Research governance requirements in relation to investigational medicinal products have evolved in response to a number of different factors: 

  1. Mistakes or problems with medicinal products historically have increased the need for product regulation 
  2. Abuse of humans rights and incidences of fraud have increased the need for tighter ethical controls (e.g. Tuskegee Syphilis Study)
  3. 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.