Leading advice on research governance issues
Research governance is one of the core standards all organisations should achieve in delivering NHS care. Funders, sponsors and investigators have duties to undertake research work which complies with both statutory and ethical requirements. The organisations providing the care must ensure that these duties are met and the research work undertaken is regulated in the appropriate fashion. The Research Governance Framework for Health and Social Care provided by the Department of Health in September 2008 sets out the broad principles of good research governance and we have assisted NHS trusts in its interpretation.
Key services and issues
- The Health and Social Care (Community, Health and Standards) Act 2003 Section 45 and the impact of research on the duty of quality
- The Human Tissue Act 2004
- The Mental Capacity Act 2005 and its safeguards for participants who lack capacity to consent to research
- Medicines for Human Use (clinical trials) Regulations 2004: the ethical approval and responsibilities of sponsors
- Advice on adverse incidents and reporting to the NPSA
Doctors in private practice and private healthcare operators are often innovators, developing software, equipment and treatments, and building a ‘brand.’ Using these more widely, both in British healthcare and further afield, could bring benefits to patients - and private practitioners are often keen to help this happen. However, they need to consider what happens to their intellectual property in their innovations. IP is a valuable asset – as is being increasingly realised by the NHS – and needs protecting.