School of Health and Related Research

Ethics Application Form

for Undergraduate & Postgraduate Taught Students

Guidance Notes for Completion

Should you complete the Ethics Application Form?

You should complete this form if you are an undergraduate or a postgraduate-taught student
who plans to undertake a research project which will not involve the NHS but which will
involve people participating in research either directly (e.g. interviews, questionnaires)
and/or indirectly (e.g. people permitting access to data).

Who decides if ethics approval is required for your proposed research?

If you are an Undergraduate, your Personal Tutor usually decides and if you are a
Postgraduate Taught student, your Supervisor decides.

Why is ethics approval necessary?

The main purpose of the Department’s procedures for gaining ethics approval is to facilitate
the carrying out of your research in a way that protects both you and your research
participants.

Which documents should you submit with the application form?

This form should be accompanied by your research proposal.

Where appropriate you should submit an information sheet/covering letter/written script that
informs prospective participants about the proposed research and/or a consent form that
prospective participants will sign.

Who decides if your proposed research should be classed as ‘low risk’ or

potentially ‘high risk’?

Again, if you are an Undergraduate, your Personal Tutor usually decides and if you are a
Postgraduate Taught student, your Supervisor decides.
If your personal tutor/supervisor classes your proposed research as potentially ‘high risk’, two
members of the department’s research ethics committee must review your research ethics
application form. This fuller review is not required if your personal tutor/supervisor classes
your proposed research as ‘low risk’.

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What do you do if your proposed research is classed as LOW
RISK?
You must complete the application form and sign Annex 1, the student declaration.

Undergraduates:
Your designated supervisor will be review the application form along with a copy of your
research proposal. (S)he will sign Annex 1 and give you a copy of it at your first meeting. This
confirms that (s)he agrees with your personal tutor’s classification of the proposed research
as ‘low risk’ and completes the ethics review. Your research now has ethics approval.

Postgraduate taught students:

Your supervisor will review the application and sign Annex 1 and give you a copy of it. This
should be submitted to ethics administrator, Cheryl Oliver and you will receive confirmation of
your ethics approval.

You must not begin your proposed research until you have a letter of approval. You
must hand in this fully signed copy of Annex 1 and letter of approval with your
dissertation/research project so please keep it safe.

What do you do if your research is classed as HIGH RISK?

You must complete the application form Annex 1, the student declaration, and your
Personal Tutor/Supervisor must complete Annex 2. Submit your application form to Cheryl
Oliver for ethical review to be undertaken.

Undergraduates:
Your designated supervisor will inform you of the outcome of the ethics review and of any
ethics conditions that have been set at your first supervision meeting. Your supervisor will
then give you a fully signed copy of Annex 1 and Annex 2. This completes the ethics review
and your research now has ethics approval. You must advise your personal tutor if you wish
to begin the research before your first meeting with your supervisor so that the department
can make alternative arrangements for advising you of the outcome of the ethics review.

Postgraduate taught students:

You will receive confirmation of the outcome of the ethics review and of any ethics conditions
that have been set at your first meeting. You should discuss any conditions set with your
supervisor

You must not begin your proposed research until you have a fully signed copy of
Annex 1 and Annex 2 and a letter of approval. You must hand in these fully signed
copies of Annex 1 and Annex 2 with your dissertation/research project so please keep
them safe.

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 School of Health and Related Research
Ethics Application Form
for Undergraduate & Postgraduate Taught Students

I confirm that I plan to inform the prospective participants about the research
project by using an Information Sheet/Covering Letter/Pre-Written Script:

Yes:  Mark 1 Box No:

(if yes, then this must be enclosed)

I confirm that I plan to invite prospective participants to sign a consent form:

Yes:  Mark 1 Box No:

(if yes, then this must be enclosed)

A1. Title of research project:

Components of an Effective Early Supported Discharge Team for Stroke: A West

Ethicshire Perspective.

A1. 1 URMS Number:

A1.2 Research sponsor, where appropriate: N/A

A2. Name of Student: Tara Morgan

Department: SCHARR PG taught student

Email: TAMorgan1@sheffield.ac.uk

Tel: 334455

Degree registered for: Master Of Public Health (Europubhealth) 2009-2011

Name of Supervisor: Professor John Smith

A3. Proposed Project Duration:

Start date: 22/12/2010 End date: May 10th 2011

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A4. Mark ‘X’ in one or more of the following boxes if your research:
Please tick YES NO

1. Does your research involve participants who are particularly

vulnerable or unable to give informed consent (e.g. adults with mental
X
incapacity or mental illness)?

2. Does your research involve children or young people under the age
X
of 18?

3. Will it be necessary for participants to take part in your research

X
without their knowledge/consent at the time?

4. Will your research involve discussion of topics that the participants

X
might find sensitive (e.g. sexual activity, own drug use)?
X
5. Will your research involve prolonged or repetitive testing?

6. Could your research induce psychological stress or anxiety or cause

harm or negative consequences beyond risks encountered in normal
X
life?

7. Will financial inducements (other than reasonable expenses and

X
compensation for time) be offered to participants?

8. In terms of personal safety, are you putting yourself and/or your

participants at risk in any way? e.g. out alone at night, interviewing in
X
your or your participant’s home alone, carrying out observation in
potentially volatile or sensitive situations.

9. Will your research involve the production of recorded media such as

X
audio and video recordings?

10. Will the study involve the recruitment of research participants

X
through Sheffield City Council or any other council?
Please note: if you tick ‘yes’ to question 1 or 2, you may require a Criminal Records
Bureau (CRB) check. Your proposed research will be designated potentially high risk
and two members of the department’s research ethics committee will review your
application to decide if one is necessary.

If you have answered ‘yes’ to any of the above questions, please note the number in
this box and explain how you will manage the ethical issue (continue on a separate
sheet if necessary)

9. Subject informed consent will be gained prior to entry into focus groups. This will comprise
statement of understanding of the information sheet and agreement to be audio-taped. Subjects
will be identified in transcripts and tape recordings by their role only e.g. therapist 1, support
worker 1, manager 1 etc. No names or other identifying information will be included in the
transcripts resulting from this study. Anonymsied transcripts will be kept under lock and key or
in password protected files for the duration of the study.

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A5. Briefly summarise the project’s aims, objectives and methodology?
(This must be in language comprehensible to a lay person)

A recent study of early supported discharge researchers agreed the components of an

“effective” early supported discharge (ESD) team for stroke. They involve the composition of
the team; it’s method of working, intervention and measures of success. The aim of this
study is twofold:
 to apply these components to the Rehabilitation in the Home service in Western
Ethicshire to see if they are achieved, and
 To understand whether these components are important from a staff point of view.
A mixture of secondary data analysis and primary data collection will be undertaken.
Population level, service level and individual patient data will be collected in anonymised
format in order to study the number of clients accepted, their severity of stroke, the outcome
measures taken and their discharge destination.
Rates of institutionalisation, re-admission to hospital and lengths of stay for stroke patients
will be studied in the years before and since the introduction of the ESD service in order to
investigate trends.
Focus groups will be conducted of staff in order to discuss the importance of the components
identified in the research and to uncover themes relating to the implementation of ESD for
stroke in this health service with these components in mind.

A6. What is the potential for physical and/or psychological harm / distress to
participants?

There are no foreseeable risks or discomforts that may be associated with the focus group
discussion although some people may feel uncomfortable voicing opinions in front of others
or having their point of view challenged. It will be up to subjects how much they wish to take
part and they will be free to discontinue involvement at any time by notifying the group
facilitator.

A7. Does your research raise any issues of personal safety for you or other
researchers involved in the project? (especially if taking place outside working
hours, off University premises or outside the UK)

No

If yes, explain how these issues will be managed

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A8. Explain how the potential participants in the project will be

(i) Identified?

The service employs approximately 30-40 staff. All paid staff will be eligible to be included in
the focus groups. Focus groups will be conducted for managers and coordinators of which
there are 5, so all will be approached. Another focus group will include therapists and support
staff who will be invited purposively to ensure a balanced group according to gender, clinical
experience, number of years with the service and age.

(ii) Approached?

Subjects will be invited at a team meeting and/or by email.

(iii) Recruited?

Those agreeing to be involved will be chosen according to the desired balance of factors
above. Informed consent will then be gained.

9. Will informed consent be obtained from the participants?

YES X NO

If informed consent or consent is not to be obtained please explain why.

A9.1. This question is only applicable if you are planning to obtain informed consent:
How do you plan to obtain informed consent? (i.e. the proposed process?):

Subjects will be invited into the study and given the information sheet to read before
consenting to the study. They will also be encouraged to talk to the researcher and others
prior to agreeing to be involved as necessary. They will then be requested to sign the
consent form. They will also be advised that they can discontinue their involvement at any
time without explanation.

A10. What measures will be put in place to ensure confidentiality of personal data,
where appropriate?
No personal data will be collected in this study. Consent forms and information sheets
will be kept under lock and key in the service office. All secondary data will be
requested without names, medical record numbers, dates of birth or addresses for
the individual patient level data. Focus group participants will be identified by role only
and notated as such in transcripts. Anonymised transcripts will be kept in password
protected files and in locked drawers.
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A11. Will financial / in kind payments (other than reasonable expenses and
compensation for time) be offered to participants? (Indicate how much and on
what basis this has been decided)
YES NO X

A12. Will the research involve the production of recorded media such as audio
and/or video recordings?

YES X NO

A12.1. This question is only applicable if you are planning to produce recorded media:
How will you ensure that there is a clear agreement with participants as to how
these recorded media may be stored, used and (if appropriate) destroyed?

The information sheet will contain details as to the storage and use of the recordings and
whether subjects will be identifiable. Consent will be gained for the use of audio recording.
Subjects will also sign that they understand that they will not be identifiable and that they
understand the contents of the information sheet. Information sheets will be given to
participants to keep after consent is gained and a record kept of this. Consent will also be
requested to use the transcripts for future study.

A13. Does this work involve data collection outside of the UK?

YES X NO

If yes, please explain how the proposed research meets the ethical and legal requirements
of the country where the research is being undertaken?

An application has been made to the Ethicshire Area Health Service Human Research Ethics
Committee for ethical approval for all sites involved in the research in Western Ethicshire. It
has been made on the standard application form along with copies of the information sheet
and consent form in line with the requirements of the ethics committee. The study has the full
support of the Hospital management staff. I am an employee of the service being studied.

A13.1 Do you have approval from the hosting country or organisation within that country to
undertake the research?
YES X NO

If yes, please provide copies of letters/ documents granting approval for the research

Copies included YES NO X

If no, please justify why approval has not been sought.

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I am awaiting approval documents from the ethics committee. No formal documented
approval given, only informal agreement given by management. Ethics committee will sit
February 8th 2011.

Guidance fact-sheets on ‘Safety and Well-Being’, on ‘Consent’ and on ‘Anonymity,

Confidentiality and Data Protection’ are at:
www.shef.ac.uk/researchoffice/gov_ethics_grp/ethics/factsheets.html

These three fact-sheets have been updated in the light of new findings from three Social
Research Association-funded research projects, which were published in 2008, that focused
on the perspective of participants regarding their experience as participants.

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 Annex 2
School of Health and Related Research
Ethics Application Form
for Undergraduate & Postgraduate Taught Students

Student Declaration

(the student completes Annex 1 if the Supervisor has classed the

student’s proposed research project as ‘low risk’)

The Supervisor needs to receive an electronic copy of the form, and other
documents where appropriate, plus a signed, dated paper copy of this Annex 1
‘the Student Declaration’.

Full Research Project Title: Components of an Effective Early Supported Discharge

Team for Stroke: A West Ethicshire Context.

In signing this Student Declaration I am confirming that:

 The research ethics application form for the above-named project is accurate to the best
of my knowledge and belief.
 The above-named project will abide by the University’s ‘Good Research Practice
Standards’ : www.shef.ac.uk/researchoffice/gov_ethics_grp/grpstandards.html
 The above-named project will abide by the University’s ‘Ethics Policy for Research
Involving Human Participants, Data and Tissue’:
www.shef.ac.uk/researchoffice/gov_ethics_grp/ethics/system.html
 Subject to the above-named project being ethically approved I undertake to adhere to
any ethics conditions that may be set.
 I will inform my Supervisor of significant changes to the above-named project that have
ethical consequences.

 I will inform my Supervisor if prospective participants make a complaint about the above-
named project.
 I understand that personal data about me as a researcher on the research ethics
application form will be held by those involved in the ethics review process (e.g. my
Supervisor and the Ethics Administrator) and that this will be managed according to Data
Protection Act principles.

Name of Supervisor:

Name of student:

Signature of student:

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 Annex 2
Date: 2 February 2011
nd

School of Health and Related Research

Ethics Application Form
for Undergraduate & Postgraduate Taught Students
Supervisor Declaration
(the Supervisor completes Annex 2 if s/he has classed the student’s
proposed research project as potentially ‘high risk’)

The Ethics Administrator needs to receive an electronic copy of the form, and
other documents where appropriate, plus a signed, dated paper copy of this
Annex 2 ‘the Supervisor Declaration’.

Full Research Project Title: insert name

In signing this Supervisor Declaration I am confirming that:
 The research ethics application form for the above-named project is accurate to the best
of my knowledge and belief.
 The above-named project will abide by the University’s ‘Good Research Practice
Standards’: www.shef.ac.uk/researchoffice/gov_ethics_grp/grpstandards.html
 The above-named project will abide by the University’s ‘Ethics Policy for Research
Involving Human Participants, Data and Tissue’:
www.shef.ac.uk/researchoffice/gov_ethics_grp/ethics/system.html
 Subject to the above-named project being ethically approved I will undertake to ensure
that the student adheres to any ethics conditions that may be set.
 The student or the Supervisor will undertake to inform the Ethics Administrator of
significant changes to the above-named project that have ethical consequences.
 The student or the Supervisor will undertake to inform the Ethics Administrator if
prospective participants make a complaint about the above-named project.
 I understand that personal data about the student and/or myself on the research ethics
application form will be held by those involved in the ethics review process (e.g. the
Ethics Administrator and/or reviewers) and that this will be managed according to Data
Protection Act principles.

Name of Supervisor: insert name

Name of student: insert name

Signature of Supervisor: sign here

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 Annex 2
Date: insert date