What regulatory systems do not do

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  • Format Audio, Texts
  • Language/s English
  • Target Audience Self-directed learning
  • Duration <5 mins
  • Difficulty Introductory

Key Concepts addressed


Although regulatory systems for research impose onerous requirements on researchers before studies start, there are many things they conspicuously fail to do, or do not do well.

[thumb]Many systems do not do enough to ensure that proposed studies are actually needed – for example, they do not require researchers to demonstrate that they have undertaken a thorough review of the existing evidence before embarking on new studies.

Moreover, most of the effort in regulating research is at the start-up stage, with the emphasis on controlling the entry of participants to studies. But there is surprisingly little effort devoted to monitoring studies once they are running, and to ensuring that researchers publish reports promptly at the end of their work (or even at all), stating how their findings have reduced uncertainty.

People who are invited to participate in research on the effects of treatments need to have confidence that the studies are worthwhile, and that their contributions will be useful. Regulatory systems need to do more to reassure them on both counts and dismantle needless barriers to good research directed towards research questions that matter to patients.

There is a growing realization that testing treatments is everybody’s business. As patients and the public take up the opportunities now being offered to become involved in planning and conducting research, they are likely to have an increasing voice in ensuring that regulatory obstacles are addressed.

Review of the Key points

  • Regulation of [getit]research[/getit] is unnecessarily complex
  • Current systems of research regulation discourage [getit term=”fair comparisons of treatments”]fair tests of treatments[/getit] that would make for better healthcare
  • Despite the onerous regulatory requirements placed on researchers, regulatory systems do little to ensure that proposed studies are genuinely needed
  • Research regulation does little to monitor and followup approved research

More: References (Section 9)

Next Chapter: Research – good, bad and unnecessary


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Ichalmers 10:09am Mon 20 Feb 2012

see Chapter 8

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