In the IACUC/OLAW framework, what is an Assurance, and who submits it?

• A. An Assurance is the institution's internal safety policy submitted to OLAW.
• B. An Assurance is a grant proposal to fund animal care facilities.
• C. An Assurance is the institution's financial plan to cover animal care costs, submitted to OLAW.
• D. An Assurance is the institution's formal plan to comply with humane care and use standards, submitted by the institution to OLAW.

Answer: (D)

An Assurance is the institution's formal plan to comply with humane care and use standards for animals in research, and it is submitted by the institution to OLAW. This document outlines how the institution will structure and oversee its entire animal care and use program, including the IACUC, personnel training, veterinary care, facilities, and adherence to the applicable policies and guides. It is submitted by the institution—typically through the Institutional Official or a designated administrator—to the Office of Laboratory Animal Welfare (OLAW) and is kept on file as a condition for receiving or continuing PHS funding, with periodic updates as standards or practices change. The other options don’t fit because the Assurance is not merely an internal safety policy, a grant proposal, or a financial plan; it is the formal, comprehensive commitment to meet humane care and use standards required by OLAW for PHS-supported activities.