Health research carried out by the NHS in England and Wales must meet new standards designed to protect participants, improve quality, and stop research fraud, according to recommendations proposed in a draft governance framework published by the Department of Health last week.
The framework sets out standards, delivery mechanisms, and monitoring arrangements for all research carried out by the NHS in England and Wales, including joint projects with other partners such as universities, charities, research councils, and pharmaceutical companies.
It brings together for the first time a wide range of existing guidelines to set clear standards for NHS research.
Dr Elizabeth Clough, deputy director of research and development for the Trent region and member of the steering group that developed the framework, said: “There were two main motivations for developing the framework. First, it sets out standards and mechanisms to protect the needs, rights, wellbeing, and safety of research participants. Second, the recommendations are designed to promote excellent quality research and, on the flip side, to prevent less good practice.”
The framework makes the interests of study participants key to how research should be conducted, stating: “The rights, safety and well-being of participants must be the primary consideration in any research study.”
The draft framework (Research Governance Framework for Health and Social Care) is now being circulated for consultation and is available at www.doh.gov.uk/research/whatsnew.htm
The governance framework's recommendations
Ethics
The rights, safety, and wellbeing of participants must be the primary consideration in any research study
All research involving patients, users, and carers or volunteers, or their data or material, must be reviewed independently to ensure it meets ethical standards
Patients' data must be protected
Research should reflect the diversity of the population
Science
Research that duplicates other work unnecessarily or which is not of sufficient quality to contribute something useful to existing knowledge is unethical
All health and social care research should be subjected to rigorous review by recognised experts
Information
There should be free access to information on research and on its findings, once these have been subjected to appropriate scientific review
Researchers should aim to publish their work and open it to critical review in the scientific press
Studies involving direct contact with patients, users, and carers or the public should provide accessible accounts of the research
Health and safety
The safety of research participants and staff must be given priority at all times
Finance
Financial probity and compliance with the law and with the rules laid down by the Treasury for the use of public funds are as important in research as in any other area
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