New River Valley Research Institute participates in industry-sponsored pharmaceutical research studies that are designed to evaluate the safety, tolerability, and effectiveness of investigational medicines (medicines that are not yet approved by the FDA). We also participate in research studies that test medicines that are already approved and on the market for new uses and indications.

Like so many other industries, many pharmaceutical companies have become global enterprises. Most of the clinical research studies that New River Valley Research Institute participates in are also being conducted in other countries around the world. Regardless of the origin of a pharmaceutical company, if they are using sites in the United States for their clinical trials they must abide by the rules and guidelines set forth by the US FDA (United States Food and Drug Administration).

In addition to the FDA guidelines, each clinical research study that will be conducted in the US must be reviewed and approved by an organization called an Institutional Review Board, or IRB. The IRB is comprised of a panel of both medical and scientific experts and of persons who do not have scientific or medical backgrounds. This is to ensure that the study protocol (the study plan) is properly designed to ensure the safety of all participants as well as to yield the best data about the medication.

No clinical research study can begin until the protocol and the consent form have been reviewed and approved by an IRB. Institutional Review Boards are independent from both the FDA and the pharmaceutical companies to ensure that their review is fair and objective