A Missing Piece in Clinical Trial Inspections in Latin America: Interviews With Research Subjects in Peru

Abstract

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.

Keywords

clinical trials ethical standards inspections informed consent regulations

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