Please download and read the guidelines before completing this form: http://www.bangor.ac.uk/healthcaresciences/ethics.php.en
Please answer all the questions; applications that are not fully completed will be returned to the applicant.
Are you:
A member of Bangor University Staff
An undergraduate student
A postgraduate student on a taught programme (MSc., Prof Doc)
A postgraduate student on a research programme (MRes, MPhil, PhD)
Please check this box to request an Expedited Review
(if you do not request expedited review your application will be reviewed at the next meeting of the HCMS AEC)
Please check all that apply
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Which external bodies will your proposal be submitted to for approval?
NHS REC
Social Care REC
R&D Committee
I will not be submitting this proposal for external REC or R&D approval
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Version 2: April 2013 Proposal number:

PART ONE: GENERAL INFORMATION
1 Date
2 School/Institute
3 Applicant
4 Supervisor (if relevant)
5 Study funder
6 Project Title
7 Name + local residential address of those conducting the study (the address to which we should send any correspondence about your project and where it will reach you promptly)
8 Email addresses of those conducting the study
9 Name and contact details of supervisor
(for all student projects)
10 Study type (please tick)
SMS/HCS/Other
☐ Evidence synthesis (including realist, meta-ethnography and other similar approaches)
☐ Primary data collection
☐ Secondary data analysis
☐ Audit
☐ Evaluation
☐ Experimental/Quasi Experimental
☐ Other (please state below)
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PART TWO: ETHICAL CONSIDERATIONS
1 Will you describe the main study procedures to participants in advance, so that they are informed about what to expect before they make a decision to take part?
YES NO N/A
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2 Will you tell participants that their participation is voluntary? ☐ ☐ ☐
3 Will you obtain written consent for participation? ☐ ☐ ☐
4 If the study is observational, will you ask participants for their consent to being observed?
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5 Will you tell participants that they may withdraw from the research at any time and for any reason without repercussion?
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☐ ☐ ☐ 6 With questionnaires, will you give participants the option of omitting questions they do not want to answer?
7 Will you tell participants that their data will be treated as confidential and anonymised so that they cannot be identified from it?
8 Will you debrief participants at the end of their participation?
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If you have ticked No to any of Q1-8, but have ticked box A overleaf, please give an explanation on a separate sheet.
9 Will you be accessing patient data, personal or confidential information (e.g. medical records), including genetic or other identifiable information, concerning identifiable individuals?
10 Does your study involve a therapeutic intervention?
YES NO N/A
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11 Will your study involve deliberately misleading participants in any way?
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12 Is there any realistic risk of any participants experiencing either physical or psychological distress or discomfort? If Yes, give details on a separate sheet and state what you will tell them to do if they should experience any problems (e.g., who they can contact for help)
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13 Is there any realistic risk of any participants experiencing discomfort or risk to health, subsequent illness or injury that might require medical or psychological treatment as a result of the procedures?
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☐ ☐ ☐ 14 Does your study involve the use of ionising radiation on human subjects?
15 Does your study involve the use of human tissue? ☐ ☐ ☐
If you have ticked Yes to any of Q9-15, you should normally tick Box B overleaf; if not, please give a full explanation on a separate sheet .
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16 Does your project involve work with non human animals? If yes, please tick box B overleaf.
YES NO N/A
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17 Does your project involve payment of participants? Is there a significant concern that the levels of payment you offer for this study will unduly influence participants to agree to procedures that they may otherwise find unacceptable? If yes to either, please tick box B and explain in the full protocol.
18 Do participants fall into any of the following special groups? Tick box B overleaf.
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Children (under 18 years of age)
N.B. You must ensure that you have made adequate provision for child protection issues
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People with learning or communication difficulties N.B.
You must ensure that you have provided adequate provision to manage distress
Participants covered by the
Mental Capacity Act: i.e. Adults over 16 years of age who lack the mental capacity to make specific decisions for themselves. You must ensure that you have appropriate consent procedures in place. All studies involving participants who lack capacity will require review by an NHS REC.
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☐ ☐ ☐ Patients N.B. You must ensure that you have provided adequate provision to manage distress. .
Studies involving patients will require review by an NHS REC
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People in custody
People engaged in illegal activities (e.g. drug-taking)
Physically vulnerable adults
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Pregnant women or participants studied with respect to contraception or conception
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PLEASE TICK EITHER BOX A OR BOX B OVERLEAF AND PROVIDE THE
DETAILS REQUIRED IN SUPPORT OF YOUR APPLICATION. Most applications may have some ethical implications and Box B will be mostly appropriate
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BOX A
A. I consider that this project has no significant ethical implications to be brought before the Academic Ethics Committee.
Please tick
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Give a brief description (max 2000 words) of the study, including:
1.
The research question or aims and objectives;
2.
Study methodology and methods;
3.
Participants, sample and recruitment including inclusion and exclusion criteria;
4.
Data management and analysis;
5.
Proposed start and end date of the study.
Please also include / attach copies of: a) Project summary for participants; b) Participant information sheet; c) Consent form; d) Debrief form (if appropriate) e) Interview schedule / topic guide.
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Summary of Project
1.
The research question or aims and objectives
2.
Study methodology and methods;
(max 2000 words)
3.
Participants, sample and recruitment including inclusion and exclusion criteria;
4.
Data management and analysis;
5.
Proposed start and end date of the study
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BOX B
B. I consider that this project may have ethical implications that should be brought
Please tick before the Academic Ethics Committee, and/or it will be carried out with children or
☐ other vulnerable populations.
Please provide all the further information listed below in a separate attachment , in this order.
1. Title of project
2. Purpose of study (rationale, brief background to the study, research question and/or aims and objectives)
3. Participants: sample and size, recruitment methods, age, gender, exclusion/inclusion criteria
4. Research design (methods and measurements and data analysis)
5. Qualifications of the researchers to use the measures (e.g. specific questionnaires) or equipment involved
6. Venue for investigation and whether appropriate authorisation has been sought and granted
7. Estimated start date and duration of the study
8. Ethical issues and how they will be addressed
9. Procedures to ensure confidentiality and data protection
10. Project summary, consent form, participant information sheet and, where appropriate, a debriefing form
11. Approval of relevant professionals to undertake study if appropriate (e.g. Managers,
GPs, Consultants, Teachers, parents etc.)
12. Details of any payment to: participants, investigators, departments/institutions
13. Equipment required and its availability
14. If students will be engaged a project involving children, vulnerable adults, specify on a separate sheet the arrangements for training and supervision of students.
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If you tick yes to any of the questions in the table below, please outline on a separate sheet the probability and significance of the risks involved and the means proposed for the management of those risks .
1. Activity
Where relevant, please also describe the procedures to be followed in the event of an adverse event or emergency.
YES NO N/A
1 Is there significant potential risk to participants in any of the following ways?
Potential adverse effects
Potential distress/ upset
Potential for persisting or subsequent illness or injury that might require medical or psychological treatment
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☐ ☐ 2 Is there significant potential risk to researcher in any of the following ways?
Potential risk of violence or other harm to the investigator(s) (e.g., through work with particular populations or through context of research).
3 Is there significant potential risk to the institution in any way?
(e.g., controversy or potential for misuse of research findings.)
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Potential risk of allegations being made against the investigator(s).
(e.g., through work with vulnerable populations or context of research).
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4 Is there significant potential risk to other members of staff or students at the institution? (e.g., reception or other staff required to deal with violent or vulnerable populations.)
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2. Degree of Risk
The following questions address specific situations that can carry risks to the researcher and/or participants.
If you tick “yes” to any of the questions below, please refer to the guidance given (see Ethics Guidance and Procedures) on procedures for dealing with these risks and,
If you tick “yes” to any of the questions on a separate sheet, outline how these risks will be dealt with in your project.
YES NO N/A
5
6
Does the research involve the investigator(s) working under any of the following conditions: alone; away from the School; after-hours; or on weekends?
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Does the study procedure involve touching participants? ☐
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7 Does the research involve vulnerable adults or children visiting the
University?
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There is an obligation on the lead researcher to bring to the attention of the Academic Ethics
Committee any risk implications of the research not clearly covered by the above checklist.
PLEASE COMPLETE PART THREE OVERLEAF.
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The purpose of this section is to decide whether the University (as Sponsor) requires additional insurance cover for a research project. In the case of student research, this section should be completed by the supervisor.
1 Is the research to be conducted in the UK?
YES
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NO
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N/A
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2 Is the research based solely upon the following methodologies?
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Psychological activity
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Interviews/Focus Groups
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Questionnaires
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Measurements of physiological processes
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Venepuncture
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Collections of body secretions by non-invasive methods
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The administration by mouth of foods or nutrients or variation of diet other than the administration of drugs or other food supplements
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Use of ionising radiation on human subject
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ETHICAL APPROVAL APPLICATION FORM (FORM 1) CHECKLIST
Complete the submission checklist and PLEASE ATTACH all relevant information
(e.g. external REC forms, study summary, consent forms, patient information sheets, questionnaires).
Before submitting your ethics application form, please check that you have:
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Read and followed the advice provided in the Ethics Guidance & Procedures.
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Provided names and email addresses for all investigators (as this is the means we will use to contact you regarding the outcome of your ethics review).
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In Part One of the forms, ticked either Box A or Box B and provided the further information required.
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In Part Two of the forms, provided, on a separate sheet, further information on any risks likely to be incurred in conducting the study.
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Attached a project summary sheet, consent form, interview schedule and participant information sheet(s).
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Attached any questionnaires to be used in the study. If these have been validated in
English, they should not be translated. However, if these are not validated questionnaires or study instruments, you will need to include a version of each in the
Welsh language also.
PLEASE PROVIDE ELECTRONIC SIGNATURE AND DATE THE DECLARATIONS ON
THE FINAL PAGE OF THIS FORM OVERLEAF.
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1. Declaration of Ethical Compliance
This project will be carried out in accordance with the guidelines laid down by the Healthcare and Medical Sciences Academic Ethics Committee at Bangor University. I understand that I am responsible for the ethical conduct of the study. I confirm that I am aware of the requirements of the Data Protection Act and the University’s Data Protection Policy, and that this study will comply with them.
2. Declaration of Risk Assessment
The potential risks to the investigator(s) for this project have been fully reviewed and discussed. As an investigator, I understand that I am responsible for managing my safety and that of participants throughout this study. I will immediately report any adverse events that occur as a consequence of this study.
3. Declaration of Conflicts of Interest
To my knowledge, there is no conflict of interest on my part in carrying out this research.
4. Declaration of Data Ownership and IPR (for students)
I understand that any data produced through this project are owned by the University and must be made available to my supervisor on request or at the end of the project. I confirm that I am aware of the University’s Intellectual Property Policy and that this study will comply with it.
Please insert electronic signatures below, or scan paper signatures in ‘PDF’ format and attach. (If you are unable to provide an electronic or scanned signature please print and sign a hard copy and forward to: The Ethics Committee Administrator, School of
Healthcare Sciences, Bangor University, Fron Heulog, Friddoedd Road, Bangor, Gwynedd,
LL57 2EF).
I understand that in signing this form I am certifying that the study described meets appropriate methodological standards AND that I have reviewed the procedures described to ensure that they comply with ethical guidelines as published by appropriate School’s Ethical Guidance Procedures.
(Associate investigator(s)/student(s) (Chief investigator/supervisor)
Print name:
Signed:
Date:
Print name:
Signed:
Date:
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