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.

Agency
National Institute of Health (NIH)
Institute
National Heart, Lung, and Blood Institute (NHLBI)
Type
Research Project (R01)
Project #
5R01HL075538-04
Application #
7172960
Study Section
Special Emphasis Panel (ZRG1-EDC-3 (90))
Program Officer
Werner, Ellen
Project Start
2004-01-15
Project End
2008-12-31
Budget Start
2007-01-01
Budget End
2007-12-31
Support Year
4
Fiscal Year
2007
Total Cost
$622,324
Indirect Cost
Name
Johns Hopkins University
Department
Type
Organized Research Units
DUNS #
001910777
City
Baltimore
State
MD
Country
United States
Zip Code
21218
Hall, Mark A; Friedman, Joelle Y; King, Nancy M P et al. (2010) Commentary: Per capita payments in clinical trials: reasonable costs versus bounty hunting. Acad Med 85:1554-6
Weinfurt, Kevin P; Hall, Mark A; Hardy, N Chantelle et al. (2010) Oversight of financial conflicts of interest in commercially sponsored research in academic and nonacademic settings. J Gen Intern Med 25:460-4
Fortune-Greeley, Alice K; Hardy, N Chantelle; Lin, Li et al. (2010) Patient reactions to confidentiality, liability, and financial aspects of informed consent in cardiology research. Circ Cardiovasc Qual Outcomes 3:151-8
Hall, Mark A; Weinfurt, Kevin P; Lawlor, Janice S et al. (2009) Community hospital oversight of clinical investigators' financial relationships. IRB 31:7-13
Weinfurt, Kevin P; Hall, Mark A; King, Nancy M P et al. (2009) Disclosure of financial relationships to participants in clinical research. N Engl J Med 361:916-21
Weinfurt, Kevin P; Hall, Mark A; Friedman, Joelle Y et al. (2008) Effects of disclosing financial interests on participation in medical research: a randomized vignette trial. Am Heart J 156:689-97
Weinfurt, Kevin P; Seils, Damon M; Tzeng, Janice P et al. (2008) Consistency of financial interest disclosures in the biomedical literature: the case of coronary stents. PLoS One 3:e2128
Weinfurt, Kevin P; Hall, Mark A; Dinan, Michaela A et al. (2008) Effects of disclosing financial interests on attitudes toward clinical research. J Gen Intern Med 23:860-6
Weinfurt, Kevin P; Allsbrook, Jennifer S; Friedman, Joelle Y et al. (2007) Developing model language for disclosing financial interests to potential clinical research participants. IRB 29:1-5
Friedman, Joelle Y; Sugarman, Jeremy; Dhillon, Jatinder K et al. (2007) Perspectives of clinical research coordinators on disclosing financial conflicts of interest to potential research participants. Clin Trials 4:272-8

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