Disclosing Conflict of Interest to Research Participants

描述：（由申请人提供）最近大量的注意力集中在管理研究中的利益冲突上。虽然现在认为在知情同意过程中披露利益冲突的必要性很重要，以便潜在的参与者能够将这一信息纳入其决策过程，但仍有许多问题不清楚。具体而言，由谁、如何、何时和在何处披露利益冲突，以及此类披露对潜在参与者的理解、决策、信任和参与研究的影响，都不清楚。因此，如果申办者、研究者或IRB将未经研究的利益冲突披露机制纳入知情同意过程，可能会产生非预期和不可预见的负面后果。因此，本项目的首要目标是提供数据，以告知这些不确定性。最终，这些数据将被用于制定一个全面的和普遍的方法来披露利益冲突，通过创建强大的，验证的方法来披露知情同意过程中，以及帮助建立健全的政策和实践，披露研究中的利益冲突。为了实现这一目标，我们将努力实现四个具体目标。 目标1：确定患者、IRB管理人员和专家在临床研究中财务关系和披露方面的重要问题和关注点。目标2：确定申办者和研究团队之间的财务关系类型以及披露的类型/格式如何影响患者的理解、信任和参与临床研究的意愿。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：评估在实际临床试验中使用不同的披露方法。为了解决这个问题的复杂性和严重性，我们使用了一个复杂的研究策略，结合定性和定量的方法来研究各种各样的人，包括IRB管理人员，健康的外行人，慢性和危及生命的疾病患者，以及儿科患者的父母。在本项目结束时，我们将获得关于申办者和研究团队之间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的丰富数据，以加强临床研究的知情同意过程。

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.