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UNIVERSITY OF ULSTER

RESEARCH GOVERNANCE

RG1a APPLICATION TO UNDERTAKE RESEARCH ON HUMAN SUBJECTS


PLEASE REFER TO THE NOTES OF GUIDANCE BEFORE COMPLETING THIS
FORM. (Available from the Research Governance website at
http://www.ulster.ac.uk/research/rg/)
All sections of this form must be completed (use minimum font size 11). If the
form is altered in any way it will be returned unconsidered by the Committee.
This form should be used for research in categories A, B and D
Do not use this form for research being conducted in collaboration with the
NHS/HPSS (category C).

SECTION A
Chief
Investigator

Mr Terry Quigley

Title of
Project

Informative Graphics for COPD Diagnosis Patients

Student and
course (if
applicable)

Lauren Smyth BDes Qualification in Design

Additional
Investigators

Padraic Lynch
Chloe Marren

Declaration - Chief Investigator:


I confirm that
this project meets the definition for research in category* (please insert)
this project is viable and is of research or educational merit;
all risks and ethical and procedural implications have been considered;
the project will be conducted at all times in compliance with the research
description/protocol and in accordance with the Universitys requirements on recording
and reporting;
this application has not been submitted to and rejected by another committee; and
Permission has been granted to use all copyright materials including questionnaires and
similar instruments

Signed:

Date:

Once complete, this application and all associated materials must be submitted for peer review

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*In addition, you should complete form RG1d for all category D research and
form RG1e for both category B and D research
Peer Review

Those conducting peer review should complete form RG2 and attach it to this form (RG1). RG1,
RG2 and all associated materials should then be returned to the Chief Investigator.

Depending upon the outcome of peer review, the Chief Investigator should arrange to submit to
the Filter Committee, resubmit the application for further review or consider a new or
substantially changed project. The application must not be submitted to the Filter Committee
until the peer review process has been completed (except as permitted below)

Please note that peer review can be conducted by the Filter Committee if time and
capacity allow. This is at the discretion of the Chairperson of each Filter Committee and is
subject to change.

Filter Committee

The application must be considered by the Filter Committee in accordance with the
requirements of the University

The Filter Committee should complete form RG3 and write to the Chief Investigator
indicating the outcome of its review

Depending upon the outcome of the Filter Committee review, the Chief Investigator
should arrange to proceed with the research OR submit to the Universitys Research
Ethics Committee OR resubmit the application for further review OR consider a new or
substantially changed project

The Filter Committee should retain a complete set of original forms.

SECTION B
1. Where will the research be undertaken?
During the Pulmonary Rehabilitation groups held within the Trust at:
110 Saintfield Rd, Belfast, County Antrim BT8 6GR
2. a. What prior approval/funding has been sought or obtained to conduct this.
research? Please also provide the UU cost centre number if known
Permission from the Belfast Health and Social Care Trust through Sharon
Madigan and Tracy Haylett
b. Please indicate any commercial interest in/sponsorship of the study
Final deliverables are for future use within the Trust and potentially across the
Health Boards nation wide
3. Duration of the Project
Start: 12/1/16

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End: 12/5/16

Duration: 5 Months

4. Background to and reason(s) for the Project


Please provide a brief summary in language comprehensible to a lay person or nonexpert. Full details must be provided in the description/protocol submitted with this
application (see Notes of Guidance)

A dietetics student on placement in the Belfast Health and Social Care Trust came
to Magee at the start of the year pitching an idea for a collaborative project
between the Trust and the University. She was intending on working with a design
student to help her come up with a set of visual aids to help the patients she was
working with. There currently is nothing in place already and so Miss Marren
realised these graphics were a necessity. The research and content will all be
supported and carried out by the Trust and all design aspects will be carried out by
myself within the University.

5. Aims of the Project


Please provide a brief summary in language comprehensible to a lay person or nonexpert. Full details must be provided in the description/protocol submitted with this
application (see Notes of Guidance)

During this project I will be researching and creating a set of specialised


infographics for patients which have been diagnosed with Chronic Obstructive
Pulmonary Disease. These patients all attend a set of rehabilitation classes within
the Belfast Trust to learn about their recent diagnosis and how they can lessen the
severity of the diseases progression through lifestyle and diet choices. With
information gathered from the patients, these infographics will be created, printed
and readily available to be handed over to the patients to take home. Helping them
remember any information they were taught during the classes. A secondary
deliverable will be to write up and set out a body of text based on how Healthcare
and Design can work together. This will be created with the end goal of potential
future publication in selected journals.

6. Procedures to be used
a. Methods
Please provide a brief summary in language comprehensible to a lay person or nonexpert. Full details must be provided in the description/protocol submitted with this
application (see Notes of Guidance)

As this project is very specifically user group based, I will be sitting in a few of
these rehabilitiation meetings to find out exactly the user would like to see. I will be
presenting them with a few multiple choices visuals (i.e. a set of different colour
schemes to choose from, a range of different illustration styles, print sizes etc) and
one they have chosen their preferred options I can gather together the information
and draw up a conclusive evaluation of the design choices I need to make. This
means all the visual choices made, colours used, fonts used, and graphics will all
be totally justified.

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b. Statistical techniques
Please provide details of the statistical techniques to be used within the
project description/protocol (see Notes of Guidance)
7. Subjects:
a. How many subjects will be recruited to the study (by group if
appropriate)?
Rehabilitation Patients

b. Will any of the subjects be from the following vulnerable groups YES NO
Children under 18
Adults with learning or other disabilities
Very elderly people

X
X

Healthy volunteers who have a dependent or


subordinate relationship to investigators
Other vulnerable groups
If YES to any of the above, please specify and justify their inclusion
All these patients have been diagnosed with COPD, some will be carrying
around oxygen tanks, masks and other breathing apparatus and all have a lot
difficulty breathing. As all of the attendees are fifty years and above the likelihood
of them having other health problems is quite high.

c. Inclusion and exclusion criteria


Please indicate, with reasons, the inclusion criteria for the project
The attendees of these meetings are all ideal to contribute. It is solely because of
their state of health that I need to ask their opinion.
Please indicate, with reasons, any exclusion criteria for the project
N/A

d. Will any inducements be offered? If Yes, please describe


No inducements will be offered

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e. Please describe how and where recruitment will take place


The subjects of this survey are whoever is in attendance of the Pulmonary
Rehabilitation meetings within the Trust. I will not be contacting them beforehand
or afterwards. I do not need their contact details or any personal information. I
have been granted permission to ask the group questions by the Dieticians who
run these groups.
8. Ethical implications of the research
Please provide an assessment of the ethical implications of the project
I do not believe that there will be any ethical implications with this evaluation as
the questions are based on what aesthetics they personally think are better.
What colours they prefer etc.

9. Could the research identify or indicate the existence of any undetected


healthcare concern?
Yes

No

If Yes, please indicate what might be detected and explain what action will be
taken (e.g. inform subjects GP)

10. Risk Assessment **


Please indicate any risks to subjects or investigators associated with the project
This assessment carries minimal risk. There is no potential for any harm to come
to any of the participants. As previously mentioned there will be no personal
details, names, patient or medical details taken down about any of these patients.

**If you wish, you can use form RG1c Risk Assessment Record (available from the
Research Governance website) to help you assess any risks involved

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11. Precautions
Please describe precautions to be taken to address the above
N/A

12. Consent form


It is assumed that as this study is being conducted on human subjects, an
information sheet and associated consent form will be provided. A copy of
the information sheet and form must be attached to this application. See
Notes of Guidance.
If a consent form is not to be used, please provide a justification:

13. Care of personal information


Please describe the measures that will be taken to ensure that subjects personal
data/information will be stored appropriately and made available only to those
named as investigators associated with the project.

14. Copyright
Has permission been granted to use all copyright materials including
questionnaires and similar instruments?
Yes
No
If No, please provide the reason

Once you have completed this form you should also complete form RG1d for
all category D research and form RG1e for both category B and D research

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