Pathologists Find Research Rules Too Complex

Ninety two per cent of pathologists feel that the regulations controlling their work using human tissues is too complicated and a lack of useful guidance puts them off carrying out this research, according to a report published by the national cancer biobanking group onCore UK .

This lack of guidance means that 60 percent of pathologists find research using human tissues difficult while 13 per cent are deterred from this type of research completely, as the regulatory environment is seen as strict.

The survey, which was carried out in collaboration with the Pathological Society, questioned 242 pathologists and researchers who work in the NHS and universities. Pathology research is vital to understand how diseases like cancer develop and can lead to new strategies to tackling disease, but in the UK it has been on the decline for several years. One of the perceived barriers to pathology research is the complexity of regulation that researchers must follow.

Clear and appropriate guidance is needed to ensure that pathology research can prosper again, which most researchers do not currently believe exists. Only 17 per cent were certain where to find it and how to use this guidance while the majority, 58 per cent, felt that they need assistance finding it or it requires work to find it.

When they are able to find the guidance 70 per cent reported that the provision of guidance by different sources can be confusing, unhelpful or time wasting.

Dr Brian Clark, chief executive officer of onCore UK, said: “Our survey shows how the lack of coherent and clear guidance for researchers is deterring them from research with human tissues and biological samples. 83 per cent of respondents said that they would be more active in research if there was an easily accessible source of consolidated guidance endorsed by all regulators – that is extremely telling.

“In a strict regulatory and governance environment the antidote to encourage researchers should be provided through effective and clear guidance. This guidance should be readily accessible, from easily identified sources, be authoritative, trusted, and consistent to ease the path of research and not impede it.”

This report will support the work of the National Cancer Research Institute’s (NCRI) Task Force on Pathology and Research which is exploring why pathology research in the UK is on the decline. To better understand this and inform the work of the Task Force, onCore UK conducted this survey to gain evidence for why pathology is on the decline.

Guidance and support on some aspects of research are already provided by the Medical Research Council (MRC) through web based Tool Kits developed by its Regulatory Support Centre.

Dr Sarah Dickson, head of the MRC Regulatory Support Centre: “Pathology is fundamental to the advancement of medical science, and in response to this survey, the Centre will enhance the Data and Tissues Tool Kit, in partnership, to further assist pathologists with research. This will include the consolidation of consistent guidance, which is well publicised and freely available to all.”

Professor David Levison, chair of the NCRI Task Force on Pathology and Research, said: “The results of this survey, on perceptions of the regulatory environment governing the use of human tissues for research, will inform our work on the barriers that prevent pathologists engaging with research. We need to understand such constraints to be able to create an environment where translational research in the UK works effectively and efficiently”.

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