Clinical research studies are research projects done with human volunteers to find out if new vaccines and medications are safe and effective. In clinical research studies, the participants get an investigational vaccine or treatment under the care of a doctor and other medical professionals. The word “investigational” means it isn’t available or approved yet for the regular public.
All clinical research studies are regulated by government agencies. What’s more, they’re reviewed and watched over by panels of qualified doctors, scientists, religious representatives, and other members of the community. These review boards make sure your safety, rights, and welfare are protected, and that the study is being done for ethical and honest reasons. No vaccine or treatment can be completely safe for every person, but research studies help make sure the benefits outweigh the possible risks for most people.
Yes! The study team can’t tell anyone that you’re participating in a research study without your permission. The information collected during research studies is kept confidential, and patient names aren’t listed in any reports based on studies.
Clinical research studies need patients with a healthy mix of racial and ethnic backgrounds because drugs and vaccines can affect different groups differently. It’s very important to understand this before new treatments can be approved for everyone to use. Also, some groups may be affected by certain diseases more than others. So it’s important to strive for a diverse group of patients in research studies, as long as they meet the requirements for the studies.
If you get matched to a study and have questions for the study team about safety or other concerns, please ask them! It’s actually very important that all your questions are answered and that you feel comfortable about your participation. Also, keep in mind that you may leave research studies at any time, for any reason. The power is yours!