Research Governance, Scientific and Ethics Review
The School’s research governance procedure
In order to comply with the Department of Health’s Research Governance Framework for Health and Social Care, the University operates a research governance procedure for health care research projects that are led or supervised by University of Sheffield members of staff.
The Department of Health defines health care research as:
“All research that relates to the responsibilities of the Secretary of State for Health. That is, research concerned with the protection and promotion of public health, research undertaken in or by the Department of Health, its non-Departmental Public Bodies and the NHS, and research undertaken by or within social care agencies. It includes clinical and non-clinical research, research undertaken by NHS or social care staff using the resources of health and social care organisations, and any research undertaken by industry, charities, research councils and universities within the health and social care systems that might have an impact on the quality of those services” (The Research Governance Framework for Health and Social Care, p. 2).
Each academic department has at least one designated health care research governance contact, who administers the procedure for health care research undertaken in the department, and who is available to provide support and advice for researchers. The designated contact for the School of Nursing and Midwifery is Jane Flint, email@example.com
An overview of the research governance procedure can be found here.
For further information about research governance in general see: http://www.sheffield.ac.uk/ris/other/gov-ethics/governance
Research in the NHS
The Department of Health has published a revised version of its policy document 'Governance arrangements for research ethics committees', which outlines the remit of the NHS ethics review procedure. The following types of research no longer automatically require approval by an NHS ethics committee (REC):
- Research carried out on NHS premises
- Research carried out on NHS staff
In both cases, ethics approval can be sought through the University, as long as the research does not involve any other categories for which NHS REC approval would be required. Full guidance on the types of research for which NHS REC approval is required can be found in the Department of Health's policy document: www.dh.gov.uk/en/Publicationsandstatistics/Publications/PublicationsPolicyAndGuidance/DH_126474
If your research involves NHS patients you will require NHS research ethics review. The Integrated Research Application System (IRAS) application form contains a section 'Declaration by the Sponsor'. This section of the form requires the authorisation of a designated authorised signatory for your department. This will need to be arranged by your departmental healthcare research governance contact and can be done by either obtaining a wet ink signature or via electronic authorisation.
In order for this authorisation to be granted, your healthcare research governance contact will first need to see confirmation of independent scientific approval (the funder's approval letter in the case of externally-funded research) before the application can be authorised. Please note it is not necessary to submit both an ink and electronic signature.