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									Research Governance and Ethics Committee (RGEC): College of Health and
Social Care, University of Salford

Guidance Notes for Completing the RGEC 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, Research and Governance and Ethics
Committee. 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 (approx 20 words)

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 focus (approx 100 words)

Provide a short overview of the aims of the research study, such as: What are you going to do,
who will it involve, what do you hope to achieve.

3. Project objectives (between 3-5 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 the knowledge of…

4. What is the rationale which led to the study? (approx 300 words)

Providing a rationale for the study refers to the presentation of a clear comprehensive summary
of background research/literature which has informed your study development. In this section
you need to generate an argument as to what has been done, what we already know about the
phenomenon being researched, what the gaps are in the research knowledge and what your
project will contribute to or add to this body of knowledge. All research publications need to be
clearly referenced and a full list of references provided in section 12.

5. Is your project linked to any other projects?

Linked projects are acceptable, but separate ethical applications must be made by each
applicant. Where your project forms part of a larger project, or is a joint project with another


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student then this should be clarified in section 5. Each applicant must give a clear outline of
their particular roles and responsibilities within the project. For example, please make clear
your responsibilities. e.g. If researcher A will be undertaking the interviews and researcher B
collecting numerical data need to ensure they understand the ethical implications of each
activity. In addition, a clear participant information sheet that outlines all the project
interventions and expectations of the participants needs to be included. This may mean that the
information sheet is the same for the linked projects.

.

6. Research strategy (approx 300 words)
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:
 - Who will be approached, how many participants, what will their involvement entail, how
      often, where are they from/located. You need describe the sampling frame you have
      chosen, why you have selected to approach x amount of people and identify how the
      sample represents the wider population so the results can be generalised.
 - Identify the research methodology you have adopted, such as epidemiology,
      phenomenology, action research, whatever you choose make sure it is clear to the reader
      why this method is important.
 - 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.

7. Number of participants to be recruited and rationale for sample size (approx 100
   words)

For a study to be ethical it needs to be performed on sufficient numbers to allow the results to
fully represent the wider population and thus be generalised. 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 student research that large samples may be unmanageable 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 similar numbers recruited within previous work/studies that have
been shown to be appropriate to substantiate the study findings.

To fully understand the impact of the number of participants you have selected for your study
sample it is important to provide a total number of potential participants so a percentage of the
total possible sample can be reviewed (for example total number of people on a course
compared with the 20 students enrolled in the study).

8. Organisational agreement for the research study to take place (approx 100 words)


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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.

9. Approaching individual’s to be involved in the research (approx 200 words)

This section needs to clearly explain how and which individuals you propose to recruit for the
research study. You need to clearly identify a recruitment plan and add supporting material
(copies of Posters, newspaper adverts, website, emails, 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?

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 has privy to this information and ask participants to reply directly to you providing
their own contact details. If you wish to approach 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.

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 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.

10. Gaining informed consent (approx 200 words)

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


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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). Nationally the ethical guidelines stipulate that a
research participant should be given a minimum of 24 hours to consider their involvement in a
research study although longer is advised, you need to make clear the time a person will be
given to consider their involvement.

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. For research taking place face-
face then written consent should always be obtained, this also allows the research participant
to ask direct questions. 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.

11. Data protection issues (approx 100 words)

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, accessed only by the researcher.
   All data collected such as questionnaires, interview tapes, transcripts, should be
    anonymous and coded, hard paper copies of data 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.



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   All data transported on computer discs, CD’s and USB memory sticks should be
    anonymous identified only by a code and where possible 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.


12. Other ethical issues to consider (approx 200 words)

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.

Language Barriers – 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.

Failure to consider ethical issues adequately will result in your application being returned for re-
submission or amendments.


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



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assessment form are attached to the application form and clearly indicated on the
applicant’s checklist.




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