Materials to support discussion process and mutual learning elements in moving away from the deficit model of communication.
A guide that serves as input for six to eight homogeneous discussion groups in different social groups and professional communities (e.g. patients, senior citizen centres, youth organisations, ethnic groups, etc.) in order to collect their opinions, expectations, ideas, concerns, and needs for further information or education.
A series of freeform and structured interviews with relevant patients, patient relatives and patient representatives, the results of which will inform a survey (to gather further input, and seek views on proposed solutions) targeting the same classes of stakeholders plus consortia and networks of clinical diagnosticians, ethicists, and policymakers. This survey will be the basis for genuine patient involvement in developing control mechanisms over personal genome data. The survey will result in a set of recommendations to be implemented by the various patient organisations and hospitals.
The point of reference for all communication and implementation activities will be the GCOF portal (http://www.geneticsclinicofthefuture.org/), which we will set up as a virtual genetics clinic including all its elements and sections. At the portal we will collect all illustrations, text, data, documents and other materials that support the partners in the consortium in disseminating and communicating the elements of the GCOF.
A collection of examples of current consent practices encountered throughout the different disciplines represented – online, and through internal and external partners’ networks, and an exploration of how clinical and research consent practices overlap and diverge.
The report reflects on the 3 main activities of WP2: 1. Background research and expert interviews on existing and developing models for data access in health research, but also in less obvious areas like finance and social media; 2. A multidisciplinary European workshop on ‘novel approaches to data access’, of which outcomes and recommendations will be published; 3. Development of data access scenarios (e.g. access for patients, access for insurance companies) to be put to the test in the simulation project of Task 1.2.
Based on the results of that survey and together with a multistakeholder group, we will compose a white paper that evaluates the possible benefit/harm of different types of results to the study subjects, plan generic ways of giving such results supported with information available on biobank website and draft a role for GCOFs for a more individual approach to returning the results.
A report in Month 15 that describes the progress in the project.
A report on how the tension arising from conflicting principles of informed consent and respecting the individual’s right not to know can be tackled, and on the value of having a clear and flexible approach to consent.
A report on mutual learning and debate models for societal implementation of future concepts. Both the ambassadors and the other experts shall use the available materials to disseminate the results among their peers and through their networks.
A evaluation report on the various GCOF scenarios that will be effectuated based on simulated genomic data of 5-10 individuals.
Evaluation of the two main models for data collection that are being examined: 1. data collection by patients/families using existing tools and those under development, e.g. web-based tools where patients/families can themselves fill in data . 2. collecting data from hospital files to specific registries either ‘conventionally’ by clinicians and researchers or with methods based on electronic, structured health records which enable automated collection of the data.
Document on the exploration of relevant policy issues for data sharing emerged in the context of rare disease registries via background research, based on relevant European initiatives (e.g. BBMRI, GEN2PHEN, PACITA), input from the other WPs and participation of WP6 members in activities in the other WPs, predominantly WP2 and WP4. We will generate a list of policy issues that will serve as an initial framework to guide the other activities in WP6.
A summary report of Task 6.2, describing: - a framework to standardize and automate data extraction (in terms of collecting, storing and distributing data) for policy making around the GCOF; to enable efficient and cost-effective research in the field of genetics it is essential to link patient registries in hospitals and to automate data extraction. standardized methods in research around health economic aspects of the GCOF; to enable more efficient decision-making. Which data should be collected, what are the outcome measures, what is the link between better diagnostics and treatment are essential questions to be answered. how the economic, societal and political value for genomic data can be assessed (e.g. for reimbursement of care, or trading genomic data); one of the questions to be answered by many of the stakeholders is whether a genetic test has added value (e.g. for economy, for the clinic, or for society as a whole). These outcomes should be the result of extensive discussions with researchers in the clinic who have set up the research questions for innovative approaches.
We will generate simulated whole exome or whole genome sequencing data from 5-10 individuals, each with specific mutations and other variants that evoke challenging scenarios in the GCOF. We will introduce both known mutations (e.g. BRCA1) and hypothetical ones (e.g. a ‘happiness’ variant) in these data. The hypothetical variants are not necessarily expected to be identified in future genetic research; they rather reflect controversial topics that could be appearing from general health-related research, and that could evoke fundamental societal challenges. The data will be stored on a central server (Cartagenia, biologis) and made available for all stakeholders in the project in a controlled and condensed way.