Ethics Pathways for Student Projects 2012
As of February 2012, all student research projects must be logged through the University of Southampton’s Ethics and Research Governance Online (ERGO)
system. This includes research proposals put through both the Faculty of Medicine Ethics Committee (FoMEC) and the NHS National Research Ethics
System (NRES) though the Integrated Research Assessment System (IRAS). When determining which body you will apply to there are several points to
consider:
NRES approval is required if your research includes:
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identifiable patient data for any NHS and adult social services, including those who died within last 100 years
use of xenotransplantation (animal tissue transplanted into humans)
private and voluntary sector nursing homes and residential care homes
practising midwives conducting a clinical trial
human tissue collected where kept beyond 7 days and not held on Human Tissue Authority licensed premises
collection and analysis of DNA material from NHS patients, if tissue needs to be collected to extract a cellular such as serum/plasma/DNA; collection
of patient information for DNA analysis
University of Southampton, Faculty of Medicine Ethics Committee (FoMEC) approval is required if your research does not involve any of the above
criteria, but does include:
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NHS staff recruited as participants via by virtue of their professional role; (NOTE: where tissue collected and storage beyond 7 days NRES required
or other material ethical issues involved (enquire with your supervisor or the FoMEC PRIOR to formal submission))
use of anonymised patient data or tissue from pre-existing clinical routine care (NOTE: tissue storage over 7 days requires NRES)
healthy volunteers with use of NHS facilities/staff (unless NRES is legally required, e.g. for Phase I/II CTIMPs or with ionising radiation such as DXA,
X-rays, CT-scan, Fluoroscopy, vascular imaging)
healthy volunteers not recruiting by virtue of having been NHS patient in the past (e.g. use of NHS patient database); e.g. healthy volunteer
endo/bronchoscopies, skin prick tests, ultrasound, laser camera (FoMEC is sufficient)
healthcare market research and registries collecting anonymised product info (NOTE: informed consent must still be obtained for additional
procedures such as interviews/questionnaires or provision of personal data)
Please note that regardless of what route your research project takes, you are still required to register your project through ERGO as this allows the
University to maintain a full list of research projects being undertaken at any given time for insurance purposes.
Type of Project
Projects not involving humans
Apply for FoMEC approval on ERGO
Projects involving humans and
questionnaires
Register your project to the RGO office
for insurance via ERGO
Projects involving human samples
Apply for FoMEC approval on ERGO
Projects planned to take place outside
of the UK
Foreign Ethics Approval -> confirm
approval via application to FoMEC via
ERGO
Projects involving patients
(thus requiring IRAS approval)
IRAS -> register project via ERGO
Pathway
1. Apply for FoMEC approval through ERGO by completing the IRGA form and uploading all relevant documentation.
1. Register your research project on ERGO by completing the IRGA form and uploading all relevant documentation.
1. Apply for FoMEC approval through ERGO by completing the IRGA form and uploading all relevant documentation.
*Please note that ‘all relevant documentation’ includes, FoMEC Ethics Application Form, Risk Assessment, and all supporting documentation
(includes for example: Patient Information Sheet, Adverts, Consent Form, etc).
1. Successfully complete an ethics application according to the policies outlined by the government in the country
where your study is scheduled to take place.
2. Apply to the FoMEC in order to confirm approvals, by completing the IRGA form online and uploading all relevant
documentation.
1. Apply for IRAS approval.
2. Register your research project on ERGO – this can be done simultaneously with your IRAS application - by
completing the IRGA form and uploading all relevant documentation.
*Please note that prior to starting your project, you will need to successfully obtain IRAS approval and complete an application through ERGO
noting the approvals number given to you by IRAS.