● This form should be completed for all projects seeking light touch ethics approval from 25S onwards.

● This form should be completed in line with the relevant guidelines appropriate to your area of study.

● Research studies that need ethics approval must not commence until ethical approval has been granted; it is the responsibility of the Researcher for ensuring due diligence and accountable decision making.

● Studies that intend to run within the NHS, Ministry of Defence, or the Prison Service will require additional approval – please seek advice from your Faculty Ethics Champion or the Research Governance Manager BEFORE completing this application form. Separate or replacement ethics forms may be required.

● Please familiarise yourself with the criteria for HIGH and LOW risk research in the USW Ethics policy

Overview of Proposed Study

Project Title:

The title of the dissertation - type of project

(e.g. How does Diabetes affect 55-year-olds? - A literature review)

This study is:                              

Low risk ☐          

Name of USW Principal Investigator:

Your full name

Is this a student project?

NO ☐                        

YES X                         

If Yes, please name the academic supervisor overseeing this project

Name of your Supervisor

Please list all co-investigators involved in the project

Name

Institution

Role in project

Do you confirm they are qualified for their role

Leave blank as this should not be applicable

Leave blank as this should not be applicable

Leave blank as this should not be applicable

Leave blank as this should not be applicable

Is this project funded?

NO ☐                        

YES ☐                        

If Yes, please name funding body and EFAS number:

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Intended start date:

Upon receipt of ethical approval

End date:

Your Professional Project submission deadline

Please list any codes of conduct that relate to your discipline or area of study?

USW Ethics Guidance for Research and Consultancy USW Research Governance Framework

Include all codes applicable for your project, for example, the Declaration of Helsinki or the National Health Service Guidelines on Clinical Audit.

Briefly outline of your Research Study (max 1000 words) to include:

Rationale, research aims and/or questions, and overview of methodology

This information will be taken from your Professional Project Proposal.

Research setting. Please state locations of data collection.

This information will be taken from your Professional Project Proposal.

Your relationship to participants (if any)

This information will be taken from your Professional Project Proposal.

Describe the sample and sampling strategy, including who your intended sample are. Please describe the number of participants you require.

This information will be taken from your Professional Project Proposal.

How will data be collected?

This information will be taken from your Professional Project Proposal.

How will data be analysed?

This information will be taken from your Professional Project Proposal.

Informed Consent

Describe how, and from where you will gain access to the participants?

This should not apply to your project if low risk, put N/A. If this does apply to your project, please contact your supervisor and the ethics team: ethicsassessments@learna.ac.uk

Please include the name and contact details of any ‘gate keepers’ of your intended research participants. 

This should not apply to your project if low risk, put N/A. If this does apply to your project, please contact your supervisor and the ethics team: ethicsassessments@learna.ac.uk

How will you provide participants with information about the study before they agree to participate? 

This should not apply to your project if low risk, put N/A. If this does apply to your project, please contact your supervisor and the ethics team: ethicsassessments@learna.ac.uk

Will you inform participants of a complaints procedure?

This should not apply to your project if low risk, put N/A. If this does apply to your project, please contact your supervisor and the ethics team: ethicsassessments@learna.ac.uk

How will you record informed consent from the participants? 

This should not apply to your project if low risk, put N/A. If this does apply to your project, please contact your supervisor and the ethics team: ethicsassessments@learna.ac.uk

Checklist for Managing Informed Consent

All participants will be given an appropriate level of information about the project and be given adequate time to think about the information before being asked to agree to participate

 NA X                         

YES ☐                      

All participants will be informed of any limits to confidentiality, or circumstances where confidentiality may need to be broken, such as the disclosure of criminal activity, mal practice, misconduct or risk of harm.

NA X                         

YES ☐                      

All participants being asked to provide personal data will have the following statement on the consent form or their questionnaire ’I consent to the processing of my personal information for the purposes of this research study. I understand that such information will be treated as confidential and handled in accordance with the General Data Protection Regulations 2016 and will be destroyed once it is no longer required

NA X                        

YES ☐                        

All respondents will be told that they can withdraw at any time, and ask for their data to be removed from the project, until it is no longer practical to do so (e.g. when a report or publication has been written and submitted)

NA X                        

YES ☐                         

All participants taking part in an interview, focus group, observation (or other activity which is not questionnaire based) will be asked to sign a consent form

NA X                        

YES ☐                        

All participants completing a questionnaire will be informed: 

  i.   On the Information Sheet that returning the completed questionnaire implies consent to participate

NA X                       

YES ☐                        

 ii.   At the beginning and end of the questionnaire ‘that returning the completed questionnaire implies consent to participate’. Conditions of consent must also be provided such as those found on a consent form

NA X                        

YES ☐                        

Duty of Care

Is there any chance that a participant’s well-being might be affected by this research? If YES, how will this be managed? What provision will be put in place by the researcher?

This should not apply to your project if low risk, put N/A. If this does apply to your project, please contact your supervisor and the ethics team: ethicsassessments@learna.ac.uk

Are there any risks to the participants? Please identify and describe how they will be managed/mitigated.

This should not apply to your project if low risk, put N/A. If this does apply to your project, please contact your supervisor and the ethics team: ethicsassessments@learna.ac.uk

Does any of the research team have any potential conflict of interest with the study population or study funders? If so, please list them and describe how the conflicts will be mitigated.

This should not apply to your project if low risk, put N/A. If this does apply to your project, please contact your supervisor and the ethics team: ethicsassessments@learna.ac.uk

Are there any issues around researcher safety and if so how will risks be managed?

This should not apply to your project if low risk, put N/A. If this does apply to your project, please contact your supervisor and the ethics team: ethicsassessments@learna.ac.uk

Managing Data

Who will have access to the raw data?

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Will data be passed outside of the university network?

NO  X          

YES ☐             

If YES, do you confirm personal data will always be secured by encryption or password protection?

YES ☐

NA   ☐

How will you ensure the confidentiality of the research participants?

This should not apply to your project if low risk, put N/A. If this does apply to your project, please contact your supervisor and the ethics team: ethicsassessments@learna.ac.uk

If confidentiality is limited please describe how this will be managed. Under what circumstances would confidentiality need to be broken?

This should not apply to your project if low risk, put N/A. If this does apply to your project, please contact your supervisor and the ethics team: ethicsassessments@learna.ac.uk

Will research findings be fed back to the research participants? If YES, how?

This should not apply to your project if low risk, put N/A. If this does apply to your project, please contact your supervisor and the ethics team: ethicsassessments@learna.ac.uk

Will the research be disseminated to the wider community? If YES, how?

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How will you ensure the anonymity of the research participants?

This should not apply to your project if low risk, put N/A. If this does apply to your project, please contact your supervisor and the ethics team: ethicsassessments@learna.ac.uk

Checklist for Managing Issues of Confidentiality and Anonymity

Questionnaires will be returned anonymously and indirectly (not handed to the researcher)

NA X                        

YES ☐                        

Questionnaires and/or interview transcripts will only be identifiable by a unique identifier (e.g. code/pseudonym)

NA X                        

YES ☐                        

Lists of identity numbers or pseudonyms linked to names and/or addresses will be stored securely and separately from the research data

NA X                       

YES ☐                        

All name of people, places or organisations which could lead to the identification of individuals or organisations will be changed

NA X                         

YES ☐                        

I confirm that my research records will be held securely at USW according to the General Data Protection Regulations that came in force in 2018 and in accordance with USW research data management guidelines

NA X                         

YES ☐                         

I confirm that I will not use the research data for any other purpose than that declared on the study consent form

NA ☐                        

YES X                        

Data will be stored on a password protected personal computer. Documents will be kept locked in a secure filing cabinet or similar. Data will be destroyed in line with the data Protection Act and preserved/destroyed in line with the USW data management guidance

NA X 

*Unless the project involves secondary data analysis of publicly available datasets then you should tick ‘Yes’                       

YES ☐                       

Insurance / Indemnity

Please confirm if the USW is acting as scientific sponsor for this study - where USW is taking responsibility for the design of the study, the soundness of the science, the project safety, and the ability for the project to achieve its aims?

NA X

YES ☐

Please indicate all that apply:

NA to all X

-   Investigating or participating in methods of contraception?

YES ☐                        

-   Assisting with or altering the process of conception?

YES ☐                        

-   The use of drugs?

YES ☐                        

-   The use of surgery? (other than biopsy)

YES ☐                        

-   Genetic engineering?

YES ☐                        

-   Participants under 5 years of age? (other than activities above)

YES ☐                        

-   Participants known to be pregnant? (other than activities above)

YES ☐                        

-   Pharmaceutical/medical product/appliance designed or manufactured by host institution?

YES ☐                        

-   Work outside of United Kingdom?

YES ☐                        

-   Other approvals, for example approval of external organisations allowing you access to their participants.

YES ☐                        

If any of the above apply, YOU will need to notify the University Research Governance Officer before you start your research project

Security Sensitive Material

Will your project involve any of these?

NA to all X

●      Ministry of Defence-commissioned work on military equipment or policy

YES ☐

EU security research including policy development

YES ☐

●      All work related to extremist groups (e.g. related to animal rights campaigners)

YES ☐

●      IT encryption design for public bodies or businesses

YES ☐

●      All work related to terrorism

YES ☐

If you respond YES to any of the above please ensure your research is also registered via the USW PREVENT for RESEARCH.

Attachments to this Application

As part of an ethics review it is necessary to submit copies of additional documents. Please indicate the documents included to accompany this ethics application form.

Participant Information Sheet

NA X       YES ☐                        

Consent Form

NA X      YES ☐                        

Data collection tools (questionnaire, interview questions, survey, etc.)

NA X       YES ☐                        

Researcher Safety Protocol / risk assessment

NA X      YES ☐                        

Letters/confirmation from gatekeepers granting access to participants

NA X       YES ☐

Other supporting documents such as debrief sheets, information about support networks, sources of counselling, etc. Please list those that are attached.

NA X      YES ☐                        

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Applicant’s Declaration

If your project is approved you must follow the research protocol and documents that have been approved. If your application is not approved you will need to refer to this version of your application when preparing your re-submission. Please note if you intend on deviating from the approved protocol or documentation you will need to request approval for any changes.

I understand that failure to follow my approved protocol constitutes research misconduct and the policy for such offences will be followed in such an instance. Please see the USW Research Misconduct Policy

YES X                         

I understand that I must contact the relevant Faculty Research Ethics Chair and seek approval for any amendments to, or deviations from, the approved project protocol before continuing with my research project

YES X

I have read and agree to abide by the guidelines set out with in the USW Research Ethics Policy

YES X                         

I confirm that all procedures that will occur within the research will adhere to USW Policy on Health and Safety

YES X                        

Print name:  

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Date: Click here to enter a date.

Signature: Click here to enter text or click icon below to add scanned signature.

Decision

Approval

Further Information needed and Resubmission required

Rejected

Notes

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