Completing the University of South Wales Faculty Subgroup Low Risk Application Form for Ethics Committee approval of a postgraduate Professional Project



                                               FACULTY OF LIFE AND SCIENCES AND EDUCATION                                                          FACULTY ETHICS SUBGROUP LOW RISK APPLICATION FORM


Overview of Proposed Study 
Name of Chief Investigator: Your full name
Staff or Student Project:Professional Project - Module 2 of your MSc
Faculty:Faculty of Life and Sciences and Education 
Programme of Study:
(If applicable)
Please click here to find out your module title
Name of Study Lead/
Supervisor:
(If applicable: if this is a staff project)
Name of your Tutor 
Proposed Project Title, and Project TypeThe title of the dissertation - type of project 
(e.g. How does Diabetes affect 55-year-olds? - A literature review)
Start Date: Upon receipt of ethical approval
Proposed end date:Your Professional Project submission deadline
Co-investigators: 
Leave blank as this should not be applicable
Code(s) of conduct to be follows or the guidelines appropriate to your area of study or discipline: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.

Please provide information for all headings, or write 'not applicable' where necessary
- a response to headings marked with an * is mandatory for your application to be reviewed


1. Rationale, research aims and/or questions **

2. Research setting (e.g. is a lone worker policy needed?)

3. Your professional role (if appropriate)

4. Your relationship to the participant (if any)

5. Details of sample and sampling strategy

6. Methods of data collection **

7. Data analysis **

This information required under these headings will be taken from your Professional Project Proposal.



Responsibilities to Participants 
1. Voluntary Informed Consent
How will you gain access to the participants?
For example, detail of advertising strategy, how you will approach the participants and who will be involved in the study. If this is in a clinical setting, any patients must be requested to participate by a member of their own care team, and you will also need to include a Participant Information Sheet.

If this does not apply to your project, put ‘N/A’

How will you provide participants with the information they need about the study? Please attach a copy of the participant information sheet that will be provided to the participants where appropriate
If this applies to your project, you can put ‘Participant Information Sheet attached’, otherwise ‘N’A’
How will you ensure that you have informed consent from the participants?  Please attach a copy of the consent form(s) that will be provided to the participants where appropriate.

Detail the process for recruiting participants for example are they given adequate time to read the information given and respond appropriately.  It is important to ensure that all participants are 'capable' of giving their informed consent. Attach a copy of your Consent form.


If this does not apply to your project, put ‘N/A’

How will you inform participants of their right to withdraw from the study?

The participants could be informed of their right to withdraw verbally in addition to the right to withdraw being clearly depicted in the Information Sheet.


If this does not apply to your project, put ‘N/A’

How will you inform participants of the complaint’s procedure?

Detail the contact information and telephone numbers of appropriate bodies that will manage any complaints. These details will be included on the Information Sheet that you hand to participants.


If this does not apply to your project, put ‘N/A’

Checklist for managing Voluntary Informed Consent - Tick all that apply
Please confirm that all respondents will be given an appropriate level of information about and be given adequate time to think about the information before being asked to agree to participate

                 

               

         or not applicable 



Please confirm that all participants taking part in an interview, focus group, observation (or other activity which is not questionnaire-based) will be informed that anything they say which either:


- Suggests harm to a person might be caused

- Indicates potential or actual professional misconduct

- Outlines criminal activity


Then, the information will need to be reported to the appropriate authorities. 

                

         or not applicable 


Please confirm that all participants completing a questionnaire will be informed on the Information Sheet that returning the completed questionnaire implies consent to participate.


On-line: this message will be presented at the start (with a reminder at the end) of the questionnaire as part of an implied consent statement.

                 √

         or not applicable 


Please confirm that all participants being asked to provide personal data (sensitive and standard) will be told which legal basis is being cited for collecting and processing their personal information – this should be conveyed on the consent form and information sheet. In accordance with the new General Data Protection Regulations (GDPR).

                 

         or not applicable 


Please confirm that all respondents will be told that they can:

- Withdraw at any time,

- Ask for their data to be removed from the project until it is no longer practical to do so (e.g. following anonymization or, when a report has been written and submitted).

                

               

         or not applicable 


Please confirm that personal data will only be retained for the purpose of this research and will be disposed of as soon as possible (e.g., immediately following anonymization).

               

         or not applicable 


Duty of Care to the Participants
How will you ensure the participants’ well-being during the research?

Please refer to: Health Research Authority. (2017, updated 2020). UK policy framework for health and social care research. Available at: 


https://www.hra.nhs.uk/planning-and-improving-research/policies-standards-legislation/uk-policy-framework-health-social-care-research/ (Accessed 01/05/2020)


If this does not apply to your project, put ‘N/A’

What information will you provide to the participants at the end of their involvement in the study (if appropriate)?


Is it necessary to hold personal contact information for this purpose?

Please clearly define what text or content will be forwarded to your participants when your research has been completed, for example, the findings of the research / further information or a notice of completion.


If this does not apply to your project, put ‘N/A’

Does the Chief Investigator or any other investigator/collaborator have any direct personal involvement (e.g. financial, shareholding, personal relationship etc.) in the organisations funding the research that may give rise to a possible conflict of interest? If so, please describe these below and any arrangements in place to mitigate the conflicts.
If this does not apply to your project, put ‘N/A’, otherwise set out personal involvement
Researcher Safety 

Are there any issues around researcher safety and if so, how will you address those?


Are there any risks? What are the arrangements in place to mitigate risk?

Prepare a risk assessment setting out any identified risks to yourself or those assisting you with your research. State the likelihood of an occurrence, the potential impact of the hazard/risk, details of hazard/risk management and what mitigating factors you will put in place.


If this does not apply to your project, put ‘N/A’


2. Managing Data
How will you ensure the confidentiality and anonymity of the research participants?

Identify the individual who is keeping the data and give contact details if this is not you.  Detail a strategy to retain participants' anonymity.  Ensure that you document a full understanding of GDPR and confirm you will implement this legislation while conducting your research.  Please also use JICS as your online data collection service (rather than alternative software such as Survey Monkey). JICS is a secure, online data collection service with a survey function: https://www.onlinesurveys.ac.uk/. The University of South Wales holds a licence for this service - for a user account please contact the Head of Learning Through Technology at the Centre for the Enhancement of Learning & Teaching.


If this does not apply to your project, put ‘N/A’

Checklist for managing issues of confidentiality and anonymity

Tick all that apply

Questionnaires will be returned anonymously and indirectly

 

                √

         or not applicable 


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

 

                √

         or not applicable 


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


               

         or not applicable 


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

  

                √

         or not applicable 


I confirm that my research records will be held securely at USW according to the Data Protection Act 1998 and 2018 (DPA), as well as the new General Data Protection Regulations (GDPR) in accordance with USW guidelines

 

               √

         or not applicable 


I confirm that I will not use the research data for any other purpose WITHOUT contacting the Faculty Ethics Champion or USW Research Governance Officer in advance. This includes the sharing of research data with people outside of the research team.  

 

              √

         or not applicable 


Data will be stored on a personal computer: both the computer and any document files will be password protected/encrypted.

 

              √

         or not applicable 


How will research findings be fed back to the research participants? 

 

If this applies to your project, will this be in the form of a letter or a personal email?  Will a summary of your findings then be sent to the participants?  Will you distribute a copy of your Professional Project to them? 

If this does not apply to your project, put ‘N/A’

If requested a summary of findings will be made available to participants.

How will the research be disseminated to the wider community?


Will this be due to your work being published in a journal or discussed at a lecture/conference?  Please clarify your intentions for presenting your work publicly.


If this does not apply to your project, put ‘N/A’


Attachments 
Tick all that are included
Data collection tools

               √

        or not applicable 


Adverts and standard letters

               √

         or not applicable 


Information Sheet(s)

              √

        or not applicable 


Consent Form(s)

             √

         or not applicable 


Researcher Safety Protocol (e.g. the lone worker policy)

            √

         or not applicable 


Other approvals, for example, approval of external organisations allowing you access to their participants; or internal approvals and USW risk assessment.

            √

         or not applicable 


Applicant’s Declaration

If your project is approved you must follow the process and documents you have submitted. 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.


Please indicate the following:

I have read and agree to abide by the latest version of the document: 

Research Ethics Policy, Terms of Reference and Operating Procedures for University Ethics Sub Group and Faculty Research Ethics Committees 

This can be found at https://www.southwales.ac.uk/research/research-expertise/research-governance/ 

Research Governance | University of South Wales

The University is committed to the following principles of good research practice. These are laid out in our USW Research Good Practice Code of Conduct which stipulates:
That our research is underpinned with common values of rigour and integrity www.southwales.ac.uk


          
I have read and agree to abide by the Code(s) of Conduct identified at the start of this form
         
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
          √
I confirm that the USW is responsible for this study
          √
I confirm that all procedures that will occur within the research will adhere to USW Policy on Health and Safety and that where applicable, a thorough risk assessment will be completed prior to the research taking place
          √


Print name:
Your full name


Please Sign:
Include a written signature here
Date: 
Supervisor’s Declaration (for students). If missing, the application should be rejected.
If the student’s project is approved they must follow the process and documents they have submitted. If their application is not approved they will need to refer to this version of their application when preparing their 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 have read and agree to abide by the Code(s) of Conduct identified at the start of this form
Ask your supervisor to review and tick here.

I have read the guidelines accompanying this application form and understand that failure to follow these and the approved protocol constitutes research misconduct and the policy for such offences will be followed in such an instance
Ask your supervisor to review and tick here.

Print Name: Ask your supervisor to review and add their name here.
Please Sign: Ask your supervisor to review and sign here with a scanned signature.
Date:


The sections below are for university use.


Decision
Approval 
Further information needed and Resubmission required 
Rejected 
Notes:


Security Sensitive Material
Will your project involve any of these

NA to all
Ministry of Defence-commissioned work on military equipment  
EU security research including policy development 
All work-related to extremist groups (e.g. related to animal rights campaigners)
IT encryption design for public bodies or businesses 
All work-related to terrorism
If you respond YES to any of the above please ensure you complete and attach the USW PREVENT for RESEARCH registration forms to this application