Year: 2000
Type: article
Abstract: Investigating allegations of research misconduct Worst outcome of Griffiths report would be that research becomes increasingly difficultEditor-The Griffiths report contained a critique of two specific research projects and proposals on the regulation of research generally.Hey and Chalmers express no view on these proposals.1 However, the accompanying editorial by Smith agrees with the report's main recommendations on the need for better research governance in the NHS without citing supporting evidence.The Griffiths report made three main recommendations which could inhibit clinical research.Firstly, concern about consent for research at times of stress.Most intensive care research requires consent at times of stress and if the researchers waited this research would be impossible.The financial cost of the suggested consent from a third party would inhibit research.Secondly, the inquiry stated that brain damage could not be reliably assessed at a short period of follow up and was critical that follow up was determined by the amount of funding available.To place a requirement that all research in children involves long term follow up studies would abolish much research.The resources required are not addressed.Thirdly, trusts should ensure that arrangements are in place for active monitoring of the progress of research.There is no indication that new funding will be available for this.Furthermore, "research involving vulnerable groups should be subject to an even greater degree of independent supervision than clinical research in general."Not for the first time will there be the paradox of well-meaning discrimination against children.This has been the case for trials of new drugs, in which the perceived obstacles deter research in children. 2 The Department of Health's draft research governance "to protect participants, improve quality and stop research fraud" gives no evidence of the magnitude of these problems and does not discuss the resource implications of implementation.3 "There are already powerful incentives to adhere to many of the principles" in the framework, including the law, duty of care, and high professional standards of researchers.No evidence is quoted to assess how often these safeguards fail.Unreferenced "recent enquiries into adverse incidents relating to research" are inadequate justification.Patients must be protected from inappropriate research, and informed consent must be obtained.However, extrapolating from the Griffiths report to clinical research throughout the United Kingdom must be thought through.Currently, 40% of drugs prescribed for children are not licensed, 4 partly because of the existing deterrents to research in children.More hurdles are likely to inhibit research further, 5 and ultimately it is children particularly who will suffer.
Source: BMJ
Authors: T. Stephenson, C. Henshall, D. Henshall, A. Wilkinson, J. Rennie, T. Wright, K. Lucking, D. Hall, P. Mellor, B. Morgan, E. Hey, E. Hey, I. Chalmers
Language: English
Subfield: Safety Research
Field: Social Sciences
Domain: Social Sciences
Open Access status: hybrid
OpenAlex ID: W148142062