Federal Guidance

The following websites provide information about research ethics and regulations. Links are also provided to other organizations with which researchers at Seattle Children's collaborate.

Office for Human Research Protections (OHRP)

• OHRP Home Page
• Federal Regulations for Research with Human Subjects
  Department of Health and Human Services, 45 CFR Part 46 including Subpart D, Additional DHHS Protections for Children Involved as Subjects in Research IRB Guidebook for Protecting Human Research Subjects
• The Belmont Report
• The Nuremberg Code
• The World Medical Association Declaration of Helsinki

U.S. Food and Drug Administration (FDA)

• FDA Home Page
• Guidance for IRBs and Clinical Investigators
• International Conference on Harmonization – ICH Guidance Documents