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Patient reactions to confidentiality, liability, and financial aspects of informed consent in cardiology research.

Publication ,  Journal Article
Fortune-Greeley, AK; Hardy, NC; Lin, L; Friedman, JY; Lawlor, JS; Muhlbaier, LH; Hall, MA; Schulman, KA; Sugarman, J; Weinfurt, KP
Published in: Circ Cardiovasc Qual Outcomes
March 2010

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<0.001). CONCLUSIONS: Recognizing elements of informed consent that elicit questions and concerns from potential research participants may help investigators design clinical research trials and model language in a way that reduces concerns or increases participant understanding, thereby enhancing informed consent for research.

Duke Scholars

Published In

Circ Cardiovasc Qual Outcomes

DOI

EISSN

1941-7705

Publication Date

March 2010

Volume

3

Issue

2

Start / End Page

151 / 158

Location

United States

Related Subject Headings

  • Research Subjects
  • Research Design
  • Patient Selection
  • Middle Aged
  • Male
  • Logistic Models
  • Linear Models
  • Liability, Legal
  • Language
  • Interviews as Topic
 

Citation

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Chicago
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MLA
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Fortune-Greeley, A. K., Hardy, N. C., Lin, L., Friedman, J. Y., Lawlor, J. S., Muhlbaier, L. H., … Weinfurt, K. P. (2010). Patient reactions to confidentiality, liability, and financial aspects of informed consent in cardiology research. Circ Cardiovasc Qual Outcomes, 3(2), 151–158. https://doi.org/10.1161/CIRCOUTCOMES.109.849273
Fortune-Greeley, Alice K., N Chantelle Hardy, Li Lin, Joëlle Y. Friedman, Janice S. Lawlor, Lawrence H. Muhlbaier, Mark A. Hall, Kevin A. Schulman, Jeremy Sugarman, and Kevin P. Weinfurt. “Patient reactions to confidentiality, liability, and financial aspects of informed consent in cardiology research.Circ Cardiovasc Qual Outcomes 3, no. 2 (March 2010): 151–58. https://doi.org/10.1161/CIRCOUTCOMES.109.849273.
Fortune-Greeley AK, Hardy NC, Lin L, Friedman JY, Lawlor JS, Muhlbaier LH, et al. Patient reactions to confidentiality, liability, and financial aspects of informed consent in cardiology research. Circ Cardiovasc Qual Outcomes. 2010 Mar;3(2):151–8.
Fortune-Greeley, Alice K., et al. “Patient reactions to confidentiality, liability, and financial aspects of informed consent in cardiology research.Circ Cardiovasc Qual Outcomes, vol. 3, no. 2, Mar. 2010, pp. 151–58. Pubmed, doi:10.1161/CIRCOUTCOMES.109.849273.
Fortune-Greeley AK, Hardy NC, Lin L, Friedman JY, Lawlor JS, Muhlbaier LH, Hall MA, Schulman KA, Sugarman J, Weinfurt KP. Patient reactions to confidentiality, liability, and financial aspects of informed consent in cardiology research. Circ Cardiovasc Qual Outcomes. 2010 Mar;3(2):151–158.

Published In

Circ Cardiovasc Qual Outcomes

DOI

EISSN

1941-7705

Publication Date

March 2010

Volume

3

Issue

2

Start / End Page

151 / 158

Location

United States

Related Subject Headings

  • Research Subjects
  • Research Design
  • Patient Selection
  • Middle Aged
  • Male
  • Logistic Models
  • Linear Models
  • Liability, Legal
  • Language
  • Interviews as Topic