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Brighton & Sussex Medical School

Guidance for BSMS staff

BSMS > Research > Support and governance > RGEC hub > Guidance for BSMS staff

Guidance for BSMS staff

BSMS staff ethics applications are made and submitted electronically via the online ethics review application system in Sussex Direct via the link below.

Visit Sussex Direct here >

Applications for a range of health-related research involving healthy human participants, their biomaterial, or personal data are all eligible for review.

Staff applications are reviewed by Brighton and Sussex Medical School's Research Governance and Ethics Committee (RGEC) which meets monthly at scheduled meetings.

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

Quick links

How to apply for ethics approval >
Help applying >
What to submit >
How to submit an online application >
Ethics review process >
Amendments to research projects after approval has been granted >

How to apply for ethics approval

  • The ethics application can be submitted by either the PI or a member of the research team in Sussex Direct.
  • 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 note ‘Honorary Contract’ and ‘Honorary Title’ denote different relationships with the University. An Honorary Contract is equivalent to a substantive employment contract with the University of Sussex, while an ‘Honorary Title’ is not. Honorary Contract holders may be named as PIs and lead BSMS research sponsored by the University of Sussex and insured under the University’s insurance policy. Be aware that applying for an Honorary Contract can take a minimum of two months since it is equivalent to a substantive employment contract in all except direct payment of salary. The status of the Honorary Contract holder’s legal relationship with the University must be established well in advance of: 
    • An application for funding of research; 
    • Application to the BSMS Research Governance and Ethics Committee (RGEC) for ethics review of the research.

This is to ensure the research can be sponsored by the University. Honorary Contract holders are entitled to a BSMS IT account including access to resources required for University-sponsored research such as research data storage (OneDrive and SharePoint). Contact Sarah Cox, interim Senior HR Business Partner via S.J.Cox@sussex.ac.uk, who will be able to advise further on obtaining a suitable contract. 

  • Please ensure you allow enough time (at least six weeks) for the review process when planning your research. Applications should be timed in advance of the intended start date to allow time for review and any amendments that may be required.
  • A review slot must be booked at a scheduled RGEC meeting for the review of the application. These are available on request by contacting RGEC: rgec@bsms.ac.uk. (Review slots are required to manage the review volume at meetings and operate on a first come first served basis).
  • Applications must be submitted online to Sussex Direct before 17.00 on the date of the submission deadline to be considered for review at the respective meeting. Please note that applications are reviewed on a first come, first serve basis. 
  • A schedule of RGEC Committee and Sub-Panel meeting dates and submission deadlines is provided below. (Meetings are held monthly and applications can be reviewed at either a Committee or Sub-Panel meeting, depending on the preferred timeline for commencing the research). 
Committee and Sub-panel meetings
 Meeting Meeting date  Submission deadline 
 Committee   17 October 2024  26 September 2024
 Sub-Panel  21 November 2024  31 October 2024
 Committee  12 December 2024   21 November 2024 

 

(Please note the deadlines and meetings only refer to Staff/PGR applications. UG/PGT applications are reviewed by a School Research Ethics Officer (SREO), unless deemed high risk).

BACKGROUND IMAGE FOR PANEL

Help applying

  • A Word version of the online ethics review application form used by Staff and PGRs for applying for RGEC review provides a template to use when preparing an application.

DOWNLOAD WORD VERSION here > 

Useful forms and guidance 

  • The Applicant Checklist provides guidance on supporting study documentation to include as part of the application:

DOWNLOAD THE CHECKLIST TOOL FOR APPLICANTS HERE >

What to submit

The documents required for staff applications are:

  • Ethical Review Application Form (online in Sussex Direct). All questions must be answered. “Not applicable” is a satisfactory answer where appropriate. Applicant guidance for completing the form is included in Sussex Direct via the ‘Help’ tab.

Supporting documentation must also be supplied and submitted in PDF format 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 >
View the INTERVIEW CONSENT FORM TEMPLATE >
View the VERBAL CONSENT 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).
  • If your research requires any travel, fieldwork conducted off-campus, or takes place in a foreign country, completion of the University of Sussex’s Overseas Travel Safety and Security Risk Assessment (OTSSRA) Form requiring approval from the Head of School or Division will be required for your research. View the website here. 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).
  • 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 you are conducting research outside the UK, a completed Applicant Checklist Tool for Research Conducted Overseas will be required. 

Download the applicant checklist tool here >

  • Summary Curriculum Vitae (CV) for non-BSMS supervisors.
BACKGROUND IMAGE FOR PANEL

How to submit an application online

  • The applicant completes the online application form in Sussex Direct and uploads supporting study documents before submitting the application (using a ‘Submit to BSMS RGEC for review’ button) for ethics review at the scheduled meeting booked for review of your application.
  • During the review process, the system will generate notifications (sent to the applicant’s University of Sussex email address) when the application is returned by the RGEC and requires applicant action.

Ethics review process

At the scheduled RGEC meeting, applications will be reviewed by two members of the Committee in addition to the RGEC Chair/Deputy Chair. 

Applicants may be invited to discuss their application at the meeting or, can request to attend in person to respond directly to the Committee’s questions and facilitate the review. A request should be sent to rgec@bsms.ac.uk two weeks before the meeting date to allow discussion time to be accommodated in the meeting agenda. The application will receive one of the following decisions in Sussex Direct:

  • Approved: No amendments to the application form or study documentation required.
  • Returned for Revision: Studies which are either Conditionally Approved and require relatively minor amendments to the application and/or study documentation or, Provisionally Approved and require more substantial amendments to the application and/or study documentation.
  • Not Approved: For studies which are ethically unsound or submitted in error.

The applicant will be informed of the outcome of the review via email. They will receive a letter summarising the feedback and an itemised list of changes required for approval, as well as those recommended for enhancement of the study. Conditionally Approved applications are reviewed via Chair’s Action. While Provisionally Approved applications require re-submission to a scheduled RGEC meeting. 

How long does the review process take until approval? 

The timeframe for approval will depend on the quality of the submission. On average, the process can take at least six weeks for full review and approval. It is therefore important that you submit your application in good time and when entering the dates of your proposed data collection that they are far enough in the future.

Amendments to research projects after approval has been granted 

RGEC 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 rgec@bsms.ac.uk. If you need to apply for an amendment approval, you will need to submit a ‘Request for Amendment Form’ outlining the changes that are entailed, for consideration of the RGEC Chair in Sussex Direct.

DOWNLOAD THE AMENDMENT FORM here >

In Sussex Direct: 

  • Select ‘Submit Amendment’ in the approved parent application.
  • In the ‘Supporting Documents’ section, upload the Request for Amendment Form together with any new and revised versions of the study documentation. 

Most amendment requests can be considered by the Chair within 10 working days of submission and do not require review at a scheduled RGEC meeting. Occasionally substantial amendments require comprehensive review, and the applicant will be notified.

 

GO BACK TO the RGEC homepage >