Safeguarding: Research with Children and Patients
Research with the NHS
NHS Research which involves current or previous NHS service users (or their close relatives or carers) recruited through the NHS (directly or indirectly), must be reviewed by an NHS REC through the NRES (National Research Ethics Service). The NRES system must also be used for Clinical Trials of Investigational Medicinal Products, for any research involving adults who do not have the mental capacity to give informed consent (or might lose that capacity in the course of the research), and any research using human tissue.
Staff undertaking research work which involves one-to-one or other unsupervised contact with children will be required to obtain a current enhanced Disclosure and Barring Service check issued for work conducted through the University.
The Disclosure and Barring Service’s aim is to help organisations in the public, private and voluntary sectors by identifying candidates who may be unsuitable to work with children or to hold particular positions. The definition of a child in this context is a person aged under 18 years of age.
Staff and students at whatever level undertaking research work which involves one-to-one or other unsupervised contact with children will be checked. The need for a check should be identified by the researcher and supervisor on the basis of the nature of the activity involved. The Ethics Committees may also make recommendations regarding DBS checks for projects they review.
The Ethics Committee will require confirmation that an enhanced DBS check has been obtained where researchers are working individually or unsupervised with participants who are under 18 years of age. Evidence of the check should be presented alongside all other documentation provided when making an application to the Ethics Committee.
All research undertaken by the University’s staff and students must be adequately covered by the University’s Insurance provisions. The University’s insurance policy will in most cases provide adequate cover and this will be checked as part of the ethical approval process. Researchers should be aware however that research in the health sector (for instance, working with medical devices, or in clinical settings, or where any medical intervention is undertaken) may require additional insurance to be put in place. In all such cases, research should on no account commence until ethical approval has been granted. Indemnity issues for research are coordinated by Research, Innovation and Enterprise Services and applicants may wish to discuss indemnity prior to the application for ethical approval.