Ethical Approval Panel for Research, Enterprise and Engagement V 2015/16
Guidance Notes for Completing the College Research Ethical Approval Application Form
The following notes have been compiled to act as a guide for applicants pursuing ethical
approval from the College Health and Social Care. Each section below refers directly to the
sections on the application form and highlights what minimum information is required.
NOTE: It is essential that the reviewers on the ethics committee have sufficient information
to be able to make an informed decision regarding the application. Therefore applications
with insufficient information will be returned to the applicant and need to be re-submitted
at a later date resulting in a delay in obtaining ethical approval and subsequently the start of
the research study.
1. Title of proposed research project
The title of the research project needs to be clear and succinct giving an idea to the reader
exactly what the project involves. A title to a study should not contain any acronyms but all
words should be explained in full (then abbreviated.)
2. Project summary
Provide a short overview of the research study, such as: the aims, research question/s, what
you are intending to do, who will it involve? How do you hope to achieve the aims?
3. Project objectives (between 3-5 clear bullet points)
Summarise the main objectives or outcomes expected of the research study.
For example:
To generate an understanding of certain issues...
To evaluate a particular phenomenon or service…
To highlight the differences between…
To describe/understand the experiences of…
To measure the difference between X and Y…
To improve knowledge regarding…
4. What is the rationale which led to the study?
Providing a rationale for the study refers to the presentation of a clear comprehensive
summary of background research/literature which has informed the development of your
study. In this section you need to generate an argument as to what has been done, what we
already know about the topic being researched, what the gaps are in the research
knowledge and why your study is of particular importance. Please complete this in language
comprehensible to a lay person and avoid specific scientific terminology. All research
publications need to be clearly referenced and a full list of references provided in section 13.
5. Research Methodology
This section provides a summary of the methods you are going to use to perform the
research study, the approach which you will take. Briefly describe the following:
- Identify the research methodology you have adopted, such as epidemiology,
phenomenology, cross-sectional study, whatever you choose make sure it is clear to the
Ethical Approval Panel for Research, Enterprise and Engagement V 2015/16
-
reader why this method is important. Ensure you have defined your inclusion and
exclusion criteria.
Clearly identify a recruitment plan and add supporting material (copies of Posters,
newspaper adverts, website, and letters) which will be used to attract research
participants. Where and how will the participants be recruited, using what method?
How will research participants communicate that they are interested in being involved?
Please also stipulate the age group you plan to recruit.
In the majority of research studies research participants should be recruited voluntarily by
advert or poster, although be aware this can be a slow process. If you are contacting
participants directly by letter then you need to describe where you will get their names and
addresses from. Ideally you should not be given a list of names to contact as this information
is confidential to the target organisation/participant. It is best that letters are distributed by
a third party who is privy to this information and ask participants to reply directly to you
providing their own contact details. If you wish to recruit a certain cohort of students
undertaking a specific course then you need to have recruitment letters and information
sheets distributed by the programme leader in advance to when you want to undertake data
collection to give participants time to consider whether to be involved. Organisational
agreement will need to be sought from the Programme Leader for permission to recruit
participants during class time and once received contact the Module Leader/Lecturer out of
courtesy. Please do not approach people directly or use a global email to recruit your
participants.
If you plan to use posters to recruit participants, please ensure that they include the
following details
1. A clear study title
2. An inoffensive image
3. Clear aims of the study
4. The University contact details of the researcher and supervisor
5. The current University logo
It is essential that you assure research participants that their involvement will be
confidential (where at all possible). This means that no other person should know that they
are involved in your research study unless they themselves choose to disclose this fact. If
you are recruiting participants to a group interview you need to confirm that all group
participants agree to keep the identity of other members of the group confidential.
An ethical requirement with respect to recruiting participants for research is that they are
fully informed of what the study entails, what their participation will involve, how long the
study will take, what difference it will make to them. Once a person understands the
research study and their involvement then they can make an informed decision about
whether to get involved and provide informed consent (agreement to be involved having
been told all the facts about the study).
In this section you need to describe the process by which you are going to ensure a research
participant provides informed consent. This must include providing the patient with an
information sheet in clear, easy to understand format (the committee recommend following
the Information Sheet guidelines provided). Whilst wherever possible a minimum of 24 hours
should be given between the potential participants being given the PIS and signing the
consent form (we appreciate that this not always possible.) In cases where the applicant
Ethical Approval Panel for Research, Enterprise and Engagement V 2015/16
thinks this may be a problem, please declare it on the application giving sound reasoning for
your decision (you need to make clear the time a person will be given to consider their
involvement.) You should make it clear who will see the research data you collect and the
results, i.e. you, your supervisor and any other people involved in your data collection, for
example, technicians or audio transcribers.
Once a research participant has decided to be involved in the research study informed
consent must be obtained. The committee prefers written consent from research
participants (where at all possible) for this a standard consent form (see Research Participant
Consent Form) has been devised which the committee would prefer you to use. Where
written consent is not appropriate and/or available please give a coherent rationale as to
why this is the case and also an explanation of how you will ensure and record informed
consent. For survey research where questionnaires are posted to participants it is
appropriate to presume participants consent to being involved in the research by returning a
completed questionnaire, so written consent is not required.
It is equally as important that the research participant understands that they can withdraw
from a research study at any time without any consequences, even after data has been
collected they can ask for their data not to be included and subsequently destroyed. This is
stipulated on the written consent form and information sheet but you need to mention it in
your description of how informed consent is to be obtained.
It is essential that a person who is being approached to be involved in a research study is
considered mentally competent to provide informed consent. Where this is in question
further safeguards need to be described and an argument presented as to why it is
important for these people to be involved in the study.
What method are you using to gather data, data collection tools, interview guides,
questionnaires etc. whatever you use you must include (in the appendices with the
application) a copy of the instrument or at least a draft copy of any instrument or
interview guide (this should be version dated and identified on the checklist).
- Explain how the data will be analysed – for example using quantitative data packaged
such as SPSS, what statistical tests will be applied and/or using qualitative techniques
such as thematic, content, explanation building analysis.
Please provide an indication of the project duration or project schedule in your research
strategy or as an appendix.
-
6. Number of participants to be recruited and rationale for sample size
For quantitative studies the number of participants should be sufficient to produce
meaningful results. Often a power calculation will ensure appropriate numbers.
You need to provide a clear rationale why you chose the size of sample for your study.
Identify whether a power calculation was performed/appropriate and how this was
determined. The committee acknowledges particularly for PGR student research that large
samples may be unfeasible, but the rationale as to how you determined the size of your
study sample needs to be explained and what problems a small sample may have on the
study findings acknowledged. One method of determining a sample size could be to use
Ethical Approval Panel for Research, Enterprise and Engagement V 2015/16
similar numbers recruited within previous work/studies that have been shown to be
appropriate to substantiate the study findings.
7. Organisational agreement for the research study to take place
Whilst the ethics committee does not advocate approaching and gaining consent from
organisations to undertake research prior to ethical approval being granted, it is
recommended that the applicant consider how they will obtain agreement and what
strategies they have developed to enable this. For example, it is acceptable that applicants
approach organisations to seek advice about the process of gaining approval and provisional
support for the study, prior to applying for approval. The strategy ensures that the
organisation is receptive to the applicant’s project and would be in principle, willing to
approve the project once college ethical approval has been obtained. Please include emails/letters of agreement as appendices.
8. Code of ethical conduct/Governance Framework
Researchers should attempt to follow a Code of ethical conduct that is Profession specific.
Research within the NHS should be governed by the Research Governance Framework for
health and Social Care.
9. Data protection issues
Protecting sensitive data needs to be considered and how you can ensure participants’ data
remains confidential, such as the names/contact details of research participants and/or
personal information disclosed within a research study. You need to describe the methods
you will use to achieve this, the committee recommends that:








All research participants will be provided with a research code, known only to the
researcher to ensure that their identity remains anonymous and confidential
Names and contact details of research participants should be stored on a password
protected computer (consider the use of UoS shared drives), accessed only by the
researcher and others as appropriate.
All data collected such as questionnaires, interview recordings, transcripts, should be
anonymous and coded, hard paper copies of data, including consent forms should be
stored in a locked filing cabinet within a locked room, accessed only by the researcher
Data stored electronically must be on a password protected computer, accessed only by
the researcher. It is recommended that information is stored on a network drive which is
password protected, preferably the F drive or other shared drive.
All data transported on computer discs, CD’s and USB memory sticks should be
anonymous identified only by a code and encrypted to protect against loss.
All publications of data should be written in a way so as to disguise the identity of the
research participants involved. Data should not be used which can identify an individual
unless prior consent has been obtained from the individual involved.
Data should be stored and archived for a minimum of 3 years, after the graduate award
has been made, to allow verification of data from external sources if necessary, or
longer if used for further research.
Data sharing to allow secondary analysis of a different member of the original research
team should be consented for. The data must be fully anonymised in order for this to
happen.
Ethical Approval Panel for Research, Enterprise and Engagement V 2015/16
10. Other ethical issues to consider
There are a number of other ethical issues that you need to consider and explain in this
section if they are relevant to your study. How each of these issues is mitigated for so that
risk of harm or discomfort is reduced should be described. This should be considered for the
participant and the researcher.
Language Barriers – Participants must be able to understand the study. It is unethical to
exclude participants who do not speak English as their first language unless your study is
particularly focusing on English speaking individuals. Therefore you must identify whether
non-English speaking people could be part of your sample and what steps you will take to
make sure they can participate in the study, understand the information provided and be
able to provide informed consent.
Minority Groups – it is important to ensure that minority groups are considered and where
appropriate equally represented within a research study sample. You need to identify how
you will make sure that your sample is representative of the wider population, that there are
sufficient numbers of minority group participants to ensure that findings can fully represent
a particular group. This may involve participant’s who are blind/deaf and it is important to
clearly explain the methods taken to involve all participants, ensure they are adequately
informed.
Addressing Sensitive Issues – The researcher needs to demonstrate that they are aware that
when participants recollect/describe bad experiences, discuss sensitive information/feelings,
that this could impact negatively upon the research participant. A clear explanation should
be provided which describes how this impact will be minimised or prevented. Using a
sensitive interview approach, stopping interviewing if participant distressed, providing
contact details of an appropriate support service to refer/recommend to the participant to
discuss issues further with a professional.
Researcher skills and training – If the researcher proposes to carry out a procedure which
they have learned as part of their programme of study, for example finger-pricking, the
student must submit confirmation that they have undertaken this training to the panel as
part of their application. Where relevant to their application, students should also indicate if
they have been CRB checked.
Failure to consider ethical issues adequately will result in your application being returned for
re-submission or amendments.
11. Incentives/reimbursements
If reimbursements/incentives are being offered to the participants, please identify how this
is being funded and what is in place to ensure participants who receive extra financial
support are not affected.
12. Dissemination strategy
Please provide what dissemination processes are in place for the participants and to the
research community, e.g. thesis, dissertation, articles, conference presentation/report.
Ethical Approval Panel for Research, Enterprise and Engagement V 2015/16
13. References
Provide a Full list of references which support the background argument and rationale in
section 4.
NOTE: Ensure that all supporting documents such as copies of recruitment material,
questionnaires, interview guides, patient information sheets, consent form, risk
assessment form are attached to the application form and clearly indicated on the
applicant’s checklist.
Ethical Approval Panel for Research, Enterprise and Engagement V 2015/16
Example/Guidance for Participant Information Sheet
Informed consent from research participants is crucial. Therefore your information sheet
must use language that is readily understood by the general public.
Study Title
Does this explain the study in simple English? The title used needs to be in ‘lay’ terms so that
it is easy to understand for everyone. One consistent title should appear on all your study
documents and be self-explanatory. Any acronyms need to be written out in full.
Invitation paragraph
You need to explain that you are asking the participant to take part in research. For
example:
I would like to invite you to take part in a research study. Before you decide you need to
understand why the research is being done and what it would involve for you. Please take
time to read the following information carefully. Ask questions if anything you read is not
clear or would like more information. Take time to decide whether or not to take part.
You might want to add a couple or sentences explaining about the study here.
What is the purpose of the study?
Purpose is an important consideration for participants, and we recommend you present it
clearly and succinctly, in the context of other work in the field. Primarily the purpose may be
educational, such as undertaking a research study as part of a course. If this is the case, then
this purpose should be made clear.
Why have I been invited?
You should explain briefly why and how the participant was chosen and how many others will
be in the study.
For example explain clearly why you have chosen to recruit participants within a particular
ethnic group, or age group, healthy volunteers, students on a particular course, males or
females and why you are studying this particular population group.
Do I have to take part?
You should explain that taking part in the research is entirely voluntary. The following is an
example:
It is up to you to decide. We will describe the study and go through the information sheet,
which we will give to you. We will then ask you to sign a consent form to show you agreed to
take part. You are free to withdraw at any time, without giving a reason. (if applicable – this
will not affect the standard of care you receive).
You should explain that there is a withdrawal timeline and that possibility to withdraw will
be based upon this. You also need to explain that there may be withdrawal of information
issues based on certain constraints, for example:
Focus groups data is difficult to withdraw once the group has taken place. Interview data
cannot be withdrawn once a report of the research has been sent for publication
Ethical Approval Panel for Research, Enterprise and Engagement V 2015/16
What will happen to me if I take part?
To answer this question, try to ‘put yourself in the subject’s shoes.’
This section should include:
How long the participant will be involved in the research
How long the research will last (if different)
How often they will need to attend, meet a researcher, visit a clinic or their GP (if
appropriate)
How long these visits will be
What exactly will happen, for example: access to personal information, questionnaires,
interviews, discussion groups, measurements, blood tests, sample collection, x-rays etc.
Use the most appropriate format to demonstrate their involvement (diagrams/tables). The
detail will depend on the complexity of the study. It may help if the information is displayed
in a flow chart or grid indicating what will happen at each visit, where appropriate.
It should be clear which procedures are over and above those used in standard treatment or
management. It is also essential to explain whether any normal treatment will be withheld
for all or part of the study. Long-term monitoring/follow up should be mentioned.
If the study will involve video/audio-taping or photography, you should explain what is
intended, including the confidentiality issues. Specific consent will be needed if material of
any sort will be published that identifies the subject.
You should set out simply the research methods you intend to use.
Expenses and payments?
You should explain if any expenses (for example travel, meals, child-care, compensation for
loss of earning etc.) are available. You should consider whether any gifts or vouchers which
you intent as a thank-you should be detailed in the information sheet.
What are the possible disadvantages and risks of taking part?
Any risks, discomfort or inconvenience should be briefly outlined. You should consider
carefully how to explain any risks involved in your study, as this can be difficult.
Risks may include possible side effects from medication, potential injury from exercise trials,
or the use of additional ionising radiation within x-rays, or distress from recollecting
unpleasant memories and feelings.
For example:
if you are discussing or exploring sensitive issues with a participant that could upset them
then you need to identify this so the participant is fully aware. After the research is
completed make appropriate support services available for the participant to access if further
support is required.
What are the possible benefits of taking part?
Explain these, but where there is no intended benefit for the participant, this should be
stated clearly. It is important to not exaggerate the possible benefits. It would be reasonable
to say something similar to:
We cannot promise the study will help you but the information we get from the study will
help to improve the treatment of people with (name of condition)
Or
We cannot promise the study will help you but the information we get from the study will
help to increase the understanding of (name the focus of the research)
Ethical Approval Panel for Research, Enterprise and Engagement V 2015/16
What if there is a problem?
You should inform participants who to go to if they have a complaint about the research
study, their experience, and/or the researcher. A contact number should be given. This may
be the researcher in the first instance, who can try to resolve the problem. However a
participant may not wish to complain to the researcher if he/she is the object of the
complaint, and may wish to make a more formal complaint for example:
If you have a concern about any aspect of this study, you should ask to speak to the
researchers who will do their best to answer your questions (contact number). If you remain
unhappy and wish to complain formally you can do this through… (add appropriate contact
details of NHS, Private facility, University complaints procedure).
You need to identify the appropriate complaints procedure and provide the contact
details/location of where this can found, for example: NHS Complaints Procedure (or
Private Institution), University Complaints Procedure, - if student -Supervisor's name and
contact details etc, who they should be directed to in the first instance and then to Anish Kurien Research Centre’s Manager
University of Salford
G.08, Joule House, Acton Square, Salford, M5 4WT
t: +44 (0) 161 295 5276 | e: a.kurien@salford.ac.uk
If a member of staff please give Anish’s details (as above).
In addition to identifying a clear complaints procedure you need to identify appropriate
redress and/or compensation that would be available if the research participant came to any
harm as a result of the research study. As a student of the University and/or NHS employee
you need to fully explore the compensation arrangements. If there are no such
compensation/insurance/indemnity schemes in place then this needs to be clearly explained.
Will my taking part in the study be kept confidential?
You should tell the participant how their confidentiality will be safeguarded during and after
the study. You may wish to tell the participants how your procedures for handling, processing,
storage and destruction of their data match the Cadicott principles and/or Data Protection
Act 1998.
A safeguarding statement must be added where appropriate. For example:
I am aware that if I reveal anything related to criminal activity and/or something that is
harmful to self or other, the researcher will have to share that information with the
appropriate authorities.
The participant should be told:
How their data will be collected.
That it will be stored safely, giving the custodian and level of identification, for example:
o Individual participant research data, such questionnaires/interviews/samples/ x-rays will
be anonymous and given a research code, known only to the researcher/research team
Ethical Approval Panel for Research, Enterprise and Engagement V 2015/16
o A master list identifying participants to the research codes data will be held on a password
protected computer accessed only by the researcher/research team
o hard paper/taped data will be stored in a locked cabinet, within locked office, accessed
only by researcher/research team
o electronic data will be stored on a password protected computer known only by
researcher/research team
What it will be used for. For example it must be clear if the data is to be used for future
studies and whether further ethical approval will be sought.
Who will access to view identifiable data (authorised persons such as researchers within
the team, supervisors, sponsors and for monitoring the quality, regulatory authorities /R&D
audit).
How long will it be retained and that is will be disposed of securely (the College
Ethics panel recommends a minimum of 3 years)
Example introductory statement includes:
All information which is collected about you during the course of the research will be kept
strictly confidential, and any information about you which leaves the
hospital/surgery/university will have your name and address removed so that you cannot be
recognised.
Involvement of the General Practitioner/Family Doctor (GP) (Please note this is an
optional section and only needs including where applicable)
Some studies require that the research participant’s GP be informed if they are involved in
studies that may affect their normal health status. You need to explain to the research
participant if their GP needs to be contacted and seek their consent to do this. You should
clearly explain what information will be exchanged.
There are other studies/circumstances which may not impact on the health of the participant
therefore it would not be appropriate for you to contact their GP, or in some
cases it may not be possible.
What will happen if I don’t carry on with the study?
There are different positions to take on what will happen if a participant withdraws from a
study and it up to the researcher to determine what is applicable to their study and ensure
that this is clearly communicated to the participant prior to them agreeing to take part.
Three possible scenarios include:
If you withdraw from the study all the information and data collected from you, to date, will
be destroyed and you name removed from all the study files.
Or
If you withdraw from the study we will destroy all your identifiable samples/ tape recorded
interviews, but we will need to use the data collected up to your withdrawal.
Or
You can withdraw from the study/treatment but keep in contact with us to let us know your
progress. Information collected may still be used. Any stored blood/tissue samples or taped
interviews that can still be identified as yours will be destroyed if you wish.
What will happen to the results of the research study?
Participants often want to know the results of the study in which they were involved. You
should tell participants what will happen to the results, whether they will be published and
Ethical Approval Panel for Research, Enterprise and Engagement V 2015/16
how the results will be made available to them. You should add that they will not be
identified in any report/publication unless they have given their consent.
Who is organising or sponsoring the research?
The answer should include the organisation or company sponsoring the research and funding
the research if these are different (e.g. Research Charity, academic institution, NHS
employee).
Further information and contact details:
The additional information that participants require can sometimes be divided into the
following four categories. You need to identify where to locate additional information or who
to contact to address the different enquires.
1. General information about research (e.g. list relevant documents or websites)
2. Specific information about this research project (e.g. contact details of researcher)
3. Advice as to whether they should participate (e.g. contact details of a different health care
professional who can provide impartial advice)
4. Who they should approach if unhappy with the study (e.g. contact details of complaints
procedure if not listed earlier)
A minimum prerequisite in this section is that the contact details of the researcher (email
address) should be clearly identified.