Primary Responsibility of the Institutional Review Board (IRB)
The primary responsibility of an Institutional Review Board (IRB) is to protect the rights and welfare of human subjects participating in research studies by ensuring appropriate safeguards exist through the ethical review of research protocols. 1
Core Functions of IRBs
IRBs serve as the reviewing entity established by federal regulations to protect human research participants through advance and periodic independent review of research proposals 1, 2
They evaluate research protocols to ensure they meet criteria for approval as outlined in the Code of Federal Regulations (Revised Common Rule: 45 CFR 46.111) 1
IRBs assess whether investigators have considered and addressed how best to protect individuals and communities who may be vulnerable due to their circumstances 1
They conduct comprehensive examinations of studies for ethical issues, including invasiveness and management of personal information 3
Regulatory Framework
The protection of human subjects in the United States is codified within the Code of Federal Regulations (Revised Common Rule: 45 CFR 46,2018, Food and Drug Administration: 21 CFR Parts 50,56) 1
IRBs operate under principles established in the Belmont Report, which forms the foundation for human research protection regulations 4
They are required to perform regular and independent reviews to ensure ongoing protection of research participants 3
Key Areas of IRB Review
IRBs focus on evaluating the risks and benefits of proposed research to ensure participant safety 5
They assess whether research subjects are recruited fairly and that potential benefits are distributed equitably 5
IRBs review the informed consent process to ensure participants have sufficient opportunity to consider whether to participate 1
They evaluate study design to determine if it has the possibility of answering the research hypothesis 5
IRBs assess plans for protecting research subjects from risks and managing data, especially protected health information 5
Special Considerations for Vulnerable Populations
IRBs pay particular attention to the vulnerability of individuals or populations who may be asked to participate in research 1
They ensure additional protections for vulnerable groups such as the elderly, persons with medical comorbidities, and racial/ethnic minorities who may be disproportionately affected in certain research contexts 1
IRBs evaluate whether investigators have addressed how best to protect the welfare of individuals affected by special circumstances, such as disasters 1
Common Pitfalls and Challenges
Inconsistency in IRB reviews across different institutions can lead to varying requirements for identical protocols 6
The review process can sometimes be perceived as time-consuming and burdensome without clear evidence of effectiveness 2
IRBs may face challenges in balancing thorough ethical review with the need for timely research implementation, particularly in time-sensitive contexts like disaster research 1
Many IRBs lack specific training for specialized research contexts, such as disaster research protocols, which may require unique ethical considerations 1