ETHICS AND RISK IN RESEARCH ASSESSMENT FORM

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.

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:
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.

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7. RESEARCH ETHICS DECLARATIONAll 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 [Form3]

  • Consent form for research involving ‘less powerful’ subjects, minors, or those under 18 years [Form4]

  • Neonatal material [Form5]

  • Conflict of interest [Form6]

  • Drugs and medical devices [Form 7]

  • Animal welfare [Form 8]

  • General risk assessment [Form9]

  • 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 [Form13]

  • 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.

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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: / 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)

FORM2

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: / Number
  • healthy subjects
/ Others – specify:
  • in-patients
/ a)
  • clinic attendees
/ b)
  • minors
/ c)
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 Form3
/ 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 organization and if so by whom?
/ Yes / No
  • 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).

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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 / Yes / No
b)Physical contact / Yes / No
c)Any procedure that may cause mental distress / Yes / No
8. Outline the procedures involved in your study
  • Are samples to be taken? If YES, indicate:
/ Yes / 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 partof 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 inSection 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:
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 / No
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:
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:
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 / 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 / Verbal:
Written:
Witnessed:
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:

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)
Attach a copy of the consent form and any other relevant material / Type here:
5. Has parent's/guardian's consent to be obtained? / Yes / 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 / Verbal:
Written:
Witnessed:
Otherspecify:
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

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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: / Date:
Signature of Consultant: / Date:
Hospital:

FORM6 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:

FORM7

DRUGS AND MEDICAL DEVICES

Please refer to the Irish Medical Board web page for more information

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
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?
/ Yes / No
  • Is any drug or device being supplied by a company with a Clinical Trial Licence issued by the Irish Medical Board?
/ Yes / No
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:

FORM8

FOR RESEARCH INVOLVING WORK WITH ANIMALS

Note: In Ireland, scientific research and experimental activity on live animals may only be performed whereno alternative procedure is available and under licencefrom the Minister for Health and Childrenunder 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
  • If YES, by whom?

6. How is the work to be funded?
7. Is the use of animals essential? / Yes / No
8.Justify why animals should be used Type here:
9. Could the objective of the experiment be achieved using alternative techniques? / Yes / No
  • 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)

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FORM 8continued

FOR RESEARCH INVOLVING WORK WITH ANIMALS

11. Identify the principal techniques to be used: Tick as appropriate
  • Interruption of function
/
  • Parenteral administration
/
  • Inhalation

  • Removal of tissues/organs
/
  • Drug testing/ manufacture
/
  • Oral administration

  • 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
  • Give details:

15. Will the person conducting the experiment receive adequate training? / Yes / No
  • Give details:

16. Do you have a relevant current license for animal experiments? / Yes / No
  • If YES, have there been any conditions attached to the license? Attach a copy of the license to this form
/ Yes / No
  • 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:

FORM9

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.