EC1 - Version 5 - August 2014
School of Health & Life Sciences
Application and Guidance notes for Ethical Approval for
Research
The School of Health and Life Sciences has three departmental ethics committee. Please
tick which committee you wish to submit your application to (please indicate with an X)
Nursing and Community Health (Chair: Dr Nicola Roberts)
Psychology, Social Work and Allied Health Sciences (Chair: Dr Phil Dalgarno)
Life Sciences (Chair: Dr Les Wood)
Category of principal applicant (please indicate with an X)
Staff:
Research student (PhD/Prof D/DPsych):
Taught postgraduate student:
Undergraduate student:
Location of research work (please indicate with an X)
On campus:
Off campus:
One copy of all of the paperwork for an ethics application should be submitted
electronically to HLSEthics@gcu.ac.uk
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School of Health & Life Sciences Ethics Committee Application Form
Project Title:
Principal Investigator (s):
Supervisor:
Other academic staff involved:
Project start date:
Date application Submitted:
Email address:
Project Duration:
Is this a clinical trial:
YOU MUST ANSWER ALL QUESTIONS
1
2
3
Will you provide participants with a written information sheet in advance of
the study describing the main procedures so that they are informed about
what to expect in your study?
Will you tell participants that their participation is voluntary?
9a
Will your participants be able to read and understand the participant
information sheet?
Will you obtain written informed consent for participation?
(consent is implied for questionnaire studies)
Will you tell participants that they may withdraw from the research at any
time without penalty and for any reason?
With questionnaires/interviews, will you give participants the option of
omitting questions they do not want to answer?
Will you tell participants that their data will be treated with full
confidentiality and that, if published, it will not be identifiable as theirs?
Will you give participants a brief explanation of the purpose of the study at
the beginning of their participation in it, and answer any questions?
Will your project involve deliberately misleading participants in any way?
9b
If YES, go to question 9b. Please note you must provide a justification in the
research proposal.
If YES, will an explanation be offered following participation?
4
5
6
7
8
10
11
Is there a realistic risk of the participant/researcher experiencing either
physical or psychological distress or discomfort?
If YES, give details in the research proposal and state how you will address
these risks (e.g. who they can contact for help).
Do the participants fall into any of the following special groups? If the
answer is YES, indicate which group(s) by ticking the appropriate box(es):
Children (under 18 years of age)
Children (under 5 years of age)
People with a disability such as learning and communication
difficulties.
Please specify:
Pregnant women
People studied with respect to mental or sexual health
People in custody
People engaged in illegal activities (e.g. drug-taking)
Non-human animals
Patients/service users
NOTE: You may also need to obtain clearance from Protection of
Vulnerable Groups (PVG) or an equivalent authority.
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YES
NO
N/A
You must tick either Box A or Box B below and provide all relevant information in support of your
application. If you answered NO to any questions 1 – 3, 5-8, or YES to any questions 9 – 11, then you must
check Box B.
I consider that this project has no significant ethical implications to be brought to the attention of the
University Research Ethics Committee.
Please provide a short study protocol in a separate attachment of no more than 2 sides of A4 (Arial font size 10). The
accompanying notes give additional information about how to write the protocol. Your proposal must include the
following sections:
1. Project title (with student name or staff member name clearly stated)
2. Version number.
3. Background information.
4. Aims and objectives of the study.
5. Brief description of participants and recruitment methods (sample, numbers, access, recruitment and inclusion
and exclusion criteria)
6. Brief description of the research methods and measurements. Include details on how the data will be securely
stored and disposed of.
7. Consent, confidentiality and anonymity
8. Risks to participants/self
Arrangements for debriefing.You must also provide the intended (1) Participant Information Sheet(s), (2) Consent
Form(s), (3) copies of any non validated or validated tools/questionnaire(s), (4) details of interview questions you plan
to use, (5) notices advertising the study,(6) draft letter(s) for gatekeeper access permission to recruit participants and
(7) replies/proof of gatekeepers approval for access to recruit participants
A
I consider that this project may have significant ethical implications that should be brought to the
attention of the University Research Ethics Committee.
Please provide a short study protocol in a separate attachment of no more than 4 sides of A4 (Arial font size 10). The
accompanying notes give additional information about how to write the protocol. Your protocol must include the
following sections:
1. Project title (with student name or staff member name clearly stated)
2. Version number.
3. Background information.
4. Aims and objectives of the study.
5. Brief description of participants and recruitment methods (sample, numbers, access, recruitment and inclusion
and exclusion criteria)
6. Brief description of the research methods and measurements. Include details on how the data will be securely
stored and disposed of.
7. Consent, confidentiality and anonymity.
8. Risks to participants/self (include a risk assessment form).
9. Arrangements for debriefing.
10. A clear statement of the ethical considerations raised by the project and how you intend to deal with them.
B
You must also provide the intended (1) Participant Information Sheet(s), (2) Consent Form(s), (3) copies of any non
validated or validated questionnaire(s), (4) details of interview questions you plan to use, (5) notices advertising the
study, (6) Risk Assessment form, (7) draft letter(s) for gatekeeper access permission to recruit participants and (8)
Replies/proof of gatekeepers approval for access to recruit participants
Declaration
I am familiar with the Declaration of Helsinki and professional body code of human research ethics (e.g.
BPS), and have discussed them with the other researchers involved in the project. I confirm that my research
abides within these guidelines.
Signature
Date
Principal Investigator
Supervisor
There is an obligation on the Principal Researcher and/or the Supervisor to bring to the attention of
the Ethics Committee any issues with ethical implications not covered by the above checklists.
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Please complete the checklist with details of the documents which are included in your
submission (where applicable)*
EC1 form
2 page protocol (for those with no significant
risks) or 4 page protocol (for those WITH
significant risks)
Participant information sheet(s)
Consent form(s)
Non-validated or validated tools / questionnaires
Interview guide/ schedule
Advert / notices for study
Risk assessment form (if applicable for those WITH
significant risk))
Your letter(s) which request access permission to
recruit participants
Gatekeepers approvals for access permission to
recruit participant
*Paperwork associated with your application does not need to be anonymised. Only one set of these
documents are needed. These can be sent as one large word document, please do not send a combined
PDF document.
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Version 5- August 2014
School of Health & Life Sciences Ethical application Guidance Notes (EC1 form)
This document is intended as a guide to the provision of sufficient information for the
Ethics Committee to assess any ethical matters connected to your proposed research project, and if so,
whether these have been addressed in an appropriate and satisfactory manner. You should bear in mind that
the reviewers may not be familiar with your specific area and should therefore try to keep the content
understandable to a non-expert (so as jargon free as possible, explain any acronyms etc).
SENDING YOUR APPLICATION
Once you have completed the forms, checklist and paperwork, please ensure that if you are a student that
your supervisor has seen your application and signed and approved this (this can be typed into the form or a
scanned copy of the first page with signatures included in the application). The application should be sent as
a word file not a PDF. When you send your application your supervisor MUST BE included in the email and
equally when you are resubmitting any corrections. The application is paperless and should be sent by email
to HLSethics@gcu.ac.uk and marking for the attention of the relevant departmental committee ticked on the
EC1 form.
*Supervisors should have reviewed the proposal, and have signed the application form and be included
(cc’ed) in the email submission
FILLING IN THE EC1 FORM
Page 1 of the EC1 form
Please give details of the departmental ethics committee that you plan to submit your ethical application to.
There are three committees within the school (Nursing and Community Health; Psychology, Social Work and
Allied Health Sciences; and Life Sciences). Please give details of the principal applicant and the location
where the project will take place (on/off campus).
Page 2 of the EC1 form
Please give details of the title, the principal investigators’ name and contact details as well as your
supervisor’s name (where appropriate).
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Q1 Potential study participants should be given written information about the study you are asking them
to take part in. This is known as a participant information sheet and has a standard format. Examples are
included on the ethics webpages for you to use.
http://www.gcu.ac.uk/media/gcalwebv2/hls/content/patientinformationsheet.doc.
Answer ‘yes’ if you are providing
this.
Q2 Participants should be able to participate and leave a study whenever they want and should not feel
coerced to participant, it is important that participants are made aware that they do not have to take part
and this should be included in your consent and information sheets as guided. Answer ‘yes’ if you are
including this in your information and consent forms.
Q3 Make sure that you write your information sheet so that it is easy to understand and potential
participants will be able to read this easily. Answer ‘yes’ if you have done this.
Q4 Written consent should be obtained from participants, this should have the participants name and
signature as well as the researchers name and signature. This should follow a standard template which is
available at the weblink below http://www.gcu.ac.uk/media/gcalwebv2/hls/content/consentform.doc Tick
yes if you are obtaining written consent
Q5-9b explore whether you have considered that participants can: withdraw from the study, miss
questions out in questionnaire/interview, confidentiality issues, provided a full explanation of the nature
of participating and in the study and if deliberate deception will be involved as part of the study’s design..
Ensure that you have considered these issues and tick ‘YES’ if you have addressed these. If you have ticked
‘NO’ to any of these questions you will need to give further details later on in the application.
Q10 If there is any risk of distressing participants or the researchers involved or causing any physical harm
this should be considered. If you answer ‘YES’ to this question, you will have to provide more details about
this further on. You will need to give details of how you are going to manage and overcome these risks.
Q11 If you are using vulnerable groups such as young children, or those with learning difficulties you will
need to provide more information, please give details of any of the vulnerable groups if you plan on
working with them and provide PVG/disclosure.
Once you have completed Q1-11 you must tick either Box A or Box B, depending on your answers to
these questions. If you answered ‘NO’ to any questions in 1 –3, 5-8, or ‘YES’ to any questions 9 – 11,
then you must check Box B.
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If you ticked box A or B the following information should be included in your proposal
Box A – no significant risks
Box B – significant risks
Protocol* - a short study protocol in a separate
attachment of no more than 2 sides of A4
Protocol* - a short study proposal in a separate
attachment of no more than 4 sides of A4
Your proposal must include the following sections:
1. Project title (with student name or staff
member name clearly stated)
2. Version number.
3. Background information.
4. Aims and objectives of the study.
5. Brief description of participants and
recruitment methods (sample, numbers,
access, recruitment and inclusion and
exclusion criteria)
6. Brief description of the research methods
and measurements. Include details on
how the data will be securely stored and
disposed of.
7. Consent, confidentiality and anonymity
8. Risks to participants/self
9. Arrangements for debriefing.
Your protocol must include the following sections:
1. Project title (with student name or staff
member name clearly stated)
2. Version number.
3. Background information.
4. Aims and objectives of the study.
5. Brief description of participants and recruitment
methods (sample, numbers, access, recruitment
and inclusion and exclusion criteria)
6. Brief description of the research methods and
measurements. Include details on how the data
will be securely stored and disposed of.
7. Consent, confidentiality and anonymity.
8. Risks to participants/self ( risk assessment
form).
9. Arrangements for debriefing.
A clear statement of the ethical considerations raised by
the project and how you intend to deal with them.
Participant Information Sheet(s)
Participant Information Sheet(s)
Consent Form(s)
Consent Form(s)
Copies of any non validated/ validated
questionnaire(s)/tool(s)
Copies of any non validated/ validated questionnaire(s)/
tool(s)
Details of interview questions you plan to use
(interview guide/schedule)
Details of interview questions you plan to use (interview
guide/schedule)
Notices advertising the study
Notices advertising the study
Draft letter(s) for access permission to recruit
participants
Risk Assessment form (if applicable).
Gatekeepers approvals for study access
Draft letter(s) for access permission to recruit
participants
Gatekeepers approvals for study access
These documents do not need to be anonymised and only one copy needs to be sent to the HLS ethics
mailbox.
*Further guidance on writing a protocol is available on Page 9
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Page 3 DECLARATION
The declaration should be completed by the Principal Investigator and the supervisor (where appropriate)
and signed electronically or scanned. All researchers are obliged to ensure as far as possible that their
research is ethical and that their participants are protected from harm.
Both postgraduate and undergraduate students should have the submission version of their protocol and
supporting documents reviewed by their supervisor. Both student and supervisor must sign the application
prior to submission, and this should be regarded as taking joint responsibility for both the content of the
proposal and observing the ethical principles agreed to for the duration of the study. Please send a signed
copy of the signature page if electronic signatures are not available for the form, as well as a word version of
the file (please do not send a pdf version of the form).
Page 4 of the EC1 form
This is a checklist for the ethics committee to check before reviewing your application that you have
included the relevant files. Fill this in at the end once you have completed the rest of the form. Please
ensure that you complete this fully. Only one copy of this document is needed and does not require to be
anonymised. Please ensure these are separate files or forwarded emails where appropriate.
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ACCOMPANYING DOCUMENTATION: PROTOCOL
Your protocol must include all of the following headings and contain the specified information;
supplementary headings and information may be added where appropriate (but be mindful of the space
restrictions). This should be either 2 pages or 4 A4 pages depending on whether Box A or B is ticked in the
EC1 form.
TITLE: The full title of your study with your name (as PI/principal investigator) and the name of your
supervisor, where appropriate.
VERSION NUMBER: Please provide a version number (e.g. Version 1, 11 August 2012). If you subsequently
wish to make changes to the protocol, you must first obtain approval from the Ethics Committee (by
submitting a ‘Protocol Amendment’), and then revise the version number and date in the new document.
INTRODUCTION: This section should provide the background information to your study.
 What are the main issues your study will focus on?
 What makes this area of research important?
 What work has already been conducted in this area (include key/relevant references)?
AIMS AND OBJECTIVES: The research questions and/or hypotheses you plan to test should be stated
clearly here. This information should follow on clearly from what you've already said in the introduction.
You can list aims/objectives as bullet points.
PARTICIPANTS & RECRUITMENT METHODS: In this section, you must provide the following information
about potential participants;
 Who are they?
 How will they be identified?
 How will they be contacted?
 How do you plan to get their consent for participation?
 How many do you plan to recruit?
 Where applicable, inclusion/exclusion criteria (This will include age range as well as any other
requirements for your study)will they be anonymous?
DESIGN & METHODS: In this section you must describe what will be expected of the participants in your
study. You should provide some detail about the following:
 Where the study will take place (e.g. On campus, if appropriate or off-campus, the location or
collaborating institution, online, etc).
 How much time will the participant be expected to give up to participate in the study.
 Whether any payment/reward/incentive for participation will be offered (if so, provide details).
 Where appropriate, specify all procedures including recording of biometric data and clinical
measurements (refer to non-invasive and minimally invasive protocols if applicable)
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 Where appropriate give details of all nutritional supplements and pharmaceuticals (name,
concentration and dose) and specify their status (over-the-counter, prescription-only medicine(s);
investigational product or unapproved applications). Name the investigator(s) responsible with clinical
qualification or specialist training and attach a copy of the appropriate forms to be filed with the
relevant agency for investigational products
 Where questionnaires are to be used, a copy should be included as an appendix to the application.
 Where the study involves focus groups or semi structured or structured interviews, then an outline of the
questions should be provided as an appendix to the application.
 Outcome measures (quantitative studies); what do you actually plan to measure and what data will you
collect?
 What is the format you will use in your data recording? Computer records? Audio recordings? Video
recordings? Hard/paper records?
 Will the data collected be confidential and fully anonymised? If not, please give reasons for this.
 What arrangements are in place for the storage of the data collected? Has security been considered? Who
will have access to the data and how long do you plan to keep it for? Have you considered appropriate
GCU policies? (e.g. Data protection and IT)
Please note: if you plan to conduct work off campus (outside of the university) then you will also require
written permission to access potential participants from the appropriate authority/agency.
RISKS TO THE PARTICIPANTS: Do you foresee any risks to your participants? By this we mean physical or
psychological harm or discomfort. If the answer to this is no, then you should say "no known risks from
participating in this study" at this point.
If, on the other hand, there is any risk to the physical or mental wellbeing of the participant - regardless of
how small or inconsequential you consider this to be - then you must indicate the nature of the risk and
then state how you would propose to deal with it. Note: an effective method of circumventing issues of this
sort is to be as clear and unambiguous as possible regarding the nature of the research in your initial
information materials, making it clear that participation is completely a matter of personal choice.
If you consider there to be potentially a high risk of harm/distress to the participants in your study and are
unsure of how to deal with these, speak to your supervisor in the first instance and if concerns remain then
contact one of the ethics committee chairs.
DEBRIEFING AND FEEDBACK ARRANGEMENTS: You must provide details of the information you will give to
participants following the study. If your project involves deception, you must provide participants with an
opportunity to withdraw their data after debriefing. If there is any possibility of participants becoming
upset or experiencing discomfort after debriefing, you must explain how you propose to deal with this. If
your research uncovers a previously undiagnosed condition (i.e. dyslexia, hearing or visual defect, etc.),
specify your back-up assessment or referral procedures.
SPECIAL ETHICAL CONSIDERATIONS (This applies to those who ticked Box B on the ethics form)
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If you answered "NO" to any of the questions 1 to 8 or "YES" to any of the questions 9-11 then you must
provide a satisfactory justification for this. We draw your attention in particular to any projects involving any
form of deception of the participant(s).
If your intended participants are minors below the age of 18 or people with a disability (particularly learning
difficulties or communication impairment) then you must provide full details regarding obtaining informed
consent from parents, guardians, people acting in loco parentis and carers.
If your intended participants are pregnant women, people studied with respect to contraception or
conception, people in custody or people engaged in illegal activities, then your application may need to be
referred to the University insurers, please contact your departmental chair to discuss this.
If you plan to work with groups such as NHS patients, people in custody or non-human animals, then your
application will need to be reviewed by another ethics committee (e.g. NRES, SPS) as well as the
departmental one. For those who have already got external ethical approval, you will need to complete an
EC3 form.
OTHER ACCOMPANYING DOCUMENTATION:
Examples of participant information sheets and consent forms are available on the ethics webpages
www.gcu.ac.uk/hls/ethics, please follow the weblink for examples of how these should be constructed.
If you are undertaking interviews or questionnaires an interview guide or sample questionnaire should be
included in your application
RISK ASSESSMENTS
A risk assessment should be completed if you have ticked Box B and your project has significant ethical risk
GATEKEEPER ACCESS
Please discuss with your supervisor or research team about when it is appropriate to contact external
organisations for external ethical approval or permission to access potential participants. Or alternatively
contact one of the ethics chairs for a discussion about your project. Please include your invitation emails or
letter and/or any replies that you have received if you have started this process already.
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