Each Faculty is now required by the University of Bristol (UoB) to have a properly constituted Committee for Research Ethics. It is the purpose of the Faculty of Medicine and Dentistry Committee for Ethics (FMDCE) to meet regularly to discuss any research-associated ethical issues arising within the Faculty, to review projects submitted for ethical approval, and to implement policy decisions of the UoB Ethics of Research Committee. The FMDCE is responsible to the Dean of the Faculty who, if deemed necessary, will forward FMDCE decisions to the UoB Ethics of Research Committee.
Most clinical and basic human research with the Faculty is already bound by stringent requirements for ethical review through the NHS National Research Ethics Service (NRES). Non-human animal research also has its own review process for ethical approval. The FMDCE has no intention of duplicating procedures which already exist. However, there are research projects which recruit healthy human participants through routes not involving health care providers. Those which do not generally involve drug administration, invasive techniques or tissue sampling may fall outside of the NRES remit and within the area of the FMDCE. Some examples (by no means exclusive) may include:
In every such case, the FMDCE expects to be informed prior to initiation of the study. The research ethics coordinator, Liam.McKervey@bristol.ac.uk may be contacted for informal discussion and advice. If the FMDCE considers it appropriate that a research project which is not covered by NRES does require ethical approval it will ask the Principal Investigator to submit an application to the FMDCE.
In 1st September 2011, new Governance Arrangements for Research Ethics Committees (GAfREC) came into effect. As a result research involving NHS Staff or premises is now undertaken via University ethics review. However, please be advised that as your project involves NHS Staff or Premises you must apply for NHS Trust R&D approval before any project activities can begin within that Trust.
The application form should be completed in accordance with the guidelines and submitted as an attachment to the Research Ethics Coordinator, Liam.McKervey@bristol.ac.uk, together with relevant supporting material. All applications will be processed by the FMDCE and decisions reached and communicated to the Principal Investigator within 60 working days of the date of confirmation of finalisation of the Faculty Ethics Committee meeting agenda.
Applications submitted less than ten working days prior to an FMDCE meeting will be held over until the following meeting unless there are exceptional circumstances justifying urgent consideration. There will be a right of appeal to the UoB Ethics of Research Committee on any FMDCE decision, through the Faculty UoB Ethics of Research Committee representative. In the event that the committee meeting agenda becomes full the Chair of the committee reserves the right to close the agenda before the deadline for applications and applications will be held over until the following meeting.
The UoB may also require a sponsor to be identified for the research. For details see the University Research Governance pages.
For research collaborations with other institutions please refer to the Collaborator Checklist.
For research projects outside the UK please refer to the non UK project guidelines (Word, 24Kb).
The FMDCE intends to encourage a positive and helpful culture within the Faculty with an ‘ethical research is good research’ ethos. To this end, the FMDCE will provide information, advice and support to all researchers within the Faculty while emphasising that the primary responsibility for ethical conduct of a project lies with the PI or supervisor who is expected to familiarise themselves with, and comply with, the regulations governing ethical approval.
Please feel free, whether student or staff, to contact the Research Ethics Coordinator, Liam.McKervey@bristol.ac.uk if you have any queries regarding ethics of research for planned studies or for any ethical issue which may arise in existing projects.
Application Form (word, 28Kb)
Peer Review Form, (word, 4Kb)
Guidelines (pdf, 163Kb)
Dates of FMDCE meetings in 2012/13
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