Regulations and Policies
The Office of Human Research Protection (OHRP) within the U.S. Department of Health & Human Services (HHS) evaluates written substantive indications of noncompliance with HHS regulations. OHRP provides public disclosure of cases involving violations and remedies. These disclosures illustrate issues where institutions and individuals, are in non-compliance with federal regulations during the course of research project activities.
The scope of violations often involves unforeseen risks to human subjects in the course of experimental studies, the under-reporting of issues related to noncompliance on the part of principal investigators and other parties, and the failure of institutional bodies to provide appropriate oversight and corrective action, including prompt reporting to the OHRP and funding sources, if any.
Consequences of violations of the requirements of Title 45 – Public Welfare Part 46 of the Code of Federal Regulations (45 CFR 46) are severe, Penalties can range from written warning and reprimand, to fines and sanctions against the offending institution and/or researchers, and in some cases the withdrawal of federal funding for all sponsored projects.
Title 45 CFR U.S. Dept. of Health & Human Services, Part 46: Protection of Human Subjects
Title 45 CFR, Part 46, Subpart B: Additional Protections for Pregnant Women, Human Fetuses and Neonates Involved in Research
Title 45 CFR, Part 46, Subpart C: Additional Protections Pertaining to Biomedical & Behavioral Research Involving Prisoners as Subjects
Title 45 CFR, Part 46, Subpart D: Additional Protections for Children Involved as Subjects in Research
OHRP Frequently Asked Questions (FAQ)
OHRP Vulnerable Populations
OHRP Vulnerable Populations – Children
OHRP Vulnerable Populations – International
OHRP Vulnerable Populations – Prisoners