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Brighton & Sussex Medical School

Guidance for Ethics Review

BSMS > Research > Support and governance > RGEC hub > Guidance for Ethics Review

Guidance for Ethics Review

Undergraduate and Postgraduate taught students projects

For applications subject to ethical review, students will need to submit an electronic application form on Ethics RM. 

For multi-student projects, a nominated student should start an application on the behalf of the group, and share the application with the co-researchers through the roles function on Ethics RM. 

Please review the User Guide for UG/PGT Applicants for help applying on Ethics RM. 

Students must ensure the application is completed to the satisfaction of the supervisor (including undertaking any supervisor directed changes) before submission for ethics review. The SREO will return incomplete applications.

Most BSMS Undergraduates will be submitting independent research projects in their fourth year, please see the next section.

Independent Research Projects

Independent research projects (IRP) which involve human participants and/or their data will require ethical review and/or additional approvals before they can commence. The School Office staff will confirm with student supervisors which permissions will be required for each respective project. 

Any necessary changes to any project subject to additional approvals should be discussed with the approval provider before being implemented. These include changes to the procedures used, participants involved, and data collected. Please also notify the module team of any changes. 

Please see below to determine the review pathway for your IRP.

Non-NHS based audits and service evaluations

IRP team to confirm that the project is not high-risk (see research ethics policy)

Service Evaluations and Audits which are low risk are not subject to ethical review through the University of Sussex governance procedures, but students/supervisors should consider whether ethical review may be required for publication purposes.

NHS-based audits and service evaluations 

All NHS-based audits and service evaluations will require approval from the relevant Trust the project is being conducted under, and approval from the SREO team who have assessed the risk level and kept a record of this process.

To begin with:

Confirm that the project is not research using hradecisiontools.org.uk/research.

Confirm whether deemed high or low risk.

Low Risk:

Projects considered low risk are not subject to ethical review but will be overseen by a nominated individual of the BSMS SREO team. 

Instead, low risk proposal forms will be submitted by supervisors on Ethics RM and signed off by a nominated individual.

Changes to the project must be notified and the appropriate route followed should the risk level increase. 

Researchers should consider the impact on their ability to publish the results of the audit or service evaluation should this be their intention. 

High Risk:

Whilst these have clinical governance oversight of the trust, this does not extend to ethical review and thus these projects must still progress through University of Sussex internal process for review, as well as having clinical governance approval.

High risk applications will be submitted by students on Ethics RM and signed off by their supervisor.

Non-NHS based research

The student will submit via the University of Sussex’s on-line application system. Projects deemed to present a lower level of risk will be approved by the supervisor and SREO. 

Those deemed to be higher risk will be reviewed by the supervisor, SREO and 1 member of the Faculty REC.

Contact details

If you have any queries concerning your IRP, please contact the IRP module team. For any queries concerning ethical approval granted by a BSMS SREO please contact SEMFRECBSMS@sussex.ac.uk.

BACKGROUND IMAGE FOR PANEL

Supervisors of student researchers

Projects should be submitted by the student; however supervisors are expected to oversee the student’s work in addition to sign off. Students and their supervisors should work closely together and approach the completion of an ethics application as a shared task, as they are jointly responsible for obtaining the appropriate permissions. 

If you are a supervisor of either a BSMS taught student (undergraduate or postgraduate) or a postgraduate research student, you will be actively involved in the online submission of your student’s ethics application.

Supervisor authorisation in Ethics RM

Supervisors of BSMS UG, PGT, and PGR students will need to authorise their student’s application in Ethics RM. The student will alert the supervisor that an application requires their review, by clicking the request signature button as a PGR (UG and PGT should also share their supervisor into the application via the roles function, so they can receive correspondence). 

Students must ensure the application is completed to the satisfaction of the supervisor (including undertaking any supervisor directed changes) before submission for ethics review. The SREO will return incomplete applications.

  • A Supervisor’s Checklist offers guidance on whether a student’s project is ready for ethics review

DOWNLOAD THE CHECKLIST TOOL FOR SUPERVISORS HERE >

A BSMS faculty supervisor with a Sussex.ac.uk email address linked to a University of Sussex ITS account is required to authorise the student’s application in Ethics RM to ensure appropriate oversight for supervised research. 

To be eligible to supervise a research project, academics must be employed by the University of Sussex or a clinical academic with an Honorary Contract (and not ‘Honorary Title’) at BSMS. Please see the FAQs page for more information.

Postgraduate researchers and staff projects

PGR and staff applications are reviewed by the Science Engineering and Medicine Brighton and Sussex Faculty Research Ethics Committee (SEM: BSMS FREC)

  • Applications to SEM: BSMS will be reviewed via one of two pathways. Applications considered to be of lower complexity are reviewed outside of a scheduled Committee meeting and are reviewed by 1 F-REC member and the chair if they are low risk, and 2 F-REC members, the chair/deputy chair and any specialists if they are high risk. Please see the ethics policy for further details.
  • Those considered to be of higher complexity will continue to be reviewed at a meeting. Applications will be triaged on submission to determine which pathway they will follow. Applicants will be notified of this decision.
  • Please see FAQ page for committee meeting schedule
  • To be eligible for ethics review staff must be employed by the University of Sussex or a clinical academic with an Honorary Contract (and not ‘Honorary Title’) at BSMS. Please see the FAQ page for more information
  • Please review the User Guide for PGR and Staff Applicants for help applying.

Using the online ethics application system (Ethics RM)  

BSMS applications are made and submitted electronically via the online ethics review application system in Ethics RM via the link below.

VISIT ETHICS RM HERE >

Applications for a range of topics involving human participants, their biomaterial, or personal data (including secondary data) are all eligible for review. Please see the research ethics policy and supporting notes for more detailed information

*Ethics approval must be obtained before the research starts, and any data collection or recruitment activities commence*

Watch the Ethics RM 'How to' videos for further information and guidance.

WATCH THE 'HOW TO' VIDEOS HERE >

All BSMS researchers will require a Sussex.ac.uk email address either to apply for review, or to authorise the student’s application in Ethics RM to ensure appropriate oversight for supervised research. 

Useful forms and guidance 

BACKGROUND IMAGE FOR PANEL

What documents to include in an ethics application 

The documents required (non-exhaustive) for ethics applications are:

  • Main Application Form (online in Ethics RM). All questions must be answered. 

Supporting documentation must also be supplied and submitted if they are relevant to your project:

  • Participant Information Sheet (PIS) for each group of participants involved in the study

View the Participant Information Sheet Template >

  • Consent Form (CF) for each group of participants involved in the study to be signed by each participant.

View the Consent Form Template >

  • Recruitment materials: posters, copies of letters or emails of invitation to recruit participants, social media posts, etc.
  • Copies of relevant authorisations such as consent from any organisational, institutional, or participant group ‘gatekeepers’ to gain access to the research participants or data.
  • Questionnaires – where applicable.
  • Interview topic guide(s) – where applicable.
  • Focus Group topic guide(s) – where applicable.
  • For complex studies: Study protocol (this supports the ethics application but does not replace the requirement for the Ethical Review Application Form to be completed).
  • Contracts: Will you be sharing data derived from research with collaborators from other institutions, HEIs, or third-party service providers? If so, the PI will need to arrange and sign contracts, such as a Memorandum of Understanding (MoU), Collaboration Agreement, or Data Sharing Agreement, determining the governance and legal arrangements for the research. Where research participants’ personal data will be shared and processed by parties outside BSMS, either the University of Sussex GDPR team GDPR@sussex.ac.uk or Data Protection Officer (dpo@sussex.ac.uk) will be required to draft a Data Sharing Agreement. Otherwise, please verify any contracts that may be required via the Research Contracts Team contracts.instructions@sussex.ac.uk and ensure relevant contractual conditions are specified in the ethics application.
  • If your research requires conducting fieldwork off-campus, including lone working, domestic or overseas travel, or is taking place in a foreign country, completion of a University of Brighton Risk Assessment will be required addressing the hazards, risks, and control measures and should be included as a supporting study document in your ethics application. Please note, if your fieldwork involves an overnight stay, University travel insurance will also be required.

DOWNLOAD the risk assessment here >

• If your research will require high risk travel or fieldwork conducted in high-risk locations (for example, a country within Sub-Saharan Africa), an online Risk Assessment must be completed in AssessNET for the project (students), or OTSSRA form (staff) to provide institutional oversight.

• You will need to check if there are any travel warnings in place. (Please refer to the Foreign, Commonwealth and Development Office website here for information on countries or territories with travel warnings).  

• Please see guidance on overseas research for more details.

BACKGROUND IMAGE FOR PANEL

Overseas research projects

A significant proportion of BSMS staff and postgraduate research students conduct projects which take place entirely overseas, often as part of an international collaboration. These studies frequently present complex ethical considerations and involve several governance requirements.  Researchers should be aware that they must seek a two-fold ethics review:  

  1. BSMS Faculty Research Governance and Ethics Committee (FREC) ethics approval: See how to guidance within this page for more details
  2. Local ethics approval: Obtained via a research ethics committee in the country(ies) in which the research is to take place, in accordance with local requirements. Local oversight and approval from a recognised Research Ethics Committee (REC) or Institutional Review Board (IRB) in the host country (or countries) where research activity will be carried out are required (and must be secured before any data collection or fieldwork commences).  
  • Approval of studies conducted overseas through the BSMS FREC is conditional on the securing of local ethics approval in the study country(ies).
  • All University-sponsored research carried out outside the UK is expected to comply with the University of Brighton and University of Sussex research ethics policies and guidelines while conforming to in-country regulations, practices, and laws.
  • Researchers planning to carry out research overseas should first determine the appropriate research ethics committee ethics to apply to in the country(ies) in which the research is to be conducted. All relevant local ethics approvals for the country or countries where research is to be carried out should be in place prior to the commencement of the activity/activities to which they apply.
  • To be eligible for BSMS FREC ethics review and University sponsorship, students must be a registered Doctoral student at Brighton and Sussex Medical School.   

Useful forms and guidance for all applicants 

We recommend reading the Best Practice Guidance for Ethics Review of BSMS-Led Research Projects Conducted Outside the UK. 

View the guidance here >

A completed Applicant Checklist Tool for Research Conducted Overseas must be completed and submitted for the project to demonstrate that the applicant has complied with governance and legal requirements and prepared strategies for how they will minimise the risk of potential harm to participants. 

Download the applicant checklist here >


Additional approvals for overseas research

Staff Researchers

If your research requires any travel, or takes place in a foreign country, please note that you will need additional approvals from the University of Sussex for your research:

  • International Travel: Institutional travel insurance is mandatory for all research related international travel. BSMS staff should arrange travel insurance via the University of Sussex. Guidance is available on the University of Sussex website here. Contact the University of Sussex Insurance Officer for further information: FinanceServiceDesk@sussex.ac.uk.
  • Insurance for staff and affiliated academics domiciled in the country where they intend to undertake research: Such as, external collaborators undertaking funded research in connection with, or as part of, the University of Sussex. Studies may be led by research staff employed by the Medical School, or a collaborating Investigator financed under an externally funded grant via the University of Sussex. Confirmation of which institution will insure and indemnify the research must be obtained at an early stage, and prior to submitting an application for ethics review by the BSMS FREC.
  • Risk Assessment to establish responsibility for professional indemnity insurance to cover the fieldwork: BSMS staff travelling to conduct fieldwork overseas must complete and submit a University of Sussex Overseas Travel Safety and Security Risk Assessment (OTSSRA) form here. Part 1 of the OTSSRA form is completed regarding all travel. Where a Foreign, Commonwealth & Development Office (FCDO) warning is against travel or against all but essential travel to the location the member of staff intends to visit, Parts 1 and 2 of the form should be completed and the OTSSRA form should be signed by the Head of School for BSMS or their representative. (Please refer to the Foreign, Commonwealth and Development Office website here for information on countries or territories with travel warnings).
  • A completed Applicant Checklist Tool for Research Conducted Overseas (download here) must be completed and submitted for the project to demonstrate that the applicant has complied with governance and legal requirements and prepared strategies for how they will minimise the risk of potential harm to participants. 

PGR Researchers 

If your research requires any travel, or takes place in a foreign country, please note that you will need additional approvals from the University of Brighton for your research:

  • International Travel: Institutional travel insurance is mandatory for all research related international travel. Insurance for student research projects involving international travel is arranged via the University of Brighton. Insurance guidance is available via Personal Accident and Travel insurance (via SharePoint). Contact the University of Brighton Insurance Officer for further information: insurance@brighton.ac.uk. (Please refer to the Foreign, Commonwealth and Development Office website here for information on countries or territories with travel warnings).
  • Insurance for PGR students domiciled in the country where they intend to undertake research: Such as, students employed or affiliated with external collaborators undertaking funded research in connection with, or as part of, the Universities of Brighton or Sussex. Or, students funded by BSMS, or financed under an externally funded grant via the University of Sussex or the University of Brighton. Confirmation of which institution will insure and indemnify the research must be obtained at an early stage, and prior to submitting an application for ethics review by the BSMS FREC.
  • Risk Assessment to establish responsibility for professional indemnity insurance to cover the fieldwork is required before data collection can commence: BSMS Post Graduate Research students conducting fieldwork overseas must complete a University of Brighton Risk Assessment using the University’s online Risk Assessment form. Download the risk assessment form here >
  • If your research will require high risk travel or fieldwork conducted in high risk locations (for example, a country within Sub-Saharan Africa), an online Risk Assessment must be completed in AssessNET for the project, to provide institutional oversight. 
    • Students must first request the setup of an AssessNET account. Contact Nicola Arnold, Safety HUB Manager, Occupational Safety and Health Services, n.j.arnold@brighton.ac.uk to arrange an account to be activated.
    • AssessNET is accessed via SharePoint, the University of Brighton’s intranet. View it here. Located in the search menu under ‘Find It’ ‘Access a system’ ‘Assessnet’.
    • Please provide a PDF copy of the AssessNET Risk Assessment as part of the supporting study documents appended to the ethics application in Sussex Direct. Risks Associated with Research - University of Brighton Risk Assessment and Travel Insurance Requirements (Download) offers further guidance.

Amendments to research projects after approval has been granted 

Approval must be sought for any changes that are made to projects following ethics approval. For example, you will need to apply for an amendment approval if you wish to:

  • Change the study design or methodology, participant recruitment process or populations. Example: recruitment of an additional cohort of participants.
  • Change any documentation previously reviewed and approved. Example: rewording of any documentation including letters or information sheets.
  • Modify the study tools, for example, the addition of a new questionnaire.
  • Extend the study end date.

If in doubt whether the change requires further ethics review please contact SEMFRECBSMS@sussex.ac.uk. 

If you need to apply for an amendment approval, you will need to submit on Ethics RM or submit a ‘Request for Amendment Form’ if the application is on our legacy system on Sussex Direct, outlining the changes that are entailed, for consideration of a School Research Ethics Officer or the faculty research ethics committee.

Amendments on Ethics RM

If your original application is on Ethics RM (Infonetica), please unlock your approved application, change Q.2 from ‘New application’ to: ‘Amendment to an already approved application’, edit the form, upload any new documents (with track-changes) and submit as an amendment application.

Most amendment requests can be considered within 10 working days of submission. Occasionally substantial amendments require comprehensive review, and the applicant will be notified.Amendments on Sussex Direct (old system)

DOWNLOAD THE AMENDMENT FORM HERE >

In Sussex Direct: 

  • Select ‘Submit Amendment’ in the original approved application.
  • In the ‘Supporting Documents’ section, upload the Request for Amendment Form together with any new and revised versions of the study documentation. Amendment requests are generally considered within 10 working days of submission.
  • The named supervisor will need to authorise and submit the amendment.