IRB Ethical Framework
The IRB primarily uses a deontology-based approach to assess the ethical acceptability of research studies, making the answer B. Deontology. 1
Regulatory Foundation
The IRB operates under a duty-based ethical framework established by federal regulations, specifically the Revised Common Rule (45 CFR 46) and FDA regulations (21 CFR Parts 50,56). 1 This regulatory structure creates mandatory duties and obligations that researchers must fulfill, which is the hallmark of deontological ethics rather than utilitarian cost-benefit analysis. 1
How Deontology Manifests in IRB Review
The deontological approach is evident in how IRBs evaluate research protocols through specific duty-based criteria:
Protection of rights and welfare is treated as an absolute duty, not as something to be weighed against potential research benefits. 1, 2
Informed consent is evaluated as a fundamental right that must be respected regardless of whether waiving it might produce better research outcomes. 1
Risk minimization is assessed as a mandatory obligation to protect participants from harm, not as a calculation of acceptable risk-benefit ratios. 1
Confidentiality protections are required as an inherent duty to protect privacy, mandated by regulations like HIPAA. 1
Fair subject selection must avoid exploitation as a duty-based requirement, even if certain populations might benefit more from the research. 1
Why Not Utilitarianism
While utilitarian considerations (maximizing overall benefit) might inform research design, the IRB's primary framework explicitly rejects pure utilitarian calculus. 1 This is most clearly demonstrated in the treatment of vulnerable populations—IRBs provide additional protections for groups like the elderly, cognitively impaired, and racial/ethnic minorities even when their inclusion might maximize research benefit. 1, 3 Protection of individual participant welfare takes precedence over research goals, which directly contradicts utilitarian principles that would sacrifice individual welfare for collective benefit. 1
Practical Application
The IRB reviews research through duty-based checklists mandated by federal regulations, ensuring that each protocol meets specific ethical obligations before approval. 1, 4 This systematic approach to protecting human subjects has evolved over decades from historical failures (Nuremberg Code, Belmont Report) to minimize the probability of harm to research participants. 2