Assessing Whether Consent for a Clinical Trial Is Voluntary
Authors: Russell H. Horwitz, Laura W. Roberts, David W. Seal, Patrice Joseph, Karen J. Maschke, Rose I. Verdier, Sandy Nerette, Jean W. Pape, Daniel W. Fitzgerald
Journal: Annals of Internal Medicine (2013)

Letters5 February 2013Assessing Whether Consent for a Clinical Trial Is VoluntaryRussell H. Horwitz, MD, PhD, Laura W. Roberts, MD, David W. Seal, PhD, Patrice Joseph, MD, Karen J. Maschke, PhD, Rose I. Verdier, MD, Sandy Nerette, MD, Jean W. Pape, MD, and Daniel W. Fitzgerald, MDRussell H. Horwitz, MD, PhDFrom Johns Hopkins Hospital, Baltimore, Maryland; Stanford University, Palo Alto, California; Tulane University, New Orleans, Louisiana; Groupe Haitien d'Etude du Sarcome de Kaposi et des Infections Opportunistes, Port-au-Prince, Haiti; The Hastings Center, Garrison, New York; and Weill Medical College of Cornell University, New York, New York.Search for more papers by this author, Laura W. Roberts, MDFrom Johns Hopkins Hospital, Baltimore, Maryland; Stanford University, Palo Alto, California; Tulane University, New Orleans, Louisiana; Groupe Haitien d'Etude du Sarcome de Kaposi et des Infections Opportunistes, Port-au-Prince, Haiti; The Hastings Center, Garrison, New York; and Weill Medical College of Cornell University, New York, New York.Search for more papers by this author, David W. Seal, PhDFrom Johns Hopkins Hospital, Baltimore, Maryland; Stanford University, Palo Alto, California; Tulane University, New Orleans, Louisiana; Groupe Haitien d'Etude du Sarcome de Kaposi et des Infections Opportunistes, Port-au-Prince, Haiti; The Hastings Center, Garrison, New York; and Weill Medical College of Cornell University, New York, New York.Search for more papers by this author, Patrice Joseph, MDFrom Johns Hopkins Hospital, Baltimore, Maryland; Stanford University, Palo Alto, California; Tulane University, New Orleans, Louisiana; Groupe Haitien d'Etude du Sarcome de Kaposi et des Infections Opportunistes, Port-au-Prince, Haiti; The Hastings Center, Garrison, New York; and Weill Medical College of Cornell University, New York, New York.Search for more papers by this author, Karen J. Maschke, PhDFrom Johns Hopkins Hospital, Baltimore, Maryland; Stanford University, Palo Alto, California; Tulane University, New Orleans, Louisiana; Groupe Haitien d'Etude du Sarcome de Kaposi et des Infections Opportunistes, Port-au-Prince, Haiti; The Hastings Center, Garrison, New York; and Weill Medical College of Cornell University, New York, New York.Search for more papers by this author, Rose I. Verdier, MDFrom Johns Hopkins Hospital, Baltimore, Maryland; Stanford University, Palo Alto, California; Tulane University, New Orleans, Louisiana; Groupe Haitien d'Etude du Sarcome de Kaposi et des Infections Opportunistes, Port-au-Prince, Haiti; The Hastings Center, Garrison, New York; and Weill Medical College of Cornell University, New York, New York.Search for more papers by this author, Sandy Nerette, MDFrom Johns Hopkins Hospital, Baltimore, Maryland; Stanford University, Palo Alto, California; Tulane University, New Orleans, Louisiana; Groupe Haitien d'Etude du Sarcome de Kaposi et des Infections Opportunistes, Port-au-Prince, Haiti; The Hastings Center, Garrison, New York; and Weill Medical College of Cornell University, New York, New York.Search for more papers by this author, Jean W. Pape, MDFrom Johns Hopkins Hospital, Baltimore, Maryland; Stanford University, Palo Alto, California; Tulane University, New Orleans, Louisiana; Groupe Haitien d'Etude du Sarcome de Kaposi et des Infections Opportunistes, Port-au-Prince, Haiti; The Hastings Center, Garrison, New York; and Weill Medical College of Cornell University, New York, New York.Search for more papers by this author, and Daniel W. Fitzgerald, MDFrom Johns Hopkins Hospital, Baltimore, Maryland; Stanford University, Palo Alto, California; Tulane University, New Orleans, Louisiana; Groupe Haitien d'Etude du Sarcome de Kaposi et des Infections Opportunistes, Port-au-Prince, Haiti; The Hastings Center, Garrison, New York; and Weill Medical College of Cornell University, New York, New York.Search for more papers by this authorAuthor, Article, and Disclosure Informationhttps://doi.org/10.7326/0003-4819-158-3-201302050-00025 SectionsAboutFull TextPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissions ShareFacebookTwitterLinkedInRedditEmail Background: Consent is necessary for the ethical conduct of clinical research, but ensuring that consent is both voluntary and informed is challenging in resource-poor settings. Previous efforts have focused on participant comprehension (1). We report the results of a study assessing whether consent to participate in an HIV vaccine trial done in Haiti was voluntary.Methods and Findings: The study was a randomized vaccine trial; participants were aged 18 to 45 years and at high risk for HIV-1 (2). The study was approved by the institutional review boards at Weill Cornell Medical College, New York, New York, and the Haitian ...References1. Fitzgerald DW, Marotte C, Verdier RI, Johnson WD, Pape JW. Comprehension during informed consent in a less-developed country. Lancet. 2002;360:1301-2. [PMID: 12414207] CrossrefMedlineGoogle Scholar2. Buchbinder SP, Mehrotra DV, Duerr A, Fitzgerald DW, Mogg R, Li D, et al; Step Study Protocol Team. Efficacy assessment of a cell-mediated immunity HIV-1 vaccine (the Step Study): a double-blind, randomised, placebo-controlled, test-of-concept trial. Lancet. 2008;372:1881-93. [PMID: 19012954] CrossrefMedlineGoogle Scholar3. Fitzgerald DW, Behets F, Caliendo A, Roberfroid D, Lucet C, Fitzgerald JW, et al. Economic hardship and sexually transmitted diseases in Haiti's rural Artibonite Valley. Am J Trop Med Hyg. 2000;62:496-501. [PMID: 11220766] CrossrefMedlineGoogle Scholar4. Joseph P, Schackman BR, Horwitz R, Nerette S, Verdier RI, Dorsainvil D, et al. The use of an educational video during informed consent in an HIV clinical trial in Haiti. J Acquir Immune Defic Syndr. 2006;42:588-91. [PMID: 16837867] CrossrefMedlineGoogle Scholar5. Appelbaum PS, Lidz CW, Klitzman R. Voluntariness of consent to research: a conceptual model. Hastings Cent Rep. 2009;39:30-9. [PMID: 19213193] CrossrefMedlineGoogle Scholar Author, Article, and Disclosure InformationAffiliations: From Johns Hopkins Hospital, Baltimore, Maryland; Stanford University, Palo Alto, California; Tulane University, New Orleans, Louisiana; Groupe Haitien d'Etude du Sarcome de Kaposi et des Infections Opportunistes, Port-au-Prince, Haiti; The Hastings Center, Garrison, New York; and Weill Medical College of Cornell University, New York, New York.Disclosures: Dr. Horwitz: Grant: National Institute on Drug Abuse, Ruth L. Kirschstein National Research Service Award, National Institutes of Health; Grant (money to institution): National Institute on Drug Abuse, Ruth L. Kirschstein National Research Service Award, National Institutes of Health. Dr. Fitzgerald: Grant: Fogarty International Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health; Grant (money to institution): Fogarty International Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health. PreviousarticleNextarticle Advertisement FiguresReferencesRelatedDetails Metrics Cited byEthical Issues Involving Informed Consent in the Arab RegionMeasuring Voluntariness of Consent to ResearchImpact of gender on the decision to participate in a clinical trial: a cross-sectional studyStrengths and weaknesses of guideline approaches to safeguard voluntary informed consent of patients within a dependent relationshipThe Haiti Research-Based Model of International Public Health Collaboration 5 February 2013Volume 158, Issue 3Page: 222-224KeywordsAllergy and immunologyClinical trialsDrug abuseHIV vaccinesInfectious diseasesMotivationResearch assessmentSexually transmitted diseasesVaccines ePublished: 5 February 2013 Issue Published: 5 February 2013 Copyright & PermissionsCopyright © 2013 by American College of Physicians. All Rights Reserved.PDF downloadLoading ...