The Institutional Review Board (IRB), also known as the Institutional Ethics Committee (IEC) or Ethics Review Board (ERB), is a cornerstone of ethical clinical research. Its primary purpose is to safeguard the rights, dignity, and safety of human participants involved in clinical trials. Understanding the composition, responsibilities, and procedures of the IRB is essential for Pharm.D students, clinical researchers, investigators, and anyone involved in biomedical research.
What is an Institutional Review Board?
An IRB is an independent committee established by an institution to review, approve, and monitor all biomedical and behavioral research involving human participants. It ensures that the research follows ethical principles, complies with regulatory requirements, and minimizes risks to participants.
Composition of the Institutional Review Board
To ensure balanced and unbiased decision-making, the IRB must include a diverse group of individuals with varied qualifications and backgrounds. According to ethical guidelines and regulatory standards, the IRB must have:
1. Minimum Membership Requirements
- At least five members
- At least one member who is not affiliated with the institution
- At least one layperson or non-scientific member
- Both genders represented
2. Types of Members
The IRB typically includes:
- Clinicians / Medical Experts: Provide insight into clinical aspects and risk assessment
- Pharmacologists / Researchers: Evaluate scientific validity and methodology
- Legal Expert: Ensures compliance with regulations and legal protections
- Ethicist / Social Scientist: Reviews ethical and social implications
- Layperson / Community Representative: Provides a non-scientific public perspective
This multidisciplinary structure prevents conflicts of interest and ensures that decisions are fair, transparent, and ethical.
Responsibilities of the Institutional Review Board
The IRB plays a central role in protecting research participants. Its key responsibilities include:
1. Scientific and Ethical Review of Protocols
The IRB carefully evaluates each study protocol to ensure that:
- The research is scientifically sound
- The study design minimizes risk
- The expected benefits justify the risks
- Participant selection is fair
2. Review of Informed Consent Documents
The IRB ensures that the informed consent form (ICF):
- Is written in simple, understandable language
- Clearly explains risks, benefits, and procedures
- Includes emergency contact details
- Provides information on compensation and rights
3. Risk–Benefit Assessment
The IRB evaluates whether the potential benefits outweigh the risks. It ensures that risks are minimized through adequate safety measures.
4. Monitoring Ongoing Research
Research does not end with initial approval. The IRB monitors ongoing trials through:
- Continuing review reports
- Interim safety updates
- Adverse event (AE) and serious adverse event (SAE) reports
5. Reviewing Protocol Amendments
Any change in the protocol, informed consent, investigator, or study procedures must be reviewed and approved by the IRB before implementation.
6. Handling Vulnerable Populations
The IRB ensures additional protections when studies involve:
- Children
- Pregnant women
- Mentally challenged individuals
- Economically or socially disadvantaged groups
- Prisoners
7. Maintaining Records and Documentation
The IRB maintains detailed documentation such as:
- Minutes of meetings
- Membership rosters
- Protocol files
- Correspondence with investigators
- Approval letters
IRB Review Procedures
The IRB follows a structured review process to ensure fairness, ethical integrity, and regulatory compliance.
1. Submission of Documents
Investigators must submit required documents, including:
- Study protocol
- Investigator’s Brochure (IB)
- Informed Consent Form
- Case Report Forms
- Recruitment materials
- Compensation policies
2. Initial Review
The IRB conducts a full-board review, expedited review, or exemption review depending on the level of risk. In full-board reviews, all members participate in the discussion and decision-making.
3. Decision-Making
The IRB may issue one of the following decisions:
- Approval: Study can begin
- Conditional Approval: Minor modifications required
- Deferred: Major changes required
- Disapproval: Study is rejected due to ethical or scientific concerns
4. Continuing Review
IRB approval is not permanent. Studies must undergo periodic review (typically every 6–12 months) to ensure ongoing compliance.
5. Reporting of Adverse Events and Deviations
Investigators must report:
- Serious adverse events
- Unexpected problems
- Protocol deviations
- Non-compliance incidents
6. Study Closure
Once a study is completed, investigators must submit a final report. The IRB reviews this report before formally closing the study file.
Importance of the IRB in Clinical Research
The presence of an Institutional Review Board ensures that:
- Participant safety remains the top priority
- Research is ethically justified
- Regulatory compliance is maintained
- Transparent and accountable research practices are followed
- Scientific integrity is preserved
Detailed Notes:
For PDF style full-color notes, open the complete study material below:
PATH: PHARMD/ PHARMD NOTES/ PHARMD FIFTH YEAR NOTES/ CLINICAL RESEARCH/ COMPOSITION, RESPONSIBILITIES, PROCEDURES OF INSTITUTIONAL REVIEW BOARD (IRB).