Clinical Research Personnel - page 2
Institutional Review Board (IRB) Members
Clinical trials test research discoveries that scientist's hope will benefit patients in the future. The fact that participants in the trial may not derive any direct benefit from their participation, presents a wide range of ethical questions.
The Institutional Review Board (IRB) is the key to the protection of individuals who volunteer for a clinical trial. The IRB is a committee composed of people who understand the concerns of their local community where the study is being conducted.
Their mission is to review clinical trial applications and monitor ongoing studies in order to determine if the way the trial is being conducted meets ethical standards.
In order to obtain IRB approval, the clinical research protocol should carefully describe the study purpose, trial design and details about how it will be carried out. It will also include the informed consent form that must be signed by the patients who agree to participate. All of these issues are discussed later in this section.