Part A Application Form
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Application for Minimal Risk Research Approval Signatures (as appropriate)
Proposer’s Signature: ______________________
Supervisor’s Signature: ______________________
Researcher’s Signature: ______________________
Date: ______________________
Research Ethics Review
MINIMAL RISK
Application and Assessment Form
Part B – Assessment Form
Ethical Assessment of Research Proposal at Minimal Risk level
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To be completed by the Chairs of:
Institute Research Ethics Committee (IREC)
Institute Postgraduate Committee (IPC)
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Research Proposal Approved
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Research Proposal Approved subject to recommendations (attached)
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Research Proposal Approved on condition that a recognised external ethics committee is identified and the necessary approval is received prior to recruitment of participants / data collection
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Research Proposal requires more thorough research ethics evaluation.
Research Proposer/Supervisor/Researcher instructed to submit a full Ethics Application to the Institute Research Ethics Committee (IREC) for approval. Recruitment of research student may proceed in accordance with Institute enrolment/recruitment policy subject to full ethical approval being sought. No primary research involving the recruitment of or engagement with participants can take place until full ethics approval has been received
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Research Proposal Rejected on the grounds:
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that the Institute is not licensed of otherwise authorised to approve such research
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that the project presents major ethics concerns
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Chairman of Institute Research Ethics Committee
(BLOCK LETTERS) _____________________________
Signature: _____________________________________
Date: __________
Chairman of Institute Postgraduate Committee
(BLOCK LETTERS) ______________________________
Signature: ______________________________________
Date: ____________
Appendix 4
Research Ethics Committee Application Form
For Applicant to complete:
Applicant’s Name:
Short title of Project:
It is essential that this form is completed fully and the relevant enclosures are received if the study is to receive proper scrutiny by the Research Ethics Committee (REC). Please refer to the checklist below before sending the form.
Please also ensure that all supporting documents are attached securely to the12 copies of the application form and secured together with a staple.
Applications which are not collated in sets will be returned to the author.
Address to send application: REC Application, Development Office, Institute of Technology Tralee, Co. Kerry, Ireland.
Checklist
Please indicate if the following have been enclosed by selecting Yes/No/Not applicable options below. Please forward copies of the form and relevant enclosures required as outlined below.
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Yes
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No
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Not
applicable
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12 copies of application form (double-sided if possible)
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12 copies of protocol (no more than 4 A4 : pages double-sided if possible)
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12 participant consent form(s)
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12 participant information sheet(s)
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12 Questionnaire (s)
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12 copies of lead applicant’s CV on 1 side A4
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I confirm that if necessary, a member of the research team can attend the next REC meeting to address application. The representative of the research team must be the Principal Investigator or other person thoroughly familiar with and able to represent all aspects of the protocol.
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SECTION 1 Details of applicant(s)
1. Short title of project (in not more than 6 words)
Full title
Period for which approval is sought
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2. Applicant (All correspondence will be sent to this address unless indicated otherwise.)
Family Name Forename: Title:
Present appointment of applicant:
Qualifications:
Address (for correspondence regarding application):
Tel: Fax: Email:
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3. Other workers and departments/institutions involved
Name Department Appointment
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Signature of relevant personnel
Applicant
I undertake to carry out the work outlined here in accordance with the principles of the Declaration of Helsinki (5th Revision 2000) - and its amendments. The details contained in this document are, to the best of my knowledge, correct. I confirm that any training necessary for the execution of this project will be undertaken by current and by future researchers on the project.
Signature of applicant Date
Head of Department/Supervisor with overall responsibility for the project
I am fully aware of the details of this project and agreeable for it to continue as outlined here. I can confirm that the necessary facilities and resources are available to the researcher.
Signature Date
NAME AND TITLE IN CAPITALS
DEPARTMENT: …………………………………………………………………………………………………..
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SECTION 2 Details of project
This section must be completed. A copy of the protocol should be enclosed with the application form but it is not sufficient to complete questions by referring to the protocol. Please summarise in the space provided.
5. Aims and objectives of project (i.e., what is the intention of the project?)
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Study endpoints:
Summary of practical benefits/improvements which are envisaged
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6. Background to study
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7. Brief outline of project (i.e., what do you intend to do?)
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8. Study design
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9. i) Hypothesis or key research questions to be answered
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ii) Plan of Investigation?
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iii) Procedures or investigations involving risks to participants’ well being or safety (What, when, how often and risk(s) associated with all procedures)?
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10. Does the study fall into any of the following categories?
Pilot Yes No N/A
Multi-centre study Yes No N/A
Undergraduate student project Yes No N/A
If student project, what course is being undertaken, in which institution?
If this is a multi-centre study, please complete the details below, otherwise go to Question 11.
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i) Which centres are involved?
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ii) Which ethics committees have been approached, and what is the outcome to date?
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Who will have overall responsibility for the study?
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Who has control of the data generated?
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11. Location of the study?
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12. Has any funding been obtained, or is it being sought by the investigator in respect of this study (include research grants)?
- funding applied for Yes No
- funding secured Yes No
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If relevant, where will research funds be lodged? N/A
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Does the investigator(s) have any direct personal involvement (e.g. financial, share-holding etc) in the sponsoring organisation? Yes No
If yes, give details:
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Will any restrictions be placed on dissemination of findings or publication of results? Yes No
If yes, give details:
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13. Schedule
Proposed starting date: ___________ Proposed duration: _____ months
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SECTION 3 Recruitment of participants
14. a) How will the participants in the study be selected, approached and recruited?
b) What inclusion and exclusion criteria will be used?
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15. How many participants will be recruited and of what age groups?
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16. How will the control group (if used) be selected, approached and recruited; what inclusion and exclusion criteria will be used? (Type NA if no controls and go to question 18).
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17. How many controls will be recruited and of what age groups?
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18. Are the participants included in this study involved in any other research investigation at the present time?
Yes No Not known
If Yes, please give details.
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19. Will participants receive any payment or other incentive to participate?
Yes No
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If yes, give details of incentive per participant?
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ii) If yes, what is the source of the incentive?
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SECTION 4 Consent
20. Is written consent to be obtained?
Yes No
If Yes, please attach a copy of the consent form to be used.
If no, please justify
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21. Does the study include participants for whom English
is not a first language?
Yes No NA
If Yes give details of arrangement made; if No please justify.
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22. Are the participants in one of the following groups?
Children under 16 Yes No Unknown
People with learning difficulties Yes No Unknown
Other vulnerable groups e.g. psychological disorders, dementia Yes No Unknown
If Yes, please complete the details below, otherwise go to Question 23.
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i) What special arrangements have been made to deal with the issues of consent and assent, e.g. is parental or guardian agreement to be obtained, and if so in what form?
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ii) In what way, if any, can the proposed study be expected to benefit the individual who participates?
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23. Will the participant be given a written information sheet or letter?
Yes No
If Yes, please attach copy to this application form.
If No, please justify.
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SECTION 6 Risks and ethical problems
24. Are there any ethical problems or considerations that the investigators consider to be important or difficult with the proposed study?
Yes No
If Yes, please give details:
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25. Are there any potential hazards to participants or patients?
Yes No
If Yes, please give details, and give the likelihood and details of precautions taken to minimise them, and arrangements to deal with adverse events, including reporting to the relevant authorities.
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26. Is this study likely to cause discomfort or distress to participants/patients?
Yes No
If Yes, estimate the degree and likelihood of discomfort or distress entailed and the precautions to be taken to minimise them.
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SECTION 7 Indemnity and confidentiality
Product liability and consumer protection legislation make the supplier and producer (manufacturer) or any person changing the nature of a substance, e.g. by dilution, strictly liable for any harm resulting from a consumer's use of a product.
27. i) What arrangements have been made to provide indemnification and/or compensation in the event of a claim by, or on behalf of, a participant for negligent harm?
N/A
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ii) What arrangements been made to provide indemnification and/or compensation in the event of a claim by, or on behalf of, a participant for non-negligent harm?
N/A
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iii) Will an undergraduate student be involved directly in conducting the project?
Yes No
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28. i) Will the study data be held on computer? Yes No
ii) If Yes, will the data be held so that participants cannot be identified from computer
files (i.e. no name, address or other potential identifier such as GMS or RSI number) ?
Yes No
iii) If No, give reasons
iv) Will records (preferably paper records) linking study participant ID numbers with identifying features be
stored confidentially? Yes No
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29. Will the study include the use of any of the following?
Audio/video tape recording Yes No
Observation of participants Yes No
If Yes to either,
a) How are confidentiality and anonymity to be ensured?
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b) What arrangements have been made to obtain consent?
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c} What will happen to the tapes at the end of the study? [(Note: they should usually be stored for data verification
or transcribed)]
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Please ensure that you complete the checklist on the front cover of the application form and include all relevant enclosures.
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