IRB Ethical Assessment Framework
The primary approach used by Institutional Review Boards (IRBs) to assess the ethical acceptability of research studies is deontology (Answer: B), which is a duty-based ethical framework that prioritizes the mandatory protection of human subjects' rights and welfare through adherence to regulatory obligations, rather than weighing outcomes or consequences. 1
Deontological Foundation of IRB Review
The IRB operates fundamentally on deontological principles, where protection of research participants is treated as an absolute duty rather than a calculation of benefits versus harms:
Federal regulations establish mandatory duties and obligations that researchers must fulfill, codified in the Code of Federal Regulations (Revised Common Rule: 45 CFR 46,2018, Food and Drug Administration: 21 CFR Parts 50,56), which forms the duty-based framework for IRB review 1, 2
Protection of participant welfare takes precedence over research goals, even when studies could advance important scientific knowledge, reflecting the deontological principle that certain duties cannot be compromised for potential benefits 1
IRBs serve as the reviewing entity to protect human research participants through independent review that ensures appropriate safeguards exist, regardless of the potential scientific value of the research 1
Why Not Utilitarianism
While IRBs do consider risks and benefits, this is not a utilitarian calculation where the greatest good for the greatest number justifies the research:
The IRB's primary responsibility is protecting rights and welfare of subjects, not maximizing overall societal benefit 1, 3
Vulnerable populations receive additional protections even when their participation might yield valuable research data, demonstrating that individual rights cannot be sacrificed for collective benefit 1, 2
The principle goal of the IRB is to protect human subjects, growing out of a history where utilitarian justifications led to unethical research 4
Key Duty-Based Review Criteria
IRBs evaluate research through mandatory checklists that reflect deontological obligations:
Subject selection fairness is assessed as a duty to avoid exploitation, not merely as a means to optimize research outcomes 1
Risk minimization is evaluated as a fundamental duty to protect participants from harm 1, 2
Informed consent process is treated as a fundamental right that must be respected, reflecting the duty to respect autonomy 1, 2
Confidentiality protections are required as part of the duty to protect privacy 1, 2
Regulatory Framework Supporting Deontology
Federal legislation requires IRB review of all research involving human subjects to protect human rights, establishing this as a mandatory duty rather than optional consideration 5
Ethical principles of respect for persons, beneficence, and justice guide IRB decisions, all of which are deontological principles focused on duties owed to individuals 5
IRBs conduct regular and independent reviews to protect health, rights, and welfare of research subjects as an ongoing obligation 6
Common Pitfall
The most common misunderstanding is viewing IRB review as a utilitarian cost-benefit analysis. IRBs do not approve studies simply because potential benefits outweigh risks; they ensure that fundamental duties to protect participants are fulfilled, that risks are minimized as an obligation, and that informed consent respects individual autonomy as a right, not as a means to an end 1, 7.