delete PART 46—PROTECTION OF HUMAN SUBJECTS
Federal regulation establishing IRB oversight and ethical requirements for human subjects research conducted, supported, or regulated by any federal agency. Requires informed consent, special protections for vulnerable populations, and compliance with Belmont Report principles. Creates complex administrative regime covering domestic and international research with extensive exemptions and waiver processes.
Imposes massive compliance costs that divert research funds to bureaucracy, disproportionately harming small institutions and delaying life-saving discoveries. Federal overreach replaces state-level and professional self-regulation with one-size-fits-all rules. Unseen consequence: defensive IRB practices block socially valuable research, while the administrative state expands its power through periodic reinterpretation of 'identifiable' data definitions.