How has Research Governance Developed?
Research Governance has been shaped and influenced in response to a number of different factors over the past century such as:
- Mistakes and/or problems with medicinal products have increased the need for product regulation;
- Abuse of human rights have increased the need for tighter ethical controls;
- Divergence of regulations and guidance in different countries has resulted in duplication of research, which raises concerns about:
- the cost of research
- the ethical implications of repeating studies
- the need to rationalise and harmonise research governance requirements
The timeline below summarises the main developments in clinical research governance over the past 80 years:
- Elixir of suphanilamide disaster in the USA - an improperly prepared medicine resulted in mass poisoning which led to the establishment of a product authorisation system in the USA.
- World War II and the Nuremburg Trials - the Nuremburg Code a set of research ethics principles for human experimentation, were established as a result of the subsequent Nuremburg Trials at the end of WWII.
- Thalidomide Birth Defect Crisis - this resulted in worldwide legislative changes to ensure stricter testing of medicinal products prior to licensing.
- Declaration of Helsinki
- Medicines Act (UK)
- Tuskegee Syphilis Experiment - the exposure of the 40 year US public health study of the progression of syphilis infection led to change in the law governing the protection of research participants.
- World Health Organisation Conference of Drug Regulatory Authorities - this led to the production of action plans for regulations of medicinal research.
- International Conference on Harmonisation - the first ICH meeting was held between EU, Japan and USA regulatory authorities in order to harmonise practices.
- ICH Guideline on Good Clinical Practice
- EU Directive on Clinical Trials (2001/20/EC)
- Research Governance Framework for Health & Social Care (UK)
- Medicines for Human Use (Clinical Trials) Regulations (UK)
- Human Tissues Act (UK)