IRB Ethical Review Approach
The Institutional Review Board (IRB) primarily uses a deontology-based approach (Answer B) to assess the ethical acceptability of research studies, including those involving vulnerable populations like elderly individuals with Alzheimer's disease receiving fish oil supplementation.
Primary Ethical Framework
The IRB system is fundamentally grounded in duty-based (deontological) ethics rather than outcome-based (utilitarian) reasoning:
- IRBs are established to protect the rights and welfare of research subjects as their primary duty, regardless of the potential benefits the research might yield 1, 2
- The protection of human subjects is codified in federal regulations (45 CFR 46,21 CFR Parts 50,56) that establish mandatory duties and obligations that researchers must fulfill 1, 2
- The principle goal of the IRB is to protect human subjects, not to maximize overall societal benefit 3
Why Deontology, Not Utilitarianism
The distinction is critical in understanding IRB function:
- Deontological approach: IRBs focus on whether the research respects fundamental rights, duties, and principles (informed consent, privacy, autonomy) independent of outcomes 2, 4
- Utilitarian approach would: Weigh potential benefits to society against harms to participants, potentially justifying harm if overall benefit is maximized
- IRBs explicitly reject utilitarian calculus by requiring protection of individual participants even when research could benefit many others 5, 6
Application to Alzheimer's Research
For the described study involving elderly Alzheimer's patients receiving fish oil:
- IRBs must assess vulnerability of this population (elderly with cognitive impairment) as a duty-based consideration, not merely weighing potential benefits 1
- Informed consent capacity must be evaluated as a fundamental right, regardless of how beneficial fish oil might be 2
- Protection of participant welfare takes precedence over research goals, even if the study could advance Alzheimer's treatment 1
Key IRB Review Criteria (Deontological Framework)
IRBs evaluate research through duty-based checklists that include 1:
- Research design adequacy (duty to conduct scientifically sound research)
- Subject selection fairness (duty to avoid exploitation)
- Risk minimization (duty to protect from harm)
- Informed consent process (duty to respect autonomy)
- Confidentiality protections (duty to protect privacy)
Common Pitfall
The most common error is assuming IRBs use utilitarian reasoning (weighing societal benefits against individual risks). While IRBs do assess risks and benefits, this assessment is constrained by deontological principles—certain rights cannot be violated even for greater good 5, 4.