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，以便潜在的参与者可以将这些信息纳入他们的决策过程，但仍有许多不清楚的地方。具体来说，谁、如何、何时、何地披露利益冲突是不清楚的，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，如果申办者、研究者或伦理委员会将未经研究的有关利益冲突的披露机制纳入知情同意过程，可能会产生意想不到的和不可预见的负面后果。因此，这个项目的首要目标是提供数据来告知这些不确定性。最终，这些数据将用于开发一个全面的和可推广的方法来披露利益冲突，通过在知情同意过程中创建稳健的、经过验证的披露方法，并有助于建立关于披露研究中利益冲突的健全政策和实践。为实现这一目标，我们将努力实现四个具体目标。

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.