IRB Guidance

As of March 1, 2016, all new applications, modifications, renewals, reportable new information and other work must be submitted to the HSPP via Click IRB. Visit the Click IRB Resources page for additional information.

Web Resources

The following websites provide information about research ethics and regulations. Links are also provided to other organizations with which researchers at 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 (PDF)
• The World Medical Association Declaration of Helsinki

U.S. Food and Drug Administration (FDA)

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