The policy provides the regulatory definition for a prisoner and outlines additional safeguards and conditions for conducting research involving prisoners.  The policy also discusses what to do if a research subject becomes a prisoner while they are enrolled in a study.

The policy provides definitions and outlines what conditions must be met before the IRB can approve research involving pregnant women, fetuses, and neonates of uncertain viability.

The policy establishes guidelines for when and how to assess for decision making capacity in adults participating in a research study.

This policy describes additional responsibilities assigned to the IRB and to the investigator under DHHS regulations (45 CFR 46 Subpart D) and FDA regulations (21 CFR 50 Subpart D), as applicable.  These regulations protect children who are the subjects of research.

The policy describes additional requirements for the review of research involving minors who are Wards of the State.  A “Ward” or “Ward of the State” shall mean a minor (under 18 years of age) who is under the legal custody of a state or a subdivision of the State (e.g., a minor placed in foster care in accordance with applicable state law).