NRES - Research guidance

Audit or Research table
Guidelines to help researchers and RECs to decide what is appropriate/inappropriate for submission to RECs
Differentiating audit, service evaluation and research
Differentiating audit, service evaluation and research version 1.1.
NHS Research and Development Forum guidance
(External link, doc) NHS Research and Development Forum guidance on categorising and managing research and related projects.
NRES Leaflet: Defining research
NRES Leaflet: Defining research (pdf)

A genuine scientific study or market penetration? Market penetration, masked as “research” was felt to be unethical and there is clear guidance from other bodies and legal instruction that such activity is unacceptable and which also allows redress.
Deception in Medical ResearchThis paper was developed as part of a Shared Ethical Debate Exercise involving 20 Research Ethics Committees and reviewed at a workshop attended by REC Chairs and Members on the 8th July 2009.
Differentiating audit, service evaluation and research
Differentiating audit, service evaluation and research version 1.1.
Genetic ResearchThis paper was developed as part of a Shared Ethical Debate Exercise involving 20 Research Ethics Committees and reviewed at a workshop attended by REC Chairs and Members on the 13th January 2010.
Simultaneous participation in more than one trial

Simultaneous participation in more than one trial version 1.0.
Time to ConsentConsent must be informed, voluntary and time given to consideration to participate needs to be thought through on a case by case basis.

DH consent home page
(External link)
DH Mental Capacity Act 2005 guidance page
(External link) Department of Health Mental Capacity Act 2005 guidance page
DH research governance home page and index
(External link) Department of Health research governance home page and index
Model clinical trials agreements
(External link)
Research Governance Framework for Health and Social Care
Research Governance Framework for Health and Social Care (‘RGF’) 2nd edition

Diagnostic archives releasing tissue for research - joint NRES/HTA statement
Diagnostic archives releasing tissue for research - joint NRES/HTA statement
Human Tissue Act 2004 Questions and Answers
Human Tissue Act 2004 - questions and answers on consent, ethical review and licensing, version 2.0.
Human Tissue Authority
(External link) Human Tissue Authority
MRC e-learning module
A free e-learning module, designed in consultation with the Human Tissue Authority and NRES, giving an overview of human tissue legislation in all parts of the UK with practical examples of how it applies to research. Suitable for researchers, research managers, members of RECs and others with an interest in the subject.
NRES HTA Memorandum of Understanding
Memorandum of Understanding between the Human Tissue Authority and the National Research Ethics Service.

Ethical review of research databases
Ethical review of research databases
Information Commissioner's Office
(External link) Information Commissioner's Office
National Information Governance Board for Health and Social Care (External link) National Information Governance Board for Health and Social Care
Security of NHS patient data shared for research purposes
NHS Information Governance - Guidance Note: Security of NHS patient data shared for research purposes

Approval of research involving ionising radiation
NRES guidance on the approval of research involving ionising radiation, version 2.0
Ionising radiation flowchartIonising radiation flowchart
Ionising Radiation Regulations
Ionising Radiation (Medical Exposure) Regulations 2000
Ionising Radiation Regulations Amendment
(External link) Ionising Radiation (Medical Exposure) (Amendment) Regulations 2006.

No Material Ethical Issues Tool
For your application to be suitable for proportionate review, it should meet one of the study types listed in the No Material Ethical Issues Tool (NMEIT).
Proportionate Review (‘Fast Track’) Project
Information and documentation for the pilot project that sought to identify research projects with ‘no material ethical issues’ which could receive committee opinions more quickly.
Proportionate Review Service leaflet
This leaflet provides an overview of the Proportionate Review Service, which is currently being piloted. The Proportionate Review Service is designed to ensure an appropriate level of ethical review for low-risk research studies.
Submitting your application
Flowcharts and tools to help you assess your research, how to book, and where to submit your application.

Research guidance