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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

Timeline

The timeline below summarises the main developments in clinical research governance over the past 80 years:

1930s

  • 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. 

1940s

  • 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. 

1950/60s

  • 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)

1970s

  • 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. 

1980s

  • World Health Organisation Conference of Drug Regulatory Authorities - this led to the production of action plans for regulations of medicinal research. 

1990s

  • 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

2000s Onwards:

  • 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)

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