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.
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