Policy and Regulations
Mines employees and students engaged in approved Human Subjects Research are responsible for conducting the Research in accordance with the approved Research protocol, and in compliance with all applicable Mines policies and State and Federal regulations governing Human Subjects Research.
Human Subjects Research Protection Policy and Procedure
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.
Common Rule
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.
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.
The Family Educational Rights and Privacy Act (FERPA)
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
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 guidance’s pertaining to the GDPR and other international standards on human subjects protections in 131 countries and from many international organizations.