What primary ethical approach does an Institutional Review Board (IRB) use to assess the acceptability of a study involving children with diabetes in schools?

IRB Ethical Framework for Research Involving Children with Diabetes in Schools

The primary ethical approach used by Institutional Review Boards (IRBs) to assess the acceptability of research involving children with diabetes in schools is deontology (duty-based ethics), not comparatism, subjectivism, or utilitarianism. 1

Core Ethical Framework

IRBs operate under a deontology-based approach where the protection of human subjects' rights and welfare is treated as an absolute duty, not as a calculation of benefits versus harms. 1 This duty-based framework is codified in federal regulations (the Revised Common Rule: 45 CFR 46.111 and FDA regulations: 21 CFR Parts 50,56) that establish mandatory obligations researchers must fulfill. 1

Why Not Utilitarianism

The key distinction is that IRBs do not use utilitarian calculus (weighing collective benefits against individual harms). 1 Instead:

• Protection of participant welfare takes precedence over research goals, even if the study could advance diabetes treatment knowledge. 1
• Individual rights cannot be sacrificed for collective benefit, particularly when dealing with vulnerable populations like children. 1
• The IRB's primary responsibility is to protect rights and welfare through ethical review, not to maximize overall societal benefit. 1

Application to Pediatric Diabetes Research

When reviewing studies involving children with diabetes in schools, IRBs must assess several duty-based considerations:

Vulnerability Assessment

• IRBs evaluate whether investigators have addressed how to protect children, who are inherently vulnerable due to their age and developmental status. 2, 1
• Additional protections are required for vulnerable groups, and this assessment is a duty-based consideration, not merely weighing potential benefits. 1

Mandatory Review Criteria

IRBs evaluate research through duty-based checklists that include: 1

• Risk minimization as a fundamental duty to protect participants from harm 1
• Fair subject selection to avoid exploitation 1
• Informed consent process as a fundamental right that must be respected, including parental permission for children 1
• Confidentiality protections as part of the duty to protect privacy 1

Special Considerations for School Settings

The school environment adds complexity because children with diabetes require ongoing medical management during school hours. 2 IRBs must ensure that research protocols:

• Do not interfere with necessary diabetes care activities (blood glucose monitoring, insulin administration, hypoglycemia treatment) 2
• Account for the variable developmental capabilities of children at different ages to provide self-care 2
• Ensure research activities do not compromise the safety of students who may experience diabetes emergencies 2

Common Pitfalls to Avoid

• Assuming utilitarian justification is sufficient: Even if a study could significantly advance diabetes care knowledge, this does not override the duty to protect individual participants. 1
• Inadequate informed consent processes: This represents a fundamental breach of duty-based ethics, particularly problematic in pediatric research where both parental permission and child assent may be required. 3
• Failing to assess vulnerability appropriately: Children represent a vulnerable population requiring additional protections beyond standard review. 2, 1

The answer to your question is that none of the three options provided (comparatism, subjectivism, or utilitarianism) correctly describes the IRB's primary ethical approach—the correct framework is deontology (duty-based ethics). 1