Russell 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; Daniel W. Fitzgerald, MD
Potential Conflicts of Interest: 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.
Horwitz RH, Roberts LW, Seal DW, Joseph P, Maschke KJ, Verdier RI, et al. Assessing Whether Consent for a Clinical Trial Is Voluntary. Ann Intern Med. 2013;158:222-224. doi: 10.7326/0003-4819-158-3-201302050-00025
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Published: Ann Intern Med. 2013;158(3):222-224.
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 Group for the Study of Kaposi's Sarcoma and Opportunistic Infections, Port-au-Prince, Haiti. Potential participants reviewed the informed consent form during 3 educational sessions. A counselor who was not involved in the trial tested participants' comprehension of the consent form. A total of 596 potential vaccine trial participants attended 3 educational sessions and completed the assessment of comprehension; 529 (89%) passed.
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