Applicable Regulations or Guidance

The FDA and the DHHS have regulations that contain provisions for protecting various categories of vulnerable subjects.

The following links provide access to the specific federal regulations:

• The Common Rule 45 CFR 46 Subpart B-Additional Protections for Pregnant Women, Human Fetuses and Neonates Involved in Research
• The Common Rule 45 CFR 46 Subpart C-Additional Protections Pertaining to Biomedical and Behavioral Research Involving Prisoners as Subjects
• The Common Rule 45 CFR 46 Subpart D-Additional Protections for Children Involved as Subjects in Research
• FDA 21 CFR 50 Subpart D-Additional Safeguards for Children in Clinical Investigations

The following links provide additional interpretive guidance from the FDA and the DHHS, including guidance on various vulnerable populations:

• Guidance from the FDA
• Guidance from the DHHS OHRP

Protecting Vulnerable Subjects