Compliance with the regulations | Research Governance

Research Governance

What is Research Governance?

The Department of Health published 'A Framework for Research Governance in Health and Social Care' in 2001. A second edition was published in 2005.

Download Research Governance Framework for Health and Social Care, Second edition, 2005.

The Framework was published in response to the Alder Hey and Bristol inquiries where failure to obtain consent for use of children's organs in research was a major issue. Protecting the rights of all research participants is therefore a strong theme of the Framework. However, it is also designed to ensure that researchers undertake well designed, ethical research which can reliably be used to influence practice and is of high quality.

Who does Research Governance apply to?

Research Governance affects all NHS staff and patients. Anyone connected with research which involves NHS patients, samples, information, facilities, staff or services is covered by the Framework. This includes staff with full or honorary NHS contracts, students and part-time staff or those on short term attachments.

All Clinicians

You don't actually need to be doing research yourself to be bound by the standards of the Framework. If you are asked by a researcher whether they can utilise your patients, their samples or records in a study, you are responsible for making sure that the project is compliant. This would include making sure it has ethical approval, checking consent procedures and ensuring that the patients' data is handled and processed under the Data Protection Act 1998. If you have any queries please ask the Joint Research Office for advice.

Managers

If you have managerial responsibility for individuals or teams within a specialty, ward or department you are responsible for managing their practice in service AND research. You should therefore understand what the standards of the Framework are and ensure that these are reflected in clinical supervision, appraisal and personal development planning.

Those leading research

Anyone initiating and leading a research project is responsible for ensuring that the research is compliant. This includes explaining the requirements to others working on the project and checking that they understand what is required of them.

Those supporting projects

If you are not leading a research project but are involved in helping in its day to day running (e.g. processing samples, preparing and dispensing medication, enrolling patients) you should make sure you are aware of the relevant Research Governance requirements.

The Research Governance standards

The standards cover five main themes, each with a number of standards. In summary these are:

1. Ethical Conduct of Research
The dignity, rights, safety and well-being of research subjects are paramount. All research should receive independent ethical review and approval from a recognised ethics committee prior to commencing. Informed consent is at the heart of ethical research, particularly when it involves children or incapacitated/vulnerable adults. More information about getting ethical approval>>

2. Scientific Quality
All NHS research should be of high quality. A systematic review or comprehensive literature review should be undertaken prior to the research commencing to avoid duplication of similar research, which in itself would be unethical. The Framework states that all research should receive an independent expert review (peer review) prior to commencing. More information about the peer review system>>

3. Information
Data collected for research purposes should be handled in accordance with the Data Protection Act (1998) relating to patient confidentiality and the protection of personal data. Sensitive or personal data should be protected and stored securely. The public should have free access to information on research being carried out within the organisation and details of the findings and recommendations should be presented in a format the public can understand. More information about the Data Protection Act 1998>>

4. Health, Safety and Employment
The health and safety of research staff and participants should be given priority at all times and be actively incorporated into the research process. Organisations should regularly conduct risk assessments on research projects to identify any potential problem areas and put measures in place to manage the risk. All staff involved with the research must be trained, educated and possess the appropriate knowledge to carry out their roles. Staff without an employment contract, such as University employed staff should ensure they have in place a Letter of Access or Honorary Contract with each NHS Trust they are carrying out research in. If your research involves contact with NHS patients please CLICK HERE for information on arranging for appropraite access.

5. Finance
Clear processes for financial probity should be in place. All projects receiving external funding should ensure they are compliant with the requirements of H.M. Treasury rules for the use of public funds. Compensation processes must be in place to cover negligent and, where applicable, non-negligent harm. Consideration must be given to the appropriate exploitation of Intellectual Property.

A Quality Research Culture

The Research Governance Framework states that a quality research culture is essential to the conduct of health and social care research. It defines a quality research culture as one having:

Respect for research participants' dignity, rights, safety and well-being
Valuing the diversity within society
Personal and scientific integrity
Leadership
Honesty
Accountability
Openness
Clear and supportive management
Written procedures and staff training

These points should be considered at all levels of the organisation to promote best practice and competence.

What do I need to do to ensure I am compliant?

The Joint Research Management Office has produced a leaflet to provide further guidance in the principles of Research Governance and how to make sure you are compliant.

Download Research governance leaflet.

For more information about getting Trust approval under the Research Governance Framework for your research project, visit these pages>>