1. Institutional Review Boards (IRBs)

For the SOCRA exam, IRBs (also called Independent Ethics Committees or IECs) are heavily tested, especially concerning their fundamental role and criteria for approval.

Critical Testable Concepts Key Details Citations
Primary Purpose To safeguard the rights, safety, and well-being of all human subjects/trial participants.
Membership Requirements Must include at least one member whose primary concerns are non-scientific. Must also include at least one member who is not affiliated with the institution.
Criteria for Approval The IRB must determine that all requirements of 21 CFR 56.111 / 45 CFR 46.111 are met, including: risks are minimized, risks are reasonable in relation to benefits, selection of subjects is equitable, and adequate provisions for privacy/confidentiality.
Continuing Review The IRB must conduct continuing review of research at intervals appropriate to the degree of risk, but no less than once per year.
IRB Records Retention IRB records related to conducted research must be retained for at least 3 years after completion of the research.
Expedited Review Can be used if the study involves no more than minimal risk, or for minor changes to approved research. The IRB Chairperson or a designated experienced IRB member performs this review.

2. Unanticipated Problems (UAPs)

This is a frequently tested concept, especially concerning the criteria that distinguish a UAP from a regular Adverse Event (AE) and the associated reporting timelines.

Critical Testable Concepts Key Details Citations
Definition / Criteria An incident, experience, or outcome must meet all three criteria to be a UAP involving risks to subjects or others: 1. Unexpected (in nature, severity, or frequency). 2. Related or possibly related to participation in the research. 3. Suggests the research places subjects/others at a greater risk of harm than previously known or recognized.
Examples of UAPs UAPs are not limited to AEs; they can also include protocol deviations that cause harm, confidentiality breaches (e.g., stolen unencrypted laptop data), and subject incarceration.
Investigator Reporting (to IRB) The investigator must promptly report unanticipated problems involving risk to human subjects or others to the IRB. For unanticipated adverse device effects (UADEs), the investigator must report to the sponsor and IRB no later than 10 working days after discovery.
IRB Reporting (to Officials) The IRB must report all unanticipated problems to appropriate institutional officials, DHHS, and OHRP within 1 month of receiving the report from the investigator.

3. 45 CFR Part 46

This regulation is critical because it forms the basis for human subjects protection in much federally funded research and overlaps with FDA regulations.

Critical Testable Concepts Key Details Citations
Scope This part outlines the protection of human subjects, primarily for research conducted or supported by the U.S. Department of Health and Human Services (HHS).
"The Common Rule" Subpart A of 45 CFR Part 46 is sometimes referred to as "The Common Rule".
Vulnerable Populations This regulation includes specific subparts (Subparts B, C, and D) detailing additional protections for certain vulnerable populations: Subpart B: Pregnant Women, Human Fetuses, and Neonates. Subpart C: Prisoners. Subpart D: Children.