Abstract
Availability of and access to data and biosamples are essential in medical and translational research, where their reuse and repurposing by the wider research community can maximize their value and accelerate discovery. However, sharing human-related data or samples is complicated by ethical, legal, and social sensitivities. The specific ethical and legal requirements linked to sensitive data are often unfamiliar to life science researchers who, faced with vast amounts of complex, fragmented, and sometimes even contradictory information, may not feel competent to navigate through it. In this case, the impulse may be not to share the data in order to safeguard against unintentional misuse. Consequently, helping data providers to identify relevant ethical and legal requirements and how they might address them is an essential and frequently neglected step in removing possible hurdles to data and sample sharing in the life sciences. Here, we describe the complex regulatory context and discuss relevant online tools—one which the authors co-developed—targeted at assisting providers of sensitive data or biosamples with ethical and legal questions. The main results are (1) that the different approaches of the tools assume different user needs and prior knowledge of ethical and legal requirements, affecting how a service is designed and its usefulness, (2) that there is much potential for collaboration between tool providers, and (3) that enriched annotations of services (e.g., update status, completeness of information, and disclaimers) would increase their value and facilitate quick assessment by users. Further, there is still work to do with respect to providing researchers using sensitive data or samples with truly ‘useful’ tools that do not require pre-existing, in-depth knowledge of legal and ethical requirements or time to delve into the details. Ultimately, separate resources, maintained by experts familiar with the respective fields of research, may be needed while—in the longer term—harmonization and increase in ease of use will be very desirable.
Highlights
Efforts to make data and/or samples available and accessible so that they may be reused and repurposed in different contexts by the wider research community are gaining momentum
It is reasonable to suppose that biomedical researchers cannot be expected to have detailed knowledge about all ethical and legal requirements concerning the use of sensitive data and samples in research
Tools that aim at assisting the sharing of sensitive data and samples can make researchers aware of their responsibilities and legal requirements in a way that is intuitive and actionable for them
Summary
Efforts to make data and/or samples available and accessible so that they may be reused and repurposed in different contexts by the wider research community are gaining momentum. There are other text-based resources available online, an example being the guide for ‘‘Publishing and sharing sensitive data’’ by the Australian National Data Service.[40] This tool was co-developed by authors of this article(MS, IS) within the EU FP7-funded BioMedBridges project (http:// www.biomedbridges.eu/workpackages/wp[5]). Under the IPAC umbrella, P3G offers the Generic Clauses/Agreements Database (http://www.p3g.org/resources/ipac), which is a free online open access database of generic clauses and template agreements to assist researchers in developing policy and contractual documents to facilitate data sharing both prospectively and retrospectively It provides a unique searchable database containing organized examples of generic clauses to include in consent or policy documents. The tools are characterized by the material covered (biosamples or data), the guidance specificity (how and on which basis the user is guided), the tool user the tool is aiming at, whether templates are provided,
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