IRB Ethical Assessment Framework
The IRB uses a deontology-based approach (Answer B) to assess the ethical acceptability of research studies, grounded in mandatory duties and obligations codified in federal regulations that prioritize the protection of human subjects' rights and welfare above all other considerations. 1
Primary Ethical Framework
The deontological approach means IRBs operate through a duty-based ethics system rather than weighing outcomes or consequences. This framework is established through:
- Federal regulations (45 CFR 46 and 21 CFR Parts 50,56) that create mandatory duties researchers must fulfill, forming the core of the IRB's duty-based ethics approach 1
- Three foundational ethical principles from the Belmont Report: respect for persons, beneficence, and justice, which guide IRB evaluation of individual research proposals 2, 3
- Protection of participant welfare takes precedence over research goals, even when studies could advance important scientific knowledge 1
Why Deontology, Not Utilitarianism
The IRB framework explicitly rejects a utilitarian approach (which would maximize overall benefit regardless of individual harm). Key evidence includes:
- Vulnerable populations receive additional protections demonstrating that individual rights cannot be sacrificed for collective benefit, as mandated by the Department of Health and Human Services 1
- IRBs evaluate research through duty-based checklists that include subject selection fairness, risk minimization, informed consent, and confidentiality protections as fundamental rights that must be respected 1
- The paramount responsibility is protecting rights and welfare of individual subjects, not maximizing societal knowledge gain 4
Practical Application of Deontological Review
IRBs operationalize this duty-based approach through specific mandatory criteria:
- Risk minimization is evaluated as a fundamental duty to protect participants from harm, according to Office for Human Research Protections guidelines 1
- Informed consent is treated as a fundamental right that must be respected, reflecting the duty to respect autonomy per American Medical Association standards 1
- Confidentiality protections are required as part of the duty to protect privacy, in accordance with HIPAA 1
- Assessment of vulnerability focuses on duty-based considerations, not merely weighing potential benefits against risks 1
Common Pitfall to Avoid
Do not confuse the IRB's consideration of risks and benefits with utilitarian ethics. While IRBs do assess risks and benefits 2, this assessment occurs within a deontological framework where certain duties (informed consent, protection of vulnerable populations, minimization of harm) are non-negotiable regardless of potential scientific benefit 1. The risk-benefit analysis serves to fulfill the duty of beneficence, not to calculate maximum utility.