Disclosing Conflict of Interest to Research Participants

描述：(由申请人提供)最近，相当多的注意力集中在管理研究中的利益冲突上。虽然在知情同意过程中披露利益冲突的必要性现在被认为是重要的，以便潜在参与者能够将这一信息纳入其决策过程，但仍有许多不清楚之处。具体地说，谁、如何、何时以及在哪里披露利益冲突并不清楚，这种披露对潜在参与者的理解、决策、信任和参与研究的影响也是不清楚的。因此，如果赞助商、调查人员或机构将未经研究的关于利益冲突的披露机制纳入知情同意程序，可能会产生意想不到和不可预见的负面后果。因此，该项目的首要目标是提供数据，告知这些不确定性。最终，这些数据将被用来制定一种全面和普遍的方法，通过在知情同意过程中创建强有力的、有效的披露方法来披露利益冲突，并帮助建立关于披露研究中的利益冲突的健全政策和做法。为了实现这一目标，我们将解决四个具体目标。 目的1：确定患者、IRB管理人员和专家在临床研究中有关财务关系和披露的重要问题和关注事项。目的2：确定赞助商和研究团队之间的财务关系类型及其披露的类型/格式如何影响患者对参与临床研究的理解、信任和意向。目的3：为临床研究中不同类型的利益冲突开发模型披露模板。目的4：在实际临床试验的背景下评估不同披露方法的使用。为了解决这个问题的复杂性和严重性，我们使用了一种复杂的研究策略，结合了定性和定量的方法来研究广泛的人群，包括IRB管理人员、健康的普通人、患有慢性病和危及生命的疾病的患者，以及儿科患者的父母。在这个项目结束时，我们将有一组丰富的数据，关于赞助商和研究团队之间的财务关系的类型和程度，以及如何最好地披露可接受的关系，以加强临床研究的知情同意程序。

DESCRIPTION: (provided by applicant) Substantial attention has recently focused on managing conflicts of interest in research. While the need for disclosure of conflicts of interest during the informed consent process is now understood to be important so that potential participants can incorporate this information into their decision-making process, much remains unclear. Specifically, who, how, when, and where to provide disclosure about conflicts of interest are unclear as is the effect of such disclosures on potential participants' understanding, decision-making, trust, and participation in research. As a result, there could be unintended and unforeseen negative consequences if sponsors, investigators, or IRBs incorporate unstudied mechanisms of disclosure concerning conflicts of interest into the informed consent process. Thus, the overarching goal of this project is to provide data to inform these uncertainties. Ultimately, these data will be used to develop a comprehensive and generalizable approach to disclosing conflicts of interest by creating robust, validated approaches to disclosure in the informed consent process as well as to help to establish sound policy and practice regarding disclosure of conflicts of interest in research. In order to reach this goal, we will address four specific aims. AIM 1: To identify the issues and concerns that are important to patients, IRB administrators, and experts regarding financial relationships and disclosures of them in clinical research. AIM 2: To determine how the type of financial relationships between sponsors and research teams and the type/format of disclosure of them affects patients' understanding, trust, and intention to participate in clinical research. AIM 3: To develop model disclosure templates for different types of conflicts of interest in clinical research. AIM 4: To evaluate the use of different methods of disclosure in the context of an actual clinical trial. To address the complexity and gravity of this issue, we use a sophisticated research strategy that combines qualitative and quantitative approaches to studying a wide range of people, including IRB administrators, healthy lay people, patients with chronic and life-threatening illnesses, and parents of pediatric patients. At the conclusion of this project, we will have a rich set of data regarding the types and extent of financial relationships between sponsors and research teams as well as how best to disclose acceptable relationships so as to enhance the informed consent process for clinical research.