On October 16, 2008 the Office for Human Research Protections (OHRP) released two updated Guidance documents:

• Guidance on Engagement of Institutions in Human Subjects Research [PDF - 66KB]
• Guidance on Research Involving Coded Private Information or Biological Specimens [PDF - 41KB]

• Ethical Guidelines & Regulations
• NIH Human Subjects Policies and Guidance
• OHRP & FDA

• Pregnant Women, Human Fetuses and Neonates
• Prisoners
• Children
• Persons at Risk for Suicidality
• Persons with Impaired Decisional Capacity

• Flowchart: Research Involving Private Information or Biological Specimens (PDF - 27 KB)
• Implementation Instructions and Definitions
• FAQ

• Training Resources

• From Applicants
• About Research Using Human Specimens, Cell Lines or Data

• NIH Process for Applications that Propose Research Involving Human Subjects (MS Word - 36 KB)
• Resources
• NIH Reports on Human Subjects Research
• Glossary
• NIH Forms and Applications