QUESTION-SPECIFIC ADVICE FOR APPLYING FOR
STAGE 2 ETHICAL APPROVAL
(Risk Category 3 or ‘Red’ research)
November 2015
Fifteenth Edition
Julie Scott & Dr Leslie Gelling
This guidance is aimed at Doctorate students and staff, but the process
is the same for Undergraduate and Masters student research, for
students carrying out research at our Franchise Associate Colleges, our
Research Institutes and for researchers on a Consultancy basis.
You also need to check the ethics page of your faculty website.
If you require this booklet or any of the research ethics documents in
an alternative format (e.g. Braille, large print, audio, electronic), please
contact Beverley Pascoe, Research Ethics Committee Secretary by
telephone on 0845 196 4211 or email at research.ethics@anglia.ac.uk.
2
Table of Contents
Definitions
Page 5
Faculties at Anglia Ruskin University
Faculty Research Ethics Panels Chairs
Faculty Research Ethics Panel Administrators
Research Ethics & Governance Manager
Page 5
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Page 6
Page 6
Applying For Stage 2 Research Ethics Approval
Introduction
Other Permissions
FREP deadlines for applications
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Question Specific Advice About Stage 2 Research Ethics Approval
1.
Briefly describe the rationale for and state the value of the research you wish
to undertake.
2.
Suitability/qualifications of researchers to undertake the research.
3.
What are the aims of the research?
4.
Briefly describe the overall design of the project.
5.
Briefly describe the methods of data collection and analysis.
6.
Describe the participants: give the age range, gender and any particular
characteristics pertinent to the research project.
7.
If your participants are under 18 or vulnerable adults, please advise that you
have obtained a Disclosure and Barring Service (DBS) check.
8.
How will the participants be selected and recruited?
9.
How many participants will be involved? For experimental studies, specify
how the sample size was determined. In clinical trials, a power calculation
must be included.
10. What procedures will be carried out on the participants (if applicable)?
11. What potential risks to the participants do you forsee?
12. How do you propose to amerliorate/deal with potential risks to participants?
13. What potential risks to the interests of the researchers do you foresee?
14. How will you ameliorate/deal with potential risks to the interests of
researchers?
15. Has a risk assessment been completed?
16. How will you brief and debrief participants?
17. Will informed consent be sought from participants?
18. If there are doubts about participants’ abilities to give informed consent,
what steps have you taken to ensure they are willing to participate?
19. If participants are aged 18 years or under please describe how you will seek
informed consent?
20. How will consent be recorded?
21. Will participants be informed of the right to withdraw without penalty?
22. How do you propose to ensure participants’ confidentiality and anonymity?
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23.
24.
25.
26.
27.
28.
Please describe which of the following will be involved in your arrangements
for storing data?
Will payments be made to participants?
Modifications of proposal and extensions.
(EXTERNALLY FUNDED PROJECTS ONLY). Has the funding body been
informed of and agreed to abide by Anglia Ruskin University’s Ethics
Procedures and standards?
(EXTERNALLY FUNDED PROJECTS ONLY). Has the funder placed any
restrictions on: a) the conduct of the research, and b) publication of results?
Are there any further points you wish to make in justification of the proposed
research?
Other points.
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4
Definitions
DBS checks
Disclosure and Barring Service checks
DREP
Departmental Research Ethics Panel
FREP
Faculty Research Ethics Panel
RDCS
Research, Development & Commercial Services
RESC
Research Ethics Subcommittee
Faculties at Anglia Ruskin University
ALSS
Faculty of Arts, Law & Social Sciences
FHSCE
Faculty of Health, Social Care & Education
LAIBS
Lord Ashcroft International Business School
FMS
Faculty of Medical Science
FST
Faculty of Science & Technology
Faculty Research Ethics Panel Chairs
ALSS
Dr Oriola Sallavaci: email oriola.sallavaci@anglia.ac.uk
FHSCE
Dr Sarah Burch: email sarah.burch@anglia.ac.uk
LAIBS
Dr John Salked: email Jon.Salkeld@anglia.ac.uk
FMS
Dr Nigel Sansom: email nigel.sansom@anglia.ac.uk
FST
Dr Charlotte Nevison: email charlotte.nevison@anglia.ac.uk
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Faculty Research Ethics Panel Administrators
ALSS
Helen Jones: email Helen.Jones@anglia.ac.uk
FHSCE
Claire Mitchell: email Claire.Mitchell@anglia.ac.uk
LAIBS
Karen Smallwood: email laib.frep@anglia.ac.uk
FMS
Jo Corney: email joanne.corney@anglia.ac.uk
FST
Susan Short: email FST-Ethics@anglia.ac.uk
Research Ethics & Governance Manager
RDCS
Julie Scott: email julie.scott@anglia.ac.uk
6
Applying for Stage 2 Research Ethics Approval
Introduction
Information and application forms relating to the research ethics approval procedure are
available on the Research, Development & Commercial Services (RDCS) website at:
www.anglia.ac.uk/researchethics
These are aimed at research students and staff, but the same general process applies to
undergraduate and masters students, students at our Associate Colleges, our Research
Institutes and researchers employed on a Consultancy basis.
You should also consult the ethics page of your Faculty website.
If you are applying for Stage 2 ethical approval, you will have already completed the
Research Ethics Application Form (Stage 1) and your research will have been classified as
Risk Category 3 or ‘Red’ according to the traffic-light system (which is Stage 2 Approval).
You will be applying for Stage 2 ethical approval from your Faculty Research Ethics Panel
(FREP). Contact details for these can be found on the above website.
Your research project must comply with the ‘Research Ethics Policy’ for Anglia Ruskin
University and ‘Code of Practice for Applying for Ethical Approval at Anglia Ruskin University’
(hereafter referred to as the Code of Practice) and any additional ethical requirements that
apply in specific disciplines, organisations or countries with which you are collaborating, as
well as professional codes of conduct and practice. It is also your responsibility to ensure
that your research complies with the Data Protection Act (1998) or equivalent and any other
relevant legislation.
Research taking place in the UK must comply with the Data Protection Act (1998). If
research is taking place in another country and personal data is NOT being transferred out of
that country, it must comply with the data protection laws of that country. If research is
taking place within the European Economic Area (EEA) it must comply with the laws of that
country. Research data can be transferred back to the UK. If research is taking place outside
of the EEA but personal data is being transferred back to the UK, it must comply with the
laws of the country that the research is taking place in and also the UK Data Protection Act
(1998). Please refer to Section 6.1 of the Code of Practice for Applying for Ethical Approval
for more information about the Data Protection Act (1998).
A Risk Assessment must be completed for all Risk Category 3 or ‘Red’ research, unless
advised otherwise by the Risk Management Department. Details regarding this can be found
on the above website and also in the Code of Practice.
Failure to comply with our ethics procedures may be construed as misconduct or gross
misconduct and dealt with by our Student Disciplinary Procedures or Staff Disciplinary and
Dismissal Policy and Procedures, as appropriate.
7
This guidance provides some general information about applying for Stage 2 Research Ethics
Approval and question-specific advice for completing the Research Ethics Application Form
(Stage 2).
For Stage 2 approval, the documents you need to submit are as follows:

Research Ethics Application Form (Stage 1)

Research Ethics Application Form (Stage 2)

A detailed project proposal clearly outlining the research approach and methods to
be used

Participant Information Sheet

Consent Form

Any other documentation you will be using in the study e.g. questionnaire, interview
schedule, recruitment posters etc.

If applicable, the Questionnaire for Research involving Human Participants
(Insurnace Questionnaire), which is on the RDCS ethics webisite
www.anglia.ac.uk/researchethics and the response to this.
It is essential that you complete this questionnaire if your study falls into any of the
categories defined in it. This is because your research may not be covered by Anglia Ruskin
University’s existing insurance. Please note that the questionnaire must be completed for all
research outside the UK involving human participants.
You must email the questionnaire, ethics application, proposal and other information about
your study to Andy Chapman, Corporate Risk and Compliance Officer, at
andrew.chapman@anglia.ac.uk. This must be done prior to submitting your ethics
application. You should submit a copy of the questionnaire and the response from Andy
Chapman with your ethics application. If you are told additional insurance will be required
for the research, please speak to your Supervisor/Line Manager/Faculty Director of Research
(students) as a matter of urgency to establish whether your department/faculty will fund
any additional costs that may be incurred.
Other Permissions
There are other permissions you need to consider whether you will require. Where there
are standard documents for permissions, these can be accessed from the ethics section of
the RDCS website – www.anglia.ac.uk/researchethics
8
Please note that this is only a general list. There may be further permissions or approvals
required for your own field of research. These are:

Risk assessment (must be completed for all Risk Category 3 or ‘Red’ research)

Anglia Ruskin Travel and Insurance On-line Approval form

Local ethical approval, e.g. if carrying out research in other organisations or outside
of the UK (again, refer to the Code of Practice)

Written permission from organisations you are carrying the research out in (this will
always need submitting with your ethics application or to the ethics committee prior
to starting your research. Please refer to the Code of Practice)

Equipment checks (please refer to the Code of Practice)

Disclosure and Barring Service (DBS checks – formerly CRB checks). Students can
access information about the processs for this via:
www.anglia.ac.uk/apply/dbschecks
Staff will need to speak to HR Services. Please note that copies of DBS checks should
NOT be included with your ethics application.

Research visas, permits or other permissions if carrying out research overseas

Intellectual property agreements (please see the Code of Practice)

Other legal agreements.
FREP deadlines for applications
Applicants need to look at the relevant faculty web-page about committee meeting dates
and deadlines or seek advice from their FREP Administrator.
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Question Specific Advice for Stage 2 Research Ethics Approval
1.
Briefly describe the rationale for and state the value of the research you wish to
undertake.

The rationale for your research should be grounded in existing research and the
literature. Using this material, you should convince the ethics committee that the
research is worth doing and that the methodological approach being used is the
right one to answer the research question.

Care should be taken to avoid statements such as ‘this very important research’.

Clearly state any possible benefits, direct or indirect, to your research participants.

If there are no clear benefits to your research participants you should also state this.
In these circumstances, it is not uncommon to explain how others, including future
patients/users, could benefit from the knowledge and understanding that might be
gained through the research.

You should not make claims that cannot be substantiated.

If there is any potential intellectual property arising from your research, you should
confirm that all agreements have been signed. For further information regarding
intellectual property, please look on the RDCS website:
http://web.anglia.ac.uk/anet/rdcs/compliance/forms.phtml
After consulting the website, please contact Julia Marsh (Strategic Initiatives and
Commercial Projects Manager, Research, Development and Commercial Services on
email address julia.marsh@anglia.ac.uk) if you need any further clarification.
2.
Suitability/qualifications of researchers to undertake the research. Please give
details of any internal or external ethics training you have participated in.

Please note that research ethics training is compulsory for all Doctoral candidates
and their Supervisors, as stated in the Research Degrees Regulations. Please refer to
the Research Degree Regulations, 15th Edition, September 2014, for further
information. This is Section 3.8 to 3.10 for Doctorate candidates and Section 7.7 for
Supervisors.

There is also compulsory training for all undergraduates and masters students and
their supervisors. There is a quiz at the end which must be succcessfully completed
and the confirmation of completion submitted with your ethics application. To
access the training, please go to:
10
https://vle.anglia.ac.uk/sites/non-mod/ethics1/Pages/Home3.aspx

You should demonstrate that the researcher(s) has/have the research and
practical/clinical experience required to complete the research. There are some
restrictions on who can use psychological measures, for example. The researcher
should also be experienced and have appropriate training in the use of any
equipment used during the research. In addition, the researcher must ensure that
any equipment has undergone any necessary safety or other checks.

If working with any particular groups (for example, people with mental health
problems or children), you must demonstrate that you have sufficient previous
experience of working with this particular group of people. You must ensure that
anyone 16 years of age or over does not fall under the Mental Capacity Act (2005).
Please note that people may fall under the Act as the result of short-term
conditions, such as the effects of alcohol or shock, as well as enduring conditions
such as learning disabilities or mental health problems. The emphasis of the Act is
on capacity (supporting people to make decisions) rather than lack of capacity.

If you, the lead applicant, do not possess the necessary qualifications and
experience, you should demonstrate how you will be supported in your research and
by whom. For student research, your Disseration Supervisor/Supervisor should be
able to provide this support and must be appropriately experienced.

You should include information about all members of the research team.

Any other collaborators (for example, statisticians) should also be listed.

You should demonstrate that the researchers are familiar with relevant legislation,
including the Data Protection Act (1998), the Medical Devices Regulations (2002) as
amended, the Human Tissue Act (2004), the Human Tissue (Scotland) Act (2006),
the Mental Capacity Act (2005) and the Medicines for Human Use (Clinical Trials)
Regulations (2004) as amended. You should be aware that different legislation may
apply in each of the countries which constitute the UK. If carrying out research
outside the UK, it is your responsibility to be aware of and comply with any laws of
that country relating to research.

You should be aware that some forms of research will require that you seek an
ethical opinion from an appropriate NHS REC or the Social Care Research Ethics
Committee, even if the research does not involve the NHS or social care. The
website for the Social Care Research Ethics Committee is:
http://www.scie.org.uk/research/ethics-committee/

Research that falls under the Mental Capacity Act (2005) can only legally be
reviewed by an NHS REC or the Social Care Research Ethics Committee.

If research involves human tissue or samples and does not come under the
conditions of Anglia Ruskin University’s research licence from the Human Tissue
Authority, it can only be legally reviewed by an NHS REC. For further information
11
regarding whether your study will fall under our licence please contact Matt Bristow
on email address matt.bristow@anglia.ac.uk

If your research falls under the Mental Capacity Act (2005), Human Tissue Act
(2004) or any other legislation you need to be familiar with it, in order that you plan
your research to comply with all parts of it.

Should you be proposing research that involves a medical drug, device or
intervention, please contact Michael Harrison, Director of the Anglia Ruskin Clinical
Trials Unit on email address Michael.Harrison@anglia.ac.uk in the first instance,
with details of your study.

If there are any conflicts of interest, you must state what these are. These should
also be stated in the participant information sheet.
3.
What are the aims of the research?

You should clearly state the aims of your research. These should be kept to a
reasonable number and you should be mindful of the time and resources available
to you.

You should state what the principal research question and objectives are and also
include any hypotheses that will be tested, if applicable.

Do not be too ambitious in setting aims and objectives for your research. It is
important that these can be achieved in the time available to you, especially if you
are undertaking a student project.
4.
Briefly describe the overall design of the project.

The ethics committee will need to be convinced that you have given due
consideration to the design of your research. Based on the principle that ‘bad
science is bad ethics’, it would be unethical to undertake any research that is not
well-designed.

The design should be realistic within the time and resources available to you.

You should justify your choice of design. There may be reasons, including practical
constraints, why you need to use a less robust design, but adequate justification for
this must be provided.

If you were required to obtain a power calculation for your research you must be
reasonably confident that you can obtain the required number of participants.
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
You should explain how you would deal with any problems that might arise during
the course of your research. For example, what would you do if you found it difficult
to recruit a sufficient number of participants?

You should give careful consideration to whether a pilot study should be
undertaken. If carrying out a pilot study, you must obtain ethical approval for this.
Should you make any changes following the pilot study, these need to be submitted
to the ethics committee for approval.

If you are designing a questionnaire, it is advisable that you undertake a pilot study
to ensure that the questions and instructions are clear.

If you are seeking data through an anonymous questionnaire, you would still have a
participant information sheet, but informed consent can be implied by the return of
the completed questionnaire and an informed consent form will not be required. It
is good practice, however, to include a box that participants can check to confirm
that they have read the participant information sheet and understand the
requirements of the study.
5.
Briefly describe the methods of data collection and analysis.

You must only collect the data that you will need. Ask yourself ‘do I really need this
information about an individual? What will I use it for?’

You must separate the data from any identifying information as soon as possible e.g.
by assigning participants a code. As the researcher, you will still be able to link the
code with the participant, if required, but personal information (including that held
on consent forms) and the data should be stored separately and securely held.

Provide the ethics committee with clear but brief details about how you will collect
and analyse the data.

Describe any software you are planning to use.

Describe the techniques, both qualitative and/or quantitative, that will be used
during data analysis.

Detail who will be involved in the data analysis. For example, will your supervisor
have access to the data and will you be seeking advice from a statistician? If you are
involving a statistician, you should explain what stages of the research that he/she
will be involved in. Other members of the research team should only have access to
anonymised data wherever possible. Ask yourself ‘is access to personal information
limited to those who strictly need to know?’ Details of who will have access to the
data must be detailed on the participant information sheet.

It is important that you provide details about how you will analyse your data. For
example, writing that you will use ‘statistical analyses’ or ‘parametric statistics’ is not
sufficient. You should provide information about the types of statistical tests you
13
are planning to use and your rationale for selecting these tests. You should
demonstrate that all data collection, storage and analysis will comply with the eight
principles of the Data Protection Act (1998). You can find more information about
the Data Protection Act on the Information Commissioner’s Office website.

You should provide information about how you will manage data if the plan is to
transfer the data outside the European Economic Area, where data protection may
not be of the same standard as required by the Data Protection Act (1998).

If the funding body for your research has any requirements that they store or use
your data at a later date (including the storage of data in a repository), this must be
stated in your ethics application form and on the participant information sheet and
consent form.
6.
Describe the participants: give the age range, gender and any particular
characteristics pertinent to the research project. For experimental studies states
the inclusion and exclusion criteria.

Provide a clear description of the participants in your research. Leave the ethics
committee in no doubt as to why you have chosen these participants for your
research.

State the inclusion and exclusion criteria clearly. You need to provide justification as
to why you are excluding participants.

Pay particular attention to groups who might be classified as vulnerable, including
children and young people. You need to justify why you are involving these groups.
In general, it is not acceptable to involve vulnerable groups if you could answer the
research question using another group of people that does not fall into this
category. Please note that, if your research involves vulnerable people over the age
of 16 years of age and any of the participants are unable to consent, the research
falls under the Mental Capacity Act (2005) and requires referral to an NHS REC or
the Social Care Research Ethics Committee (or the Welsh Assembly Government, as
appropriate). These are the only RECs in England that are authorised by the
Secretary of State for Health to review research that falls under the Act. University
RECs are not authorised to do this. You also need to be aware of all the
requirements of the Mental Capacity Act (2005).
7.
If your participants are under 18 or vulnerable adults, please advise that you have
obtained a Disclosure and Barring Service (DBS) check.

If your research involves children and/or young people, you should demonstrate an
awareness of the legal requirements with these groups, especially the age of
consent for research.
14

If a DBS Check is required, you should allow sufficient time to obtain this in the
planning stage of your research.

Students need to refer to: www.anglia.ac.uk/apply/dbschecks

Staff need to refer to HR Services.

You must give details about who you have applied to in order to obtain your DBS
check.
8.
How will the participants be selected and recruited?

If using a recruitment poster, this should include information about possible
exclusion criteria. This should stop people approaching you when they are not
suitable for your research, which would waste both their time and yours. It also
means that you are not collecting information about people that you do not need, to
establish whether they can be included.

You should provide information about how you will identify potential participants.
You should always keep in mind the requirements of the Data Protection Act (1998).
For example, someone who works at another organisation with access to the
contact details of potential participants is not permitted to pass these contact
details to you. An exception to this may arise when participants have given
permission for their information to be passed onto you. Even if you already work at
an organisation and have access to names and addresses, this does not
automatically mean that you can use them to send information to people for
research purposes. You should check this with an appropriate senior person in your
organisation.

You should provide information about how potential participants will be informed
about the research. In most instances, potential participants are provided with
written and verbal information about the research. In some circumstances, you may
need to consider providing translated information sheets, information sheets
written for different age groups or information sheets written in Braille or large print
or formatted electronically or in audio format. You might also consider providing
this information through another means, including video clips or recordings. In line
with the Mental Capacity Act (2005), participants over the age of 16 years who are
classified as vulnerable or there is another reason why they may not be able to
consent (e.g. effects of alchohol or shock) should be given all appropriate support to
be able to consent to take part in research. If just one participant is unable to
consent, the research falls under the Mental Capacity Act (2005) and must be
reviewed by an NHS REC or the Social Care Research Ethics Committee (or the Welsh
Assembly Government as appropriate). University RECs are not authorised to
review research that fall under the Act. You must take all the requirements of the
Act into account, in order to determine whether it is still possible to undertake your
research. For example, you should not be able to carry out the research equally well
on people that have the capacity to consent, otherwise you cannot justify involving
people who are unable to consent. It is your responsibility as the researcher to
15
comply with all the legal requirements of the Act throughout your research.
Researchers must also be familiar with and adhere to the Code of Practice for the
Mental Capacity Act (2005).

You should provide information about how and when participants will give informed
consent. Be clear about how long potential participants will have to decide about
their participation in the research. Normally this is at least 24 hours, but in general,
potential participants should be given as long as they need to decide about their
involvement in your research (within the time frame of the study) and given the
opportunity to discuss it with family and friends. You should also be clear who will
be responsible for obtaining informed consent.

Consent must be viewed as a process, not just the signing of a consent form.
Remember that people may not understand as much as you think. You must never
assume understanding and should check that people understand all the components
of your research. Remember that people who do not work in research might not be
familiar with terms such as ‘randomisation’. In some research, especially when
working with vulnerable groups, you may need to periodically check that people still
consent to participate in your research. This can be done informally by asking
people questions about the research. If you plan to do this, you should include it in
your ethics application form, because the ethics committee will want to be
reassured that consent will be fully informed.

You should remember that it is never acceptable to use family members or friends
to translate participant information sheets. A professional interpreter must be used.
The consent form should also be translated.

In some cultures, it will not be appropriate for written consent to be obtained. In
these instances, you need to provide details about the appropriate way to obtain
consent and justify why written consent is not appropriate.

You need to take into account any other cultural norms when carrying your research
in other countries. If you need to carry out your research in a certain way, in order
to take into account cultural norms, you should explain this to the ethics committee.

You should make it clear to the ethics committee that all potential participants are
able to freely give an informed decision about their participation in your research.
The ethics committee will be concerned if they suspect any coercion. You need to
be aware of power relationships that might exist between you and potential
participants, which may make them feel that they should take part. For example,
are you in a senior role to potential participants? You should also be aware of this
issue when recruiting people working in organisations, in case they have been told
by those senior to them that they should take part. If people know you on a
personal level, they may also find it difficult to decline an invitation to participate in
your research. You should ensure that people feel able to decline your invitation
and consider that people may not feel comfortable doing this face-to-face.

There are special ethical issues relating to internet research, for example the
complexities of obtaining informed consent and the illusion of privacy in cyberspace.
It is also impossible for researchers to validate the identity of people taking part in
16
research online and possible for participants to create a different identity. Related
to this, it is not possible to determine whether people may be taking part in the
research when it is not appropriate for them to do so e.g. people under 18 years of
age. You must address these issues and explain how you intend to minimise risk in
your ethics application. Please refer to Section 3.16 of the Code of Practice for more
information about research involving the internet.
9.
How many participants will be involved? For experimental studies, specify how
the sample size was determined. In clinical trials, a power calculation must be
included.

Tell the ethics committee how many participants you plan to recruit to your
research and why.

You need to convince the ethics committee that you will recruit a sufficiently large
sample to answer your research question or to meet the aims of your research.

If you are adopting a quantitative approach, you might need to include details of a
power analysis or offer other justification for your sample size.

If you are adopting a qualitative approach, you should offer a rationale for your
anticipated sample size and may wish to indicate a maximum number of
participants.

You should ensure that you indicate a realistic sample size, with reference to the
time and resources available to you.
10.
What procedures will be carried out on the participants (if applicable)?

You should provide information about all procedures, distinguishing between those
that are standard procedures and those that will be undertaken purely for the
purposes of your research. Procedures include questionnaires and interviews. If
you are planning to use data about participants that has already been collected for a
purpose other than research, this is a procedure that must be clarified in the ethics
application form.

If you intend to use data that is already held for another purpose for your study,
people will normally need to consent to this being used. If this is just one
component of the study, you must ensure that you state that you intend to do this
in the participant information sheet and, if appropriate, the consent form.

Of primary interest to the ethics committee will be the safety aspects of any
procedures carried out and whether any standard treatment or procedures will be
withheld from participants as a result of the study. For example, if researching in a
school, will the children miss any of their normal lessons?
17

The ethics committee will also be interested to know what will happen if an
intervention, for example in a school, proves to be beneficial. If there is a control
group, will they also be offered the intervention after the research has ended? If the
intervention proves to be beneficial before the intervention ends, will it be offered
to the control group then if appropriate to do so?

The ethics committee will be interested in the frequency of each procedure and will
want to know how long it will take to complete each of these.

You should also give thought to what you will do if the research has a number of
procedures and a participant is happy to do some of these, but not others. Can they
still be included in the research?

If a procedure will require an individual to travel to participate in your research, you
should include details of how much travel will be required, how this will be
organised and if expenses will be reimbursed. If expenses cannot be reimbursed,
the potential participants should be informed of this in the information sheet.

The ethics committee will want to see the details of these procedures clearly
explained in the participant information sheet.
11.
What potential risks to the participants do you foresee?

You should remember that all research involves risk and this should be reflected in
your response to this question. Think about all the possible risks, not just the most
obvious ones, such as the risk of physical harm or emotional upset For example,
there may be a risk that participants will suffer from boredom and fatigue. If you
are carrying out a postal questionnaire and consent is implied by its return, there is a
risk that respondents may not fully understand all the aspects of the research or that
you send it to people who do not have the capacity to consent.

If it can be reasonably foreseen that there is a risk that some participants might
become emotionally distressed, including during interviews and focus groups,
measures must be put in place to minimise this risk and procedures should be in
place to support participants if it should occur (e.g. access to counselling). Also,
remember to take into account your research sample when considering what may
be emotive. For example, a study investigating memory techniques is likely to be
emotive to people who have dementia or memory problems.

In addition to the direct physical and emotional risks to participants, you need to
consider the possible risks associated with data storage or the use of human tissue
samples.

The ethics committee needs to be reassured that you have identified and considered
all the potential risks that might be reasonably foreseen.
18

12.
Details about all the potential risks and benefits should also be included in the
participant information sheet. You must ensure that the risks are made clear to
potential participants during the process of gaining informed consent. Please be
aware that if any new risks emerge as your research progresses, these must be
included on a revised participant information sheet, which must first be approved by
the ethics committee. If the new risk is of a serious nature, the study must be halted
immediately, unless doing this will cause harm to participants, and advice sought
from your Supervisor/Dissertation Supervisor and FREP Chair.
How do you propose to ameliorate/deal with potential risks to participants?

You should detail the actions you will take to minimise the risks.

You should also detail the plans in place to deal with situations if they should occur.
For example, if there is a risk that participants might become distressed during an
interview, have you found out about local services that participants can access? You
should also give consideration as to how quickly people can access these services if
required. What if a participant becomes distressed and requires immediate
support? It is not your role as a researcher to counsel participants, but you need to
ensure that they have access to support required in a timely manner.

One risk you should anticipate involves a participant disclosing information that you
are professionally, or in some cases legally, required to act upon. For example, a
participant may inform you of criminal activity or you may have cause to belief that
there is a risk that the individual might harm him/herself or others. You should
inform the ethics committee what you would do in such circumstances. You should
also include a statement in the participant information sheet informing participants
what action you would take should this situation arise. Students should refer to
their supervisor before taking any action, except in circumstances where action
needs to be taken immediately. You should include information regarding this in the
Risk Assessment you carry out prior to the study. In terms of criminal activities, in
general there is no legal obligation to report an offence (except in certain terrorism
and money laundering cases), but careful consideration of the Serious Crime Act
(2007) should be undertaken by the researcher. If you are going to disclose any
information, you should discuss this with the participant beforehand, unless doing
this will place you at risk in any way. If you have any doubts about whether telling
the participant your intention to disclose will place you at any risk, do not tell him or
her and discuss this with your Supervisor/Dissertation Supervisor as a matter of
urgency.

There may also be other types of information that, if disclosed, you might need to
pass on. For example, if carrying out research in an organisation you work in,
someone may disclose that they he/she is not complying with policies and
procedures. You should carefully consider what types of information could be
disclosed to you and whether that information should be passed on. Include in the
participant information sheet in what situations you would need to do this (unless
by doing this you think your safety would be put at risk).
19

13.
There may be situations where stating that information disclosed about criminal
activity will be reported to the relevant authorities would make the research
impossible. For example, interviewing young people about alcohol consumption
would be likely to uncover illegal activity. In circumstances such as this, you would
need to justify the value of the research to the ethics committee and demonstrate
that the research could not be done in any other way.
What potential risks to the interests of the researchers do you foresee?

You should not underestimate the risks to which the researcher might be exposed.
For example, there is a risk that a participant might complain about the researcher.
You should address all risks and work out ways to minimise them. The website
information for complaints is:
http://web.anglia.ac.uk/anet/staff/sec_clerk/
and should be be included on the participant information sheet, but participants
should be encouraged to initially seek informal resolution by speaking to you and
your Supervisor/Dissertation Supervisor.

14.
If the researcher is working alone s/he must ensure that compliance with any lone
worker policies of the organisation(s) where the research is being undertaken. A
Risk Assessment must also be completed for Anglia Ruskin University.
How will you ameliorate/deal with potential risks to the interests of researchers?

15.
The ethics committee will want to know what actions you will take to minimise the
risks to the researcher and others collaborating in your research.
Has a risk assessment been completed? Please be aware the risk assessment must
be kept on file and updated annually.

A Risk Assessment (Health and Safety) must be completed for all Risk Category 3
(Red) research.

This needs to be completed in conjunction with your Supervisor/Dissertation
Supervisor, kept on file and updated annually.

The action plan arising from the Risk Assessment should state clearly how you plan
to deal with potential risks.

For further information about and help completing the Risk Assessment, please
contact Sarah Day, Risk Management Officer on email address
sarah.day@anglia.ac.uk
20
16.
How will you brief and debrief participants?

Remember that this is a two-part question, requiring information about briefing and
debriefing.
Briefing

You should inform the ethics committee how you will provide information about
your research to potential participants. This is most often provided as written
information and you can find a information about what to include at:
www.anglia.ac.uk/researchethics
This is not intended to be used as a template, but provides examples of the types of
information you need to include. There may be further information that you need
to include that is not covered here.

Briefing potential participants should also involve a detailed verbal explanation,
when this is possible, and there should be ample opportunity for potential
participants to ask questions and to discuss the research with others if they should
wish to do so.

The researcher and their supervisor names and contact details should be provided in
the participant information sheet, in order that potential participants can contact
someone to ask further questions. Personal landline telephone numbers must not
be used. Only Anglia Ruskin email addresses must be used.

Participants may not always understand as much as researchers believe they do. If
the researcher has any doubts about an individual’s understanding they should ask
questions to check the potential participant’s understanding of what is being
proposed.

Be careful to avoid the use of jargon. It may be useful to show your participant
information sheet and consent form to a colleague or friend who is not in your field.

You must submit participant information sheet(s) with your application. Great care
should be taken to prepare information sheets that are appropriate for the intended
population. For example, you need to pay attention to readability.

You need to ensure that you have included all relevant information, including details
about how the findings will be disseminated, for example as a thesis or in journals.
Debriefing

It is good practice to provide participants with a lay summary of the findings of your
research. You should explain how this will be done in the participant information
sheet.
21

17.
For studies involving deception, participants should be debriefed.
Will informed consent be sought from participants?

In almost all situations, it will be necessary to obtain freely given informed consent.

If you are not satisfied that the person is able to given informed consent, you must
not proceed with the research with that participant.

There are situations when it may not be possible to get informed consent before
beginning research activities. In these circumstances, the ethics committee will
want to be convinced that there are no other ways to do the research and that the
research complies with legislation, including the Mental Capacity Act (2005).

If your research involves children and/or young people you will need to demonstrate
familiarity with best current practice.

If you plan to disseminate personally identifiable information, including
photographs, you will need to provide justification for this to the ethics committee
and also ensure that participants are aware of exactly how their information will be
used. Participants should be asked for consent on each occasion you plan to use the
material, unless they state that they would prefer to give generic consent.

You should make it clear that participants can withdraw at any time from your
research (the only exception to this would be if it comprised their safety in any way).
You should make it as easy as possible for people to withdraw e.g. they may not feel
comfortable telling you directly.

You should also think about whether data would still be useful if someone
withdraws their consent during your research. You should provide the option for
participants to withdraw their consent and also have their data withdrawn or to
withdraw, but still give consent for their data to be used.

To comply with the Mental Capacity Act (2005), if your research involves
participants who are over 16 years of age and are unable to consent for themselves
you will need to seek the opinion of an NHS REC or the Social Care Research Ethics
Committee (or the Welsh Assembly Government).
18.
If there are doubts about participants’ abilities to give informed consent, what
steps have you taken to ensure that they are willing to participate?

The ethics committee will want to be convinced that all potential participants have
the capacity to freely give informed consent or, in the case of children who are
unable to consent, that appropriate consent will be obtained from the
parents/guardians.
22

19.
If you are carrying out research with vulnerable groups e.g. people with learning
disabilities, dementia or under the influence of alcohol or drugs, you must give
potential participants all possible support to consent, in line with the Mental
Capacity Act (2005). You must, however, keep careful records and if there is any
doubt about whether someone can consent, you must not continue the research.
If participants are aged 18 years or under please describe how you will seek
informed consent.

Provide a full and detailed description of how you will identify, inform and recruit
children and young people.

Gaining informed consent for children and young people can be a complex process.
If you are planning to involve children and/or young people in your research, you
should seek advice from someone with experience in this form of research.
20.
How will consent be recorded?

In most instances, informed consent should be recorded on a consent form that has
been approved by the ethics committee.

The researcher should retain the original consent form and the participant should be
provided with a copy.

If data is being collected through anonymous questionnaires, it is not normally
necessary to record consent on a consent form. In such circumstances, informed
consent can be implied by return of the completed questionnaire, although it is
good practice asking participants to check a box to indicate they have read about
and understand the study.
21.
Will participants be informed of the right to withdraw without penalty?

Participants should be made aware that they always retain the right to withdraw
from your research at any time and without giving you a reason.

You should make it as easy as possible for people to withdraw and take into account
that they may not feel comfortable telling you directly.

In some situations, it may not be possible to withdraw the participant’s data and this
should be explained in the information sheet. For example, if the participant was
involved in a focus group with a number of other participants, withdrawing their
data would necessitate the withdrawal of the entire data set.
23

22.
In other cases, the participants’ data may be useful even if they withdraw and they
may be happy for their data to be used. If someone withdraws their consent, you
must have permission to continue using their data.
How do you propose to ensure participants’ confidentiality and anonymity?

You must differentiate between confidentiality and anonymity.

If information is provided to you ‘in confidence’ by participants, then there is an
obligation to preserve this confidentiality. However, you must consider whether
there are any limits to confidentiality and whether you might need to disclose any
information given to you from participants to a professional body for legal reasons.
If there is a possibility that you may need to disclose any information at all, this must
be clearly stated on the participant information sheet at the outset. You should
make it clear, both to the ethics committee and the research participants, how you
will deal with confidential and anonymous information. For example, the ethics
committee will want to know that an individual’s participation in the research will
remain confidential and that they will not be identified in any publications or
presentations.

At the same time, you should not give unrealistic assurances. If there is a chance
that either a participant or an organisation could be identified, even though
personal information relating to them is not used, you must be clear about this on
the participant information sheet. This situation may arise, for example, if you are
using case studies or discussing certain types of organisations in your dissemination.
You also need to be clear that it is possible, that although participants might not be
identified by the general public, they still could be identified by their peer group.

You must be familiar with the term ‘personal data’, as defined by the Data
Protection Act (1998). Data does not have to include a person’s name to be personal
data. You must also be aware of the distinction between personal data and sensitive
personal data (please refer to Information Commissioner’s Office website and
Section 6.1 of the Code of Practice).

Please be aware that people may be identifiable even when some personal data is
removed. In some cases, you may ask participants to read through what you have
written about them to check that they are happy with it.

If your research involves collecting data through tape-recording or video-recording,
special care should be taken when dealing with confidentiality and anonymity. The
recordings must be stored securely and you must provide information about this
and when recordings will be destroyed.

You should describe where you will store all data and research materials and explain
how and when this material will be destroyed.
24

If you plan to make your data open access in line with any funding body
requirements, participants must give explicit consent for this.

If you are undertaking your research in collaboration with another organisation, you
should reassure the ethics committee that the other organisation will also pay
careful attention to ensuring confidentiality and anonymity. You must also ensure
that you have obtained appropriate ethical or governance approvals required from
that organisation, if required.

If carrying out research at another organisation, you must have written permission
from them, including use and ownership of data and the right to publish. If you are
planning to use the organisation’s name or if it could potentially be identifiable from
the write-up of the research, this must be agreed in writing with the organisation.
Letters of permission must be submitted with your ethics application or, if you have
not obtained them by the time of your submission, you must state in your
application that you will forward these prior to starting your research.

You should also pay attention to the issue of anonymity of organisations. For
example, if you are comparing services across different organisations and you plan
to use the name of the organisation(s) in dissemination, you must have written
permission from them. If you only have permission to disseminate the information
in an anonymised form, you must ensure that organisations cannot be identified as
far as is reasonably possible.

If you are planning to look at a sensitive issue, for example an exploration of bad
practice across different organisations, you must ensure that the organisations in
question are fully aware of this and that you have written permission to do this.
23.
Please describe which of the following will be involved in your arrangements for
storing data.

Tick all the relevant boxes.

Describe to the ethics committee how you will ensure the security of data stored
through each of these means.

Data stored on computers should be password protected and, ideally, encrypted.

Paper documents should be stored securely on Anglia Ruskin University premises
and only members of the research team should be able to access the documents.

You should inform the ethics committee when and how electronic and hard copies
of research materials will be destroyed.

If you plan to transfer data you should explain how this will be done and how the
security of the material will be maintained during transfer. If any personal data is
leaving the European Economic Area (EEA), special measures will need to be taken
25
(please refer to Principle 8 of the Data Protection Act (1998)) and you should
comment on how the security of the data will be maintained. Ideally, only
anonymised data should leave the EEA and you must make it clear, in the participant
information sheet, exactly what will be happening to the data.
24.
Will payments be made to participants?

The researcher should be clear on the difference between payments and
reimbursement.

When possible, research participants should have expenses reimbursed, including
travel expenses. This should be made clear on the participant information sheet.

In some instances, it would not be appropriate to offer payment to research
participants. If a payment is being offered, the ethics committee will wish to be
convinced that this is appropriate and that the sum is not coercive.

Offering a gift may be alternative means of thanking someone for participating in
your research. In such circumstances, it may not be appropriate to make reference
to the gift until after the individual’s participation in the research has ended.

Information about all these matters should be included in the participant
information sheet.
25.
Modification of proposal and extensions

You should make no modifications to the proposal without first seeking approval
from the ethics committee for the amendment. This includes changes to the
participant information sheet and consent form. If you make changes and do not
first obtain approval from the ethics committee, you do not have ethical approval to
continue your research. If your research is evolving, for example if you are devising
a questionnaire as a result of the initial phase of your research, you need to state
that this will be the case in your initial application and submit the questionnaire to
the ethics committee for review before it can be used. Please refer to the procedure
for amendments in the Code of Practice.

In some cases, you will not be using a structured questionnaire. For example, in
some types of qualitative research you may have a series of themes that you are
intending to explore. If this is the case, you need to make this clear in your
application and include as much information as possible (e.g. the themes that you
intend to explore).

It is essential that you obtain ethical approval for an extension before your current
approval expires.
26
26.
(EXTERNALLY-FUNDED PROJECTS ONLY) Has the funding body been informed of
and agreed to abide by Anglia Ruskin University’s ethics procedures and
standards?

27.
You must also ensure that a Risk Assessment (Project) has been carried out for all
externally-funded research, where the funds have been applied for through Anglia
Ruskin University. Please see the guidance on the section of the RDCS website
http://web.anglia.ac.uk/anet/rdcs/compliance/index.phtml
(EXTERNALLY-FUNDED PROJECTS ONLY) Has the funder placed any restrictions on
a) the conduct of the research; b) publication of results?

If ‘yes’, what restrictions have been placed on you and how will these impact upon
your ability to complete the research?

Publication and dissemination is an essential part of the research, so the ethics
committee will wish to know about any restrictions being placed on your ability to
publish or disseminate.

If the funding body want to keep the data after your study, you must state this in the
participant information sheet.

If it is a requirement of the funding body that you put your data into a repository,
this must be made clear on the participant information sheet.
28.
Are there any further points you wish to make in justification of the proposed
research?

This is your opportunity to tell the ethics committee about any other ethical matters
you think might be important.
Other points:

Care should be taken in the preparation of your application and the supporting
documents. If the application contains multiple spelling and grammatical errors, the
ethics committee might be concerned about the care the researcher might take with
the research.
27

Please ensure that you check your application prior to submission and ensure that
the application form and the supplementary documents are consistent.

Please ensure that you spell out any acronyms the first time you use them in the
application.

In addition to the application form, the ethics committee will spend considerable
time reviewing the participant information sheet and consent form. You should take
great care in preparing these, paying particular attention to ensuring an appropriate
reading age and avoiding unnecessarily technical language.

Please include version numbers and dates on your ethics application, proposal,
participant information sheet and consent form and any other documents, which
reduces the risk of previous documentation being used in error, should you need to
make revisions to the documentation. This also means that the ethics committee
can clearly identify the current documentation.

Try to anticipate the questions the ethics committee might want to ask you and
provide the answers in the application form.

If you are making a student application, you are required to have your supervisor
sign your application. You should ensure that your supervisor has sufficient time to
read the application and comment on it before the submission deadline.

If you are carrying out research in other organisations, you will need to seek written
approval from each organisation. You should include any documentation you are
using to approach organisations with your application and send written approval
when it has been obtained. You can still submit your ethics application if the letters
are pending, but you need to make it clear that this is the case and cannot have final
ethical approval until these have been received by the ethics committee.
28