WHAT ARE HUMAN CHALLENGE STUDIES?
Human challenge studies, also known as Controlled Human Infection Models (CHIMs), Controlled Human Infection Studies (CHIS), or human challenge trials, involve healthy adult volunteers who intentionally agree to be exposed to a carefully controlled infectious agent. These studies are conducted to better understand diseases, evaluate vaccines, test potential treatments, and accelerate medical research.
Although human challenge studies are unfamiliar to many people, they have been conducted for decades with careful participant protections, scientific oversight, and ethical review.
Modern challenge studies are designed to minimize risk through careful participant selection, comprehensive informed consent, continuous medical monitoring, and independent ethical review.
The history of medical research reminds us why strong participant protections are so important. Past abuses involving vulnerable populations showed the devastating consequences of inadequate informed consent and unethical research practices. Those experiences are why today's research includes stronger ethical safeguards and greater protections for participants.
Healthy Volunteers Alliance (HVA) supports ethically conducted human challenge studies that place participant rights, informed consent, safety, autonomy, transparency, and scientific integrity at the center of the research process.
Protecting volunteers while advancing responsible medical research are complementary goals that should always go hand in hand.
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