University Research Ethics: Stage 1 and Stage 2 Approval Forms

This document provides a comprehensive overview of the research ethics approval process at a university, focusing on the Stage 1 and Stage 2 Research Ethics Approval Forms. It details the requirements for ethical clearance before any data collection commences, emphasizing the importance of the Risk Checklist and the classification of projects based on risk categories (1, 2, and 3). The document outlines the application process, including applicant details, project summaries, confirmation statements, and the risk assessment checklist. It also covers the approval process for different risk categories, the role of the Research Supervisor and Local Research Ethics Co-ordinator, and the importance of adhering to the University Research Ethics Policy and Procedures. Furthermore, it offers guidance on completing the forms, including electronic signatures, and emphasizes the need to obtain ethical approval before commencing any data collection. The document also includes information on secondary data, literature reviews, systematic reviews, and meta-analysis. It provides a detailed overview of the scientific methodology for OH&S and also includes information on quantitative vs qualitative research methods.

STAGE 1 - RESEARCH ETHICS APPROVAL FORM
STAGE 1 - RESEARCH ETHICS APPROVAL FORM
Research by students and staff at the University must receive ethical approval before any data collection
commences. Applications may be made on the Research Ethics Online system or via approval forms.
Applicants complete this Stage 1 - Research Ethics Approval Form which includes the Risk Checklist.
For student projects classified as Risk Category 1 (e.g., literature reviews), these can be approved on this Stage 1 –
Research Ethics Approval Form by the Research Supervisor.
Applicants whose research studies are classified as Risk Category 2 or 3 must also complete and submit the
separate Stage 2 - Research Ethics Approval Form.
Guidance for completion of this form and the application process is provided on pages 3 and 4.
APPLICANT DETAILS
Your name (if a group project, include all names)
Faculty or Partner Organisation
STATUS
 Undergraduate student
 Taught Postgraduate student
 Research Postgraduate student
 Staff member
 Other (give details)
IF THIS IS A STUDENT PROJECT
 Student ID
 Course title (eg, BA (Hons) History)
 Student email
 Research Supervisor’s name
Or Director of Studies’ name
THE PROJECT/STUDY
Project /study title Traffic management for Forklift operator to
prevent accident in manufacturing industry
Start date of project August 18
Expected completion date of project May 19
Project summary – please give a brief summary of your study (maximum 100 words)
The research intends to investigate the places where more traffic leads to forklift based accidents. A primary
data collection method will be used to determine the places where such accidents occur, their frequency and
previous instances.
CONFIRMATION STATEMENTS
The results of research should benefit society directly or by generally improving knowledge and
understanding. Please tick this box to confirm that your research study has a potential benefit. If you
cannot identify a benefit you must discuss your project with your Research Supervisor to help identify one
or adapt your proposal so the study will have an identifiable benefit.
Please tick this box to confirm you have read the Research Ethics Policy and the relevant sections of the
Research Ethics Procedures and will adhere to these in the conduct of this project.

RISK CHECKLIST - Please answer ALL the questions in each of the sections below – tick YES or NO
WILL YOUR RESEARCH STUDY……..? YES NO
1 Involve direct and/or indirect contact with human participants?
2 Involve analysis of pre-existing data which contains personal or sensitive information not in
the public domain?
3 Require permission or consent to conduct?
4 Require permission or consent to publish?
5 Have a risk of compromising confidentiality?
6 Have a risk of compromising anonymity?
7 Collect / contain sensitive personal data?
8 Contain elements which you OR your supervisor are NOT trained to conduct?
9 Use any information OTHER than that which is freely available in the public domain?
10 Involve respondents to the internet or other visual/vocal methods where participants may be
identified?
11 Include a financial incentive to participate in the research?
12 Involve your own students, colleagues or employees?
13 Take place outside of the country where you are enrolled as a student, or for staff, outside of
the UK?
14 Involve participants who are particularly vulnerable or at risk?
15 Involve any participants who are unable to give informed consent?
16 Involve data collection taking place BEFORE informed consent is given?
17 Involve any deliberate deception or covert data collection?
18 Involve a risk to the researcher or participants beyond that experienced in everyday life?
19 Cause (or could cause) physical or psychological harm or negative consequences?
20 Use intrusive or invasive procedures?
21 Involve a clinical trial?
22 Involve the possibility of incidental findings related to health status?
CLASSIFICATION
The following guidance will help classify the risk level of your study
Tick the box which applies
to your project
If you answered NO to all the above questions, your study is provisionally classified as
Risk Category 1 (literature reviews will be Risk Category 1).
If you answered YES to any question from 1-13 and NO to all questions 14-22, your
study is provisionally classified as Risk Category 2.
If you answered YES to any question from 14-22, your study is provisionally classified as
Risk Category 3.
DECLARATION AND SIGNATURE/S
I confirm that I will undertake this project as detailed above. I understand that I must abide by the terms of the
approval and that I may not make any substantial amendments to the project without further approval.
Signed Date
FOR RISK CATEGORY 1 STUDENT PROJECTS
Approval from the Research Supervisor or Director of Studies for a student project:
I have discussed the ethical issues arising from the project with the student. I approve this project.
Name Signed Date
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NEXT STEP
RISK CATEGORY 1 PROJECTS: IF YOUR PROJECT HAS BEEN CLASSIFIED AS RISK CATEGORY 1:
 Students: The Research Supervisor should return the signed form to the student and send a copy to the
Local Research Ethics Co-ordinator and where relevant, the Research Module Leader, for information.
 Staff: Submit this form to your Local Research Ethics Co-ordinator.
RISK CATEGORY 2 OR 3 PROJECTS: IF YOUR PROJECT HAS BEEN CLASSIFIED AS RISK CATEGORY 2 OR 3 please
complete the Stage 2 - Research Ethics Approval form and submit both forms together with supporting
documentation.
Research ethics application forms will be retained in the Faculty for the purposes
of quality assurance of compliance and audit for THREE years
NOTES FOR COMPLETION
University Research Ethics Policy and Procedures
The University Research Ethics Policy and Research Ethics Procedures should be read prior to commencing this
application. Consideration of the application by the reviewer/s will be undertaken in accordance with the Policy
and Procedures.
External requirements for the project
Applicants should consider if there are requirements by any relevant professional, statutory or regulatory body,
or learned society, which may be relevant to the project or if the project also requires external approval.
Submission
 Student applicants: email the typed form/s to your Research Supervisor or Director of Studies.
 Staff applicants: email the typed form/s to your Local Research Ethics Co-ordinator.
How to complete the form
You can navigate through the form by using the tab keys. If you prefer to complete a normal Word document, you
can unlock the form by selecting the ‘Restrict Editing’ button on the Developer tab, then click on ‘Stop Protection’.
The boxes should expand to allow space for your text.
Signatures
Electronic/typed signatures are acceptable for emailed forms, as the emails provide the audit trail for all parties’
agreement and approval of the forms (e.g., student applicant →Research Supervisor →Local Research Ethics Co-
ordinator).
Outcome
Applicants will be advised of the outcome of the application by:
 The Research Supervisor or Director of Studies for Risk Category 1 student projects;
 The Local Research Ethics Co-ordinator or the Faculty Research Ethics Committee for Risk Category 2 and 3
projects.
YOU MAY ONLY BEGIN ANY DATA COLLECTION ONCE YOU RECEIVE NOTIFICATION THAT THE PROJECT HAS
ETHICAL APPROVAL. If the circumstances of your research study change after approval it is your responsibility to
revisit the Risk Checklist and complete a further application.
Advice
When completing the Stage 1 - Research Ethics Approval Form,. if you are uncertain about the answer to any
question, read the relevant section of the Research Ethics Procedures document, and if you are still unsure:
 if you are student, seek guidance from your Research Supervisor or Director of Studies;
 if you are a staff member, contact your Local Research Ethics Co-ordinator.
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APPROVAL PROCESS
Local Research Ethics Co-ordinator = LREC
Faculty Research Ethics Committee = FREC
Category Student applicants Staff applicants
Risk
Category 1
If your study has been provisionally classified as Risk Category 1,
your Research Supervisor (or Director of Studies) can normally
give approval for the project.
You must complete this form and submit it to your Research
Supervisor for consideration.
A copy of the signed form if approved must be given or emailed
to the LREC and, where relevant, the Research Module Leader,
for information.
If your study has been classified as Risk
Category 1, you do not need ethical
approval for the project.
You must complete the remainder of this
form so that your research project is
registered with the University.
Please submit this form to your LREC.
Risk
Category 2
If your study has been provisionally classified as Risk Category 2,
your Supervisor (or Director of Studies) can recommend approval
for your study by the LREC.
You must complete this application form and also the separate
Stage 2 - Research Ethics Approval form.
Once you have completed the forms please submit both forms
and supporting documentation to your Research Supervisor for
consideration. Your Supervisor may disagree with your
assessment and ask you to make revisions or reject your
application. When the Research Supervisor is happy to
recommend the application for approval, they will send the
forms to the LREC.
The LREC will review your project and then decide to approve it,
ask for revisions, reject it or pass it on for review by the
appropriate FREC.
If your study has been provisionally
classified as Risk Category 2, your project
will be considered for ethical approval by
the LREC.
You must complete this application form
and also the separate Stage 2 - Research
Ethics Approval form. Please submit both
forms and supporting documentation to
your LREC for consideration.
The LREC will review your project and
then decide to approve it, ask for
revisions or pass it on for review by the
appropriate FREC.
Risk
Category 3
Postgraduate Research Students
If your study has been provisionally classified as Risk Category 3,
your Supervisor or Director of Studies can recommend approval
for your study by the LREC.
You must complete this application form and also the separate
Stage 2 - Research Ethics Approval form and submit both forms
to your Director of Studies.
If your Director of Studies recommends approval of your project
they will refer it to the LREC who will review your project and
decide whether to grant ethical approval, request revisions,
reject the application or refer it to the appropriate FREC for
review.
Undergraduate and Taught Postgraduate Students
If your study has been provisionally classified as Risk Category 3,
you should consult with your Research Supervisor immediately
as it is unlikely you will be able to proceed and you should
negotiate a project that is of lower risk. However, if you have
already discussed the project with your Supervisor and they have
agreed that a case for approval is warranted, proceed in line with
the details above for Research Students.
If your study has been provisionally
classified as Risk Category 3, your project
will be considered for ethical approval by
an appropriate LREC.
You must complete this application form
and also the separate Stage 2 - Research
Ethics Approval form and submit both
forms with supporting documentation to
your LREC.
The LREC will review your project and
then decide to approve it, ask for
revisions or pass it on for review by the
appropriate FREC.
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