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HIV Testing in Early Clinical Trials: Who Should Decide Whether It Is Warranted?
Author(s) -
Apseloff Glen
Publication year - 2002
Publication title -
the journal of clinical pharmacology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.92
H-Index - 116
eISSN - 1552-4604
pISSN - 0091-2700
DOI - 10.1177/00970002042006002
Subject(s) - clinical trial , medicine , clinical research , intensive care medicine , harm , food and drug administration , adverse effect , asymptomatic , pharmacology , psychology , social psychology
In phase I clinical trials intended for healthy volunteers, testing for human immunodeficiency virus (HIV) is oftentimes part of a routine screening procedure to determine eligibility. The rationale is to safeguard volunteers, to protect the scientific integrity of a clinical trial, and/or to facilitate the process of drug development. Asymptomatic HIV‐positive individuals are at increased risk for adverse events, and participating in a phase I clinical trial could also interfere with effective treatment for their disease. Although the Food and Drug Administration has not established a policy regarding HIV testing in clinical trials, some institutional review boards (IRBs) impose restrictions. The role of an IRB is to protect the rights and welfare of human subjects in clinical trials. Restricting testing does not protect subjects and may in fact harm them; therefore, an IRB should not restrict testing proposed by a pharmaceutical sponsor in agreement with a clinical investigator.