There has been a welter of recent legislation that has had an impact on the industrial landscape and the research carried out in the nutrition sector. As well as EU Directives on ‘Traditional Herbal Medicines’ and ‘Food Supplement Products’ the ‘Health Claims Directive’ has formalised the requirement to substantiate all but the most generic product claims with properly conducted research. On top of this the EU Directive on Clinical Trials has added a stringent level of controls to any investigation that is ‘medicinal’ in nature. Naturally our research projects are conceived and designed with this regulatory framework in mind.
Research carried out in the Centre conforms to the high standards expected of controlled and clinical trials. Adherence to the provisions of Good Clinical Practice (GCP), Good Research Practice (GRP) and Good Laboratory Practice (GLP) ensure that all projects are fully auditable, and we have experience of working with external auditors and Contract Research Organisations.
Although we receive funding from Research Councils and other grant awarding bodies, and run autonomous PhD programmes that investigate purely academic questions, the driver for a proportion of the research that we undertake is the increased needs of the manufacturing/retailing sector to provide scientifically valid evidence for the efficacy of their foodstuffs and supplements. It is essential that any research project carried out in this area is carefully designed and includes the appropriate cognitive and mood measures (and physiological or biomarker outcomes), to address the specific research question and satisfy the regulatory authorities. Our research in this area is designed with this end-point in mind and is conducted to the highest standards. The adoption of GCP standards in the design, conduct, performance, monitoring, auditing, recording, analysis and reporting of controlled trials provides assurance that the data and reported results are credible and accurate and that the rights, integrity and confidentiality of trial subjects are protected.
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Brain, Performance and Nutrition Research Centre
Faculty of Health and Life Sciences
4th Floor, Northumberland Building
Newcastle upon Tyne