What is an Institutional Review Board (IRB)?
An Institutional Review Board (IRB) is a committee established to assist in research involving the use of human subjects. IRBs exist to review and approve any potential research before it moves on to an active stage that involves humans. How does an IRB work, and what role does it play in the development of new drugs?
How an IRB Works
According to the FDA, an Institutional Review Board is actually a generic term for a body of officials which reviews any potential research project and oversees the conduct of that project with an eye toward protecting human subjects involved in the research. The FDA says that IRBs are often an individual function of research universities or institutions. It is their role to develop a process to review research protocols, overview informed consent documents, and generally ensure the protection of the welfare and human rights of any human subjects participating in research.
It should be noted that IRBs are required to register with the FDA and Department of Health and Human Services in the United States, but only if the research and trials involve human subjects being administered FDA-regulated products.
What Role Do IRBs Play in Drug Development?
An IRB is responsible for protecting the rights of individuals participating in any sort of research. This includes testing of new drugs in development or enhancements in development for existing drugs. According to Brown University, “the charge of the IRB is to weigh risks and benefits of participation in research to protect the rights and welfare of participants.”
When it comes to the development of new drugs, Phase I studies and beyond require healthy human subjects to participate so that the effectiveness, recommended dosage levels, frequency of dosage, and other factors such as the reaction of compounds in the body can be studied.
IRBs must act as a buffer between the goals of the research team and the rights of the human participants involved in the study. In order for research projects to move forward at Brown University, the IRB must see human research protocol tactics and the goal of the research before any activities can begin.
Often IRBs must report to federal agencies regarding research involving humans, promote awareness of ethical conduct, monitor and oversee the research including visiting in person, and keep records on the progress of research.
IRBs and Human Subjects
Although it would seem simple to define a human subject, for the purposes of research there are those who might skew the lines to get past IRB oversight. The American Public University System (APUS) offers lengthy definitions on human subjects, what constitutes a human participant, and which types of research require review from the IRB first.
For example, APUS defines human participants as anyone who is either actively involved in the research process (via interview, survey, etc.) or those who provide medical samples, leave records of activities, or even apply for licenses from municipal governments. The APUS IRB even defines research for the purposes of its oversight as “contributing to generalizable knowledge, that which is designed in advance, or utilizes a systematic approach.”
In short, Institutional Review Boards serve as an ethical compass for the conduct of research efforts that involve humans in a variety of ways.