Patient Reactions to Confidentiality, Liability, and Financial Aspects of Informed Consent in Cardiology Research
Fortune-Greeley, Alice K
Hardy, N Chantelle
Friedman, Joëlle Y
Lawlor, Janice S
Muhlbaier, Lawrence H
Hall, Mark A
Schulman, Kevin A
Weinfurt, Kevin P
Circulation. Cardiovascular quality and outcomes 2010 Mar ; 3(2): 151-8
BACKGROUND: Although the informed consent process is supposed to help potential research participants make informed and voluntary decisions about participating in research, little is known about how participants react to language in the informed consent document and whether their reactions are related to their willingness to enroll in clinical trials. We examined the relationship between patients' reactions to standard informed consent language and their willingness to participate in a hypothetical clinical trial. METHODS AND RESULTS: We simulated the consent process for a hypothetical cardiology clinical trial with 470 patients in an outpatient cardiovascular medicine clinic at a large academic medical center. We analyzed the spontaneous comments and questions that participants made during the interviews about each section of the informed consent document. Few participants made positive comments. Participants made the most negative comments about the sections on risks, study purpose or protocol, and payment for injury. Having a negative reaction to any section was associated with a lower likelihood of participating in the clinical trial. Using a multivariable model, we found that negative reactions in the patient rights, financial disclosure, and confidentiality sections predicted willingness to participate (P
Showing items related by title, author, creator and subject.
Effects of Disclosing Financial Interests on Participation in Medical Research: A Randomized Vignette Trial Weinfurt, Kevin P.; Hall, Mark A.; Friedman, Joëlle Y.; Hardy, Chantelle; Fortune-Greeley, Alice K.; Lawlor, Janice S.; Allsbrook, Jennifer S.; Lin, Li; Schulman, Kevin A.; Sugarman, Jeremy (2008-10)
Oversight of Financial Conflicts of Interest in Commercially Sponsored Research in Academic and Nonacademic Settings Weinfurt, Kevin P; Hall, Mark A; Hardy, N Chantelle; Friedman, Joëlle Y; Schulman, Kevin A; Sugarman, Jeremy (2010-05)Studies of conflicts of interest in clinical research have focused on academic centers, but most clinical research takes place in nonacademic settings.
Hall, Mark A.; Weinfurt, Kevin P.; Lawlor, Janice S.; Friedman, Joëlle Y.; Schulman, Kevin A.; Sugarman, Jeremy (2009-01)