Charité - University Medicine Berlin, QUEST - Center for Transforming Biomedical Research, Berlin Institute of Health (BIH), Berlin, Germany.
Institute for History, Ethics and Philosophy of Medicine, Hannover Medical School (MHH), Hannover, Germany.
J Med Genet. 2019 Mar;56(3):176-185. doi: 10.1136/jmedgenet-2018-105617. Epub 2018 Nov 21.
Biobank research faces many ethical challenges. Ethics research aims to develop standards for governance to meet these challenges by elaborating overarching normative principles of medical ethics in the context of biobanking. Most ethical standards are widely agreed on among biobank stakeholders and entail specific governance solutions, for example, adoption of consent procedures. In order to fully meet its goal, every governance solution needs to be implemented, evaluated and, if necessary, adapted and improved in practice. This study reviews the scientific literature on biobank ethics and governance in order to identify studies that specifically focus on practice evaluation of biobank governance.
A PubMed search was carried out. Retrieved literature was categorised and thematically clustered. All studies that focus on practice evaluation were reviewed and their objectives, results, and recommendations for practice summarised.
The findings show that the majority of studies on biobank ethics and governance are theoretical; only 25 out of 922 studies empirically evaluate biobank governance in practice. The majority of these (14; 59%) focused on informed consent. Six studies (24%) addressed practice evaluation of sample and data access; the rest focused on public involvement, ethics reporting and incidental findings. Other relevant governance areas such as ethics review, priority setting and sample ownership were not addressed.
In order to fulfil the ethical goals, more empirical research is needed that provides information on how governance mechanisms perform in practice and what improvements are needed.
生物库研究面临许多伦理挑战。伦理研究旨在制定治理标准，通过在生物库背景下详细阐述医学伦理的总体规范性原则来应对这些挑战。大多数伦理标准在生物库利益相关者中得到广泛认可，并需要特定的治理解决方案，例如采用同意程序。为了充分实现其目标，每个治理解决方案都需要在实践中实施、评估，并在必要时进行调整和改进。本研究回顾了生物库伦理和治理方面的科学文献，以确定专门关注生物库治理实践评估的研究。
进行了 PubMed 搜索。检索到的文献进行了分类和主题聚类。回顾了所有专门关注实践评估的研究，总结了其目标、结果和实践建议。
研究结果表明，大多数关于生物库伦理和治理的研究都是理论性的；在 922 项研究中，只有 25 项从实践上评估了生物库治理。其中大多数（14 项；59%）侧重于知情同意。有 6 项研究（24%）涉及样本和数据访问的实践评估；其余的研究则侧重于公众参与、伦理报告和偶然发现。其他相关治理领域，如伦理审查、优先事项设置和样本所有权，没有得到解决。
为了实现伦理目标，需要更多的实证研究，提供有关治理机制在实践中的表现以及需要改进的信息。
