Research Governance refers to a governance of research that utilises the principles of high quality ethical research in health and social care. It is the key to ensuring research is conducted legally to high methodological and ethical standards. It applies to any research on “normal volunteers” carried out in settings for which the Secretary of State for Health and Social Care has ultimate responsibility. Thus, anyone connected with research that involves the NHS is covered by the Framework in some way.
The Department of Health’s A Framework for Research Governance in Health and Social Care, published in March 2001, gives guidance on good practice in the collaboration between researchers, health and social care teams and their employers and funders. A second edition of the framework published in April 2005 takes account of changes since 2001, including the Medicines for Human Use (Clinical Trials) Regulations 2004, the Human Tissue Act 2004 and the Mental Capacity Act 2005. The Research Governance Framework sets standards for the research process and formalises the responsibilities of all those involved.
The Framework was published in response to the Alder Hey and
The standards cover five main themes; in summary these are:
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.
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.
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.
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 apply for an Honorary Contract with the Trust they are carrying out research in.
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.
Although the NHS has a responsibility for assuring the quality of all work undertaken within the service, not all innovative work should be defined and managed as research. The increasing amount of evaluation, practice development, audit and research within the NHS has resulted in a number of grey areas where it is not easy to distinguish research from other forms of innovative work.