IRB Ethical Framework: Deontology-Based Approach
The primary approach used by Institutional Review Boards (IRBs) to assess the ethical acceptability of research studies, including those involving Alzheimer's disease patients receiving fish oil, is deontology (answer b). 1
Core Deontological Framework
IRBs operate under a duty-based ethical system that prioritizes the protection of human subjects' rights and welfare as mandatory obligations, rather than weighing outcomes through utilitarian calculations. 1 This approach is codified in federal regulations (the Revised Common Rule: 45 CFR 46) that establish specific duties researchers and institutions must fulfill. 1, 2
The deontological framework means that protecting participant welfare takes precedence over research goals, even if the study could advance Alzheimer's treatment. 1 This is fundamentally different from utilitarianism, which would balance potential societal benefits against individual risks.
How Deontology Applies to Alzheimer's Research
When reviewing a study involving people with Alzheimer's disease receiving fish oil, the IRB evaluates the research through duty-based criteria:
Respect for autonomy as a fundamental right: The informed consent process must be respected regardless of potential benefits to society. 1 For Alzheimer's patients, this requires presuming capacity unless formally established otherwise and supporting decision-making before resorting to surrogate consent. 3
Duty to protect from harm: Risk minimization is evaluated as a fundamental obligation to protect participants, not as a calculation balanced against potential knowledge gains. 1
Protection of vulnerable populations: IRBs must assess vulnerability of elderly individuals with cognitive impairment as a duty-based consideration, requiring additional safeguards. 1, 4 This protection cannot be overridden by arguments about advancing dementia research. 5
Duty to ensure fairness: Subject selection must be fair to avoid exploitation, evaluated as an obligation rather than an outcome. 1
Why Not the Other Options
Utilitarianism (option a) would focus on maximizing overall benefit—weighing potential advances in Alzheimer's treatment against risks to individual participants. This is explicitly not how IRBs operate. 1 The regulatory framework establishes mandatory duties that cannot be sacrificed for collective benefit. 1
Ethical skepticism (option c) questions whether ethical knowledge is possible and would not provide a framework for systematic review—this is incompatible with the structured regulatory approach IRBs must follow. 2
Comparativism (option d) is not a recognized ethical framework used in research ethics review.
Practical Implications for This Study
For the Alzheimer's fish oil study specifically, the IRB's deontological approach requires:
Ensuring adequate informed consent processes or appropriate surrogate consent mechanisms are in place, as a duty to respect autonomy. 5
Implementing additional safeguards for this vulnerable population beyond what might be required for capable adults. 5, 4
Evaluating whether risks are minimized independent of potential benefits to Alzheimer's research. 1
Protecting confidentiality as a fundamental duty, not merely as a means to encourage participation. 1
Common Pitfall
A common misunderstanding is that IRBs perform cost-benefit analyses weighing societal gains against individual risks—this would be utilitarian reasoning. 1 Instead, IRBs enforce duty-based protections that exist regardless of how beneficial the research might be. 5, 1 This explains why important Alzheimer's research can be restricted or halted if adequate protections for decisionally impaired subjects are not in place, even when families and patients want to participate. 5