Sariyar Murat, Schluender Irene, Smee Carol, Suhr Stephanie
1 Institute of Pathology, Charite-University Medicine Berlin , Berlin, Germany .
2 TMF-Technologie und Methodenplattform e. V. , Berlin, Germany .
Biopreserv Biobank. 2015 Aug;13(4):263-70. doi: 10.1089/bio.2015.0014. Epub 2015 Jul 17.
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.
数据和生物样本的可获取性及获取途径在医学和转化研究中至关重要，更广泛的研究群体对其进行再利用和重新定位能够最大化其价值并加速发现进程。然而，由于伦理、法律和社会敏感性问题，共享与人类相关的数据或样本变得复杂起来。生命科学研究人员往往不熟悉与敏感数据相关的具体伦理和法律要求，面对大量复杂、零散甚至相互矛盾的信息，他们可能觉得自己没有能力应对。在这种情况下，为防止无意的滥用，人们可能会冲动地选择不共享数据。因此，帮助数据提供者识别相关伦理和法律要求以及如何应对这些要求，是消除生命科学数据和样本共享可能存在的障碍中必不可少且常被忽视的一步。在此，我们描述了复杂的监管背景，并讨论了相关在线工具——其中一个是作者共同开发的——旨在帮助敏感数据或生物样本提供者解决伦理和法律问题。主要结果包括：（1）这些工具的不同方法假定了不同的用户需求以及对伦理和法律要求的先验知识，这影响了服务的设计方式及其有用性；（2）工具提供者之间有很大的合作潜力；（3）丰富服务注释（如更新状态、信息完整性和免责声明）将增加其价值并便于用户快速评估。此外，在为使用敏感数据或样本的研究人员提供真正“有用”的工具方面仍有工作要做，这些工具不需要对法律和伦理要求有预先的深入了解，也不需要花费时间钻研细节。最终，可能需要由熟悉各自研究领域的专家维护单独的资源，而从长远来看，实现协调统一并提高易用性将是非常可取的。
