Vice Presidency for Planning and Academic Affairs

Ana G. Mendez University System

Vice Presidency for Planning and Academic Affairs

Associate Vice Presidency for Sponsored Programs

Office of Regulatory Compliance

Animal Care and Use Committee Review Determinations

Approve / The ACUC has determined that, for a particular animal use and teaching protocol, appropriate justification for animal use has been made, a search for acceptable alternatives to animal use has been demonstrated, and methods described are within standard and acceptable guidelines. The ACUC signifies its approval of a research protocol by issuing a letter to the Principal Investigator that the research protocol has been reviewed, approved, and may be conducted.
Modifications required (securing approval) / Protocols with a review status of modifications required are most typically in need of one (or more) minor corrections or clarifications. Conditional approval does not, however, mean that the study can be initiated. The PI must first comply fully with all conditions arising from the ACUC’s review.
Tabled / The ACUC may table a protocol pending receipt of additional substantive information or a significant revision of the protocol. This determination is used during the process of full committee review when the ACUC decides it is necessary for the whole committee to review the protocol again before further action can be taken. The protocol needs to go back to the next convened meeting
Not Approved / The ACUC has determined that, for a particular research protocol, the risks outweigh the benefits to be gained by conducting that research. Approval may be withheld if any of the PHS Policy (IV, C, 1) or AWAR (§2.31, d, 1; §2.31, d, 2, e) criteria is met. Research protocols might also be denied because:
·  The protocol is overly confusing or convoluted and not understood by the ACUC (e.g., poorly written or excessive technical language or jargon);
·  Procedures described are not considered acceptable according to current standards and justification made was not sufficient to endorse deviation.
A protocol may also be administratively disapproved when a Principal Investigator has not responded to a request for additional information and/or modifications from the ACUC in a timely fashion (30 business days). This study will not be accepted again. The PI must submit a new protocol.

ACUC_Rev_Determinations ~ 1 ~

Approved 08/09