HIV testing in early clinical trials: who should decide whether it is warranted?

In phase I clinical trials intended for healthy volunteers, testing for human immunodeficiency virus (HIV) is often times 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.