A Missing Piece in Clinical Trial Inspections in Latin America

Interviews With Research Subjects in Peru

Bibliographic Data

ID12806891
AuthorsGabriela Minaya (0000-0002-6248-6662, Ministry of Health), Duilio Fuentes (0000-0002-0086-2546, Ministry of Health), Antonio Ugalde (0000-0002-2473-8435, The University of Texas at Austin), Nuria Homedes (0000-0002-3322-3951, The University of Texas at El Paso, corresponding author)
Year2017
Volume12
Issue4
Pages232-245
Publication date2017-07-21
Open AccessYes
TypeARTICLE
VenueJournal of Empirical Research on Human Research Ethics (JOURNAL)
Journal identifiersISSN: 1556-2646 • E-ISSN: 1556-2654
PublisherSAGE Publishing (PUBLISHER • US)
DOI10.1177/1556264617720756
PMID28728496
OpenAlexW2738584891
LanguageEN
Citations received1
References cited45

Most regulatory agencies conduct clinical trial (CT) site inspections, but the experiences and behaviors of research subjects and their knowledge of the rights and obligations that ensue from participating in a CT are seldom explored. The authors assessed the technical feasibility of incorporating interviews with participants in CT inspections. This article analyzes the responses of 13 CT participants, 14% ( n = 96) of those included in three tuberculosis (TB) CTs. Participants did not object to being interviewed and provided information not obtained during regular inspections. Participants were appreciative of the agency's concern for the integrity of the CT process. Most interviewees did not understand the consent form and were unaware that they were participating in an experiment with unapproved new drugs. Participants' decision to enroll in CT related to undue inducement and therapeutic misconception. Some patients' behaviors, undisclosed to researchers, could have compromised the integrity of the data collected

Agency (philosophy · Alternative medicine · Clinical trial · Ethics committee · Family medicine · Informed consent · Medical education · Pathology · Political science · Sociology · Biomedical Ethics and Regulation · Ethics in Clinical Research · Medicine · Pharmaceutical industry and healthcare · Psychology

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