In response to the questions posed in this scenario, the Office of Laboratory Animal Welfare (OLAW) and the United States Department of Agriculture, Animal and Plant Health Inspection Service, Animal Care (USDA, APHIS, AC) offer the following clarification and guidance:

IACUC communications can be complex. USDA regulations and PHS Policy allow the IACUC Chair to designate (if Full-Committee review has not been requested by any IACUC member) at least one qualified IACUC member to review research projects involving the care and use of animals. The phrase “primary reviewer” does not exist in regulation or policy. Each Designated Reviewer has the authority to approve, require modifications in (to secure approval), or request Full-Committee review. If any Designated Reviewer calls for Full-Committee review, then the protocol must go to Full-Committee review. If modification of the protocol occurs at any stage of the review, all Designated Reviewers must see and approve the changes. If each Designated Reviewer approves the protocol they must all reference the same version of the protocol. All Designated Reviewers' approvals, requests for modifications, or calls for Full-Committee review must be documented.

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