General Information

Research studies are conducted to answer a question. It leads to important discoveries that make our lives better. A clinical trial is a research study conducted under the supervision of a qualified physician and other research professionals.  They are designed to collect data, evaluate aspects of medical devices or investigational medical products such as effective dosage and safety.  Each trial has its own rules or protocols, which vary from trial to trial.

What is an Institutional Review Board (IRB)?

An Institutional Review Board (IRB) is an independent external review body whose purpose is to ensure subject safety and protect patient rights.  Names of review boards used by clinical research facilities include: Sterling IRB, Great Lakes IRB, Western IRB, Copernicus IRB.

Who sponsors clinical trials?

Clinical trials are sponsored or funded by a variety of organizations or individuals such as physicians, medical institutions, foundations, voluntary groups, and pharmaceutical companies, in addition to federal agencies such as the National Institutes of Health (NIH), the Department of Defense (DOD), and the Department of Veteran’s Affairs (VA). Trials can take place in a variety of locations, such as hospitals, universities, doctors’ offices, or community clinics.

Who makes sure my rights are protected?

An ethics committee must review clinical research studies before they begin. In addition, the Food and Drug Administration (FDA), a department of the United States government, sets requirements for drug testing. The ethics committee reviews the results from certain clinical research studies to decide if an investigational drug should be made available to the general public.