Guidance for Completing USW's High Risk Ethics Approval Application

1

Involves anyone considered vulnerable,* such as:

∙ Anyone under 18,

∙ Adults at risk*,

Unless in an accredited setting and accompanied by a carer or professional with a duty of care.

2

Involves:

∙ Adults or children with diagnosed mental illness/terminal illness/dementia/in a residential care home,

∙ Adults or children in emergency situations,

∙ Adults or children with limited capacity to consent*

3

Involves those who are “dependent” on others (such as school children or students)

Unless in an accredited setting associated with normal working conditions or routines and within normal operating hours, such as a cultural institution, pre-school, school, university, or youth club where the research is carried out as part of professional practice such as curriculum development.

4

Requires external ethical approval, for example from a health authority such as the NHS via IRAS. However, in some cases the Faculty Research Ethics Chair can review via Chair’s action.

5

Requires a Human Tissue Act licence

6

Involves “covert” procedures as in covert observation studies

7

Involves anything considered “sensitive”. For example, does carry a risk of those involved disclosing information which compromises the research (e.g., illegal activities; activities where moral opinion may differ, potential professional misconduct – work errors).

8

Induces significant psychological stress or anxiety or humiliation* or cause more than fleeting harm / negative consequences beyond the risks encountered in the normal life of the participants (and where the potential for fleeting “harm” is clearly detailed in the participant information sheet). If in doubt regarding definition of the above terminology please contact the faculty research ethics chair.

9

Involves administration of drugs, placebos or other substances (such as food substances or vitamins) as part of this study.

10

Involves invasive procedures (including but not limited to blood sampling, collection of biological samples, or passing current through a participant’s body, etc.).

11

Offers any financial inducements to participate in the study.

12

Intends to recruit serving prisoners or serving young offenders via Her Majesty’s Prison and Probation Service.

13

Research originating from and being conducted overseas that intends to utilise identifiable human data or human participants.

14

Research that falls within the scope of the PREVENT duty guidance (security sensitive research, extremism, terrorism, radicalisation)

A1

Research Study Title:

 Provide a full title for your proposed research study 

A2

Is this project externally funded? If yes please provide the External Funding Application (EFAS) number

 This is unique code assigned to external funding applications by Research and Innovation Services and only applicable to externally funded research. 

A3

Start date:

Future start date

A4

End date:

Future end date

B1

Name:

 The student conducting this study is the Principal Investigator 

B2

Faculty:

Faculty of Life Sciences & Education

B3

Is the PI a staff member or student:

Student

B4

If staff, please state job title.

If student, please state the course you are enrolled on:

N/A

B5

Email address for correspondence:

B6

Postal address if not USW. Please don’t provide a personal or home address.

B7

Qualifications (including any training that is relevant to this research study, and your role as PI:

B8

If you are a student, please state the name of academic/lead supervisor:

Include your supervisor’s details here

C1 Please describe who else is on the research team:

Name

Current Job Title

Qualifications

Current Institution

D1   Please describe why this team are suitable for this study?

Name

Role and responsibilities

Why is this person suitable/competent for this project role?

Student Name

Principal Investigator

 Please describe the experience / training that makes this person suitable for this role. 

Supervisor Name

Supervisor

E1

Brief summary of the study in PLAIN LANGUAGE:

Describe this research project in simple language

E2

Brief overview of main ethical issues:

 Referencing where applicable (i) informed consent, (ii) minimisation of harm, (iii) maximising benefit, (iv) being fair to all involved, (v) confidentiality and anonymity, (vi) acting with integrity and transparency, (vii) conflicts of interest. 

F1

Please describe the design and methodology that will be utilised in this study including why it has been chosen.

 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. 

F2

What are the aims and objectives 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 your approval? 

F3

What is the rationale/justification for the study?

 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 your approval? 

F4

Please summarise what will happen to each research participant throughout your research, from recruitment to study exit.

 If you are not recruiting human participants, please state that. 

F5

Where will the data collection take place? Please describe/list all intended locations and organisations. (If data or recruitment from external organisations are intended, please obtain and include evidence/confirmation that they are willing to host your study).

 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. 

F6

Have or will any members of the public be involved in this study? If yes, please state what they have or will be doing.

 For example, reviewing or advising about study design, data collection, data analysis, dissemination. 

F7

Have any professional or regulatory guidelines been followed when preparing this research study? Or is the PI bound by any professional regulations?

 E.g., The Declaration of Helsinki, Nursing and Midwifery Council, General Medical Council, British Psychological Society, British Education Research Association, British Criminology Society, etc.). 

G1 Please describe the data collection tools that are being utilised during this research study (E.g., questionnaires, surveys, interview schedules, observation schedule, rating scale, AI-assisted tools, etc).

Title

For each please verify (if relevant):

1. Who created or owns the tool? / 2. Is it validated? / 3. If permission is required, please confirm permission is agreed and include evidence of confirmation which acknowledges this study title.)

 Please note, students are required to declare any use of large language models and AI-assisted tools in the development of data collection tools and collection, analysis or synthesis of data. 

 For interview schedules, you must clarify if the interview are conducted in-person or remotely, whether the interviews is audio or video recorded; if the interview is conducted online, what communication platform/modality will be used and, if applicable, how the recording is securely stored 

H1

Please describe all potential physical and psychological risks and burdens for research participants that are presented by participating in your research. Describe any potential adverse effects, pain, discomfort, distress, intrusion, inconvenience. Please describe the time commitment required from participants. Only describe risks or burdens that could occur as a result of participation in the research. Describe what steps would be taken to minimise risks and burdens as far as possible.

 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. 

H2

Please describe the intended participants for this study. Please include lower and upper age limit.

H3

Please describe and list the inclusion criteria.

H4

Please describe and list the exclusion criteria.

H5

Please describe how you will identify, gain access and approach participants including any gatekeepers who will act on your behalf.

 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 

H6

From the point of recruitment, how long do you expect each participant to be involved in the study?

H7

Are there any potential benefits for research participants?

H8

How will you obtain and record informed consent from potential participants?

 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. 

H9

If it is being collected in person, who will take informed consent?

H10

Describe how informed consent will work in practice? Describe the sequence of events and time scales involved, including the participants’ time to consider.

 For example: sending of invitation letter/email, receipt of expression of interest, sending/issuing of participant information sheet, time for potential participants to consider taking part, signing of consent form. 

H11

What arrangements will you make for persons who might not adequately understand written English, or who have communication needs?

H12

What steps will you take if a participant decides to withdraw from the study?

H13

Who is responsible for monitoring the conduct of the research throughout the study?

H14

Are there any potential risks to the researchers or anyone collecting data for this study? For example, lone researchers or researchers carrying out data collection directly/indirectly for USW, in the UK or overseas.

 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 risks have been identified. 

H15

How will each risk identified in H14 be managed and monitored?

H16

Adverse events – if any adverse events occur for the participants or research team who will notify the Faculty Ethics Chair and Research Governance Manager.

I1

Describe how will you ensure the participation of an individual is kept confidential during this study?

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 

I2

What types of disclosures could be made by a participant in this study? Are there any limits to confidentiality or scenarios when confidentiality may need to be broken, such as disclosure of illegal activity, malpractice, risk of harm, etc.

 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. 

I3

Is any personal data being collected as part of this study? Taking in account research data, informed consent forms, mailing lists, contact information, databases, etc.

Personal data is any information that can be used to identify a specific person. It can include names, addresses, phone numbers, email addresses, and more. Personal data can also include online identifiers, such as IP addresses and cookie IDs. 

Examples of personal data

● Name and surname

● Home address

● Email address

● IP address

● Medical records

● Location data

NO (skip to J1)

YES (continue)

I4

What form or format will personal data take?

I5

Who will have access to the personal data during the study?

I6

Who will be responsible for the security of the personal data while the study is ongoing?

I7

How long after being collected will personal data be discarded/data anonymised?

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 data will be anonymised. Personal data should be discarded as soon as it is no longer needed. 

I8

Please describe the arrangements for secure storage of personal data during the study, including the transportation of personal data.

 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)

J1

Who will be the long-term data custodian - responsible for the security/storage of the research data after the study has ended? (Must be a member of USW staff)

 If data are hard copy questionnaires that are being completed in another country, then the data custodian should be a permanent member of staff who can guarantee the safe custody of those data for 5 years. That might be a supervisor, or even the student (depending on their role in that institution), but potentially (e.g., in medical contexts) data might be kept securely according to a specific system. We would need a contact name/email for that person. If the student is a data custodian we’d need to know why they are the only suitable person for that role. 

 What USW needs to know is that the data custodian is able to guarantee the safe keeping of the data for as long as they are kept (usually 5 years) before ensuring they are deleted/destroyed. The data custodian is essentially responsible for this so it needs to be the right person. 

J2

How long will research data be stored after the study has ended?

 Describe how long data will be retained, and at what point data will be anonymised. Personal data should be discarded as soon as it is no longer needed. 

J3

Please describe the long-term storage arrangements for this research data. Where will data be stored, who will have access, how will long term data security be ensured?  Please note- Storage on local N Drives, personal or local hard disks are not acceptable. 

J4

Where will the research data analysis take place and by whom?

 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’. 

K1

Will participants receive any payment, reimbursement of expenses, or incentives? Please give details.

 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. 

K2

Will the researchers receive any personal payment over and above normal salary, or any other benefits or incentives for carrying out this research?

 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. 

K3

Does anyone in the research team have any form of relationship with the sponsor or funder of the research? Are there any conflicts of interest?

 Describe any conflict of interest that anyone in the research team might have. 

L1

How do you intend to report or disseminate the results of this research?

L2

How will you ensure the anonymity of participants when you publish the results of your research?

 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. 

L3

Will you inform participants of the results, and if so, how?

M1

How has the scientific quality of this research been assessed?

M2

What is the sample size for this research? e.g., number of participants required.

M3

How was the sample size decided?

M4

Please describe the methods of data analysis that will be employed.

N1 Does the research utilise any of the following?

NA to ALL. Please proceed to O1.

YES - Please indicate below and please contact the University Research Governance Manager.

● 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.

O1 Does the research utilise any of the items listed opposite? Please state which (1-7) apply or indicate (8) NA to all

1) is commissioned by the military,

2) involves the acquisition of security clearances,

3) is commissioned under an EU security call,

4) involves the design of IT encryption for public bodies or businesses,

5) involves security policy development,

6) is concerned with or is exploring (the themes of, or groups related to) terrorism, extremism, or radicalisation,

7) utilises materials that are covered by the Official Secrets Act 1989 and the Terrorism Act 2006, or the Counterterrorism and Security Act 2015.

8) NA to all, proceed to P1.

Items that apply:

O3 Confirm you have read and understood your obligations as stated in the ‘  USW Prevent Duty Policy and Procedure for Research’ 

O4 Confirm you have watched the PREVENT for Research training video found HERE.

N/A

O5 Confirm this project has been added by the lead investigator to the RISE  log of security sensitive research 

N/A

P1

Participant information sheet(s) for each different participant group.

P1

Informed consent form(s) for each different participant group.

P1

Combined Information and consent form for online use.

P2

Data collection tool(s), (such as surveys, questionnaires, interview schedules, interview themes, scales, AI-assisted tools etc).

P3

CVs of external collaborators.

P4

Letters from external collaborators to confirm they understand their role within the study and explicit agreement to contribute.

P5

Letters from external organisations to convey agreement to host your research, and confirmation that they understand what it entails for their ‘people’.

P6

Evidence of permission to reuse copyright protected data collection tools.

I confirm that all members of the research team have read and agree to abide by the latest version of the  Research Ethics Policy, Terms of Reference and Operating Procedures for University Ethics Sub Group and Faculty Research Ethics Committees.  This can be found  HERE.

I confirm that all members of the research team have read and understood the  Research Misconduct Policy. This can be found  HERE.

At the time of submitting this application, I believe it to be complete and accurate.

I acknowledge that I am only permitted to carry out the research study as is described within this ethics application, once it has been approved.

I acknowledge that any deviations from the approved ethics application will require me to contact the approving Faculty Research Ethics Committee (FREC) and inform them of the changes. In some circumstances I may be required to suspend my study until approval of the changes have been granted. This includes amendments to the research design, protocol, research team, and associated paperwork.

I understand that I may be invited to discuss my proposal with the FREC or FREC Chair.

I confirm that all members of the research team are qualified and experienced to carry out their roles within this study OR are working under the supervision of someone who is suitably qualified.

I acknowledge that it may not be possible to expedite the review of this application to fit internal or external deadlines.

I acknowledge that applications may be rejected where they are incomplete, or if there is a prevalence of grammatical or spelling errors that hinders the reviewing of it.

Signature of Principal Investigator   

Signature of Academic Supervisor (required for all students)

Date of submission

For office use

Status of application

Approved

Resubmission for Chair’s Action addressing feedback provided from the review.

Resubmission to a future meeting, addressing feedback provided from the review. (Where the amendments required are considered significant enough to warrant discussion by the committee again, at the Chair’s discretion).

Escalation to the Pro Vice Chancellor for Research and the University Ethics Sub Group

Date of decision

Name of FREC Chair