evidence EV-SAFEGUARDS-2026-64C2

Human research requires consent risk-benefit assessment and equitable selection

Evidence Record

The Belmont principles of respect for persons, beneficence, and justice lead to requirements for informed and voluntary consent, systematic assessment of the probability and magnitude of harms and benefits, and equitable participant selection. Relevant harms include psychological, social, legal, and economic harms, not only physical injury.

The handoff study therefore cannot reuse employee work traces or recruit subordinates merely because they are convenient. Participation, withdrawal, identity protection, and non-use for performance management must be explicit.

Limitations

Belmont is ethical guidance, not a repository-specific legal determination. Applicability of the Common Rule or other law requires qualified review for the actual sponsor, participants, location, funding, and intended dissemination.