Research Ethics Approval Procedure

2. Routes for obtaining Ethics Approval

The lead researcher (e.g. the principal investigator or supervisor) is responsible for deciding whether ethics approval is required, and which ethics review procedure is applicable. Ethics approval can be obtained via five standard routes, which are outlined in this section.

It should be noted that for certain types of research there are specific legal, regulatory and governance requirements that must be considered alongside the requirements for ethical review (e.g. requirements that apply to health care research, human tissue research, and clinical trials of Investigational Medicinal Products or Medical Devices); further information is provided in Research Ethics Policy Note nos. 1 (Defining Human Research Participants), 5 (Ethics Review of Health and Social Care Research) and 10 (Retrospective Ethics Review).

In addition, there is a legal requirement for research involving adults lacking in mental capacity to be reviewed by a recognised Appropriate Body under the Mental Capacity Act 2005. Appropriate Bodies include some NHS research ethics committees and the Social Care Research Ethics Committee (see section 2.3). For further information, refer to Research Ethics Policy Note no. 5 and the Specialist Research Ethics Guidance Paper entitled 'Research involving adult participants who lack the capacity to consent'.

2.1 University Procedure

This applies to research which:

  • comes under the broad definition of of ‘a process of investigation leading to new insights, effectively shared’;
  • is led by the University of Sheffield;
  • does not require ethical review via an NHS Research Ethics Committee or the Social Care Research Ethics Committee; and
  • is undertaken in the United Kingdom (or abroad, unless there is an appropriate alternative – see section 2.4 below).

For further information regarding the University Procedure, refer to Section 3 of the Policy document

2.2 Review by a National Health Service Research Ethics Committee (NHS REC)

Review by an NHS REC forms part of the Heath Research Authority’s HRA Approval process.
In general, review by an NHS REC will be required for research that involves participants identified from, or because of, their status as patients of the NHS or other Department of Health Services, and/or the relatives of such patients. There are also specific types of health care research that will require review by an NHS REC (e.g. a clinical trial of an Investigational Medicinal Product and research involving the collection of human tissue).
Research involving only the premises and/or staff of the NHS or other Department of Health services does not require review by an NHS REC. Researchers should refer to the HRA’s ethics decision tool for full details:

HRA Decision Tool Link

It should be noted that the definition of research applied by the NHS is not as broad as the definition applied by the University. Hence a project that does not need to be ethically approved by an NHS REC may still come under the remit of the University Procedure (e.g. a project that is defined as service evaluation within the NHS, but which is being undertaken as part of the research element of a University degree award, or for which there is an intention to publish the findings).

For further guidance on the NHS Ethics Review Procedure, please refer to Research Ethics Policy Note no. 5.

2.3 The national Social Care Research Ethics Committee

This route applies to certain types of social care research.

For guidance refer to the: Social Care Research Ethics Committee website and Research Ethics Policy Note no. 5.

2.4 Alternative Research Ethics Procedure

This applies to:

  • research led by University of Sheffield staff or students which is conducted outside the United Kingdom; or
  • research in which University of Sheffield staff or students may be involved, but which is led by another United Kingdom university or research organisation (which may be conducted either within or outside the United Kingdom).

For further information regarding the Alternative Ethics Review Procedure, refer to Section 4 of the Procedure

2.5 The Administrative Research Ethics Review Procedure This applies to all administrative research (i.e. research which does not form part of the standard academic research that is undertaken within departments and research disciplines). It may be undertaken by, or on behalf of, professional service departments, or the professional service functions within academic departments or faculties. For further definition and discussion of these activities and the procedures for their ethical review, see Research Ethics Policy Note no. 7, 'Administrative Research within the University'.

Section 3 University Ethics Review Procedure

Who to contact

Anita Kenny (A.J.Kenny@sheffield.ac.uk, 21400) is the first point of contact for enquiries relating to research ethics and ethics approval.

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