Health data research on sudden cardiac arrest: perspectives of survivors and their next-of-kin.
Health data research on sudden cardiac arrest: perspectives of survivors and their next-of-kin.
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DOI：
10.1186/s12910-021-00576-9
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发表时间：
2021-01-28
影响因子：
2.7
通讯作者：
Willems DL
中科院分区：
文献类型：
--
作者：
Bak MAR;Veeken R;Blom MT;Tan HL;Willems DL
由于患者至少暂时丧失行为能力或死亡，对急性和重症监护数据研究的同意是复杂的。欧盟现有的指导方针和法规帮助有限，而且缺乏关于使用这一弱势群体数据的文献。为了帮助在急性环境中建立一个以患者为中心的负责任的数据研究框架，我们探讨了患者和近亲对观察性研究中遗传和健康相关数据的收集、存储、共享和使用的看法。我们对荷兰心脏骤停幸存者进行了定性访谈（n = 19），他们为研究提供了临床和社会经济数据和基因样本。我们还采访了他们的近亲。主题由伦理文献提供信息，我们使用场景草图来帮助讨论复杂问题。心脏骤停幸存者对其参与健康数据研究及其所给予同意的内容的认识有限。我们发现，关于披露临床可操作的基因发现的偏好可能会随着时间的推移而改变。当数据的收集和使用仅限于医疗领域时，患者信任研究人员负责任地处理数据，而不用担心隐私或其他风险。对于是否应明确征求幸存者的延期同意，没有达成一致意见。如果征得同意，最好在事件发生几个月后认知能力恢复后进行。对于使用已故患者数据进行研究是否需要获得代理同意，人们的看法存在分歧。然而，人们普遍支持向亲属披露可能相关的死后基因发现。心脏骤停患者为研究提供数据的基础是对医学的总体信任，模糊了研究和护理之间的界限。我们的发现也强调了一次性同意的可接受性以及患者、研究人员和伦理委员会的责任问题。最后，需要对参与者死后数据的（继续）使用进行进一步的规范调查，这在这种情况下特别重要。我们的研究结果也被认为与其他急性和危及生命的疾病有关。
Consent for data research in acute and critical care is complex as patients become at least temporarily incapacitated or die. Existing guidelines and regulations in the European Union are of limited help and there is a lack of literature about the use of data from this vulnerable group. To aid the creation of a patient-centred framework for responsible data research in the acute setting, we explored views of patients and next-of-kin about the collection, storage, sharing and use of genetic and health-related data for observational research. We conducted qualitative interviews (n = 19) with Dutch sudden cardiac arrest survivors who donated clinical and socio-economic data and genetic samples to research. We also interviewed their next-of-kin. Topics were informed by ethics literature and we used scenario-sketches to aid discussion of complex issues. Sudden cardiac arrest survivors displayed limited awareness of their involvement in health data research and of the content of their given consent. We found that preferences regarding disclosure of clinically actionable genetic findings could change over time. When data collection and use were limited to the medical realm, patients trusted researchers to handle data responsibly without concern for privacy or other risks. There was no consensus as to whether deferred consent should be explicitly asked from survivors. If consent is asked, this would ideally be done a few months after the event when cognitive capacities have been regained. Views were divided about the need to obtain proxy consent for research with deceased patients’ data. However, there was general support for the disclosure of potentially relevant post-mortem genetic findings to relatives. Sudden cardiac arrest patients’ donation of data for research was grounded in trust in medicine overall, blurring the boundary between research and care. Our findings also highlight questions about the acceptability of a one-time consent and about responsibilities of patients, researchers and ethics committees. Finally, further normative investigation is needed regarding the (continued) use of participants’ data after death, which is of particular importance in this setting. Our findings are thought to be of relevance for other acute and life-threatening illnesses as well.
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影响因子：
2.1
作者：
Breitkopf, Carmen Radecki;Petersen, Gloria M.;Koenig, Barbara A.
通讯作者：
Koenig, Barbara A.
DOI：
10.1038/ejhg.2014.196
发表时间：
2015-10
期刊：
European journal of human genetics : EJHG
影响因子：
--
作者：
Dove ES;Joly Y;Tassé AM;Public Population Project in Genomics and Society (P3G) International Steering Committee;International Cancer Genome Consortium (ICGC) Ethics and Policy Committee;Knoppers BM
通讯作者：
Knoppers BM
影响因子：
2.7
作者：
Budin-Ljosne, Isabelle;Teare, Harriet J. A.;Mascalzoni, Deborah
通讯作者：
Mascalzoni, Deborah
影响因子：
3.5
作者：
Beier, Katharina;Schweda, Mark;Schicktanz, Silke
通讯作者：
Schicktanz, Silke
影响因子：
2.3
作者：
APPELBAUM, PS;ROTH, LH;LIDZ, C
通讯作者：
LIDZ, C