Human Studies

Human Studies

External Links

Office of Human Research Protections (http://www.hhs.gov/ohrp/)

• Belmont Report (http://www.hhs.gov/ohrp/humansubjects/guidance/belmont.htm)


• Common Rule (HHS) (http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm)


• Guidebook for IRBs (http://www.hhs.gov/ohrp/irb/irb_guidebook.htm)


• OHRP Compliance Activities: Common Findings and Guidance


• OHRP Policy Guidance by Topic (http://www.hhs.gov/ohrp/policy/index.html)

Food and Drug Administration Guidance (http://www.fda.gov/)

• Guidance for IRBs and Investigators (http://www.fda.gov/oc/ohrt/irbs/default.htm)


• Differences between FDA regulations and Common Rule (HHS) (http://www.fda.gov/oc/ohrt/irbs/appendixe.html)

HIPAA Privacy Rule Information for Researchers (http://privacyruleandresearch.nih.gov/)

International Research

• Declaration of Helsinki-Ethical Principles for Medical Research Involving Human Subjects (http://www.wma.net/e/ethicsunit/helsinki.htm).

The Council for International Organizations of Medical Sciences-International Ethical Guidelines for Biomedical Research Involving Human Subjects (http://www.cioms.ch/).