IRB Ethical Framework: Deontology-Based Approach
The IRB uses a deontology-based approach (Answer: A) to assess the ethical acceptability of this Alzheimer's disease fish oil research study, prioritizing the fundamental duty to protect participants' rights and welfare over potential research benefits. 1
Primary Ethical Framework
The IRB's ethical review is grounded in duty-based principles rather than utilitarian calculations of overall benefit. This means:
- The IRB evaluates research through mandatory duties and obligations codified in federal regulations (45 CFR 46.111), not by weighing collective benefits against individual risks. 1
- The protection of human subjects' rights takes precedence over research goals, even when the study could potentially advance Alzheimer's treatment. 1
- Federal regulations establish a deontological framework where certain protections are non-negotiable duties, not subject to cost-benefit analysis. 1
Why Not Utilitarianism
While some have argued that IRBs could use utilitarian philosophy when "public good outweighs personal risks," this approach is explicitly rejected in standard IRB practice because it violates individuals' fundamental rights to privacy and autonomy. 2 The regulatory framework does not permit IRBs to sacrifice individual protections for collective benefit. 1
Application to Vulnerable Alzheimer's Patients
For this specific study involving elderly individuals with cognitive impairment:
- IRBs must assess vulnerability as a duty-based consideration, providing additional protections that cannot be waived even if the research shows promise. 1
- The informed consent process is treated as a fundamental right that must be respected, reflecting the duty to respect autonomy—particularly critical given the cognitive impairment in Alzheimer's patients. 1
- Risk minimization is evaluated as a fundamental duty to protect participants from harm, not as one factor in a utilitarian calculation. 1
Key Deontological Review Criteria
The IRB applies duty-based checklists that include:
- Subject selection fairness as a duty to avoid exploitation of vulnerable populations 1
- Confidentiality protections as a duty to protect privacy 1
- Adequate informed consent procedures as a duty to respect individual autonomy 1
Common Pitfall
The critical error would be assuming IRBs use utilitarian reasoning to approve studies based on potential Alzheimer's treatment advances. The deontological framework means that even promising research must meet all duty-based protections, and participant welfare cannot be compromised for research goals. 1