IRB Ethical Framework
The Institutional Review Board (IRB) primarily uses a deontology-based approach to assess the ethical acceptability of research studies, focusing on duty-based obligations to protect human subjects' rights and welfare rather than weighing outcomes or consequences. 1
Primary Ethical Framework: Deontology (Answer: B)
The IRB operates fundamentally through a deontological lens, which emphasizes:
- Mandatory duties and obligations codified in federal regulations (Revised Common Rule: 45 CFR 46, Food and Drug Administration: 21 CFR Parts 50,56) that researchers must fulfill as part of the IRB's duty-based ethics approach 1
- Protection of participant welfare takes precedence over research goals, even when studies could advance medical treatment, reflecting the deontological framework where individual rights cannot be sacrificed for collective benefit 1
- Fundamental rights that must be respected regardless of potential research benefits, including autonomy, privacy, and protection from harm 1
How Deontology Manifests in IRB Review
The duty-based approach is operationalized through specific review criteria:
- Risk minimization is evaluated as a fundamental duty to protect participants from harm, not as a calculation of acceptable trade-offs 1
- Informed consent is treated as an inviolable right that must be respected as part of the duty to respect autonomy 1
- Confidentiality protections are required as part of the duty to protect privacy, mandated by regulations like HIPAA 1
- Subject selection fairness is assessed as a duty to avoid exploitation, particularly for vulnerable populations 1
Why Not Utilitarianism
While IRBs do consider risks and benefits, this is not a utilitarian calculation:
- The IRB's primary responsibility is to protect rights and welfare through ethical review, not to maximize overall research benefit 1
- Vulnerable populations receive additional protections demonstrating that individual rights cannot be sacrificed even if research could benefit society 1
- Protection standards are applied as absolute duties rather than being weighed against potential societal gains 2, 1
Regulatory Foundation
The deontological framework is embedded in federal law:
- The Code of Federal Regulations establishes IRBs as the reviewing entity to assure appropriate safeguards exist, creating legally mandated duties 2
- IRBs utilize duty-based checklists with standard questions covering research design, subject selection, risks and benefits, confidentiality, and informed consent 2
- These criteria represent obligations that must be met, not factors to be balanced against research value 1