* required * Provide detail of steps to be taken to ensure additional protection of the rights and welfare of the identified vulnerable population(s).
WHY THIS INFORMATION IS IMPORTANT TO THE IRB:
The DOH IRB follows additional guidance and regulations for certain populations considered to be vulnerable.
INVESTIGATOR HELP:
Supplemental information is required when Principal Investigators plan to conduct research involving vulnerable populations. Review of guidance documents may be helpful in completing questions on the IRB application specific to protection of vulnerable populations in research.
IRB POLICIES AND PROCEDURES:
IRB Policy 6.1 - Special Categories of Research: Pregnant Women, Fetuses, and Neonates
IRB Policy 6.3 - Special Categories of Research: Children
IRB Policy 6.4 - Special Categories of Research: Cognitively Impaired
IRB Policy 6.5 - Special Categories of Research: Prisoners
It is the policy of the DOH IRB to review, approve, and provide guidance on the special ethical and regulatory considerations when vulnerable populations are involved in human subjects research.
FEDERAL REGULATIONS/GUIDANCE:
Inclusion of Children in Research http://www.hhs.gov/ohrp/children/
Inclusion of Women/Minorities in Research http://www.hhs.gov/ohrp/irb/irb_chapter6.htm
Inclusion of Prisoners in Research http://www.hhs.gov/ohrp/special/prisoners/
IRB Guidebook - Special Participant Classes http://www.hhs.gov/ohrp/irb/irb_chapter6.htm