Reference Information for Researchers
Publications/information for clinical research operations
External websites related to Human Subject Research
About FDA Centers & Offices
This link will take you directly to the FDA's operational centers and offices.
A direct link to the Council for International Organizations of Medical Sciences’ (CIOMS) International Ethical Guidelines for Biomedical Research Involving Human Subjects.
A registry of federally and privately supported clinical trials conducted in the US and globally.
Code of Federal Regulations (CFR) Title 21
This is a direct link to FDA's regulations, Title 21 of the US Code of Federal Regulations (CFR), Parts 1-1499.
Code of Federal Regulations (CFR) Title 45 Part 46
Known as "the common rule," this is a direct link to HHS regulation, Title 45 of the US Code of Federal Regulations (CFR), Part 46, Protection of Human Subjects.
Declaration of Helsinki
A direct link to the World Medical Association's Declaration of Helsinki - Ethical Principles for Medical Research Involving Human Subjects.
HHS' Office for Human Research Protections (OHRP)
A portal to the Office for Human Research Protections (OHRP) at HHS.
HHS' Office of Research Integrity (ORI)
A portal to the Office of Research Integrity (ORI) at HHS.
International Conference on Harmonisation (ICH)
ICH GCP Guideline (E6)
National Institutes of Health (NIH)
NIH policies, guidance documents, and information on health and clinical research topics.
NIH's Office of Human Subjects Research
A portal to the Office of Human Subjects Research (OHSR) at NIH.
A direct link to the Nuremberg Code: Directives for Human Experimentation.
Running Clinical Trials
FDA resources on clinical trials.
The Belmont Report
A direct link to The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research.
US Department of Health & Human Services (HHS)
HHS regulations, policies, guidance documents, and information on health and clinical research topics.