Fradgley Elizabeth A, Chong Shu Er, Cox Martine E, Gedye Craig, Paul Christine L
Priority Research Centre for Cancer Research Innovation and Translation, University of Newcastle, Callaghan, NSW, Australia.
Priority Research Centre for Health Behaviour, University of Newcastle, Callaghan, NSW, Australia.
Asia Pac J Clin Oncol. 2019 Feb;15(1):31-37. doi: 10.1111/ajco.12866. Epub 2018 Mar 23.
Many biobanks rely upon patients' willingness to donate biospecimens and healthcare professionals to initiate opt-in consent processes. This study explored if: (1) patients accept opt-in or opt-out consent models with varying levels of professional involvement; (2) professionals discuss participation with specific patient groups; and (3) this discussion is associated with patient knowledge of biobanking processes.
Outpatients completed surveys at a tertiary cancer center in New South Wales, Australia. Eligible participants were English-speaking adults who recently had cancer-related surgery. Participants completed 27 questions exploring acceptable consent models, biobanking experiences, knowledge, and willingness. Logistic regression and chi-square tests examined differences in the characteristics and knowledge of participants who were offered the opportunity to participate versus those who were not.
A total of 113 outpatients participated (97% response). Most participants (92%) found opt-out, patient-initiated consent acceptable; however, high acceptability was reported for all models except for opt-in, patient-initiated consent (58%). University or technical qualifications (P = 0.001) was associated with increased odds (OR = 4.5) of being offered biobanking. The majority did not know what occurred to samples after surgery (59.3%) or pathology review (81.4%) and ability to answer these questions was associated with discussion of participation (P < 0.001). Of the few outpatients who discussed biobanking with their doctor (29%), all consented.
Professional-initiated, opt-in consent resulted in a few educated patients being approached; greater professional initiation of consent would be fruitful as most patients were willing to participate if asked. However, other consent approaches minimizing professional involvement were as acceptable to participants warranting further consideration.
许多生物样本库依赖患者捐赠生物样本的意愿以及医疗保健专业人员来启动选择加入的同意程序。本研究探讨了：（1）患者是否接受不同专业参与程度的选择加入或选择退出同意模式；（2）专业人员是否与特定患者群体讨论参与事宜；以及（3）这种讨论是否与患者对生物样本库流程的了解相关。
在澳大利亚新南威尔士州的一家三级癌症中心，门诊患者完成了调查。符合条件的参与者是近期接受过癌症相关手术的讲英语的成年人。参与者完成了27个问题，探讨可接受的同意模式、生物样本库经历、知识和意愿。逻辑回归和卡方检验检查了有机会参与的参与者与未参与的参与者在特征和知识方面的差异。
共有113名门诊患者参与（回应率97%）。大多数参与者（92%）认为选择退出、患者发起的同意是可以接受的；然而，除了选择加入、患者发起的同意（58%）外，所有模式的接受度都很高。大学或技术资格（P = 0.001）与被提供生物样本库参与机会的几率增加（OR = 4.5）相关。大多数人不知道手术后样本（59.3%）或病理检查后（81.4%）会怎样，能够回答这些问题与参与讨论相关（P < 0.001）。在少数与医生讨论过生物样本库的门诊患者中（29%），所有人都同意了。
专业人员发起的选择加入同意导致只有少数受过教育的患者被接触；如果更多地由专业人员发起同意，可能会有成效，因为大多数患者如果被询问是愿意参与的。然而，其他尽量减少专业人员参与的同意方法对参与者来说同样可以接受，值得进一步考虑。
