A vital part of modern medical research is "clinical research." Although laboratory and animal research are of great importance, it is clinical research that answers the question "Does it work?" To answer this question, specific conditions or treatments are studied in a RESEARCH STUDY or CLINICAL TRIAL to understand the nature of a disease or the effectiveness of a drug or medical device.

There are many contributors to the success of clinical research. The SPONSOR of the clinical trial provides the primary source of funding and may also have a role in its design and conduct. Often, the sponsor is a federal agency such as the National Institutes of Health (NIH) or a pharmaceutical company.

A key person in the research study is the PRINCIPAL INVESTIGATOR. Commonly called the "PI", this person conducts the clinical research and may have designed it or may have been chosen to conduct it by a sponsor. The PI often works with a larger group of researchers and they are usually members of RESEARCH INSTITUTIONS such as the New York University School of Medicine.

Within each research institution is an essential group of persons known as the INSTITUTIONAL REVIEW BOARD (IRB). The IRB consists of doctors, scientists, and non-medical persons, often from the community, who must review and approve all clinical research done at that institution. No research can be started without IRB approval. In various institutions across the country, the NIH has funded special research units, each called the GENERAL CLINICAL RESEARCH CENTER or just GCRC. They are special facilities, usually contained within a hospital, and are designed and staffed for the sole purpose of supporting clinical research. A recent addition to the GCRC staff is the RESEARCH SUBJECT ADVOCATE, an independent observer who reviews the activities of the GCRC with particular attention to Research Subject safety.

The most important person of all in every clinical trial is the volunteer participant, often called the RESEARCH SUBJECT. Without these volunteers no clinical research can be done!