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Annual Review Reports The Human and Animal Research Protections Office (HARPO) will monitor the cycle and forward notification to investigators of the requirements for continuing review at least thirty (30) days before the scheduled end date. An administrative review of vertebrate protocols is required prior to the end of the protocol period. The investigator will submit to HARPO, at least thirty (30) days before the first day of the anniversary month, a report of any changes or departures from the originally submitted protocol and a narrative explanation for such changes. If no changes have been made, a statement to that effect must be submitted. Changes that are minor will be approved administratively by the IACUC Chair. HARPO, on behalf of the IACUC Chair, will notify investigators of the Chair’s decision regarding the approval of the administrative review. Substantive changes must be submitted and approved by the IACUC as indicated in Modifications section. Three-Year Renewals PHS Policy (IV.C.5.) states "the IACUC shall conduct continuing review of activities covered by this policy at appropriate intervals as determined by the IACUC but not less than once every three (3) years". UMBC animal research protocols are approved for a three-year term. The investigator or instructor must resubmit, at least ninety (90) days before the next regularly scheduled IACUC meeting, a new application for Committee review in order to continue research activities. It is the responsibility of the principal investigator (PI) to maintain the “approval” status of his or her protocol(s). HARPO will generally give advanced notice when protocols need three-year renewals and will provide help when requested. Per PHS Policy, the IACUC may not extend the three-year approval by any means other than IACUC review and approval using the procedures of IV.C.2. When IACUC approval expires, it is no longer valid - there are no exceptions and no extensions of approval granted by the IACUC. No experimental use or observation of animals may take place during a protocol lapse period. Continuation of animal activities beyond the expiration is a serious and reportable violation of PHS Policy. A protocol closure report must be submitted if the protocol will not be renewed. See the UMBC IACUC Forms section of the web site for further guidance. A new Animal Research Protocol Form must be submitted; this form undergoes the same review process as any new protocol. The renewal should include all previous modifications or amendments made to the protocol since its original approval. See the UMBC IACUC Forms section of the web site for further guidance. |
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Last updated 04/28/2008 |
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