Conducting research with human participants (outside the NHS)

Queen Mary Ethics of Research Committee (QMERC) Covid-19 guidance for researchers, 14 August 2020 [PDF 293KB]

Who are we?

Queen Mary Ethics of Research Committee

The Queen Mary Ethics of Research Committee (QMERC) provides ethical scrutiny of research studies conducted by Queen Mary researchers. It exists to provide approval and oversight of research and works to ensure that research at Queen Mary is always conducted with full awareness of the ethical issues, and necessary precautions are taken to preserve the highest ethical standards.

Any research involving human participants (including personal data or human tissue) may give rise to ethical risks and researchers must take steps to manage these risks effectively. To ensure that high ethical standards are maintained, policies and procedures must be followed. Our Standard Operating Procedure sits alongside the Queen Mary Policy on Research Integrity [PDF 124KB] and Policy on Research with Human Participants [PDF 86KB].

The Queen Mary Research Ethics team sits within the JRMO.

What do we review?

The QMERC reviews ethics applications from Queen Mary researchers who are planning to conduct research involving human participants, their data or samples using Queen Mary premises or facilities, or conducted at external sites but led by Queen Mary staff. We review applications from all disciplines, across all Queen Mary Faculties, Schools and Institutes.

Who should apply?

Ethical review of international research: where all research sites are situated outside of the UK, it is expected that the research should be approved by an Ethics Committee local to the research site (in the country in which the research is to be conducted), wherever this option is available. Further ethical review by QMERC may not be necessary if the overseas research ethics process and standards are at least as rigorous as that of QMERC. Researchers who are seeking overseas ethical approval should approach the QMERC prior to study commencement, for confirmation that the ethics review process is sufficiently robust to meet Queen Mary’s standards. Notwithstanding attempts to avoid unnecessary duplication, if it is deemed appropriate, QMERC may request ethical review under its processes in addition to overseas approval.

‘Dual Review’ for Interventional/High-Risk Research: The Research Ethics team work closely with our colleagues in JRMO Research Governance, and in some circumstances (where the study procedures are classified as high risk and/or interventional), the study may also require formal sponsorship issued by the Research Governance team via a process known as ‘dual review’.

If you are unclear whether ethical approval is required, from the QMERC or any other Ethics Committee, please contact us for advice.

Who need not apply?

A few investigative activities involving human participants would not require Queen Mary Ethics of Research Committee review and approval:

Secondary data analysis (unless the following apply): the data is personal or sensitive and confidential in nature; or if data or confidential information is linked or shared beyond the initial consent (for example, if the research topic or data gathering or re-use involves a risk of information disclosure that would require the researchers to breach confidentiality conditions agreed with participants). Information freely available in the public domain (i.e. published biographies), whilst still personal data, would not require ethics review.

Service evaluation (where the following apply): the ‘service provider’ or someone acting on their behalf aims primarily to monitor or improve a service being delivered by collecting information from a ‘service user’; the conclusions are primarily applicable to the ‘service provider’; the conclusions are only internally published (such as a module coordinator seeking feedback on a module from their students). This exemption does not apply if your study explores a sensitive topic which involves vulnerable groups of participants, and if your study creates generalisable new knowledge and you intend to publish its outcomes externally (peer-reviewed journals, conferences and the like).

Audit work which aims to find out whether the quality of a particular service meets a defined standard.

If there is a legal requirement for NHS REC review: For example, studies involving NHS patients or intrusive procedures with adults who lack the capacity to consent for themselves fall outside the remit of QMERC. For confirmation of whether or not your study requires an application to an NHS REC, you are advised to use the decision tool ‘Do I need NHS REC review’ on the Health Research Authority website. For full details of the NHS REC remit and review, please find further information about the Governance Arrangements for Research Ethics Committees (GAfREC) on the HRA website.

If your study requires NHS REC review, you should contact the JRMO Governance team at research.governance@qmul.ac.uk for support and sponsorship from Queen Mary.

If you are unclear whether ethical approval is required, from the QMERC or any other Research Ethics Committee, please contact us.