DURHAM COUNTY COUNCIL
CHILDREN AND ADULTS SERVICE,
RESEARCH APPROVAL GROUP
APPLICATION FORM
Version 4
October 2015
Children and Adults Service Research Approval Group
Page 1 of 17
Children and Adults Service Research Approval Group
Before completing this form please check if any of the following applies to your research;
1
If the research involves people who lack capacity, involves Social Care studies with substantial
ethical issues or patients or users of NHS services
Social Care studies with substantial ethical issues, and all research with adults (aged 16 and over) who lack
capacity to consent MUST be approved by the Health Research Authority (HRA) using the Integrated
Research Application System (IRAS). The Health Research Authority also approves research for projects
involving;



Social Care studies funded by the DoH
Integrated health & social care studies where there are no clinical interventions
Studies in NHS setting where the approach uses social science or qualitative methods providing it does
not involve clinical intervention

Adult social care involving changes in or the withdrawal of standard care

Patients or residents in residential care homes
More information and how to apply to HRA can be found at http://www.hra.nhs.uk/
Research involving patients and users of NHS services should be approved by the HRA using the Integrated
Research Application System (IRAS). This service is responsible for approving research for projects
involving;







Participants identified as carers or relatives of patients and users for the NHS
Access to data organs or other bodily material of past and present NHS patients
Foetal material and IVF involving NHS patients
Use of, or potential access to NHS premises or facilities
NHS staff recruited as participants by virtue of the professional role
Health related research involving prisoners (in addition to their own approval process)
Processing of confidential patient information without consent where this would otherwise breach
confidentiality

Midwives conducting a clinical trial
More information and how to apply to NRES can be found at http://www.hra.nhs.uk/
2
If the proposed research has been approved by the Health Research Authority (HRA)
In principle, an application should only have to go to one Research Ethic Committee for ethical approval.
Durham County Council’s (DCC) Children and Adults Service Research Approval Group (CAS RAG) would
not need to approve projects already scrutinised and approved by HRA. CAS RAG may request a copy of
the approval form and supporting documents and share these with an appropriate CAS Strategic Manager
for information.
3
If the project involves four or more local authorities
In this case, approval must be sought from the Association of Directors of Adults Social Services (ADASS)
for projects involving adults, and the Association of Directors of Children’s Services (ADCS) for projects
involving children. ADASS/ADCS approval is not ethical approval but a decision about whether the research
is worth doing. Authorities are advised not to collaborate with projects which are rejected by ADASS or
ADCS. A local authority should be identified to undertake the lead for projects approved by ADASS /ADCS.
4
Children & Adults Service Research Projects
If you are undertaking research that targets employees or service users/carers of Durham County Council’s
Children and Adults Services, or involves their personal records, then you need to complete this application
form for ethical approval to undertake your research.
Children and Adults Service Research Approval Group
Page 2 of 17
SECTION A: RESEARCHER, CO-WORKER AND SPONSOR DETAILS
A1.
Lead Researcher Details
Forename/Initials:
Surname:
Work Address:
Job Title:
Email address:
Tel:
Relevant Qualifications - Please detail below your highest level of qualification achieved to
date
Qualification Level:
Course Title:
Date of Attainment:
Research Experience
Do you have any relevant
research experience:
No:
☐
Yes: ☐
Please give details below
Quantitative:
Qualitative:
Other:
A2
Co-worker
(If there are no co-workers go to question A4)
Forename/Initials:
Surname:
Role within this Project:
Relevant Qualifications of Co-worker- Please detail below your highest level of qualification
achieved to date:
Qualification Level:
Course Title:
Date of Attainment:
Research Experience of Co-worker
Do you have any relevant
research experience:
No:
☐
Yes: ☐
Children and Adults Service Research Approval Group
Please provide details below
Page 3 of 17
SECTION A: RESEARCHER, CO-WORKER AND SPONSOR DETAILS
Quantitative:
Qualitative:
Other:
A3
If there is more than one co-worker please tick this box and provide full details on a separate
piece of paper: ☐
A4
Please provide details below of the person within DCC Children and Adults Services who is
supporting this research (NOTE: This person should be a senior manager (Tier 4).
Forename/Initials:
Surname:
Work Address:
Job Title:
Email address:
Tel:
A5
Student applicants only Please state the name of your college/university tutor/sponsor
College Tutor Name:
Job Title:
Email address:
Children and Adults Service Research Approval Group
Page 4 of 17
SECTION B: PROJECT OVERVIEW
B1
Project Title:
☐
B2
B3
Is this research project:
a component of a university qualification
☐
intended to inform or direct service improvement and conducted by DCC staff only
☐
intended to inform or direct service improvement and not conducted by DCC staff
☐
other (please state):
☐
What is the main aim of this research?
What are the main objectives of this research?
Objective 1:
Objective 2:
Objective 3:
Objective 4:
B4
Why is this area of research important?
B5
Is there a commitment to act on the research findings?
B6
No
☐
Please state why not:
Yes
☐
Please give details:
Not Known
☐
Please give details:
Explain any way in which participants might benefit from the research (e.g. subsequent
service improvement, personal development opportunity, social contact, financial gain etc.).
Children and Adults Service Research Approval Group
Page 5 of 17
SECTION B: PROJECT OVERVIEW
NOTE - Approval cannot be given by CAS RAG if the research has already started.
Please provide a chronological timetable of the research project, including start and finish dates
for:
B7
Project Start Date:
Activity 1 - Preparation and Planning:
Start Date:
End Date:
Activity 2 - Carry Out Primary Research:
Start Date:
End Date:
Activity 3 - Analyse Data:
Start Date:
End Date:
Activity 4 - Report Findings:
Start Date:
End Date:
Will this research be repeated?
Yes:
☐
No:
☐
Please give frequency:
Completed Research Reports and findings should be available in electronic format and will be
retained on the CAS Research Database. Researches should send their final reports to;
researchapprovalgroup@durham.gov.uk.
Please provide the date by which you hope to make your project
available.
Please describe below how will the results of research be made available and publicised to
research participants and communities from which they are drawn?
B8
Research Funding
Is funding required for the research?
Yes:
☐
No:
☐
Has funding been secured?
Yes:
☐
No:
☐
Please give details of the organisation funding this research if applicable:
Name of organisation
Address
Contact Person
Telephone No.
Email Address
Amount
Children and Adults Service Research Approval Group
Page 6 of 17
SECTION C: PROJECT PARTICIPANTS AND METHODOLOGY DETAILS
(Please complete in language comprehensive to a person without expertise in the research area)
Sampling arrangements and criteria for selecting participants
Please describe below how potential participants in the study be identified/selected/approached:
C1
How will participants be selected? (Where sampling
is required, please give the techniques/methods you
will use)
From where will their contact details be obtained?
Please describe how participants will be approached
or contacted?
Please attach copies of proposed letters or emails if
appropriate.
What is the size of this population and how many
participants do you plan to involve?
What formulae have you used to determine the
number of participants you require?
If you are sampling the population, how many
potential participants will you approach to ensure
that you achieve the sample size given above?
Has statistical advice been sought on the study design?
C2
C3
Yes: ☐
Please provide details of their
comments:
No: ☐
Please explain why not:
Do you need to monitor and report the gender, race and ethnicity of research participants?
Yes:
☐
Why?
No:
☐
Why not?
Research Methods. Please select all of the research methods below that will be used:
Interviews
Please attach copies of proposed interview scripts
Questionnaires
Please attach copies of proposed questions
Children and Adults Service Research Approval Group
Structured / Semi Structured
☐
Unstructured
☐
Telephone Interviews
☐
Postal / Email Survey
☐
Face to Face Survey
☐
Internet survey
☐
Page 7 of 17
SECTION C: PROJECT PARTICIPANTS AND METHODOLOGY DETAILS
(Please complete in language comprehensive to a person without expertise in the research area)
Other methods
Other, please specify below
Please attach copies of proposed documents where
appropriate
☐
C4
Describe below the research methodology/ methodologies you will be using for your research
For example, give details of the activities and processes that will be used to measure the data
and interpret the outcomes.
C5
Describe how you will analyse your data (including any statistical methods you will use):
Children and Adults Service Research Approval Group
Page 8 of 17
SECTION D CONSENT ARRANGEMENTS
D1
Consent arrangements
The Mental Capacity Act (2005) and capacity to consent to taking part in research.
Research must fully comply with the requirements of the Mental Capacity Act 2005, in relation to
research involving service users who lack capacity to consent (Section 32(3), Mental Capacity Act
2005).
Under the Mental Capacity Act 2005, all research with adults (aged 16 and over) who lack capacity to
consent, MUST be approved by a National Research Ethics Committee and CANNOT be approved by
a local authority. More information is available on the link below;
http://www.hra.nhs.uk/resources/research-legislation-and-governance/questions-and-answers-mentalcapacity-act-2005/
D2
Vulnerability - might participants be from any of the following groups? (Tick as appropriate).
Children and Young People (Under 16 years)
☐
CAS service users or carers
☐
People with Mental Health conditions
☐
Elderly people including for example, people with dementia
☐
People with learning disabilities
☐
People from prison or detention settings
☐
Other vulnerable groups – please give details
D3
☐
Consent arrangements
If research involves children under the age of 16, how will consent be
obtained?
How will details of the project be explained to the participants?
Please attach a copy of your written explanation to this application.
Is there any difficulty expected in obtaining consent?
For example, could any of the participants have difficulty in consenting
to take part in the project?
How and where will written consent be recorded and stored?
Please attach consent forms and full details of proposed storage
arrangements
Information about the research.
All participants should be provided with detailed information about the research which should include;

the reason for their involvement in the project

notification of their right to withdraw from the study at any time

contact details of the researcher so they can ask further questions

details of how they can obtain a copy of the findings after the study is completed
Children and Adults Service Research Approval Group
Page 9 of 17
SECTION D CONSENT ARRANGEMENTS
Please explain how you intend to inform participants of this type of
information?
Please attach a research information sheet if appropriate
D4
What arrangements have been made for participants who might not adequately understand
verbal explanations or written information given in English, or who have special
communication needs? (Translation, use of interpreters etc.).
D5
Where appropriate a Personal or Nominated Consultee may need to be appointed. Please
provide their details below;
Personal Consultee: ☐
Nominated Consultee: ☐
Name:
Address:
Telephone No:
Email:
Children and Adults Service Research Approval Group
Page 10 of 17
SECTION E DATA PROTECTION
E1
Data protection arrangements
Please fully describe below the data protection arrangements in place for the collection, storage and
destruction of electronic and paper copy data collected as part of this project:
How will the data be obtained and recorded?
How will the data be stored?
In what format and for how long will the data be
retained?
How will the data be destroyed?
What security arrangements have been made to
protect personal data collected and stored as part of
this project?
E2
Will there be an exchange of personal and identifiable information from one party or agency to
another?
No: ☐
Please go to Section F
Yes: ☐
Please give details below:
Which individual(s) or organisation(s) currently holds
the information that will be shared?
With whom will the information be shared?
Why is it necessary to share the information for the
purposes of the research?
What is the specific data or information that will be
shared?
How long will the shared information be held?
How will the shared information be provided (e.g.
paper copy, electronic)?
Please describe the steps you will be taking to
safeguard the confidentiality of individuals ‘records
during the project?
Who will be responsible for the implementation of
these arrangements?
Children and Adults Service Research Approval Group
Page 11 of 17
SECTION F: RISKS
F1
Has or will this application be considered by another Research Ethics Committee?


If your proposal has already been approved by a National Research Ethics Committee (Health
Research Authority), approval from CAS RAG is not required.
If your research involves four or more local authorities, approval will be required from the
Association of Directors for Adults Social Services (ADASS) or Association of Directors of
Children’s Services (ADCS) and approval from CAS RAG is not required.
No or not applicable
☐
University/College
☐
Association of Directors for Adults Social Services (ADASS) or Association of Directors of
Children’s Services (ADCS)
☐
Health Research Authority (HRA)
☐
Other please give details
If it has been through another research committee what was the
outcome/decision
☐
Please forward a copy of the approval documents to CAS RAG
F2
Does the Lead Researcher or any other investigator/collaborator have any direct personal
involvement in the organisation(s) sponsoring or funding the research that may give rise to a
possible conflict of interest?
Employed by Children and Adults Services
☐
Student Placement with Children and Adults Services
☐
Shareholding Interest
☐
Financial Interest
☐
Other
☐
If yes to any of the above, how will the effects of the conflict/s of
interest be minimised
F3
Disclosure, Vetting & Barring checks
Researchers and Co-workers involved in this project, who will be in direct contact with vulnerable
groups or have access to personal information on vulnerable groups MUST have had appropriate
Disclosure, Vetting & Barring checks.
Please confirm these checks have been completed.
F4
Yes: ☐
No: ☐
Are any participants involved personally known to the researcher or co-workers:
Yes:
☐
No:
☐
How will the effects of this be minimised?
Children and Adults Service Research Approval Group
Page 12 of 17
F5
F6
Might participants be discussing personal, sensitive, embarrassing, or upsetting issues?
Yes:
☐
No:
☐
How will the effects be minimised:
Is the research likely to lead to participants disclosing criminal or other activities that would
likely to require action?
Yes:☐
No: ☐
What arrangements have been made to inform the participants of the
actions that will be taken if a disclosure referral is required?
What arrangements have been made by the researcher to ensure
disclosures are referred through the appropriate route?
F7
Where will the research take place?
F8
What are the potential risks to research participants, if any, and how will they be managed?
F9
What are the potential risks, if any to the researchers themselves, and how will they be
managed?
F10
What arrangements, if any, have been made to provide compensation in the event of a claim by,
or on behalf of, participants for negligent and/or non-negligent harm?
F11
☐
Arrangements have been made for negligent harm.
☐
Arrangements have been made for non-negligent harm.
☐
No arrangements have been made.
If there is any further information about your project, that you have not been able to enter on
this form which you feel is relevant, please state here (please do not repeat information already
given on this form).
Children and Adults Service Research Approval Group
Page 13 of 17
SECTION G: DECLARATION
G1
G2
Documents Attached;
A1 - co-worker sheet if applicable
Yes: ☐
No: ☐
N/A: ☐
C1 – letters/emails to participants
Yes: ☐
No: ☐
N/A: ☐
C3 – interview scripts and or questionnaire questions etc.
Yes: ☐
No: ☐
N/A: ☐
D3 - consent and research information sheets
Yes: ☐
No: ☐
N/A: ☐
F1 - Research Ethics Committee if appropriate
Yes: ☐
No: ☐
N/A: ☐
Research Applicant Declaration
-
The information in this form is accurate to the best of my knowledge and belief and I take full
responsibility for it.
-
I will carry out the research as it is described in this application form and attached documents.
-
I will stop the research within this project and resubmit an application should this research need
to be amended.
-
I am aware of my obligations to comply with legislation and relevant guidelines relating to
security and confidentiality of service user or other personal data.
-
I understand that research records/data may be subject to inspection for audit purposes if
required in future.
-
I understand that personal data about me as a researcher in this application will be held and
managed in line with the principles of the Data Protection Act and DCC policies & procedures.
-
I will undertake and carry out the research in accordance with relevant legislation including the
Mental Capacity Act 2005.
-
I have made my college/university tutor aware of this research and they fully support my
application to CAS RAG (where applicable).
-
I have made the appropriate CAS Strategic Manager (Tier 4) aware of this research and they
fully support my application to CAS RAG (where applicable).
-
An appropriate referral will be made in the event that a participant makes a disclosure during the
course of this project to myself or a co-worker and they will be informed of this action if
appropriate
-
I agree to send my completed report and findings to CAS RAG who will retain this on file
-
I agree that my project will be available for future reference within the appropriate service area if
required.
Research Applicant
Name :
Signature:
Date:
If you email your form to Children and Adults, Research Approval Group your email address will be
taken as your signature, but if you post or fax your form, you must remember to sign it.
Please return your application form to ResearchApprovalGroup@durham.gov.uk or by post to:
DCC Children and Adults. Research Approval Group, Planning & Service Strategy, County Hall
Durham, DH1 1BR
If you need this application form in other formats, such as Braille or talking tapes, please contact
03000 267 323
Children and Adults Service Research Approval Group
Page 14 of 17
Risk Analysis Tool - ONLY TO BE COMPLETED BY CAS RAG
RAG Member Guidance Note: Please select the most appropriate option for the research proposal being
considered in relation to the following areas of risk:
Risk Analysis (tick boxes to indicate judgement)
Area
High
Consent
Researcher
competence
Nature of
Information
being sought
Methods /
nature of data
collection
Informed consent and
ability to withdraw
from study not
possible or unlikely
(e.g. due to age of
child or incapacity of
adult. Communication
issues, sensory or
speech impairment)
Researcher(s) not
well qualified (e.g.
undergraduate or
qualifications below
graduate level).
AND/OR
Experience of
knowledge of only
one or none of the
following factors
 topic of
investigation
participants/
subjects
 methods to be
used
(e.g. student project
where researcher has
little experience or
knowledge of the
field)
The topic and kinds of
information being
sought/used are likely
to be regarded as
highly personal or
sensitive by those
from whom it is being
collected or about
(e.g. criminal records
psychiatric history
etc)
Research involves a
high level of direct
interaction with the
participant (e.g. face
to face, telephone,
conversation,
participant
observation,
observation study)
Medium
Low
☐
Informed consent and
ability to withdraw from
study possible with
support to overcome
communications barriers
(e.g. advocates,
translators/interpreters,
signer or technology)
☐
Informed consent
and ability to
withdraw from study
fully possible
☐
☐
Researcher(s)
reasonably well qualified
(e.g. at or above
graduate level or
equivalent)
AND
Experience and
knowledge of both of the
following factors:
 topic of investigation
participants /
subjects
 methods to be used
(e.g. non-researcher with
formal research training
working in a professional
domain offering relevant
experience and
knowledge)
☐
Researcher(s) well
qualified (e.g. at or
above masters level
or equivalent) or
graduate with
substantial formal
training in research
methods
AND
 experience and
knowledge of all
of the following
factors gained
from working
environment: topic
of investigation
participants/
subjects
 methods to be
used
☐
☐
The topic or the kinds of
information being
sought/used include
items likely to be
considered slightly
sensitive by some
people (e.g. age,
ethnicity, income)
☐
The topics and kind
of information being
sought/used do not
focus on personal
information at all (e.g.
opinion about
services received)
☐
☐
Some interaction contact
for limited amounts of
time
☐
No interaction
between investigator
and participant
☐
Children and Adults Service Research Approval Group
Risk Analysis (tick boxes to indicate judgement)
Area
High
Level of
Privacy to
participant
Relationships
between
investigator
and subjects /
participants
Adverse
Effects
Mental
Capacity
Not confidential (e.g.
focus groups where
all participants are
party to opinions
expressed or studies
where small numbers
make confidentiality in
reporting impossible
Subjects / participants
are personally known
to investigator
OR
investigator may have
other duties or
responsibilities
towards all or some
of the research
participants which
may create potential
conflict of interest
Study is likely to be
extremely sensitive
(e.g. possibility of
uncovering criminal
activity, involving
substantial
work/insufficient
funding/unjustified
expense to the
County Council or
provoking media
interest)
Study is with one or
more participants who
lack the capacity to
consent to take part in
the research
Medium
Low
☐
Confidential (e.g. data,
information can be
associated with
individuals by researcher
but individuals cannot be
identified in reports)
☐
Anonymous (e.g.
questionnaires which
cannot be traced
back to participants)
☐
☐
Limited information
about subjects /
participants is provided
to the investigator to
make the study possible
or more reliable
☐
Subjects /
participants are
unknown to the
investigator and
cannot be identified
(e.g. anonymous
questionnaires)
☐
☐
Parts of study may be
sensitive
☐
No known
sensitivities
☐
☐
Not Applicable
☐
Study is with all
participants who have
the capacity to
consent to take part
in the research
☐
Children and Adults Service Research Approval Group
RAG Member Guidance Note:
Please indicate below whether in your opinion the risk implications presented in the research proposal
being considered are acceptable or unacceptable and provide any additional comments.
Risk Assessment
Comments
Consent
Researcher Competence
Nature of Information
being sought
Methods/nature of data
collection
Level of Privacy to
participants
Relationships between
investigator and subjects/
participants
Adverse Effects
Mental Capacity
This application should be;
Approved without any amendment/s:
☒
Approved subject to the Lead Researcher satisfactorily completing the above recommendations
where questions are noted as unacceptable:
☐
Declined:
☐
Other: Please give details;
Completed by:
Children and Adults Service Research Approval Group
Date: