Create operational decentralised Local Selection Panels in participating clinical centres

Task 51 Decentralised organisation for the coordinated management of data and biological resourcesSubtask 511 The main steps managed at the local level in clinical research programmes include obtaining clearance from local ethics committees and local regulators enrolling patients and collecting then managing both biological samples and clinicalepidemiological information from enrolees Accordingly optimising local resources implies a convergence between biological resources and clinical data repositories that should be managed backtobackWe propose to implement a decentralised organisation for the management of data and biological resources that will take advantage of some of the concepts tools and processes previously developed for EVA and will adapt them to the specific case of sharing data and biological resources We will generate a catalogue of biological resources and categorised data see next section as a part of an integrated process aiming at promoting sharing of data and biological resources This will allow sustainably associating biobanking and clinical information Requests for accessing data andor biological material will be received via the internet portal and examined by a selection panel including representatives of local stakeholders of the research programme concerned and of the overarching cataloguing organisation The selection panel will also include scientists who can assess the scientific and statistical soundness of requests The composition of the local component of this selection committee will be pragmatically adapted to the local situation to include representatives of the relevant stakeholders such as biobanks clinical researchers and possibly the local ethics committee The role of the panel is to examine the application and either make a direct decision or if necessary provide recommendations or further requests to decision makers eg the scientific committee of the biobank or the local ethics committee if concerned A standardised process and the presence of representatives of local decision makers should expedite this process The selection panel will review research proposals in a timely fashion using established criteria and will maintain a publicly accessible list of ongoing research projects that includes their submission revision and approval dates to ensure accountability to both cohort studies and the larger scientific communityCriteria examined will include the academic or commercial nature of the demand its scientific relevance and degree of priority for using the available resources the categories of data that would be relevantly and safely transmitted to the applicant the regulatory and ethical considerations related to material transfer the respect of reciprocity in data sharing etc In the case additional biological analyses would be requested the panel will also examine which analyses could be performed locally and funded by the applicant or would require transfer of the samples with respect of the Nagoya protocol It will also examine how new data generated by the applicant could be produced in a standardised format and further enrich the local database A document signed by the legal representatives of both parties should govern the process clarify duties and protect rights and ownershipSubtask 512 includes creating implementing and improving the complete procedures and reference documents and creating Local Selection Panel LSP for the sites included in the study It also implies promoting intersite standardisation whilst taking into account the specificity of each local contextSubtask 513 Legal aspects of harmonized biobanking and exchange of biological materialPolicies and Acts that guide biobanking and information sharing are rapidly evolving and represent significant constraints for both originators and applicants sharing data and biological material It is important to provide to the projects partners a safe