Basics of an Institutional Review Board

Among the many guidelines we follow for proper clinical research at JBR Clinical Research, an Institutional Review Board is among the most thorough. Anyone who has been a hernia study subject, the sponsor of a migraine trial or who has participated in any part of a clinical study could have fallen under the purview of an IRB.

What are the basics of an IRB, and what are their roles both locally and centrally? Let’s take a look.

Basics

An IRB has two basic requirements that set its baseline:

1. An IRB reviews all study-related materials before and during a given trial.
2. An IRB must operate in accordance with all national and local regulations, plus must be in accordance with ICH Good Clinical Practices guidelines.

Local vs Central

There are two kinds of IRBs: Local and central. Local IRBs are part of the individual academic institutions that carry out research, and therefore are responsible only for reviewing trials at these specific institutions.

Central IRBs, on the other hand, provide reviews for multiple research entities. Some clinical investigators might not have access to a local IRB, and there might be other reasons why an institution looks to a central IRB for review. However, if a local IRB exists and an institution chooses not to use it in favor of a central IRB, they might be required to justify the decision or seek approval from the local IRB.

Requirements

IRB members have to be adequately qualified to review all scientific, medical and ethical aspects of the trial. Other IRB requirements include a need for:

• At least five members
• Members with varying backgrounds
• At least one lay member – a person who represents a non-scientific area
• At least one member not affiliated with the institution or trial site
• Competent members who can evaluate all aspects of the trial

Responsibilities

IRBs have responsibilities before, during and after a trial. Before a site can begin enrolling patients in a trial, the IRB must review all study-related materials during an initial review. During the trial, the IRB will provide periodic reviews – these may take place at least once a year, and will include the entire trial, not just new elements. They may also ask for additional information on payments to participants and the informed consent process. A principal investigator (PI) will be appointed, and will be responsible for ensuring compliance with all protocols and reporting any departure from said protocols immediately.

For more information on IRBs, or to participate in a migraine trial or any other clinical trial, speak to the professionals at JBR Clinical Research today.