Vulnerable Populations

The Office for Human Research Protections (OHRP) has identified populations in need of special protections in research. IRBs must apply additional regulations and criteria and give special consideration to recruitment, subject selection, informed consent, privacy, and confidentiality issues before approving research involving these populations:

Prisoners:

• Research Involving Prisoners
• Investigator Checklist for Studies Involving Prisoners

Children:

• Guidelines: Requirements for Research Involving Children
• Investigator Checklist for Research Involving Children
• Ambulatory Pediatric Association Policy Statement (2/2005)
• American Academy of Pediatrics: Guidelines for the Ethical Conduct of Studies to Evaluate Drugs in Pediatric Populations

Pregnant Women and/or Fetuses:

• Investigator Checklist for Research Involving Pregnant Women and Fetuses (10/2006)
• Subpart B: Additional Protections for Pregnant Women, Human Fetuses and Neonates Involved in Research (10/2006)

Ethical Principles of Human Subjects Research

• The Belmont Report (hhs.gov)
• The Nuremberg Code (nih.gov)
• The Declaration of Helsinki (wma.net)