Resources and Regulations
The Office of Research Integrity and Compliance has collected the following links as a resource for investigators and participants.
Office of Human Research Protections (OHRP):
- 45 CFR 46 – Regulations that govern all federally funded human research
- 45 CFR 164 – The HIPAA Privacy Rule as applicable for research
Food & Drug Administration (FDA) regulations:
- 21 CFR 50 – Protection of Human Subjects and Informed Consent
- 21 CFR 56 – IRBs
- 21 CFR 312 – Investigational new drugs (IND) and biologics
- 21 CFR 812 – Investigational new devices (IDE)
- The Belmont Report – This document describes the fundamental ethical principles - respect for persons, justice, and beneficence – of which form the foundation for the U.S. Federal Regulations
- The Declaration of Helsinki – This international consensus statement describes additional ethical principles to guide research with human participants.
- ICH Guidelines – These are the international standards for the conduct of clinical trials.
- International Ethical Guidelines for Biomedical Research Involving Human Subjects – This statement describes ethical principles for international research.
- Engagement of Institutions in Human Subjects Research OHRP Guidance
- OHRP and FDA Informed Consent Guidance
- Clinical Trials Guidance
- OHRP FAQs:
- Clinical Trials Registry (clinicaltrials.gov) – a search engine for registered Clinical Trials that provides information about the study’s purpose, participation, location, and contact information.
- Understanding Medical Research – project patientInform
- NIH Website:
- FDA Website:
- Association for Accreditation of Human Research Protections Programs (AAHRPP): The accreditation body that ensures human research protection programs meet rigorous standards for quality and protection
- Learn more about research with the NIH YouTube catalog
- Office of Research Integrity (ORI) website
