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Oxford University Hospitals NHS Foundation Trust
Research and Development

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Research Governance

Research Governance may be defined as the broad range of regulations, principles and standards of good practice that exist to achieve, and continuously improve, research quality in the UK and worldwide.

Who does it apply to?

Research Governance applies to everyone connected to Clinical Research, whether as a Chief Investigator, Care Professional, Researcher, their employer(s) or support staff.

By Clinical Research, we mean any health-related research that involves humans, their tissue and/or data.

Why do we need it?

Research Governance is needed to:

  • safeguard participants in research
  • protect researchers / investigators (by providing a clear framework within which to work)
  • enhance ethical and scientific quality
  • mitigate risk
  • monitor practice and performance
  • promote good practice and ensure that lessons are learned.

Key documents, regulations and other resources

Research Governance Framework

Whilst Clinical Research is essential for the successful promotion and protection of health and wellbeing, and for modern, effective health and social care services, it can also involve an element of risk, both in terms of return on investment and sometimes for the safety and wellbeing of participants.

Sound governance of research is essential to ensure that the public can have confidence in, and benefit from, quality research in health and social care. The Research Governance Framework for Health and Social Care sets out core standards that apply to the conduct of all Clinical Research.

Good Clinical Practice (GCP)

Please see:

EU directives

The EU Clinical Trials Directive (EUCTD - 2001/20/EC) is a legal document, published in 2001, which sets out how clinical trials investigating the safety or efficacy of a medicinal product in humans must be conducted. It includes medicinal trials with healthy volunteers and small scale or pilot studies.

The Good Clinical Practice (GCP) Directive (2005/28/EC) supplements the EUCTD, strengthening the legal basis for requiring Member States to comply with the principles and guidelines of good clinical practice, as set out in the ICH GCP guidelines. This Directive was adopted in April 2005.

Medicines for Human Use (Clinical Trials) Regulations

The EUCTD was implemented into UK law in May 2004, as the Medicines for Human Use (Clinical Trials) Regulations 2004, and has since been amended (2006a, 2006b, 2008).

Human Tissue Act

The Human Tissue Act 2004 repealed and replaced the Human Tissue Act 1961, the Anatomy Act 1984 and the Human Organ Transplants Act 1989 as they related to England and Wales, and the corresponding Orders in Northern Ireland. The Human Tissue Authority regulate the removal, storage, use and disposal of human bodies, organs and tissue.

Declaration of Helsinki

The Declaration of Helsinki was developed by the World Medical Association as 'a statement of ethical principles for medical research involving human subjects, including research on identifiable human material and data' (Para 1, Declaration of Helsinki).

Data Protection Act

Most Clinical Research requires the processing and/or storage of personal and sensitive information. The Data Protection Act 1998 legislates for the control and protection of personal information relating to living individuals including both facts and opinions about the individual. It is vital that all University research and researchers comply with the Act and process/store all personal information in accordance with it.

The Information Commissioner's Office provides guidance on determining what is personal data.

Risk-adapted approach

The current regulatory framework in the UK/EU allows for a range of risk-adapted approaches that may simplify the processes for initiating and conducting some clinical trials. These adaptations are largely related to how much is known about the investigational medicinal product (IMP), and are based on the marketing status of the IMP and standard medical care. Using a simple categorisation of three risk types (safety risks, risk related to participant rights and risk to reliability of results), it is possible to highlight, particularly for lower risk trials, where simplification is possible.

Further resources

Please see: