Federal Regulations


Code of Federal Regulations

The Office of Human Research Protections (OHRP) makes available the full text of the Health & Human Services regulations for the protection of human subjects in research (45 CFR 46), the Common Rule (45 CFR 46 Subpart A), and the FDA human subject protection regulations.

Code of Regulations, Title 45: Public Welfare, Department of Health and Human Services, Part 46: Protection of Human Subjects (45 CFR 46)

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The Belmont Report
The Belmont Report, Ethical Principles and Guidelines for the Protection of Human Subjects of Research, is available from the OHRP as well as other materials about the Belmont Report.
FERPA (Family Education Rights and Privacy Act)
The Family Educational Rights and Privacy Act of 1974 (20 U.S.C § 1232g; “FERPA”) sets out requirements for the protection of privacy of student records under section 444 of the General Education Provisions Act. Human subjects research that intends to use educational records protected under FERPA must comply with the federal regulations as well as Mines’ FERPA policy.

FERPA Guidance for Human Subject’s Research

GDPR (EU General Data Protection Regulation)
The European General Data Protection Regulation (GDPR) took effect on May 25, 2018. Because of its likely effect on US federally funded human subjects research conducted in Europe, the Office for Human Research Protections has compiled a listing of guidances pertaining to the GDPR. These documents are classified as:
  • General Guidance
  • Research
  • Legal Basis
  • Consent
  • International Data Transfer

Compilation of Guidances on the EU General Data Protection Regulation applicability to human subjects research.

As country-level interpretations, procedures, and applicability continue to evolve, we encourage you to reach out to Mines’ legal counsel or the Human Subjects Committee with questions around GDPR related to research.