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Guidance for BSMS Undergraduates and Postgraduate Taught Students

BSMS taught student 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.

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

If you are an undergraduate or postgraduate taught student conducting research that potentially poses minimal risks to participants for your Individual Research Project (IRP) or dissertation, your project could qualify for expedited review via a School Research Ethics Officer (SREO).

Quick links

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

How to apply for ethics approval

The ethics application is submitted by the taught student in Sussex Direct. Under ‘Choose routing of application’ ‘Brighton and Sussex Medical School Research Governance & Ethics Committee’ must be selected.
Please ensure you allow enough time (at least 2-4 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.
Sussex Direct includes a separate review pathway for undergraduate (UG) and postgraduate taught (PGT) student research projects judged as posing minimal risks to participants using an in-built risk assessment checklist. Eligible projects receive expedited ethics review from a BSMS SREO. The review of undergraduate and postgraduate taught student applications involving higher risk activities, such as in-person fieldwork, is conducted via the BSMS Research Governance and Ethics Committee (RGEC). Download the risk rating filter checklist to determine if your application is likely to be eligible for SREO review.

DOWNLOAD THE RISK RATING FILTER CHECKLIST HERE >

Help applying

A Word version of the online ethics review application form used by taught students for applying for SREO review provides a template to use when preparing an application.

Download the 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 undergraduate and postgraduate taught 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.

Download the Risk assessment document here >

Summary Curriculum Vitae (CV) for non-BSMS supervisors.

BACKGROUND IMAGE FOR PANEL

How to submit an application online

The completed application is transferred by the student to their supervisor. The system generates an email (sent to their University of Sussex email address) to alert the supervisor that an application requires their review. 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 BSMS faculty supervisor with a BSMS email address linked to a University of Sussex ITS account is required to authorise the student’s application in Sussex Direct to ensure appropriate oversight for supervised research.
Supervisor authorisation is a 2-step process:
- The supervisor approves the application (which results in a system generated notification to the student). (Select ‘Enter Decision’ > ‘Decision Status’ – select ‘Approved by supervisor’; or ‘Returned for revision (by supervisor)’ and provide an explanation of the return in the free text box).
- The application is flagged for submission and a ‘Submit to C-REC’ button is visible in the supervisor’s queue of ‘Applications submitted for supervisor approval’. The supervisor transfers the application to a SREO for ethics review via a ‘Submit to BSMS SREO for review’ button located at the bottom of the application. The Supervisor should select the appropriate SREO (for undergraduate or postgraduate taught applications) for review.

Ethics review process

Applications judged as posing few risks to participants can expect to receive decision within 10 working days of submission to the SREO. 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 via email of the outcome of review (to their University of Sussex email address). They will receive a summary of the feedback and an itemised list of changes required for approval as well as those recommended for the enhancement of the study.

How long does the review process take until approval?

The procedure is designed to be as prompt as possible while maintaining high standards. However, the timeframe for approval will depend on the quality of the submission. On average, the process can take 2-4 weeks for full review and approval.

Amendments to research projects after approval has been granted

SREO 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 the appropriate SREO (see Contact Us). 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 a School Research Ethics Officer in Sussex Direct.

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.

BACKGROUND IMAGE FOR PANEL

Independent Research Projects

Some IRP projects 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.

NHS-based audits and service evaluations

All NHS-based audits and service evaluations will require approval from the relevent Trust the project is being conducted under. Projects considered low risk are not subject to ethical review, but will be overseen by a nominated individual of the BSMS SREO team. Projects considered high risk may be subject to ethical oversight determined by preliminary review by a nominated individual of the BSMS SREO team.

Non-NHS based audits and service evaluations

Service evaluations and audits concerning special category data, sensitive questions, involvement of vulnerable individuals and/or where there is intention to submit findings for publication are subject to ethical review.

Non-NHS based research

Non-NHS based research projects are subject to ethical review. Those determined to be low risk will be reviewed by a nominated BSMS SREO. Projects determined to be of higher risk may be reviewed by RGEC.

Applying for ethical review

For applications subject to ethical review, students will need to submit an electronic application form on Sussex Direct. Projects should be submitted by the student, however supervisors are expected to oversee the student’s work in addition to sign off once submitted to Sussex Direct. 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.

For multi-student projects, a nominated student should submit an application on the behalf of the others, with all students named on the application.

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.

If you have any queries concerning your IRP please contact the module team. For any queries concerning ethical approval granted by either RGEC or a BSMS SREO please contact Alice Ashford, Senior Research Ethics and Integrity Officer (a.ashford@sussex.ac.uk).

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