a female patient speaking with her doctors

Institutional Review Board

The IRB/IEC in Clinical Trials

The International Council on Harmonisation (ICH) defines an institutional review board (IRB) as a group formally designated to protect the rights, safety and well-being of humans involved in a clinical trial by reviewing all aspects of the trial and approving its startup. IRBs can also be called independent ethics committees (IECs).

An IRB/IEC reviews the appropriateness of the clinical trial protocol as well as the risks and benefits to study participants. It ensures that clinical trial participants are exposed to minimal risk in relation to any benefits that might result from the research.

Local and Central IRBs/IECs

There are two types of IRBs/IECs: local and central. Local IRBs/IECs are functions of the academic institutions that conduct research and review only their trials, while central IRBs/IECs provide review services for multiple entities.

Some clinical trial investigators may not have access to a local IRB/IEC. There may also be compelling reasons for an institution not to use the local IRB/IEC and instead turn to a central IRB/IEC. If a trial site uses a central IRB/IEC and a local one exists, the site may be required to justify the decision or seek approval from the local IRB/IEC for the use of a central IRB/IEC.

IRB/IEC Membership

IRB/IEC members should be collectively qualified to review the scientific, medical and ethical aspects of the trial.

Per the FDA, an IRB/IEC should have:

  • At least five members.
  • Members with varying backgrounds.
  • At least one member who represents a non-scientific area (a lay member).
  • At least one member who is not affiliated with the institution or the trial site (an independent member).
  • Competent members who are able to review and evaluate the science, medical aspects and ethics of the proposed trial.

IRB/IEC Responsibilities Before, During and After a Trial

Before a site is allowed to start enrolling patients in a clinical trial, the IRB/IEC must review all study-related materials in an initial review. The IRB/IEC also performs periodic reviews—called continuing reviews—throughout the trial’s duration. Continuing reviews may take place at least once a year and include the entire trial, not just changes.

The IRB/IEC may also ask for additional information regarding payments and compensation to study participants, as well as the informed consent process.

Investigator Responsibilities for Ensuring Compliance

The principal investigator (PI) is responsible for ensuring compliance with any IRB/IEC procedures or requirements. He or she may deviate from the study protocol without prior IRB/IEC approval only to eliminate an immediate safety hazard to a study participant. In addition, the PI must notify the IRB/IEC of any departures from the protocol as soon as possible.