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J Clin Epidemiol. 2015 Dec;68(12):1472-80. doi: 10.1016/j.jclinepi.2015.03.002. Epub 2015 Mar 7.

Elements of informed consent and decision quality were poorly correlated in informed consent documents.

Author information

1
Clinical Epidemiology Program, Ottawa Hospital Research Institute, The Ottawa Hospital, General Campus, 501 Smyth Road, Centre for Practice-Changing Research, Box 201B, Ottawa, Ontario, Canada K1H 8L6; School of Epidemiology, Public Health and Preventive Medicine, University of Ottawa, 451 Smyth Road, Ottawa, Ontario, Canada K1H 8M5. Electronic address: jbrehaut@ohri.ca.
2
Clinical Epidemiology Program, Ottawa Hospital Research Institute, The Ottawa Hospital, General Campus, 501 Smyth Road, Centre for Practice-Changing Research, Box 201B, Ottawa, Ontario, Canada K1H 8L6.
3
The Dartmouth Center for Health Care Delivery Science and The Dartmouth Institute for Health Policy and Clinical Practice, Dartmouth College, 37 Dewey Field Road, Hanover, NH 03755, USA.
4
Clinical Epidemiology Program, Ottawa Hospital Research Institute, The Ottawa Hospital, Civic Campus, 1053 Carling Avenue, Ottawa, Ontario, Canada K1Y 4E9.
5
Biomedical Ethics Unit, McGill University, 3647 Peel Street, Montreal, Quebec, Canada H3A 1X1.
6
Department of Medicine, Sunnybrook Health Sciences Centre and University of Toronto Centre for Patient Safety, 2075 Bayview Avenue, Toronto, Ontario, Canada M4N 3M5.
7
Department of Epidemiology, Biostatistics and Occupational Health, McGill University, 1020 Pine Avenue West, Montreal, Quebec, Canada H3A 1A2.
8
Population Health Modeling, Social Determinants and Science Integration Directorate, Public Health Agency of Canada, 785 Carling Ave, Ottawa, Ontario, Canada K1A 0K9.

Abstract

OBJECTIVES:

Although informed consent (IC) documents must contain specific elements, inclusion of these elements may be insufficient to encourage high-quality decision making. We assessed the extent to which documents conform to IC standards and how well conformity to decision quality (DQ) standards can be predicted by IC standards, IC document characteristics, and study characteristics.

STUDY DESIGN AND SETTING:

We obtained 139 IC documents for trials registered with ClinicalTrials.gov from study investigators. Using a four-point scale, two raters independently assessed each IC document on 36 IC standard items and 9 DQ items.

RESULTS:

Overall agreement between raters across all 45 items was 93%. Across the 36 IC standards items, conformity was generally quite high but variable, with 20 items showing conformity of 80% or more and seven items showing conformity of 50% or lower. IC standards concordance, overall length of the IC document, and country of study were all significant predictors of DQ standards but together accounted for less than 20% of the variance in DQ standards.

CONCLUSION:

Conformity to recommendations for improving IC documents was relatively high but variable. The extent to which an IC document conformed to these recommendations was only moderately related to whether it conformed to recommendations for improving DQ. Existing IC regulations may not describe the optimal approach to helping people make good study participation decisions.

KEYWORDS:

Clinical trials; Decision quality; Decision support; Informed consent; Research participants; Trial participation

PMID:
25857675
DOI:
10.1016/j.jclinepi.2015.03.002
[Indexed for MEDLINE]

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