Development of research governance
Research governance requirements in relation to investigational medicinal products have evolved in response to a number of different factors:
Mistakes or problems with medicinal products historically have increased the need for product regulation
Abuse of humans rights and incidences of fraud have increased the need for tighter ethical controls (e.g. Tuskegee Syphilis Study)
A divergence in regulations and guidance in different countries has caused duplication of research, raising concerns about the:
- cost of clinical trials
- ethical implications of repeating studies
- need to rationalise and harmonise research governance requirements
Please see the timeline which summarises the main developments in clinical trial research governance over the past 80 years, with a particular focus on standards of relevance to the UK.
Any regulatory or guidance system needs to be appropriate to the level of risk to participants and researchers (i.e. research involving access to patients notes should require fewer constraints than research involving the administration of a new drug).
There have been concerns about the level of regulation of research into human health. As a consequence, research governance is likely to continue to be the focus of considerable debate.
UK Policy Framework For Health and Social Care Research
The UK Policy Framework for Health and Social Care Research outlines the principles of good governance for all research within the remit of the Secretary of State for Health.
This includes clinical and non-clinical research that is:
- concerned with the protection and promotion of public health
- undertaken by or taking place within the Department of Health; it's non-departmental Public Bodies and the NHS
- undertaken by or taking place within social care agencies
If you are involved in research in this area you must be aware of and comply with the framework.
The Research Governance Framework (RGF) was first published in 2001 and re-issued in April 2005. The 2005 edition incorporates requirements of Clinical Trials Regulations that came into effect in 2004, the Human Tissue Act 2004 and the Mental Capacity Act 2005. The RGF has been replaced by UK Policy framework for Health and Social Care Research in 2017.
A number of different individuals and organisations are involved in health and social care research, including:
- Research workers
- Students and their supervisors
- Research Ethics Committees
- Research Councils
- Health and social care organisations and their employees
- Local authorities
- Pharmaceutical and other industries
Achieving quality health and social care research depends on co-operation between all these parties. It is also important for each party to follow the standards of good practice set out in the Principles of UK Policy Framework for Health and Social Care Research.