Which of the following significant changes to a protocol could be administratively approved in principle by WVC?

Full Committee Review (FCR)

Full committee review of protocols requires a convened meeting of a quorum of the IACUC members. The PHS Policy and AWRs are explicit that proposals reviewed by the full committee must receive the approval vote of a majority of the quorum present in order to receive approval.

The Committee has the authority to approve, require modifications in (to secure approval), disapprove, or table (defer until future meeting) any proposed activity. In many cases, the Committee finds the protocols approvable on certain conditions and votes to allow the protocol to be reviewed, and approved, using the Designated Member Review (DMR) process.

Designated Member Review (DMR)

Designated member review requires that each IACUC member must be provided with a copy of the protocol document from the IACUC Chair. Committee members are given at minimum five (5) business days to review the protocol document and respond either allowing the DMR to review the protocol or to hold the protocol for the next FCR. If any one member votes to hold the protocol until the next IACUC meeting, then the protocol is placed on the agenda for the next IACUC meeting. Otherwise, the protocol is reviewed by the DMR.

The IACUC Chair designates one or more qualified members to review the proposal (or proposed amendment or annual renewal). These designated member(s) have authority to approve, require modifications in (to secure approval), or request full committee review. A designated reviewer may not withhold approval; this action may only be taken if the review is conducted using the full committee method of review.

Administrative Review (AR)

While Federal regulations allow for two types of review of animal use protocols (FCR and DMR), recent guidance from the Office of Laboratory Animal Welfare (OLAW) granted authority for a small number of items to be administratively approved. Amendment/modification applications to existing protocols that involve certain changes not considered significant can be reviewed (and approved) administratively.

Notification of Review Outcome

The IACUC Chair will notify investigators of the IACUC's decision to approve or withhold approval of those activities related to the care and use of animals, or of modifications required to secure IACUC approval as set forth in the PHS Policy IV.C.4.

Which of the following significant changes to a protocol would be administratively approved in principle by VVC?

Which of the following is considered a minor change that would not require formal IACUC review and approval?

Which of the following is the general guideline that IACUCs use to evaluate the potential pain of a procedure conducted with animals Citi?

Who is authorized to overturn a decision by an IACUC to suspend an activity involving animals?