81897631
ASSESSMENT FORM FOR ETHICS AND/OR RISK IN
RESEARCH
DRAFT – November 25th 2005
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.
31/07/2017
1
81897631
Form 1
ASSESSMENT FORM FOR ETHICS AND/OR RISK IN
RESEARCH
Completed forms should be returned to: Research Ethics Committee
1. Project Title:
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:
Tel:
E-mail:
4. Source of Funding:
Amount: €
Agency:
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. →
31/07/2017
2
81897631
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. →
31/07/2017
3
81897631
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:
Date:
Signature of applicant 3
Date:
Checklist
Please ensure the following, if appropriate, are attached:
Documents to be attached
Tick if
attached
Tick if not
appropriate
 Research Proposal
 Letters (to subjects, parents/guardians, GPs, etc)
 Questionnaire(s)
 Advertisement/Poster
 Ethical clearance from other ethical research committees
 Other (please specify)
31/07/2017
4
81897631
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:
Number
Type of Subject:
 healthy subjects
Others – specify:
 in-patients
a)
 clinic attendees
b)
 minors
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
Yes
No
 Are subjects under the age of 18 to be included? If YES, complete the Form 4
Yes
No
 Is human neonatal material to be used in this study? If YES, complete the Form 5
Yes
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
Yes
No
organization and if so by whom?
 If controls are to be included please state how they are to be selected.
NB. Names of Student Subjects receiving payment in commercially sponsored research must be notified
to the Research Ethics Committee (attach list).
p.t.o. →
31/07/2017
5
81897631
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
Yes
No
b) Physical contact
Yes
No
c) Any procedure that may cause mental distress
Yes
No
Yes
No
Yes
No
8. Outline the procedures involved in your study
 Are samples to be taken? If YES, indicate:
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?
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:
Date:
Signature of applicant 2:
Date:
Signature of applicant 3:
Date:
31/07/2017
6
81897631
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?
Yes
No
If no, complete FORM 4 for ‘less powerful’ subjects or those under 18 years.
6. If YES, what form of consent will be sought? Tick as needed
Verbal:
Please attach a copy of the relevant forms to be used
Written:
Witnessed:
Other:
7. Are the risks of the investigation judged to be minimal or nil?
Yes
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:
Date:
Signature of applicant 3:
Date:
31/07/2017
7
81897631
FORM 4
CONSENT FORM FOR RESEARCH INVOLVING
‘LESS POWERFUL’ SUBJECTS OR THOSE UNDER 18 YRS
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. Has parent's/guardian's consent to be obtained?
Yes
6. If YES, what form of consent was/will be obtained?
Verbal:
Tick as needed
Written:
Please attach a copy of the relevant forms to be used
Witnessed:
No
Other:
7. Will the child's or young person's assent be sought?
Yes
No
7. Are the risks of the investigation judged to be minimal or nil?
Yes
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:
Date:
Signature of applicant 3:
Date:
31/07/2017
8
81897631
FORM 5
RESEARCH INVOLVING HUMAN NEONETAL MATERIAL
1. Researcher’s Name: (use block capitals)
1a. Title:
2. School/Department/Centre:
2a. Location of Work [Please type here]
3. Title of Study:
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)
Type here:
 Where and how the material will be
obtained
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)
Type here:
Attach a copy of the consent form and any
other relevant material
5. Has parent's/guardian's consent to be obtained?
Yes
6. If YES, what form of consent was/will be obtained?
Verbal:
Tick as needed
Written:
Please attach a copy of the relevant forms to be used
Witnessed:
No
Other specify:
7. Will the child's or young person's assent be sought?
Yes
No
7. Are the risks of the investigation judged to be minimal or nil?
Yes
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. →
31/07/2017
9
81897631
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:
Date:
Signature of Consultant:
Date:
Hospital:
31/07/2017
10
81897631
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:
Date:
Signature of applicant 3:
Date:
31/07/2017
11
81897631
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
No
5. Does the study involve pre-marketing use of a drug/appliance or a new use for a
marketed product?
Yes
No
Yes
No
 Is any drug or device being supplied by a company with a Clinical Trial Licence Yes
No
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?
issued by the Irish Medical Board?
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?
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:
Date:
Signature of applicant 2:
Date:
Signature of applicant 3:
Date:
31/07/2017
12
81897631
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?
Yes
No
Yes
No
Yes
No
 If YES, by whom?
6. How is the work to be funded?
7. Is the use of animals essential?
8. Justify why animals should be used Type here:
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
 Physiological
 Dermatological
 Diagnostic/Forensic
 Toxicological
 Nutritional/Metabolic
 Immunological
 Tumour Induction
 Pharmacodynamic
 Pathological
 Drug Testing
 Pharmacokinetic
 Climatic
 Other (please specify)
p.t.o. →
31/07/2017
13
81897631
FORM 8 continued
FOR RESEARCH INVOLVING WORK WITH ANIMALS
11. Identify the principal techniques to be used: Tick as appropriate
 Interruption of
function
 Removal of tissues /
organs
 Parenteral
 Inhalation
administration
 Drug testing /
 Oral administration
manufacture
 Fitting prosthesis
 Implants
 Serum production
 Isolation of organs
 Surgery
 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
No
14. Have you had previous experience in the conduct of experiments on live
animals?
Yes
No
Yes
No
Yes
No
 If YES, have there been any conditions attached to the license? Attach a copy of Yes
No
 Give details:
15. Will the person conducting the experiment receive adequate training?
 Give details:
16. Do you have a relevant current license for animal experiments?
the license to this form
 Is the person conducting the experiments covered by this license?
Yes
No
 Where and in what condition will the animals be maintained?
 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:
Date:
Signature of applicant 3:
Date:
31/07/2017
14
81897631
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.
31/07/2017
15
81897631
Form 9: General Risk Assessment Sheet
Researcher’s Name: (use block capitals)
Title:
School/Department/Centre:
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
(i)
(ii)
(iii)
(iv)
HAZARD/CONSEQUENCE
Type of hazard e.g. lifting & carrying; repetitive
movements; heat or cold; sharp edges; working at
heights; noise; electrical, chemical, biological.
Injuries that could occur and how?
Who is at risk?
CONTROLS
Safe work practices, personal protective equipment, signs,
warnings, alarms, training, etc.
Frequency
Risk
(high /
medium /
low)
Physical or mental conditions that may alter the
risk? e.g. pregnancy; illness (specify); disability
(specify); height, etc.
Continuation sheet p.t.o. →
31/07/2017
16
81897631
Form 9: General Risk Assessment Sheet - Continuation Sheet:
Researcher’s Name: (use block capitals)
Title:
School/Department/Centre:
Location of Work [Please type here]
Title of Study:
1
2
3
4
5
REF
HAZARD/CONSEQUENCE
CONTROLS.
Frequency
Risk
(Hi/Med/Lo)
Assessment completed by: Print Name:
Signature:
Date:
Approved by Head of Dept./School Print Name:
Signature:
Date:
31/07/2017
17
81897631
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.
31/07/2017
18
81897631
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
31/07/2017
19
81897631
FORM 10: Chemical Risk Assessment Sheet
Researcher’s Name: (use block capitals)
Title:
School/Department/Centre:
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
REF
(i)
HAZARD/CONSEQUENCE
Hazards of chemicals used, mixtures, products,
intermediates etc. e.g. toxic by inhalation or ingestion;
skin irritant; corrosive; flammable; explosive;
carcinogenic; radioactive.
3
4
5
CONTROLS
Frequency
Risk
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. →
31/07/2017
20
81897631
FORM 10: Chemical Risk Assessment Sheet - Continuation Sheet:
Researcher’s Name: (use block capitals)
Title:
School/Department/Centre:
Location of Work
Title of Study:
1
2
3
4
5
REF
HAZARD/CONSEQUENCE
CONTROLS.
Frequency
Risk
(Hi/Med/Lo)
Assessment completed by: Print Name:
Signature:
Date:
Approved by Head of Dept./School Print Name:
Signature:
Date:
31/07/2017
21
81897631
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
31/07/2017
22
81897631
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.
31/07/2017
23
81897631
FORM 11: Biological Risk Assessment Sheet
Researcher’s Name: (use block capitals)
Title:
School/Department/Centre:
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
Hazards of biological used, blood borne infection; skin
sensitisation; sensitisation by inhalation; toxic by ingestion
or inhalation, products, intermediates etc.
CONTROLS
Frequency
Risk
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.
Laboratory containment level - specify level (1-4):
Safe work practices, personal protective equipment (ppe),
signs, warnings, alarms, training, etc.
(high /
medium /
low)
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.
Continuation sheet p.t.o. →
31/07/2017
24
81897631
FORM 11: Biological Risk Assessment Sheet - Continuation Sheet:
Researcher’s Name: (use block capitals)
Title:
School/Department/Centre:
Location of Work
Title of Study:
1
2
3
4
5
REF
HAZARD/CONSEQUENCE
CONTROLS.
Frequency
Risk
(Hi/Med/Lo)
Assessment completed by: Print Name:
Signature:
Date:
Approved by Head of Dept./School Print Name:
Signature:
Date:
31/07/2017
25
81897631
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 toxicity 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.
26
81897631
The commencement of a GMO contained use operation (bacteria, plants, or animals) prior to the
1st 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 1st 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.
27
81897631
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.
28
81897631
Information Sources: Table 1 EU legislation
Directive/
Regulation
Purpose
Competent Authority
Aspects regulated
Directive
90/219/EEC
Regulates the contained use of
GMM s
EPA
Contained use of Genetically Modified Micro-organisms (GMM's),
also GM animals & GM plants.
Directive
90/220/EEC
Directive
Regulates the deliberate
release of GMO's into the
EPA
Environmental assessment for the cultivation and importation of
GMO's in the EU;
environment for:
i. R&D purposes-Field
Trials
ii. Placing GMO
products on the market
Directive
90/679/EEC
Regulates biological
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.
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
agents in the workplace
Health and Safety Authority
(HSA)
Directive
94/55/EC
Regulates the transportation of
certain GMO's
Department of Enterprise
Trade & Employment
Transportation
Regulation
258/97/EC
Regulates Novel Foods &
Novel Food Ingredientsincluding GMO's
Department of Health &
Children
Foods and food ingredients containing or consisting of GMO's;
Regulation
1139/98/EC
Regulates the labelling of
certain foodstuffs produced
from GMO's
Department of Health &
Children
Labelling of foods derived from GM soybean and GM maize (Ciba
maize).
2309/93/EEC
Regulates GMO's for
medicinal and veterinary use
Irish Medicines Board (IMB)
Regulates medicinal & veterinary products including those products
which contain or consist of GMO's.
Directive
91/414/EEC
Regulates the use of plant
protection products
Pesticide Control Service of
the Department of Agriculture
& Food
Regulates the use of herbicides, insecticides & fungicides etc. on
crops including GM crops.
Foods and food ingredients produced from, but not containing
GMO's, for example, oil from GM soybeans.
29
81897631
Table 2 EU Legislation in preparation
Directive
Seed for
cultivation
Animal feed
Purpose
The proposed Directive will
amend current Directives
relating to seed
The proposed Directive will
amend current Directives
relating to animal feed
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.
ALSO CONTACT:
 Irish Medicines Board http://www.imb.ie
 Environmental Protection Agency: http://www.epa.ie/
 Health and Safety Authority http://www.hsa.ie
 Department of the Environment & Local Government
 Food Safety Authority of Ireland http://www.fsai.ie/
http://www.environ.ie/
 Department of Health & Children - http://www.doh.ie
 The Department of Arts, Culture, Gaeltacht and the Islands http://www.irlgov.ie/ealga/
 Department of Agriculture and Food- http://www.irlgov.ie
 EU Commission Sites: http://europa.eu.int/comm/dg11/abc.htm
 Pesticide Control Service-DAF- http://www.irlgov.ie/daff/
 http://europa.eu.int/comm/dg24/
 Department of Enterprise, Trade and Employmenthttp://www.entemp.ie
30
81897631
FORM 12: Genetically Modified Organism (GMO) Risk Assessment Sheet
Researcher’s Name: (use block capitals)
Title:
School/Department/Centre:
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.
Compliance with GMO Regulations
 Has the relevant Competent Authority been notified of the work with the GMO? Tick one only
Yes
No
Yes
No
Yes
No
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?
 When is the submission to be made?
Tick one only
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.
Continuation sheet 1 p.t.o. →
31
81897631
FORM 12: Genetically Modified Organism (GMO) Risk Assessment Sheet continuation sheet 1
Researcher’s Name: (use block capitals)
Title:
School/Department/Centre:
Location of Work
Title of Study:
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. →
32
81897631
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
2
3
4
5
REF
HAZARD/CONSEQUENCE
Hazards of biological used, blood borne infection; skin
sensitisation; sensitisation by inhalation; toxic by ingestion
or inhalation, products, intermediates etc.
CONTROLS
Frequency
Risk
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.
Laboratory containment level - specify level (1-4):
Safe work practices, personal protective equipment (ppe),
signs, warnings, alarms, training, etc.
(high /
medium /
low)
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.
Continuation sheet 3 p.t.o. →
33
81897631
FORM 12: Genetically Modified Organism (GMO) Risk Assessment Sheet continuation sheet 3
Researcher’s Name: (use block capitals)
Title:
School/Department/Centre:
Location of Work
Title of Study:
1
2
3
4
5
REF
HAZARD/CONSEQUENCE
CONTROLS.
Frequency
Risk
(Hi/Med/Lo)
Assessment completed by: Print Name:
Signature:
Date:
Approved by Head of Dept./School Print Name:
Signature:
Date:
34
81897631
FORM 13
IONISING RADDIATION
35
81897631
FORM 14
Fieldwork Risk Assessment
36