The Blurring of Treatment and Research in Clinical Trials: two problems

描述(申请人提供)：挑战领域：生物伦理挑战主题：02-OD(OSP)-105。治疗和研究之间的模糊引发了伦理问题。项目标题：临床试验中治疗和研究的模糊：两个问题。 在第三阶段临床试验中，治疗和研究之间的区别在参与者的脑海中变得模糊，被称为治疗误解(TM)。这已被广泛认为是知情同意研究的一个主要问题。受试者往往难以理解研究目标和治疗目标之间的区别，以及参与研究对他们自己的待遇的影响。然而，由于缺乏有效、可靠和易于管理的措施，对TM的研究工作受到了极大的阻碍。较少被广泛认识的是一个相关的现象，即临床研究人员也被夹在这两个原则之间，往往自己模糊了区别。与其说这是无法理解，不如说是道德或规范冲突。在最近的一项调查中，我们发现了大量证据表明，临床研究人员强烈致力于他们的“病人”，并报告说，为了提供最佳的临床护理，他们打破了常规。然而，调查数据是有限的，因为我们对偏离协议的细节以及研究人员如何处理这些偏差知之甚少。拟议的研究将在发展对这两个治疗和研究模糊的重要例子的理解方面取得重大进展。这项研究的第一个目标是开发一种健壮的、可用的、容易得分的TM测量方法。我们将使用建议的测量方法和半结构化访谈来评估300名受试者的TM，这些受试者在4个不同的地点，采用60种不同的方案。半结构化访谈及其相关的编码规则在以前的研究中已经被首席研究者用来测量TM，并将作为评估结构化测量的有效性的标准。我们还将深入采访在相同60个方案中提供日常临床护理的临床研究人员，了解他们对最近一篇论文中报道的同一调查的反应。这里的目标是评估这些与议定书的偏差是否会对试验的有效性产生严重后果，以及是否适当地报告了这些偏差，以便在分析研究结果时能够考虑到这些偏差。在这个过程中，我们将探索临床研究人员在临床试验中对临床护理的看法，并评估他们是否有某种形式的TM。 公共卫生意义：在第三阶段临床试验中保持治疗和研究之间的界限是一个严重的公共卫生问题。受试者对这两种风险的混淆削弱了他们知情同意的有效性。如果他们认为研究与治疗没有什么不同，他们就会严重误解他们同意的内容。同样严重的是，如果临床研究人员未能维持研究和治疗之间的界限，他们可能会为了他们的“患者”的利益做出违反协议的决定，从而威胁到研究的有效性。

DESCRIPTION (provided by applicant): Challenge Area: Bioethics Challenge Topic: 02-OD(OSP)-105. Ethical Issues Raised by the Blurring between Treatment and Research. Project Title: The Blurring of Treatment and Research in Clinical Trials: Two problems. The blurring of the distinction between treatment and research in the minds of participants in phase 3 clinical trials has been referred to as therapeutic misconception (TM). This has been widely recognized as a major problem for informed consent to research. Subjects often have trouble understanding the distinction between the goals of research and the goals of treatment as well as the implications for their own treatment of participating in research. However, efforts to study TM are greatly hampered by the lack of a valid, reliable, and easily administered measure. Less widely recognized is a related phenomenon that clinical researchers are also caught between the two principles and tend to blur the distinction themselves. This is not so much a failure to understand as it is a moral or normative conflict. In a recent survey we found ample evidence that clinical researchers feel strongly committed to their "patients" and report breaking protocol in order to provide optimal clinical care. However, the survey data is limited in that we do not know enough about the specifics of the deviations from the protocols and how these deviations were handled by the researchers. The proposed study will make major strides in developing the understanding of both of these important examples of the blurring of treatment and research. The first aim of the study is to develop a robust, yet usable and easily scored, measure of TM. We will use both a proposed measure and a semi-structured interview to assess TM in 300 subjects in 60 different protocols at 4 different sites. The semi-structured interview with its associated coding rules has been used in prior research by the principal investigator to measure TM and will serve as a criterion for assessing the validity of the structured measure. We will also interview in depth the clinical researchers who provide the day-to-day clinical care in the same 60 protocols about their responses to the same survey that was reported in a recent paper. The goal here is to assess whether these deviations from the protocols would have serious consequences for the validity of the trials and whether they were appropriately reported so that the deviations can be taken into account in the analysis of the results of the study. In the process we will explore the perspective of clinical researchers about clinical care in clinical trials and assess whether they have a form of TM themselves. Public Health Significance: Maintaining the boundary between treatment and research in phase 3 clinical trials is a serious public health matter. Subjects' confusion of the two risks undermine the validity of their informed consent. If they think that research is no different from treatment they will seriously misunderstand to what they are consenting. Equally serious, if clinical researchers fail to maintain that boundary between research and treatment, they may make decisions in the interests of their "patients" that violate the protocol and thus threaten the validity of the research.