011 Element Ethics application form (1000 words) (2022 MOD006278 TRI2 D01NON)

Table of Contents

CONFIDENTIAL

Stage 1 Research Ethics Application Form

Section 1: Details of the Researcher and their Research

N.B. If you are conducting research that involves ‘animals (dead or alive) and significant habitats’, please use the Stage 1 Research Ethics Application Form involving Animals and Habitats on the research ethics website.

Applicants carrying out research with children or vulnerable adults may also need to carry out an online Safeguarding course and submit the pass certificate with their ethics application. Please refer to the Question Specific Advice for the Stage 1 Research Ethics Application Form at the above weblink.

Researcher details
First name
Family name
School/Faculty	Health Education, Medicine and Social Care
Email address
Name of Institution where you study or work	Anglia Ruskin University
Are you: Please tick	Undergraduate (UG) Student Postgraduate Taught (PGT) Student Postgraduate Research (PGR) Student Member of ARU Staff Member of ARU staff carrying out Masters/Doctorate research
Students (including staff proposing research on a course/programme)

Your course/programme title	Postgraduate Research Design Module
Name of your first supervisor (for PGR) or supervisor (for UG and PGT)	G Egbury/R Pathack
Research details
Title of your research project N.B. For UG/PGT students, this is not the title of your research module
Name and institutional affiliation of any research collaborators	N/a
Date of application	30/03/2023
Start date of proposed research	May 2023
Brief Project Summary (up to 700 words) Please summarise your research in non-specialist language. Please describe where relevant: Methodology (please describe what you plan to do as opposed to providing a background in your chosen methodology) Theoretical approaches Research questions Details of participant population (recruitment, inclusion and exclusion criteria	Rationale/Background Aim: Objectives: Research Question: Inclusion Criteria Exclusion Criteria Methodology: Systematic Review Nature of data analysis
Please explain the potential value of your research to society and/or the economy and its potential to improve knowledge and understanding.	To complete

Section 2: Research Ethics Checklist (Refer to Section 3 for an explanation of the colour coding.)

N.B. If you are conducting research that involves ‘animals and significant habitats’, please use the Stage 1 Research Ethics Application Form involving Animals and Habitats, available on the research ethics website.

You must provide a response to ALL questions. Please refer to the Question Specific Advice for completing the Stage 1 Research Ethics Application Form for guidance.

	Will your research (delete as appropriate):
1	Involve human participants?	YES	NO
2	Utilise data that is not publicly available?	YES	NO
3	Create a risk that individuals and/or organisations could be identified in the outputs?	YES	NO
4	Involve participants whose responses could be influenced by your relationship with them or by any perceived, or real, conflicts of interest?	YES	NO
5	Involve the co-operation of a ‘gatekeeper’ to gain access to participants?	YES	NO
6	Offer financial or other forms of incentives to participants?	YES	NO
7	Involve the possibility that any incidental health issues relating to participants could be identified?	YES	NO
8	Involve the discussion of topics that participants may find distressing?	YES	NO
9	Take place outside of the country where you work and/or are enrolled to study?	YES	NO
10	Cause a negative impact on the environment (over and above that of normal daily activity)?	YES	NO
11	Involve genetic modification of human tissue, or use of genetically modified organisms classified as Class One activities?[1].	YES	NO
12	Involve genetic modification of human tissue, or use of genetically modified organisms above Class One activities?[2].	YES	NO
13	Collect, use or store any human tissue or DNA (including but not limited to, serum, plasma, organs, saliva, urine, hair and nails)?[3]	YES	NO
14	Involve medical research with humans, including clinical trials or medical devices?	YES	NO
15	Involve the administration of drugs, placebos or other substances (e.g. food, vitamins) to humans?	YES	NO
16	Cause (or have the potential to cause) pain, physical or psychological harm or negative consequences to humans?	YES	NO
17	Involve the collection of data without the consent of participants, or other forms of deception?	YES	NO
18	Involve interventions with people aged 16 years of age and under?	YES	NO
19	Relate to military sites, personnel, equipment, or the defence industry?	YES	NO
20	Risk damage/disturbance to culturally, spiritually or historically significant artefacts/places, or human remains?	YES	NO
21	Contain research methodologies you, or members of your team, require training to carry out?	YES	NO
22	Involve access to, or use (including internet use) of, material covered by the Counter Terrorism and Security Act (2015), or the Terrorism Act (2006), or which could be classified as security sensitive?[4]	YES	NO
23	Risk being construed as encouraging terrorism or inviting support for proscribed organisations and/or contain extremist views that risk drawing people into terrorism or are shared by extremist groups	YES	NO
24	Involve you or participants in a) activities which may be illegal and/or b) the observation, handling or storage (including export) of information or material which may be regarded as illegal?	YES	NO
25	Does your research involve the NHS (require Health Research Authority and/or NHS REC and NHS R&D Office cost and capacity checks)?	YES	NO
26	Require ethical approval from any recognised external agencies (Social Care, Ministry of Justice, Ministry of Defence)?	YES	NO
27	Involve individuals aged 16 years of age and over who lack ‘capacity to consent’ and therefore fall under the Mental Capacity Act (2005)?	YES	NO
28	Involve processing special category data[5] and/or intend to recruit 100 or over participants?	YES	NO NO
29	Pose any ethical issue not covered elsewhere in this checklist (excluding issues relating to animals and significant habitats which are dealt with in a separate form)?	YES	NO

Please note that the Faculty Research Ethics Panel (FREP) will refer to the Office of the Secretary and Clerk any application where, in the view of the Chair, the proposed research poses a risk of a legal or security related nature to ARU. The Chair will seek guidance from the Secretary and Clerk before the FREP decides if the proposed research can be granted ethical approval and/or the nature of any special arrangements which need to be put in place.

Section 3: Approval process

All student applications must be sent to your supervisor for checking.

Your supervisor must then forward the application to the SREP/FREP (as appropriate)

FREP = Faculty Research Ethics Panel

SREP = School Research Ethics Panel

NO answered to all questions

Risk category Green

Complete Section 6 of this form and then send it to your SREP.

You do not require ethical approval from a committee.

You can start your research immediately.

YES to any of Questions 1-11 and/or 29 but NO to all other questions

Risk category Yellow

Complete Section 4 -6 of this form and submit it, and the Participant Information Sheet (PIS) and Participant Consent Form (PCF), to your SREP. Your faculty may require further documents.

You need to wait for ethical approval before you start your research.

YES to any of Questions 12-24

Risk Category Red

Complete Section 5 and 6 of this form and complete the Stage 2 Approval form. Submit both, and any other documents required, to your FREP.

If you answered YES to Question 23 you must also complete and submit for consideration by the committee the Stage 3 Approval form.

You need to wait for ethical approval before you start your research.

YES to any of Questions 25-27

Risk Category Purple

Yes to Question 28

Risk Category Blue

You need external approval(s) which, if granted, may be regarded as equivalent to approval from an ARU ethics committee.

Refer to the Question Specific Advice for the Stage 1 Research Ethics Application Form and Code of Practice for Applying for Ethical Approval for further information

You need to wait for ethical and/or governance approval before you start your research.

You must also complete the Special Category Data Questions and submit these with your application (see Section 5).

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Management of Ethical Risk

For each of Questions 1-11 and Question 29, where you have responded ‘Yes’, please explain for the panel how you justify and will manage the ethical risk created. Your research is in the Yellow risk category.

Not applicable

Section 5: Data Protection

If your research involves personal data:

1. You must complete the Research Checklist for Data Protection and confirm that you have done this in Section 6.

https://myaru.sharepoint.com/sites/student-office-for/SitePages/data-protection-in-research.aspx#research-checklist-for-data-protection

2. If you have said ‘yes’ to Question 28, you must also complete the Further Data Protection Questions and follow further instructions if applicable. You need to submit this document with your ethics application.

https://myaru.sharepoint.com/sites/student-office-for/SitePages/data-protection-in-research.aspx#further-data-protection-questions

3. If your research will not involve the UK, you need to confirm in Section 6 that you will comply with the data legislation relating to the country you are carrying research out in or transferring data in or out of.

Section 6: Declaration statements

	Confirmation Statements (delete as appropriate)
1	I have completed the relevant training in research ethics.[6]	Yes
2	I have consulted the Research Ethics Policy and the relevant sections of the Code of Practice for Applying for Ethical Approval, available at www.aru.ac.uk/researchethics	Yes
3	I have completed a Risk Assessment (Health and Safety) and had it approved by the appropriate person.[7]	Not applicable
4	I have reviewed the Research Checklist for Data Protection and EITHER my research will comply with its requirements (and comply with privacy laws of other countries where applicable). OR If my research did not comply with any of the requirements I consulted ARU’s Data Protection Officer, made any changes as required, and have his approval to proceed.	Yes
5	If I needed to complete the Further Data Protection Questions EITHER my research will comply with its requirements (and comply with privacy laws of other countries where applicable). OR If my research did not comply with any of the requirements I consulted ARU’s Data Protection Officer, made any changes as required and have his approval to proceed. I obtained advice from ARU’sData Protection Officer if any of my responses were ‘no’ and submit the correspondence with this ethics application. If I need to consult the Data	Not applicable
6	For research funded externally where the funding was acquired via ARU, I have completed a Project Risk Assessment.	Not applicable
7	I have attached my confirmation of passing a Safeguarding course.	Not applicable
8	If my research project involves a contract between ARU and an external party, I have had the contract approved by the Secretary and Clerks Office[8]	Not applicable

Applicant Declaration

By sending this form from my ARU e-mail account, I confirm that I will undertake the research as detailed here. I understand that I must abide by the terms of my ethical approval and that I may not amend the research without further ethical approval. I also confirm that the research will comply with all ARU ethical guidance, all relevant legislation and any relevant professional or funding body ethical guidance.

Supervisor/First Supervisor Declaration

By sending this form from my ARU e-mail account, I confirm the statements in the Applicant Declaration and that I will supervise the research as detailed in the application.

Thank you for completing the Stage 1 Research Ethics Application Form.

Please submit it as follows:

Staff Researchers: Send form directly to the relevant committee.

Student Researchers (including staff carrying out research in a student capacity): Send form to supervisor/first supervisor.

Supervisor/First Supervisor: Check application and forward to the relevant committee.

For FREP/SREP details please visit the ethics website. On this page you will also find links to each Faculty’s website where more information on SREPS can be found.

Date

1 April 2022

Certificate of achievement

[1] Email SE-Biologicalsafety.GMO@aru.ac.uk for further information.

2 As above.

[3] For any research involving human material you must contact ARU-HBMC@aru.ac.uk for further guidance on how to proceed.

[4] The Counter Terrorism and Security Act (2015) and Terrorism Act (2006) outlaws web posting of material that encourages or endorses terrorist acts, even terrorist acts that have occurred in the past. Sections of the Terrorism Act also create a risk of prosecution for those who transmit material of this nature, including transmitting the material electronically. The storage of such material on a computer can, if discovered, prompt a police investigation. Visits to websites related to terrorism and the downloading of material issued by terrorist groups (even from open-access sites) may be subject to monitoring by the police. Storage of this material for research purposes may also be subject to monitoring by the police. Therefore, research relating to terrorism, or any other research that could be classified as security-sensitive (for example, Ministry of Defence-commissioned work on military equipment, IT encryption design for public bodies or businesses) needs special treatment. If you have any doubts about whether your research could be classified as security-sensitive, please speak to your FREP Chair.

[5] Special category data is defined as personal data which reveals racial or ethnic origin, political opinions, religious or philosophical beliefs, or trade union membership, and the processing of genetic data, biometric data for the purpose of uniquely identifying a person, and data concerning health or data concerning a person’s sex life or sexual orientation.

[6] Where required, UG or PGT students must submit confirmation with this form that they have passed the online ethics training:

For Science and Engineering, Health Education Medicine and Social Care, and Social Sciences: Error! Hyperlink reference not valid.

Or for Business and Law, Arts and Humanities: https://anglia-ruskin-university.learnworlds.com/course?courseid=researchprofethics

[7] For research conducted at ARU including University Centre Peterborough and College of West Anglia, go to https://myaru.sharepoint.com/sites/student-office-for for the relevant guidance. Students at other institutions must follow local processes.

[8] For details go to https://myaru.sharepoint.com/:b:/s/student-share/EaJia8aoLOBMopoyKYQvzcIBF65UYJeIwCKACIsv2TGenA?e=JDfnBb