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Abstract
Background: Ethical principles obligate researchers to maximize study participants’ comprehension during the informed consent process for clinical trials. A pilot evaluation of the consent process was conducted during an international clinical trial of treatment for pulmonary tuberculosis to assess the feasibility of conducting an evaluation in a larger population and to guide these future efforts. Methods: Study staff administered an informed consent assessment tool (ICAT) to a convenience sample of trial participants, measuring comprehension of consent components as derived from the Common Rule and FDA Title 21 Part 50, and satisfaction with the process. Participating site staff completed a consent process questionnaire about consent practices at their respective sites and provided improvement recommendations. ICAT scores and corresponding practices were compared where both were completed. Results: ICATs (n = 54) were submitted from one site in Spain (n = 10), one in Uganda (n = 30), and five in the United States (n = 14). Participants were primarily male (76%), born in Africa (n = 31, 57%), and had a median age of 27 years (interquartile range [IQR]: 24–42). Median ICAT scores were 80% (IQR: 67–93) for comprehension and 89% (IQR: 78–100) for satisfaction. Ugandan participants scored higher than participants from other sites on comprehension (87% vs. 64%) and satisfaction (100% vs. 78%). Staff from 14 sites completed consent process questionnaires. Median ICAT scores for comprehension and satisfaction were higher at sites that utilized visual aids. Practice recommendations included shorter forms, simpler documents, and supplementary materials. Conclusions: Participants achieved high levels (≥80%) of comprehension and satisfaction with their current consent processes. Higher ICAT scores at one site suggest an additional evaluation may identify approaches to improve comprehension and satisfaction in future trials. Through this pilot evaluation, complexities and challenges were identified in obtaining consent in a large, international multicenter trial and provided insights for a more robust assessment of the consent process in future trials.
SUPPLEMENATAL MATERIAL
Supplemental data for this article can be accessed on the publisher's website.
PREVIOUS PRESENTATIONS
Preliminary results of this evaluation were presented at a poster presentation at the 2011 Advancing Ethical Research Conference, Public Responsibility in Medicine & Research, Poster No. 31, Programmatic Submission, December 1–4, 2011, National Harbor, MD.
ACKNOWLEDGMENT
We thank all of the study participants who contributed their time to this study. We greatly appreciate all TBTC site study staff members who participated, as well as those who were willing to participate yet were constrained by logistical issues (please see full list of site staff in Dorman et al. 2012). We appreciate the invaluable guidance offered by TBTC's Community Research Advisory Group (CRAG). We acknowledge Nigel Scott, Pei-Jean Feng, and Charles Heilig for their outstanding statistical and epidemiological support. We appreciate the technical and editorial review provided by Andrew Vernon, John L. Johnson, Amera Khan, and Wanda Walton.
AUTHOR CONTRIBUTIONS
Kimberley N. Chapman: design, analysis, writing, editing, review; Eric Pevzner: analysis, writing, editing, review; Joan M. Mangan: writing, editing, review; Peter Breese: analysis, writing, editing, review; Dorcas Lamunu: analysis, writing, editing, review; Robin Shrestha-Kuwahara: design, editing, review; Joseph G. Nakibali: editing, review; and Stefan V. Goldberg: design, analysis, writing, editing, review.
DISCLAIMER
The findings and conclusions in this report are those of the authors and do not necessarily represent the official position of the Centers for Disease Control and Prevention.
ROLE OF THE FUNDER/SPONSOR
Sanofi had no role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the article; and decision to submit the article for publication.
CONFLICTS OF INTEREST
Kimberley N. Chapman is employed by the CDC Foundation.
ETHICAL APPROVAL
TBTC Study 29, the clinical trial within which this project was conducted, was approved in May 2008 by the institutional review boards (IRBs) of the CDC and participating institutions, and was registered with ClinicalTrials.gov (Study 29: NCT00694629). Some local IRBs ceded oversight of the TBTC protocols to the CDC's IRB (U.S. Department of Health and Human Services 2009). For this project, the CDC's National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention determined that the assessment of the consent process constituted a program evaluation and did not require IRB review (Centers for Disease Control and Prevention 2010). Additionally, each site followed local review policies and procedures.
Funding
This work was supported by the U.S. Centers for Disease Control and Prevention (CDC), Division of Tuberculosis Elimination, National Center for HIV, Viral Hepatitis, STD, and TB Prevention. Sanofi donated the rifapentine used in this study. Since 2007, Sanofi has donated $2.26 million to the CDC Foundation to supplement available funding for TBTC rifapentine research.