IRB Ethical Framework
The IRB uses a deontology-based approach to assess the ethical acceptability of research studies, focusing on duty-based obligations to protect human subjects' rights and welfare rather than weighing outcomes or consequences. 1
Primary Ethical Approach: Deontology (Answer: B)
The federal regulations that govern IRB review establish mandatory duties and obligations that researchers must fulfill, reflecting a fundamentally deontological framework rather than utilitarian cost-benefit analysis. 1 This duty-based approach is codified in the Code of Federal Regulations (Revised Common Rule: 45 CFR 46,2018) which establishes IRBs as the reviewing entity to ensure appropriate safeguards exist to protect the rights and welfare of research subjects. 2, 1
How Deontology Manifests in IRB Review
The deontological framework is evident in several key aspects of IRB review:
Protection of rights takes precedence over research goals - Individual participant welfare cannot be sacrificed for collective benefit or scientific advancement, even if the research could produce valuable knowledge. 1
Duty-based review criteria - IRBs evaluate research through mandatory checklists that assess fundamental duties including subject selection fairness (duty to avoid exploitation), risk minimization (duty to protect from harm), informed consent (duty to respect autonomy), and confidentiality (duty to protect privacy). 1
Vulnerable population protections - Additional safeguards for vulnerable groups demonstrate that individual rights are inviolable regardless of potential benefits, a core deontological principle. 1
Regulatory compliance as moral obligation - The federal regulations establish absolute requirements that must be met, not flexible guidelines to be balanced against outcomes. 1, 3
Why Not Utilitarianism
While IRBs do assess risks and benefits, this is done within a deontological framework where certain duties cannot be violated even if the research promises significant societal benefit. 1 The primary goal is protecting human subjects through adherence to ethical duties, not maximizing overall utility or favorable outcomes. 4, 5
Common Pitfall
A frequent misunderstanding is that IRB risk-benefit assessment represents utilitarian thinking. However, the IRB's evaluation of risks and benefits occurs only after establishing that fundamental duties (informed consent, privacy protection, fair subject selection) have been met - these duties are non-negotiable regardless of potential benefits. 1, 3