Written versus verbal consent: a qualitative study of stakeholder views of consent procedures used at the time of recruitment into a peripartum trial conducted in an emergency setting
Written versus verbal consent: a qualitative study of stakeholder views of consent procedures used at the time of recruitment into a peripartum trial conducted in an emergency setting
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DOI：
10.1186/s12910-017-0196-7
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发表时间：
2017-05-24
影响因子：
2.7
通讯作者：
Denison, F. C.
中科院分区：
文献类型：
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作者：
Lawton, J.;Hallowell, N.;Denison, F. C.
背景：在经历产科紧急情况时，获得女性参与试验的前瞻性书面同意具有挑战性。一些临床医生和生物伦理学家提倡其他同意途径，例如在入组时获得口头同意，然后再获得书面同意，但很少受到实证关注。我们探讨了女性和工作人员对内部试点试验 (GOT-IT) 期间使用的同意程序的看法，该方案允许工作人员在招聘时获得口头同意。方法：采访工作人员 (n = 27) 和参与的女性 (n = 22)。对数据进行专题分析，并对访谈进行交叉比较，以确定参与者对所使用的同意程序的看法的差异和相似之处。结果：女性和一些工作人员强调了在试验入组时获得口头同意的好处，包括加快招募和减轻因分娩而疲惫不堪的人的负担。然而，尽管在临床实践中习惯于使用口头程序，但大多数直接负责征求同意的工作人员表示在获得书面同意之前极不愿意继续进行登记。为了解决这种阻力，工作人员对研究和临床护理进行了严格区分，并建议在招募患者参加试验时需要获得更高级别的同意。在此过程中，工作人员强调需要让妇女参与反思性决策，并强调填写同意书在促进和证明这一过程中可以发挥的作用。虽然大多数工作人员提到了他们对女性的道德责任，但他们也表示担心，如果在招聘时没有签署同意书，如果个人在审判期间出现并发症，可能会使他们面临更大的诉讼风险。围产期试验的招募经验不足以及接受过同意培训的工作人员数量有限，也强化了在招募时获得书面同意的偏好。结论：虽然替代同意途径在推进急诊医学研究方面发挥着重要作用，并且可能会受到潜在招募者的赞赏，但它们可能会给工作人员带来意想不到的道德和后勤挑战。工作人员将受益于培训和支持，以增加他们使用替代同意途径招募参加试验的信心和意愿。
Background: Obtaining prospective written consent from women to participate in trials when they are experiencing an obstetric emergency is challenging. Alternative consent pathways, such as gaining verbal consent at enrolment followed, later, by obtaining written consent, have been advocated by some clinicians and bioethicists but have received little empirical attention. We explored women's and staff views about the consent procedures used during the internal pilot of a trial (GOT-IT), where the protocol permitted staff to gain verbal consent at recruitment.Methods: Interviews with staff (n = 27) and participating women (n = 22). Data were analysed thematically and interviews were cross-compared to identify differences and similarities in participants' views about the consent procedures used.Results: Women and some staff highlighted benefits to obtaining verbal consent at trial enrolment, including expediting recruitment and reducing the burden on those left exhausted by their births. However, most staff with direct responsibility for taking consent expressed extreme reluctance to proceed with enrolment until they had obtained written consent, despite being comfortable using verbal procedures in their clinical practice. To account for this resistance, staff drew a strong distinction between research and clinical care and suggested that a higher level of consent was needed when recruiting into trials. In doing so, staff emphasised the need to engage women in reflexive decision-making and highlighted the role that completing the consent form could play in enabling and evidencing this process. While most staff cited their ethical responsibilities to women, they also voiced concerns that the absence of a signed consent form at recruitment could expose them to greater risk of litigation were an individual to experience a complication during the trial. Inexperience of recruiting into peripartum trials and limited availability of staff trained to take consent also reinforced preferences for obtaining written consent at recruitment.Conclusions: While alternative consent pathways have an important role to play in advancing emergency medicine research, and may be appreciated by potential recruits, they may give rise to unintended ethical and logistical challenges for staff. Staff would benefit from training and support to increase their confidence and willingness to recruit into trials using alternative consent pathways.