This report is Deliverable 5.1 of the Social Sciences and Humanities Open Cloud (SSHOC) project, and a result of Task 1 focusing on the legal, ethical, and technological issues of access to biomedical data. The aim of the task is to make biomedical data available to the research community via data access that follows the FAIR principles.
Measuring health and its associations with indicators of socio-economic status are important objectives for population-based (social) surveys. While self-reported health measures carry important information, they need to be supplemented by objective health measures to distinguish, as much as possible, the objective health status from the respondent's subjective perception of this status. Two salient examples may illustrate this point. Data derived from dried blood spot samples allow a better evaluation of the risk of cardiovascular diseases and cognitive decline than self-reports. Objective physical activity data collected through accelerometers allow capturing vital determinants for old age mobility and health such as activity levels, sleep patterns and sedentary behaviour better than a self-report of daily activities that may be wishfully biased.
In connection with this development and in particular in relation to the question of how these new data can be made accessible to researchers, questions related to ethics considerations and the FAIR Guiding Principles for scientific data management and stewardship (FAIR) had to be addressed. This deliverable therefore provides general guidelines for ethics considerations in making such objective health dataFAIR, based on the experiences made in Wave 6 of the Survey of Health, Ageing and Retirement in Europe (SHARE) when the collection of objective health data alongside regular survey data in the form of dried blood samples was introduced. This development was continued in SHARE Wave 8 with the introduction of accelerometer data.
This deliverable first addresses ethical considerations. For instance, the principle to not harm survey participants needs an extension when collecting biomarker data in surveys – this means that avoiding harm besides avoiding violation of confidentiality and resultant consequences needs to include avoidance of physical harm such as temporary discomfort or pain. Similarly, the concepts of informed consent and protection of anonymity and confidentiality demand an adequate adaption to suit the collection of objective health data in survey settings. To ensure the appropriateness of the practical implementation of the ethics standards and principles as well as data protection measures within a research project a review by a competent ethics committee can be helpful (and therefore is recommended) in many cases when collecting objective health data in the context of a survey – and in some cases, such as the inclusion of a blood sample collection, is legally required by law (in many countries).
Moreover, this deliverable explains the general requirements and considerations of the FAIR principles, according to which all research data needs to be "Findable, Accessible, Interoperable, Re-usable". In this connection the compliance of SHARE data, including the biomarker and accelerometer data, with the FAIR principles is examined and clarified in an exemplary manner.
Findability is ensured through all data being permanently identifiable and locatable through DOIs (Digital Object Identifiers) and registration in a repository that also contains metadata, a collection of bibliographical and content information, referring to the registered dataset. Access to SHARE data is provided free of charge to the scientific community after registration in accordance with clearly defined Conditions of Use. Furthermore, access to the data is subject European Union as well as national data protection provisions. The evaluation of special requirements regarding access to sensitive health data has been taken into consideration. The interdisciplinary interoperability of SHARE data is ensured by its availability for a variety of statistical software and its comprehensive documentation. Re-usability is ensured through several measures such as archiving of the SHARE data with a detailed documentation of the (meta)data, the publication of data quality assurance processes or the provision of generated modules and datasets.
In summary, this deliverable provides guidelines for making biomedical survey data satisfy recognised ethical standards, as well as ensuring such data are FAIR, in particular, by using SHARE and its new objective health data as an example.