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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