IRB Responsibilities

IRB responsibilities in clinical research focus on protecting the rights, safety and well-being of trial participants. An Institutional Review Board (IRB), also referred to in many regions as an Independent Ethics Committee (IEC), is an independent body that provides ethical review of clinical trials.

The IRB/IEC provides independent ethical review of a proposed clinical trial and determines whether the trial may receive approval or favourable opinion before participants are enrolled. Its composition, legal status and specific regulatory responsibilities may vary according to the country or region.

Review of the Clinical Trial

The IRB/IEC should review the proposed clinical trial before it begins.

Current international expectations for IRB/IEC review are described in the ICH E6 Good Clinical Practice guideline.

The review includes relevant scientific, medical and ethical aspects of the trial necessary to determine whether the proposed research is ethically acceptable.

Relevant materials may include:

• Clinical trial protocol
• Protocol amendments
• Investigator’s Brochure or other relevant safety information
• Informed consent materials
• Participant recruitment materials
• Information concerning payments or compensation to participants
• Investigator qualifications
• Information about the suitability of the trial site or facilities
• Other documents required for ethical review

The IRB/IEC may approve or provide favourable opinion, require modifications before approval, or disapprove the proposed trial.

Protection of Trial Participants

Protecting the rights, safety and well-being of trial participants is a fundamental responsibility of the IRB/IEC.

Particular consideration should be given to trials involving participants who may be vulnerable to coercion or undue influence or who may require additional protections.

The IRB/IEC should evaluate whether the anticipated benefits and risks are ethically acceptable and whether appropriate measures are in place to protect participants.

Review of Informed Consent

The IRB/IEC should review the informed consent process and the information that will be provided to prospective participants.

Consent information should appropriately explain relevant aspects of the trial so that participants or their legally acceptable representatives can make an informed decision about participation.

The IRB/IEC may require additional information to be provided when it considers that the information would meaningfully improve protection of participants’ rights, safety or well-being.

Participant Payments and Compensation

Where participants are compensated for taking part in a trial, the IRB/IEC should review the amount and method of payment.

Payment arrangements should not create inappropriate coercion or undue influence.

Information about payment arrangements should also be appropriately described in the informed consent materials or other participant information.

Continuing Review

The IRB/IEC should conduct continuing review of ongoing clinical trials at intervals appropriate to the degree of risk to participants and in accordance with applicable regulatory requirements.

Continuing review supports ongoing protection of participants but should not be confused with sponsor monitoring of trial operations or source data.

Review of Trial Changes

Changes to an approved clinical trial may require IRB/IEC review before implementation.

Investigators should generally not implement changes or deviations from the approved protocol without prior IRB/IEC approval or favourable opinion when such approval is required, except when necessary to eliminate an immediate hazard to trial participants or where permitted under applicable requirements.

Relevant changes should be submitted to the IRB/IEC in accordance with applicable procedures and regulatory requirements.

Safety Information

The IRB/IEC should receive relevant new information that may affect the safety of participants or the continued ethical acceptability of the trial.

This may include important new safety information and other significant developments requiring IRB/IEC review under applicable regulatory requirements.

The investigator and sponsor have separate safety-reporting responsibilities, and not every adverse event is necessarily reported individually to the IRB/IEC.

Protocol Deviations and Noncompliance

The IRB/IEC may receive information about significant protocol deviations, noncompliance or other events when required by applicable regulations or institutional procedures.

Such information should be evaluated when it may affect participant rights, safety or well-being or the continued ethical acceptability of the clinical trial.

Suspension or Termination of Approval

The IRB/IEC may suspend or terminate previously granted approval or favourable opinion when appropriate.

The reasons for such decisions should be documented and communicated according to applicable procedures and regulatory requirements.

Documentation and Records

The IRB/IEC should maintain appropriate records of its activities.

These may include:

• Written procedures
• Membership information
• Submitted documents
• Meeting agendas and minutes
• Decisions and correspondence
• Records of continuing review

Records should be retained in accordance with applicable regulatory requirements.

Independence of the IRB/IEC

Independent ethical review is essential to the protection of clinical trial participants.

Individuals with conflicts of interest in relation to a particular trial should not participate in the IRB/IEC’s decision-making for that trial.

Investigators, sponsor representatives or other individuals may provide information when appropriate but should not participate in the IRB/IEC’s independent decision-making.

Importance of IRB Responsibilities

IRB responsibilities are central to the ethical conduct of clinical research. Through independent review, informed consent oversight, continuing review and evaluation of relevant new information, the IRB/IEC helps safeguard the rights, safety and well-being of trial participants.

The IRB/IEC complements—but does not replace—the responsibilities of investigators, sponsors and regulatory authorities involved in the conduct and oversight of clinical trials.

For the broader ethical and quality framework governing clinical trials, see Principles of Good Clinical Practice.

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