. →
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726902943
FORM 12: Genetically Modified Organism (GMO) Risk Assessment Sheet continuation sheet 2
Researcher’s Name: (use block capitals) Title:
School/Department/Centre: Location of Work
Title of Study:
1
REF
2
HAZARD/CONSEQUENCE
Hazards of biological used, blood borne infection; skin sensitisation; sensitisation by inhalation; toxic by ingestion or inhalation, products, intermediates etc.
3
CONTROLS
Laboratory containment level - specify level (1-4):
Safe work practices, personal protective equipment (ppe), signs, warnings, alarms, training, etc.
Injuries that could occur and how?
Who is at risk?
Physical or mental conditions that may alter the risk? e.g. pregnancy; illness (specify); disability (specify); height, etc.
Environmental controls (specify types): exhaust ventilation; safety or fume cupboards; limited access to work area; protective clothing; respiratory protection; information; supervision; monitoring and control
Arrangements for disinfection and disposal methods of samples, contaminated materials, sharps etc.
Further control measures to be considered e.g. use of more extensively disabled host; enclose process etc.
4
Frequency
5
Risk
(high / medium / low)
Continuation she et 3 p.t.o. →
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FORM 12: Genetically Modified Organism (GMO) Risk Assessment Sheet continuation sheet 3
Researcher’s Name: (use block capitals) Title:
School/Department/Centre:
Title of Study:
Location of Work
1
REF
2
HAZARD/CONSEQUENCE
3
CONTROLS.
Assessment completed by: Print Name:
Approved by Head of Dept./School Print Name:
Signature:
Signature:
4
Frequency
Date:
Date:
5
Risk
(Hi/Med/Lo)
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FORM 13
IONISING RADDIATION
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FORM 14
Fieldwork Risk Assessment
36