Biomedical research using human biological material and data is essential for improving human health, but it requires the active participation of many human volunteers in addition to the distribution of data. As a result, it has raised numerous vexing questions related to trust, privacy and consent. Trust is essential in biomedical research as it relates directly to the willingness of participants to continue participating in research. Privacy and the protection of personal information also influence trust. Informed consent has proven to be insufficient as it cannot overcome the informational deficit between primary and unknown future uses of material and data and is therefore not fully informed and invalid. Broad consent is also problematic as it takes full control of samples and data flow from the research participant and inherently requires that a participant must trust that the researcher will use their material or data in a manner that they would find acceptable. This paper attempts to offer some insight into how these related issues can be overcome. It introduces dynamic consent as a consent model in research involving human biological material and its associated data. Dynamic consent is explained, as well as its claims of superiority in instances where future research is possible. It is also shown how dynamic consent contributes to better control of the samples and data by the research participant, and how trust may be improved by using this consent model. Dynamic consent’s co-existence with and support of the South African Protection of Personal Information Act of 2013 is also assessed. The limitations of dynamic consent are also discussed.

中文翻译：

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在南非引入动态同意，以提高涉及人类生物材料和相关数据的研究中的信任和隐私

利用人类生物材料和数据进行的生物医学研究对于改善人类健康至关重要，但除了数据的分发之外，还需要许多人类志愿者的积极参与。因此，它引发了许多与信任、隐私和同意相关的棘手问题。信任在生物医学研究中至关重要，因为它直接关系到参与者继续参与研究的意愿。隐私和个人信息的保护也会影响信任。事实证明，知情同意是不够的，因为它无法克服材料和数据的主要用途和未知的未来用途之间的信息缺陷，因此不完全知情且无效。广泛的同意也是有问题的，因为它需要完全控制研究参与者的样本和数据流，并且本质上要求参与者必须相信研究人员将以他们认为可接受的方式使用他们的材料或数据。本文试图对如何克服这些相关问题提供一些见解。它将动态同意作为涉及人类生物材料及其相关数据的研究中的同意模型引入。解释了动态同意，以及在未来研究可能的情况下其优越性的主张。它还显示了动态同意如何有助于研究参与者更好地控制样本和数据，以及如何通过使用这种同意模型来提高信任。还评估了动态同意与 2013 年《南非个人信息保护法》的共存和支持情况。还讨论了动态同意的局限性。