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



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



PLEASE READ - Information for applicants 


  • This form should be completed for all high-risk LSE research studies. A low risk route of approval is available if your study is appropriate for low risk review. Please speak to the Research Governance Officer if you have any doubts.
  • Research recruitment and data collection must not commence until approval from the Faculty Ethics Sub Group (FESG) has been granted - where approval is required. For the avoidance of doubt, data collection cannot begin until you have received written confirmation of approval from the faculty ethics sub group.

  • It is not the responsibility of the ethics committee to amend, re-draft or interpret what is presented to them. The ethics committee serve to protect participants of research, researchers and the reputation of the University. It is therefore the responsibility of all the researchers named on an application to ensure that each relevant section is accurately completed. Pre-submission guidance can be available from the Faculty Research Ethics Chair, PVC R and/or Jon Sinfield.

  • External ethics approval – NHS ethics approval will be required when the research study includes:
    A) Participants who are recruited from the NHS.
    B) Use of NHS patient data, premises, NHS resources, and facilities.

    http://www.hra.nhs.uk/about-the-hra/our-committees/res/ 

  • If your research study will require NHS approval please complete the RES application form, print a copy, and submit it for approval to the Faculty Ethics Sub Group. Use of the RES IRAS form replaces the need to complete this form.  Please contact the FESG secretary before you complete any forms.


    https://www.myresearchproject.org.uk/

  • If you are unsure of the required ‘approvals’ for your proposed research study please contact Dr Simon Williams (swilliams@learna.ac.uk)

    The Faculty Ethics Champion is: peter.mccarthy@southwales.ac.uk
    Please contact: naomi.phillips@southwales.ac.uk to discuss FLSE submission requirements

  • Submission must be 10 working days before any scheduled meeting.

It may be necessary to defer review where any meeting is already fully subscribed. 


Please note: If your project requires cover by the university insurance policy, or requires a statement of sponsorship from the university, ethical approval from the FESG must be sought. Evidence of such cover is available from Jonathan.sinfield@southwales.ac.uk 


January 2015

PART A
N.B All questions should be addressed (e.g. provide an answer or state why not applicable) 
1) RESEARCH STUDY TITLE:
Provide a full title for your proposed research study
2) NAME OF PRINCIPAL INVESTIGATOR:    

QUALIFICATIONS:    

JOB TITLE:

EMAIL:


ADDRESS (IF NOT STAFF OF USW):


 The student conducting this study is the Principal Investigator
3) CO-INVESTIGATOR(S): 


IF APPLICABLE, NAME OF RESEARCH SUPERVISOR:


Provide names of any co-investigators.

If Applicable: 
Give your supervisor's name, qualifications, position and address here
4) IMPERATIVE: Please provide the EFAS number for this project (available from the Research Governance Officer):
Insert ‘not applicable’
5) i) DOES THIS PROPOSAL REPRESENT PART OF AN EDUCATION/TRAINING PROGRAMME? 

     (If you answer YES to this question, please complete part ii below)  


    YES                              NO


ii) IF YES, WHAT QUALIFICATION WILL THIS THE PROJECT LEAD TOWARDS?


Give the title of your MSc course (e.g. MSc Obesity and Weight Management)
6) BACKGROUND AND CONTEXT / RATIONALE

(Max 100 words):


        Provide a clear and precise introduction and
      rationale for your project. What are you proposing to
     do and why is your proposed study important enough
     for the Ethics Committee to grant you approval?
 
7) AIMS AND OBJECTIVE(S) OF THE RESEARCH STUDY:

Provide clear aims and/or objectives. For example, ‘The aim of this project is to undertake an audit of the use of GLP-1 agonists in patients being treated for obesity’. You can complete this section by inserting your research question (e.g. This study aims to address the question: Is there an association between infant mode of delivery and obesity at 1-year of age?).

IT IS IMPERATIVE THAT THE REVIEWER OF YOUR PROJECT CAN UNDERSTAND EXACTLY WHAT YOU ARE AIMING TO DO OR WHAT QUESTION YOU ARE TRYING TO ANSWER.


Provide a clear and precise introduction and rationale for your project. What are you proposing to do and why is your proposed study important enough for the Ethics Committee to grant you approval? 

8) STATEMENT OF STUDY DESIGN (E.g. RCT, Crossover, Cohort studies, Case control, Action research, etc.  Max 700 words)

Describe the study design, methodology. Discuss why it has been chosen. Please include information pertaining to the timetable / phases of the research study, and where any data collection (interviewing, surveying, etc.) will take place. Please include timescale.

In this section you should provide details of your study design (e.g. a case-control study, a cross-sectional survey) and why you have chosen this design to try and answer your research question or to address your study aim(s). This information can be taken from your project proposal but bear in mind that an ethics reviewer is not marking your application and they may require more information than you have provided in your proposal.


9) i) What procedures/interventions will be carried out as part of the research study?

ii) What resources/facilities will be used during the research study?

iii) Where will the study take place? (If external, please include a letter of support that conveys agreement from the external venue)

       i) It is unlikely that you will have an intervention in
          your study, but data collection methods such as
          questionnaires should be described. 

 
ii) 
If your data collection or study will take place away from your normal place of work this should be explained and, when necessary, supporting evidence or a letter of the agreement provided.
10) PARTICIPANTS

Discuss the number of participants required, from where the participants will be recruited, and the exclusion and inclusion criteria. Please include power calculations where applicable.

The recruitment of participants is an essential part of the study and an ethics reviewer will require you to provide some justification for your sample size. If you are recruiting participants to your study, you should provide a sample size calculation whenever possible. If a sample size calculation is not possible, consider other ways of justifying your sample size (e.g. reference to other similar research). If you are using existing data, describe how you will select participants from the clinical record or other source of participants (e.g. random or non-random sampling).

 

Ensure you provide lists of inclusion and/or exclusion criteria.


11) HAVE NATIONALLY APPROVED / REGULATORY BODY GUIDELINES BEEN FOLLOWED IN PREPARING THIS PROTOCOL? 



(E.g. Association of the British Pharmaceutical Industry Guidelines (1983), Royal College of Physicians Guidelines, The Declaration of Helsinki, British Psychological Society guidelines, BERA, etc.).          If so, please specify.



12) HAVE POTENTIAL PARTICIPANTS BEEN INVOLVED IN, PLEASE INDICATE. IF NO, PLEASE INDICATE WHY. 



YES

NO

THE DESIGN OF THIS STUDY




INFORMED CONSENT DOCUMENTS




DATA COLLECTION TOOLS





13) DATA COLLECTION TOOLS 

Have you tested the data collection tool(s) for face validity? Where more than one tool is being utilised please fill in the table.



YES                              NO        NA (ALL tools are already validated)


Title of DCT

Validated by you? (Y / N / NA - already validated)

Is permission necessary?

Do you have permission? (Supply permission separately)














In section 9 you may have described data collection tool(s) that you will use in your study (e.g. a quality of life questionnaire). In this section you should describe whether you are using previously validated instruments or whether you need to complete your own validation study (i.e. assess that the instrument is producing valid or accurate data). Some instruments require permission to use them and some have a financial cost. 


PART B
N.B. All questions should be addressed (e.g. provide an answer or state why not applicable).

14) POTENTIAL RISKS AND BURDENS

Describe potential risks and burdens for your participants. Include any potential for distress, discomfort, with an explanation of why it is necessary. For any risk stated here please state what will be done to minimise such effects.

As examples; complications during a surgical intervention, the risk of breaching confidentiality, or the causing of upset during a qualitative interview, would be considered as valid risks or burdens. Potential risks and burdens should be conveyed in the study participant information leaflet so that a participant can clearly understand what is involved if they consent to take part. 
15) DISCLOSURE OF INFORMATION FROM INTERVIEW/QUESTIONNAIRE

As stated above, it may be possible that a participant will disclose sensitive information that requires action (e.g. disclosure of sexual abuse). You should describe how you will deal with such a scenario and this should also be described in the participant information sheet. When answering question 15, refer to the participant information sheet and the specific section where this is covered.

16) POTENTIAL RISKS TO THE RESEARCHER
As a student conducting research as part of a University of South Wales academic programme, the University has a duty to ensure that your health and safety are not at risk during the conduct of your research project. If you cannot identify any risks, you should state that no risk have been identified.
17) SCREENING OF IDENTIFIABLE PERSONAL INFORMATION

Give details of the sources (e.g. patient notes) of identifiable personal information that will be used to identify potential participants. 


In a clinical context, if the person responsible for identifying a patient as a potential participant is not part of that patient’s clinical team, please explain why.


Please remember, where researchers are required to identify potential participants from clinical records, the clinical team should first seek consent from the patient to allow access for the researcher; this is to avoid a breach in confidentiality. All data received by the research team must be handled in accordance with the Data Protection Acts 1998 and 2018 (DPA), as well as the new General Data Protection Regulations (GDPR)

18)  ADVERTISEMENTS

All advertising material intended to recruit research participants must be reviewed by the Faculty ethics subgroup. This includes but is not limited to: posters, letters, web pages and radio/TV broadcasts.


Are you intending to use any advertisements?                      YES                   NO


If yes, please list the documents appended to this application.


If you have answered ‘yes’ to this question you should list all types of advertisements that you plan to use. Attach each item to this application and ensure you provide a version number and date on each item so that they can be identified by a reviewer. For examples see below:

 

Item 1: draft recruitment letter to potential participants (Recruitment Letter, version 1, 18th January 2021).

Item 2: draft email to potential participants (Recruitment email, version 1, 18th January 2021).

 

Following ethics review, your draft advertising material may be approved, or it may require amendment. If it is approved, you should not make any changes to the wording when you use the item to recruit participants. Making changes to an item that has been approved may constitute a serious breach of your ethics approval and result in your project being stopped. If you are requested to make changes, you should create a new version of the item and save it as version 2 with a new date (e.g. Recruitment Letter, version 2, 3rd February 2021). This new version will be submitted for review.

19)  APPROACHING PARTICIPANTS

Describe how potential participants will be approached and who will be involved.

In a clinical context, patients should be initially approached by a member of their clinical care team.


Copies of documentation used to approach potential participants should be enclosed with this application (see section 18). A copy of the participant information sheet should also be attached and named, dated and given a version number as described in section 18. An example of a participant information sheet is available on Moodle, this should be used as guidance as all information sheets will be unique and specific to the project. You should not change the information sheet once it has been approved. If you do need to amend the information sheet you will need to contact your supervisor as you may need to submit a new consent form to the Ethics Committee

20) INFORMED CONSENT

Describe the arrangements for taking consent from research participants prior to their participation in the research study. Describe the time allowed to decide to take part. Please include a copy of a written consent sheet (where used) with this application.


For consent to be ethical and valid in law participants must be ‘capable’ of giving consent. Please ensure you have adhered to current guidance on the attributes of a capable person and adhered to such guidance in your recruitment strategy. The informed consent form should be named, dated and given a version number and attached to this application form. You should not change the consent form once it has been approved. If you do need to amend an approved consent form you will need to contact your supervisor as you may need to submit a new consent form to the Ethics Committee. 

21) INFORMED CONSENT TOOLS 

Please confirm the information sheet and consent form have been considered as appropriate for the target audience?

            

YES                             NOT APPLICABLE (state why below)   


If you are planning to recruit participants to your study, you must submit your participant information sheet and consent form with this application. Examples of a participant information sheet and consent form are available on Moodle. Please note that these are for guidance only, your information sheet and consent form will be specific to your study. These examples show how these documents should be written and constructed. You should ensure that each document is dated and has a version number, information that should be shown in the ‘footer’ of the document.          

22) DATA ANALYSIS / STATISTICS
Please describe the arrangements for analysing your data (qualitative and quantitative). Where appropriate discuss what data/statistical analysis will be completed. Where used, please remember to discuss sample size and how the sample size was decided upon. 

You should include a data analysis plan. This plan would typically include details of initial descriptive analysis and main analysis, it may also include details of any exploratory analysis. It is not enough to simply state that ‘data will be analysed using SPSS’.
23) DATA CUSTODIAN
Please identify the person who is responsible for overall data security: This will be your Supervisor.
24) DATA MANAGEMENT

Please describe how research data will be stored, including the location and arrangements for data storage. Describe where/how your data will be securely stored during, and after the research study has completed. Describe how long data will be retained, and at what point will data be anonymised. Personal data should be discarded as soon as it is no longer needed. 


Your data should be stored in a secure way. For example, on a PC or laptop that is password protected. Any files that contain data should be password protected and encrypted. You should state how long you intend to store your data and justify this decision. Some guidance on data storage can be found by following this link:


Background and scope (ukri.org) 


Are the data being collected regulated by the Data Protection Act as well as the new General Data Protection Regulations (GDPR)?

            

YES                              NO


If YES, please confirm that the data will be retained and stored in accordance with the General Data Protection Regulation (2018) by initialling below. 


Principal Investigator Initials Principal Investigator Initials:


                         _________________________


25)  CONFIDENTIALITY OF DATA
Describe the provision for ensuring that the confidentiality of personal data is preserved, such as a strategy for anonymity.

Describe how you will ensure the confidentiality of any personal data you collect. Guidance on what constitutes personal data can be found by following this link:

What is personal data? | ICO
26)  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)’

In the UK, there are six legal bases for collecting and processing personal data. One of these is that an individual has provided you with ‘consent’. Further information about the legal basis for collecting and processing personal data can be found here:

 

Lawful basis for processing | ICO


27)  PAYMENT TO RESEARCH PARTICIPANTS

Please note, participants should not be paid for taking risks. Payment should not be set to a level that would unduly influence potential participants. Information pertaining to participant payment should be included on the Participant Information Sheet. 


Will participants be paid?                            YES                             NO


If yes, please give details.

28) PAYMENT TO RESEARCHER
Describe any payment that the research team is receiving as part of carrying out this research study. Researcher payment should be recorded in the participant information sheet.
29) CONFLICT OF INTEREST
Describe any conflict of interest that anyone in the research team might have.     
30) ENSURING ANONYMITY OF IDENTIFIABLE DATA IN PUBLICATIONS
Describe the provision for ensuring anonymity in any publication or publicly available output produced from this research study.

Your dissertation and any subsequent publications should not contain any information that would allow an individual to be identified. Please describe how you will ensure this.
31) SCIENTIFIC SCRUTINY AND RESOURCING

Has this research study been peer-reviewed? 

YES (internal USW)                             YES (external)                               NO


If YES, please provide information about the review, including the reviewing body and date of review/approval.

32) INSURANCE INDEMNITY

i.    Does this research study require indemnity/insurance cover from the University of South Wales?


    YES        - the answer here is yes 


ii.    Will the research take place on University of South Wales’ premises?


    YES                              NO


If NO, give details of any offsite locations:


iii.    DOES THE RESEARCH UTILISE ANY OF THE FOLLOWING (PLEASE INDICATE ALL THAT APPLY):


Investigating or participating in methods of contraception?

Assisting with or altering the process of conception?

The use of drugs?

The use of surgery? (other than biopsy)

Genetic engineering?

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

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

Pharmaceutical product/appliance designed or manufactured by host institution?

Work outside of United Kingdom?
If YES to any of the above please contact the Research Governance Manager – jonathan.sinfield@southwales.ac.uk


Security Sensitive Material

Will your project involve any of these?

 

NA to all ☐

Ministry of Defence-commissioned work on military equipment or policy

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 your complete and attach the USW PREVENT for RESEARCH registration forms to this application


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


 

  • At the time of signing this application, I consider it to be complete and accurate

 

  • I will notify the faculty ethics sub group immediately if i subsequently consider the application requires any correction or qualification, or if there is any revision to the proposal.

 

  • ·      I understand that i may be invited to discuss my proposal with the faculty ethics sub group.

 

SIGNATURE OF INVESTIGATOR       .............................................................................

 

SIGNATURE OF SUPERVISOR           ………………………………………………….

               (MSc Students)

 

DATE OF SUBMISSION                      .............................................................................

      

 

SIGNATURE OF APPROVAL              ………………………………………………...

(Chair/Secretary – FESG)

 

DATE OF APPROVAL                         ..............................................................................