Are clinical trials safe?

All clinical research plans—known as “research protocols”—must go through a rigorous process to ensure that the research is not only scientifically sound, but also safeguard’s study volunteers’ health and human rights. All research studies conducted in the U.S. must abide by the ethical principles found in the Declaration of Helsinki, Good Clinical Practice (GCP) guidelines, and other strict federal guidelines.

Clinical trials also enlist the support of Institutional Review Boards (IRB) to protect participants’ safety. An IRB is an independent group made up of scientists, doctors and other people from the local community. IRBs play a critical role in protecting the interests of study volunteers by ensuring that any risks to their safety are minimized and study volunteers’ rights are fully protected.

While study volunteers’ safety is paramount, there may be risks, both known and unknown, associated with taking an experimental treatment. When considering participation, it’s critical to understand the known potential side effects and weigh these with any potential benefits. Moreover, as a study volunteer, its crucial to know what to do if a complication should arise. It’s also a good idea to discuss the study and your participation with your doctor.

Click here to read a US News report on ways that volunteers are protected.

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