Risk assessment criteria for health and/or social care human interventional studies* NOT involving the NHS or social care services

This page provides guidance for University ethics reviewers in assessing the risk of studies that they have identified to be health and/or social care human interventional studies which don’t involve the NHS or social care services.

These studies would not normally be required to follow the University’s Research Governance Procedure; however, they may present particular risks. The criteria set out below aim to help reviewers in identifying risks, and should these be identified, the study will be required to follow the Research Governance Procedure to ensure these risks are managed appropriately.

*The University's definition of a human interventional study can be found here

Risk criteria:

If the ethics reviewer answers ‘yes’ to any of the below questions, the study should be classed as medium/high risk within the Ethics Review Form.

[Studies classed as low risk require only University ethics approval. Studies classed as medium/high risk require University ethics approval AND will be required to follow the Research Governance Procedure. Marking a study as medium/high risk will generate an email to the Ethics Administrator asking them to notify the applicant, and the department's Research Governance Contact, of this requirement.]

1. Does the study involve administering any active substance(s)?
(Even if these are NOT considered to be an investigational medicinal product (IMP) by the MHRA. Please note even over-the-counter substances may be considered to be an IMP. IMPs must be reviewed by an NHS Research Ethics Committee)

2. Will the study involve a medical device? (A medical device is any instrument, apparatus, appliance, material or other article, including software or apps, which may be used for a medical purpose or to benefit healthcare provision (NB. such studies may be subject to the Medical Devices Regulations, in which case they must be reviewed by an NHS Research Ethics Committee))

3. Will the study involve the exposure of participants to radiation or other noxious substances?

4. Does the study have the potential to have a significant negative effect upon the health of the participants, whether physical or psychological?

5. Is the study potentially controversial?

6. Is the intervention invasive? (invasive means involving the introduction of instruments or other objects into the body or body cavities.(e.g. surgery; obtaining tissue; taking blood; inserting a device)

7. Does the study involve vulnerable groups? (under-18s, pregnant women, those lacking mental capacity, those under the control of others)

8. Is this an international study?

9. Is this a multi-site study?

If further advice is required regarding the assessment of risk, ethics reviewers can contact Lindsay Unwin (l.v.unwin@sheffield.ac.uk; x21443).