Over-regulation of clinical research: a threat to public health

Warlow, Charles

doi:10.7861/clinmedicine.5-1-33

Cited by 36 publications

(26 citation statements)

References 29 publications

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“…Overregulation and excessively burdensome requirements of R&D committees using different formats from ethics committees, together with almost unanswerable questions on costs, have discouraged enthusiastic clinicians. 5 In addition, the requirements of research councils and medical schools to form large research groupings to permit clinical research or obtain research grants are often inimical to the innovative and inquiring spirit of individual NHS clinicians.…”

Section: Obstructions To Nhs Researchmentioning

confidence: 99%

Chasing ideas: clinical research in the NHS

Watkins¹

2005

Clinical Medicine

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Section: Obstructions To Nhs Researchmentioning

confidence: 99%

Chasing ideas: clinical research in the NHS

Watkins¹

2005

Clinical Medicine

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“…In others, such as the United Kingdom and New Zealand, there is no formal legal requirement to seek ethical approval for university-based research unless it is medical research or research in an area that is covered by legislation (human tissue and research involving people lacking the mental capacity to consent). A relatively complete listing of legislation governing research can be found in Office for Human Research Protection (OHRP) (2009). this apparent overregulation of research (see, for example, Warlow 2005;Stewart et al 2008;Sullivan 2008;Dyer and Demeritt 2008).…”

mentioning

confidence: 94%

Research Exceptionalism

Wilson

Hunter

2010

The American Journal of Bioethics

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Research involving human subjects is much more stringently regulated than many other nonresearch activities that appear to be at least as risky. A number of prominent figures now argue that research is overregulated. We argue that the reasons typically offered to justify the present system of research regulation fail to show that research should be subject to more stringent regulation than other equally risky activities. However, there are three often overlooked reasons for thinking that research should be treated as a special case. First, research typically involves the imposition of risk on people who do not benefit from this risk imposition. Second, research depends on public trust. Third, the complexity of the moral decision making required favors ethics committees as a regulative solution for research.

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“…This trend has been characterised by Charles Warlow as 'a threat to public health' . 14 Those who have promoted recent trends in regulation appear not to have considered the responsibilities of clinicians faced with uncertainties about the effects of treatments. The situation has never been more succinctly summarised than by the paediatrician Richard Smithells, who declared 30 years ago: 'I need permission to give a drug to half of my patients, but not to give it to them all' .…”

Section: Confronting Therapeutic Uncertainties Through Research Withimentioning

confidence: 99%

Is the NHS willing to help clinicians and patients reduce uncertainties about the effects of treatments?

2005

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-Uncertainty is an inevitable component of clinical practice. Clinicians have a responsibility to minimise it by keeping up-to-date with current knowledge: but what is the responsibility of individual clinicians in reducing collective uncertainty? In all fields of medicine there are important questions relevant to both patients and clinicians, which can be answered only by clinical research. Unfortunately, much of the clinical research that attracts funding does not address the questions that both patients and clinicians regard as important. Furthermore, although the NHS has a proud record of innovation and clinical research, recent changes are jeopardising the ability and willingness of NHS clinicians to continue undertaking such work. A combination of increased bureaucracy in obtaining research ethics and local research and development (R&D) governance approval and the pressures on management to deliver service targets threaten to strangle research by NHS clinicians. Policy makers argue for informed patient choice, modernisation and improved quality. It is not in the interest of patients when research designed to address important therapeutic uncertainties is seen as an optional extra, rather than an intrinsic element of a health service interested in improving quality. The NHS needs to listen to its users, ie the patients, and to its clinical staff, and to encourage them to engage in research to help reduce those uncertainties. KEY WORDS: health policy, NHS clinical research, patient involvement, psoriasis, uncertaintyThe importance of addressing uncertainties about the effects of treatments Clinicians and patients have to deal with several kinds of uncertainties when selecting treatments from among alternatives. Sometimes they are uncertain because they are unaware of the strength of existing evidence from research, as was the case for many years with thrombolysis in acute myocardial infarction. 1 Even if clinicians and patients are aware of relevant evidence, however, there will almost always be residual uncertainty about whether a treatment known to be helpful on average will help an individual patient: a patient's sensitivity to aspirin, for example, may preclude use of the drug to reduce the risk of cardiovascular disease.Sometimes, a search for reliable evidence about the relative merits of different treatment options will make clear that no such evidence exists -a situation of 'certain uncertainty' . Choices among treatment options in these circumstances may sometimes be driven by strong patient preferences, for example, to avoid surgery. But what are the responsibilities of clinicians when patients have no strong preferences and little or nothing is known about the relative merits and disadvantages of different treatment options? 2 Clinical practice would become impossible if clinicians tried to deal with all such 'informed uncertainties' , and often little harm to patients will result from not doing so. However, acquiescence in 'informed uncertainty' sometimes results in avoidable suffering ...

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Over-regulation of clinical research: a threat to public health

Cited by 36 publications

References 29 publications

Chasing ideas: clinical research in the NHS

Chasing ideas: clinical research in the NHS

Research Exceptionalism

Is the NHS willing to help clinicians and patients reduce uncertainties about the effects of treatments?

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