Ethics for applicants

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Ethical consideration is a central issue in the design of any research project involving human participants, their data or tissue to ensure research integrity and good conduct.

It is therefore an integral and important part of the University’s research governance policy and procedures.

This means that most projects involving humans require ethical approval. This page explains the procedures for different categories of human research.

The University has divided research into 5 main categories for ease of use and to guide researchers through the different routes to approval.

The categories are based on level of risk and the different environments in which research involving human participants takes place.

Risk Level Categories
Category	Risk Level
A	Low Risk This is for research which is very low risk. It might include surveys, observational studies and other research with healthy adult volunteers. It does not include significant interventions, novel methods, children, vulnerable adults, patients or service users, clinical trials. Research in this category can be approved to proceed by a filter committee and does not need additional review by UREC or and HRA ethics committee. Further information on Low Risk research
B	Higher Risk This is for research which is higher risk including new methods, vulnerable populations including children, interventions. It does not include research involving patients, service users or clinical trials. Research in this category requires review by a filter committee and additional review by UREC before it can proceed. Further information on Higher Risk research
C	NHS and HSC This is for all research which involves patients or service users of the HSC, NHS and/or private health and social care providers in Northern Ireland. It also includes research involving prisoners. Research in this category requires review by a filter committee and additional review by an HRA ethics committee and by or on behalf of the research site before it can proceed. Further information on NHS research
D	Human Tissue This is for research which is regulated by the Human Tissue Act 2004 and which does not fall into Category C above. Research in this category requires review by a filter committee and additional review by UREC before it can proceed. Further information on research involving Human Tissue
E	Clinical Trials This is for research which involves clinical trials of investigative medicinal products, regulated by the MHRA under the UK Clinical Trials Regulations. Please contact Research Governance for advice before taking any further action.