Research standards
QUALITY CRITERIA
We have mapped, through a comprehensive survey and intensive desk research, applicable quality and safety relevant international and national laws, policies, international and European standards, guidelines as well as scientific recommendations and best practices for biospecimen handling to improve and facilitate these procedures across ISIDORe partners.
International Laws
To facilitate a mutual understanding between all services provided by ISIDORe partners an overview of applicable international laws and regulations for infectious disease research services was compiled. These include safety regulations, regulations for the transport of biospecimens, regulations on the handling of genetically modified organisms (GMOs), animal welfare, data protection regulations, ethics, the conduct of clinical trials and the handling of medical products.
NATIONAL LAWS
National laws for handling (potentially) infectious materials serve multiple purposes. They are primarily aimed at protecting public health and preventing the spread of infectious diseases. ISIDORe partners providing infectious disease research services must ensure that they comply with all relevant legal requirements (permits and agreements). In addition to the relevance for the service providers the overview of national laws and regulations enables users of ISIDORe services to identify applicable requirements and to ensure that they are acting in accordance with the respective laws in each country.
Overview of relevant ISIDORe Work packages and the required and/or provided biospecimens for offered services
To leverage the full potential of the ISIDORe consortium and thus to realise more ambitious and impactful research projects in the field of infectious disease research, an interdisciplinary approach is necessary.
International Standards, best practices, guidelines and recommendations FOR BIOSPECIMENS
International standards, best practices, guidelines and scientific recommendations are of paramount importance for ISIDORe partners, which provide services and biospecimens for infectious disease research. Adherence to these international standards increases the comparability and consistency of research data and results and enables more effective collaboration among scientists from different countries and institutions.
These standards serve to maintain high-quality research standards, from provision of reference samples, collection and processing of biospecimens to data analysis and reporting. This improves the reliability of data and the reproducibility of biomedical research. Similarly, compliance with these standards is critical to protecting the rights and welfare of participants (and/or animals), better navigating the various regulatory environments, streamlining approval processes, and thereby maintaining the trust of the public and regulators.
International Standards, best practices, guidelines and recommendations FOR infectious disease RESEARCH services
In this section an overview of all infectious disease research services offered by ISIDORe service partners, a general overview of relevant international standards and scientific recommendations as well as specific minimum requirements for each service provider to use their services is presented.