IRB Ethical Framework
The Institutional Review Board (IRB) primarily uses a deontology-based approach to assess the ethical acceptability of research studies, focusing on mandatory duties and 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 duty-based ethical framework where:
Federal regulations establish mandatory duties and obligations that researchers must fulfill, forming the core deontological approach used by IRBs. 1 This is codified in the Code of Federal Regulations (Revised Common Rule: 45 CFR 46,2018) which establishes non-negotiable requirements. 1
Protection of participant welfare takes precedence over research goals as an absolute duty, not as a calculation of benefits versus harms. 1 This means that even if a study could advance medical knowledge significantly, the IRB's primary obligation is to protect individual rights.
Individual rights cannot be sacrificed for collective benefit, demonstrating the deontological rejection of utilitarian calculations. 1 The Department of Health and Human Services guidelines explicitly establish this principle for vulnerable populations. 1
How This Differs from Utilitarianism
The IRB does not use a utilitarian approach (Option A) because:
- IRBs do not simply weigh potential societal benefits against risks to participants. 1
- The framework treats certain protections as absolute duties rather than factors to be balanced in a cost-benefit analysis. 1
- Vulnerable populations receive additional protections regardless of whether this maximizes overall research benefit. 1
Key Deontological Review Criteria
The IRB evaluates research through duty-based checklists that include:
- Risk minimization as a fundamental duty to protect participants from harm, not merely as one factor among many. 1
- Informed consent process as a fundamental right that must be respected, reflecting the duty to respect autonomy. 1
- Confidentiality protections required as part of the duty to protect privacy, in accordance with HIPAA. 1
- Subject selection fairness as part of the duty to avoid exploitation. 1
Practical Application
When reviewing protocols, IRBs:
- Assess whether investigators have considered and addressed how best to protect individuals and communities who may be vulnerable due to their circumstances, treating this as a mandatory obligation. 1
- Ensure appropriate safeguards exist through ethical review, with the primary responsibility being protection of rights and welfare. 1
- Evaluate whether the informed consent process provides participants sufficient opportunity to consider participation, treating consent as an inviolable right. 1
Common Pitfall
A critical mistake is assuming IRBs perform utilitarian calculations where research benefits can justify compromising individual protections. 1 The deontological framework means certain protections are non-negotiable regardless of potential scientific advancement. 1