HRPP Manual Section 6-8

Special Categories of Research Subjects

Revised Common Rule (2018 Requirements)

“(b) When some or all of the subjects are likely to be vulnerable to coercion or undue influence, such as children, prisoners, individuals with impaired decision-making capacity, or economically or educationally disadvantaged persons, additional safeguards have been included in the study to protect the rights and welfare of these subjects.” 45 CFR 46.111(2018 Requirements)

Pre-2018 Requirements

“(b) When some or all of the subjects are likely to be vulnerable to coercion or undue influence, such as children, prisoners, pregnant women, [handicapped, or] mentally disabled persons, or economically or educationally disadvantaged persons, additional safeguards have been included in the study to protect the rights and welfare of these subjects.” 45 CFR 46.111(Pre-2018 Requirements), 21 CFR 56.111 [FDA]

Institutional Review Board (IRB) members should evaluate research studies to determine what, if any, subjects likely to be vulnerable to coercion or undue influence will be included in the research population, such as children, prisoners, pregnant women, mentally disabled persons, individuals with impaired decision-making capacity, and economically or educationally disadvantaged persons. If the research population includes subjects likely to be vulnerable to coercion or undue influence, IRB members should evaluate whether additional safeguards are necessary to protect these subjects. If the investigator has included additional safeguards, the IRB members should evaluate whether the safeguards are adequate.

Additional provisions of the federal regulations governing human subjects research also govern research and related activities involving pregnant women, human fetuses, and neonates, (45 CFR 46 subpart B), prisoners (45 CFR 46 subpart C) and children (45 CFR 46 subpart D; 21 CFR 50 subpart D).

Applicability of the Revised Common Rule (2018 Requirements)
See HRPP Manual Section 4-11 “Applicability of the Revised Common Rule (2018 Requirements),” for a description of whether the Revised Common Rule (2018 Requirements) or the Pre-2018 Common Rule Requirements apply.

Additional Considerations
For policies and procedures on certain vulnerable populations, see the following sections of the Human Research Protection Program (HRPP) Manual:

6-8-A        Pregnant Women, Human Fetuses and Neonates
6-8-B        Prisoners
6-8-C        Children and Minors
6-8-D        Individuals with Diminished Capacity
6-8-E        HIV and AIDS

For research studies subject to the requirements of the U.S. Department of Education or the International Conference on Harmonization Good Clinical Practice (E6), see the following sections of the HRPP Manual:

2-2-D        U.S. Department of Education
2-4            International Conference on Harmonization Good Clinical Practice (E6)

This policy and procedure supersedes those previously drafted.

Approved By: Vice President of Research and Graduate Studies, 4-21-2005. Revision 1 approved by VP Research & Graduate Studies on 7-22-2011. Revision 2 approved by Senior VP for Research and Innovation on 1-18-2019.

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