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Proportionate Review Form for Primary Research - Desklib

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Added on  2023/06/11

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This is a Proportionate Review Form for Primary Research that focuses on minimally sensitive topics and involves participants who are not vulnerable. It includes a researcher declaration, participant information sheet, and data handling and confidentiality. The form also provides eligibility criteria for participants and a section for the supervisor or head of department to approve the project. Learn more at Desklib.

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University Research Ethics Committee (February 2018)
COMPLETE FOR PRIMARY RESEARCH
Proportionate Review Form
The Proportionate Review process may be used where the proposed research raises only
minimal ethical risk. This research must: focus on minimally sensitive topics; entail minimal
intrusion or disruption to others; and involve participants who would not be considered vulnerable
in the context of the research.
PART A: TO BE COMPLETED BY RESEARCHER
Name of Researcher:
School
Student/Course Details (If Applicable)
Student ID Number:
Name of Supervisor(s)/Module Tutor:
PhD/MPhil project:
Taught
Postgraduate
Project/Assignmen
t:
Award
Title:
Modul
e Title:Undergraduate
Project/Assignmen
t:
Project Title: To evaluate the prevalence of clinical depression among young
people (16-24 years old).
Project Outline: To evaluate the prevalence of clinical depression among young
people (16-24 years old).
Give a brief description
of participants and
Participants will be adults of age between 16 -24.

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University Research Ethics Committee (February 2018)
procedure (methods,
tests etc.)
Survey method is chosen to collect data
Expected Start Date: Expected End Date:
Relevant professional body ethical guidelines should be consulted when completing this form.
Please seek guidance from the School Ethics Coordinator if you are uncertain about any ethical
issues arising from this application.
There is an obligation on the researcher and supervisor (where applicable) to bring to the attention
of the School Ethics Coordinator any issues with ethical implications not identified by this form.
Researcher Declaration
I confirm that:
1. The research will NOT involve members of vulnerable groups.
I consider that this project has no significant ethical implications requiring full ethical review
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University Research Ethics Committee (February 2018)
Vulnerable groups include but are not limited to: children and young people (under
18 years of age), those with a learning disability or cognitive impairment, patients,
people in custody, people engaged in illegal activities (e.g. drug taking), or
individuals in a dependent or unequal relationship.
2. The research will NOT involve sensitive topics.
Sensitive topics include, but are not limited to: participants’ sexual behaviour, their
illegal or political behaviour, their experience of violence, their abuse or exploitation,
their mental health, their gender or ethnic status. The research must not involve
groups where permission of a gatekeeper is normally required for initial access to
members, for example, ethnic or cultural groups, native peoples or indigenous
communities.
3. The research will NOT deliberately mislead participants in any way.
4. The research will NOT involve access to records of personal or confidential
information, including genetic or other biological information, concerning
identifiable individuals.
5. The research will NOT induce psychological stress, anxiety or humiliation, cause more
than minimal pain, or involve intrusive interventions.
This includes, but is not limited to: the administration of drugs or other
substances, vigorous physical exercise, or techniques such as hypnotherapy
which may cause participants to reveal information which could cause concern,
in the course of their everyday life.
6. The research WILL be conducted with participants’ full and informed
consent at the time the study is carried out:
The main procedure will be explained to participants in advance, so
that they are informed about what to expect.
Participants will be told their involvement in the research is voluntary.
Written consent will be obtained from participants. (This is not
required for self-completion questionnaires as submission of the
completed questionnaire implies consent to participate).
Participants will be informed about how they may withdraw
from the research at any time and for any reason.
YE
S
N/
A
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University Research Ethics Committee (February 2018)
For questionnaires and interviews: Participants will be given the
option of omitting questions they do not want to answer.
Participants will be told that their data will be treated with full
confidentiality and that, if published, every effort will be made to
ensure it will not be identifiable as theirs.
Participants will be given the opportunity to be debriefed i.e. to find out
more about the study and its results.
7. A risk assessment has been completed for this research project YE
S
N/
A
If you are unable to confirm any of the above statements, please complete a Full Ethical Review
Form. If the research will include participants that are patients, please complete the Independent
Peer Review process.

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University Research Ethics Committee (February 2018)
8. Information and Data
Please provide answers to the following questions regarding the handling and storage of information
and data:
a) How will research data be stored (manually or electronically)?
electronically
b) How is protection given to the participants (e.g. by being made anonymous through coding and
with a participant identifier code being kept separately and securely)?
By being anonymous
c) What assurance will be given to the participant about the confidentiality of this data and the
security of its storage?
They will be provided confidentiality about research work through discussion
d) Is assurance given to the participant that they cannot be identified from any publication or
dissemination of the results of the project?
Yes
e) Who will have access to this data, and for what purposes?
Researcher for conducting study
f) How will the data be stored, for how long, and how will it be discarded?
In pendrive and laptop
Supporting Documentation
Signature of Researcher: Date:
NB: If the research departs from the protocol which provides the basis for this proportionate
review, then further review will be required and the applicant and supervisor(s) should consider
whether or not the proportionate review remains appropriate. If it is no longer appropriate a full
ethical review form MUST be submitted for consideration by the School Ethics Coordinator .
All key documents e.g. consent form, information sheet, questionnaire/interview schedule are
appended to this application.
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University Research Ethics Committee (February 2018)
PART B: TO BE COMPLETED BY SUPERVISOR/MODULE TUTOR (If student) OR Head of
Department/
Next Step:
STUDENTS: Please submit this form (and supporting documentation) for consideration by your Supervisor/
Module Tutor.
STAFF: Please submit this form to your Head of Department or a Senior Researcher in your School. Once
they have reviewed the form, this should be forwarded to the Research Administrators in RIIS
(ethics@staffs.ac.uk) who will arrange for it to be considered by an independent member of the School’s
College of Reviewers .
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University Research Ethics Committee (February 2018)
Senior Researcher (if staff)
I consider that this project has no significant ethical implications requiring full ethical
review by the Faculty Research Ethics Committee.
I have checked and approved the key documents required for this proposal (e.g.
consent form, information sheet, questionnaire, interview schedule).
Signature of
Supervisor/ Head of
Department/ Senior
Researcher:
Date:
PART C: TO BE COMPLETED BY A MEMBER OF THE SCHOOL’S COLLEGE OF ETHICAL
REVIEWERS
This research proposal has been considered using agreed University Procedures and is
now approved.
Or
This research proposal has not been approved due to the reasons given below.
Next Step: Please forward this form to the Research Administrators in RIIS (ethics@staffs.ac.uk) who will
arrange for it to be considered by an independent member of the School’s College of Ethical Reviewers ,
having no direct connection with the researcher or his/her programme of study.

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University Research Ethics Committee (February 2018)
Recommendation (delete as appropriate): Approve/ Amendments required/ Reject
Name of Reviewer:
Date:Signature:
Signed (School
Ethical
Coordinator)
Date:
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INSERT DATE IN HEADER
COMPLETE FOR PRIMARY RESEARCH
INFORMATION SHEET FOR PARTICIPANTS
Title of study
INSERT TITLE HERE
Invitation
I would like to invite you to participate in this research project which forms part of my INSERT
DEGREE TITLE HERE Knowledge Exchange Project. Before you decide whether you want to
take part, it is important for you to understand why the research is being done and what your
participation will involve. Please take time to read the following information carefully and discuss
it with others if you wish. Ask me if there is anything that is not clear or if you would like more
information.
What is the purpose of the study?
This research will investigate…
The study aims to identify… The
study will focus on…
Why have I been invited to take part?
You have been invited to take part in this research project, to INSERT RESEARCH AIMS HERE
See below for eligibility criteria for this study, if you do not fulfil the criteria, please inform
INSERT YOUR NAME HERE
INSERT ELIGIBILITY HERE
What will happen if I take part?
INSERT RESEARCH METHOD HERE AND WHAT PARTICIPANTS WILL NEED TO DO
Once the data has been collected, all participant information will be coded and therefore
anonymous and unbiased when analysing.
Do I have to take part?
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2
Participation is completely voluntary. You should only take part if you want to and choosing not to
take part will not disadvantage you in anyway. Once you have read the information sheet, please
contact us if you have any questions that will help you make a decision about taking part. If you
decide to take part we will ask you to sign a consent form and you will be given a copy of this
consent form to keep.
Data handling and confidentiality
Your data will be processed in accordance with the data protection law and will comply with
the General Data Protection Regulation 2016 (GDPR).

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3
INSERT DATE IN HEADER
Data will be stored electronically on the Staffordshire university secure Office 365 Drive.
Data Protection Statement
The data controller for this project will be Staffordshire University. The University will process
your personal data for the purpose of the research outlined above. The legal basis for processing
your personal data for research purposes under the data protection law is a ‘task in the public
interest’ You can provide your consent for the use of your personal data in this study by completing
the consent form that has been provided to you.
You have the right to access information held about you. Your right of access can be exercised in
accordance with the General Data Protection Regulation. You also have other rights including
rights of correction, erasure, objection, and data portability. Questions, comments and requests
about your personal data can also be sent to the Staffordshire University Data Protection Officer. If
you wish to lodge a complaint with the Information Commissioner’s Office, please visit
www.ico.org.uk.
What if I change my mind about taking part?
You are free withdraw at any point of the study, without having to give a reason. Withdrawing from
the study will not affect you in any way. You are able to withdraw your data from the study up until
the point that stage 1 of data collection has been completed, after which withdrawal of your data
will no longer be possible due to the data would have been processed/ anonymised in readiness to
inform the practical training framework.
If you choose to withdraw from the study we will not retain any information that you have provided
us as a part of this study.
What will happen to the results of the study?
INSERT HOW YOUR RESEARCH WILL BENEFIT YOUR CHOSEN ORGANISATION
Who should I contact for further information?
If you have any questions or require more information about this study, please contact me using the
following contact details:
INSERT YOUR DETAILS HERE
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What if I have further questions, or if something goes wrong?
If this study has harmed you in any way or if you wish to make a complaint about the conduct of
the study you can contact the study supervisor or the Chair of the Staffordshire University Ethics
Committee for further advice and information:
Thank you for reading this information sheet and for considering taking part in this
research.
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University Research Ethics Committee February 2018
COMPLETE FOR SECONDARY RESEARCH
Disclaimer Form
The following declaration should be made in cases where the researcher and the supervisor (where
applicable) conclude that it is not necessary to apply for ethical approval for a specific research
project.
PART A: TO BE COMPLETED BY RESEARCHER
Name of Researcher:
School
Student/Course Details (If Applicable)
Student ID Number:
Name of Supervisor(s)/Module Tutor:
PhD/MPhil project:
Taught
Postgraduate
Project/Assignmen
t:
Award Title:
Module
Title:
Undergraduate
Project/Assignmen
t:
Project Title:
Project Outline:
Give a brief description
of research procedure
(methods, tests etc.)
Expected Start Date: Expected End Date:

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University Research Ethics Committee February 2018
Declaration
I/We confirm that the University’s Ethical Review Policy has been consulted and that all ethical issues and
implications in relation to the above project have been considered. I/We confirm that ethical approval need
not be sought. I/We confirm that:
The research does not involve human or animal participants
The research does not present an indirect risk to non-participants (human or animal).
The research does not raise ethical issues due to the potential social or environmental
implications of the study.
The research does not re-use previously collected personal data which is sensitive in nature, or
enables the identification of individuals.
Has a risk assessment been completed for this project? Yes
N/A
Signature of Researcher: Date:
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University Research Ethics Committee February 2018
Signature(s) of Project
Supervisor(s) (If student) OR
Signature of Head of
Department/ Senior researcher
(if staff)
Date:
NB: If the research departs from the protocol which provides the basis for this disclaimer then ethical
review may be required and the applicant and supervisor (where applicable) should consider whether or
not the disclaimer declaration remains appropriate. If it is no longer appropriate an application for ethical
review MUST be submitted.
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