CIP Study Guide 2026

Expedited review is a specific category of IRB review designed for research studies that pose no more than minimal risk to participants and fall into certain federally defined categories. This process allows for a quicker review by a single IRB member or a small subcommittee, rather than the full board. It streamlines the approval process for low-risk research while still ensuring ethical oversight.

Continuing review is a mandatory periodic review of ongoing research protocols by the IRB, typically conducted at least annually. Its purpose is to ensure that the research continues to meet ethical standards, that participant safety is maintained, and that any changes or new information are properly assessed. This ongoing oversight ensures compliance throughout the study's duration.

Data confidentiality is a cornerstone of ethical research overseen by IRBs. It ensures that sensitive information collected from participants is safeguarded, preventing unauthorized access or disclosure. This protection is crucial for upholding the trust between researchers and participants, and for minimizing potential harm or stigma associated with their involvement in a study.

The body of knowledge guides daily decision-making.

Protocol amendments that increase risk or burden to subjects must receive prospective IRB approval before implementation; retrospective events require reporting but not pre-approval.

IRB administrators are responsible for the operational aspects of the IRB, including scheduling meetings, preparing agendas, and ensuring all necessary documentation is present. They play a critical role in maintaining compliance with federal regulations, institutional policies, and ethical guidelines by managing the review process efficiently and accurately. Their work supports the IRB's ability to protect human subjects effectively.