Institutional Animal Care and Use Committee

Use of Designated Member Review for Animal Protocols

 

Including addendum to an animal use protocol for a pilot study to be performed using Core Service-where Core service is used just to generate data from a pilot study, provided all procedures are approved in the Core Protocol. 

Only two protocol review methods fulfill USDA and PHS requirements—full committee and designated member. The actual Policy description of “designated-member review” is as follows: “If full committee review is not requested, at least one member of the IACUC, designated by the Chairperson and qualified to conduct the review, shall review those research projects and have the authority to approve, require modifications in (to secure approval) or request full committee review of those research projects.”

This method is equally acceptable for use by IACUCs when conducting protocol review, but it must proceed as outlined in the PHS Policy. Using this method, all IACUC members receive a list of proposed research projects and access to the necessary information on the protocol to be reviewed. If any member feels that this protocol should go before a full committee, then its review must be deferred to the next full IACUC meeting. Any member can make the decision to send the protocol to full-committee review at any time during the time period designated for providing this opportunity. It is useful for IACUCs to allow a predetermined time period during which members may indicate which method of review is preferred. If no member calls for a full-committee review, then the Chair can refer the protocol in question to a designated reviewer. The Chair may select one or more members, qualified to review this specific protocol, who will act on behalf of the entire IACUC to approve the protocol, request additional information from the PI to approve it, or refer it for full review. The designated reviewer does not have the power to withhold approval, however, but must in such cases refer the protocol for full-committee review.

The designated-reviewer approval has equal validity to full-committee review approval and does not require subsequent re-approval or notification by a convened meeting. It is always possible for the IACUC to discuss protocols approved by either method in future meetings as a form of continuing review or in response to animal welfare concerns.

See:

 https://grants.nih.gov/grants/guide/notice-files/NOT-OD-09-035.html 

https://grants.nih.gov/grants/guide/notice-files/NOT-OD-11-053.html 

https://grants.nih.gov/grants/olaw/references/laba02v31n9.htm 

Addendum to Animal Use Protocol 

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