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National Patient Safety Agency - National Research Ethics Service - facilitating and promoting ethical research
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Research guidance

Research or audit?

Issues and arguments

  • 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 Research This 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 Research This 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 Consent Consent must be informed, voluntary and time given to consideration to participate needs to be thought through on a case by case basis.
     


Research Governance Framework (RGF) and other Department of Health guidance

Human Tissue

  • Diagnostic archives releasing tissue for research - joint NRES/HTA statement Diagnostic archives releasing tissue for research - joint NRES/HTA statement
     
  • Guiding principles for biobanks A statement of guiding principles for research tissue  banks / biobanks, published by the National Cancer Research Institute’s (NCRI) Confederation of Cancer Biobanks (CCB).
     
  • 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.
     
  • Template policy for access to samples and data A toolkit created by the National Cancer Research Institute (NCRI) to assist organisations in developing a policy for access to collections of samples or data, including a template Material Transfer Agreement.
     
  • UK Stem Cell Tool Kit A regulatory tool for those conducting human stem cell research in the UK.
    Navigate your way through the regulations by responding to a series of key questions and building your own route map.
     


Personal data

Ionising radiation

Proportionate Review

  • 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 Service FAQThis leaflet answers frequently asked questions about the Proportionate Review Service. 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.
     

Student Research