HSR - Regulations - Research and Technology Transfer

Federal Regulations

Human Subject Regulations Decision Charts

The Office of Human Research Protections (OHRP) provides guides for institutional review boards (IRBs), investigators, and others to aid in determining if an activity is research involving human subjects that must be reviewed by an IRB under the requirements of the U.S. Department of Health and Human Services (HHS) regulations at 45 CFR 46.

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)

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.

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

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

International Compilation of Human Research Standards, 2020 Edition.

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