ࡱ> PROc kbjbjʉʉ AHffkjj,!|||$!||"0+?[^ 0!q"Zq"q"|Z@4Jv|||F|||!q"|||||||||j u: ACUC Protocol Amendment Policy (protocol amendment.doc; version: April 6, 2015; originally approved by the ACUC October 25, 2006) Investigators contemplating changes to approved protocols should consult the ACUC Chair, University Veterinarian, or Office of Research Compliance Associate for advice. A change is called an amendment and may have either a minor or major (significant) impact to the conduct of the study in terms of the use of animals. Federal regulations and guidelines both instruct on what is a major change and allow for the establishment of policy as well at the institutional level when it is approved by the ACUC. According to current policy, an amendment must be filed with the ACUC and approved. The table below summarizes the established amendment policies as reviewed by the ACUC and the appropriate action that can be taken. A procedure not included in the table is not to be construed as meaning no amendment is required. In such a case, please consult with the ACUC. Amendments should be filed using the ACUC e-protocol system at:  HYPERLINK "https://academic.cpp.edu/animalcare/" https://academic.cpp.edu/animalcare/ In late 2014, the PHS Policy on Humane Care and Use of Laboratory Animals and USDA Animal Welfare Regulations both defined the responsibilities of an animal care and use committee regarding review and approval of proposed significant changes to animal activities. Modifications were made subsequently to this guideline and include veterinary review of items marked * in Major (Significant) Change Procedure below. Minor Change Procedure - can be approved by the Chair (administrative review) - can be deferred to review (designated member or full committee) by the ACUC at Chairs discretionAny change (addition or deletion) in personnel other than the responsible principal investigator (PI, usually a faculty member); the ACUC must be advised of the addition of students, whether as research associates or graduate studentsapproved October 25, 2006An increase of up to 5% in the number of rats or mice approved for use for the 3-year approval period of the protocolapproved October 25, 2006Addition of a class section for teaching protocolsapproved October 25, 2006 Major (Significant) Change Procedure - must be reviewed (either designated member or full) by the ACUC - changes that have, or have the potential to have, a negative impact on animal welfareObjective(s) of the studyapproved October 25, 2006Change in the PIapproved October 25, 2006Switching from non-survival to survival surgeryapproved October 25, 2006The degree of invasiveness of a procedure or the amount of discomfort experienced by an animalapproved October 25, 2006Addition or change in the species (or strain, in special cases)approved October 25, 2006An increase in the number of animals to be used (greater than 5% rodents)approved October 25, 2006Change in anesthetic agent(s); the use or withholding of analgesics; sedation*, or experimental substances*approved October 25, 2006; modified April 06, 2015Change in the method of euthanasia approved in the AVMA Guidelines*approved October 25, 2006; modified April 06, 2015Duration, number, type*, or frequency of procedures performed on an animalapproved October 25, 2006A change that would impact personnel safetyapproved April 06, 2015A change in housing and or use of animals in a location that is not part of the animal program overseen by the ACUCapproved April 06, 2015Addition of the use of other hazardous materials (chemical, biological, physical) with no change to a safety level such as ASBLapproved April 06, 2015 (moved from minor) AGHNP[ 9 A a g | } ~  V reererhoht CJ^JaJhoh.CJ^JaJhoh0=CJ^JaJhohy:oCJ^JaJhoh CJ^JaJhoh|~CJ^JaJhohtCJ^JaJhohNACJ^JaJ hNAhNAh0=CJaJhoCJaJh|~CJaJhNAhNACJaJhNAhNA>*'} ~ *+By$$7$8$H$Ifa$gdo 7$8$H$`gdNA hh7$8$H$`hgdt$ hh7$8$H$`ha$gdt$a$gdNA * + ] ^ !)*+B`xy̻̒{{qcVIVVh\zQh.CJ^JaJh\zQhy:oCJ^JaJh\zQhNA5CJ^JaJh CJ^JaJhhCJ^JaJhCJ^JaJhohxCJ^JaJhoh|~0JCJ^JaJhoh|~CJ^JaJ!jhoh|~CJU^JaJhohtCJ^JaJhoh0=CJ^JaJhoh CJ^JaJhoht CJ^JaJ `Ztu.̾}抱}}}p}}p}}}}pb}}h\zQh0=5CJ^JaJh\zQh0=CJ^JaJh\zQh0=CJ^JaJh\zQhNACJ^JaJh\zQhtCJ^JaJh\zQh)CJ^JaJh\zQhNACJ^JaJh\zQhy:o5CJ^JaJh\zQhJZCJ^JaJh\zQh.CJ^JaJh\zQhy:oCJ^JaJh\zQhK|CJ^JaJ#rr $7$8$H$Ifgdo~kd$$Ifl$$ t0$622 s2:44 lasp yt\zQZthZZ $7$8$H$Ifgdokd$$Ifl0P$P@ t0$622 s2:44 laspyt\zQtuhZZ $7$8$H$Ifgdokdf$$Ifl0P$P@ t0$622 s2:44 laspyt\zQhZZZZ $7$8$H$Ifgdokd%$$Ifl0P$P@ t0$622 s2:44 laspyt\zQ/hWWW$$7$8$H$Ifa$gdokd$$Ifl0P$P@ t0$622 s2:44 laspyt\zQ./134 Smn   01PQRkŸŸŸŸŸŸŸŸshKWhKWCJ^JaJhKWCJ^JaJh\zQhCJ^JaJh5CJ^JaJhKWhCJ^JaJhCJ^JaJh\zQh0=CJ^JaJh\zQh0=CJ^JaJh\zQh|~CJ^JaJh|~h|~CJ^JaJh|~CJ^JaJh0=CJ^JaJ-rr $7$8$H$Ifgdo~kd$$Ifl$$ t0$622 s2:44 lasp yt\zQhZZ $7$8$H$IfgdokdX$$Ifl0$ t0$622 s2:44 laspyt\zQ3hZZ $7$8$H$Ifgdokd$$Ifl0$ t0$622 s2:44 laspyt\zQ34hZZ $7$8$H$Ifgdokd$$Ifl0$ t0$622 s2:44 laspyt\zQfXX $7$8$H$Ifgdokd$$Ifl0$ t0$622 s2:44 laspyt\zQ SmfXX $7$8$H$IfgdokdX$$Ifl0$ t0$622 s2:44 laspyt\zQmn fXX $7$8$H$Ifgdokd$$Ifl0$ t0$622 s2:44 laspyt\zQ RhZZ $7$8$H$Ifgdokd$$Ifl0$ t0$622 s2:44 laspyt\zQkm~!)-/01:>GOSVhijkȻȻ줱ss줱l hNAhoYh\zQhxCJ^JaJhxhxCJ^JaJhxCJ^JaJh\zQh|~CJ^JaJh\zQh|~CJ^JaJh|~CJ^JaJh\zQh0=CJ^JaJh\zQh0=CJ^JaJhKWCJ^JaJh\zQhKWCJ^JaJh5CJ^JaJhCJ^JaJ'hZZ $7$8$H$Ifgdokd $$Ifl0$ t0$622 s2:44 laspyt\zQ0hZZ $7$8$H$Ifgdokd\ $$Ifl0$ t0$622 s2:44 laspyt\zQ01hZZ $7$8$H$Ifgdokd $$Ifl0$ t0$622 s2:44 laspyt\zQ>VihZZZ $7$8$H$Ifgdokd $$Ifl0$ t0$622 s2:44 laspyt\zQijkhcgdokd $$Ifl0$ t0$622 s2:44 laspyt\zQ?0P&P:po/ =!"#$% Dp$$Ifl!vh#v$:V l t0$65$22 s2:asp yt\zQ$$Ifl!vh#vP#v@ :V l t0$65P5@ 22 s2:aspyt\zQ$$Ifl!vh#vP#v@ :V l t0$65P5@ 22 s2:aspyt\zQ$$Ifl!vh#vP#v@ :V l t0$65P5@ 22 s2:aspyt\zQ$$Ifl!vh#vP#v@ :V l t0$65P5@ /  22 s2:aspyt\zQ$$Ifl!vh#v$:V l t0$65$22 s2:asp yt\zQ$$Ifl!vh#v#v :V l t0$655 22 s2:aspyt\zQ$$Ifl!vh#v#v :V l t0$655 22 s2:aspyt\zQ$$Ifl!vh#v#v :V l t0$655 22 s2:aspyt\zQ$$Ifl!vh#v#v :V l t0$655 22 s2:aspyt\zQ$$Ifl!vh#v#v :V l t0$655 22 s2:aspyt\zQ$$Ifl!vh#v#v :V l t0$655 22 s2:aspyt\zQ$$Ifl!vh#v#v :V l t0$655 22 s2:aspyt\zQ$$Ifl!vh#v#v :V l t0$655 22 s2:aspyt\zQ$$Ifl!vh#v#v :V l t0$655 22 s2:aspyt\zQ$$Ifl!vh#v#v :V l t0$655 22 s2:aspyt\zQ$$Ifl!vh#v#v :V l t0$655 22 s2:aspyt\zQ$$Ifl!vh#v#v :V l t0$655 22 s2:aspyt\zQw2 0@P`p2( 0@P`p 0@P`p 0@P`p 0@P`p 0@P`p 0@P`p8XV~ 0@ 0@ 0@ 0@ 0@ 0@ 0@ 0@ 0@ 0@ 0@ 0@ 0@ 0@6666_HmH nH sH tH H`H Normal CJOJQJ_HaJmH sH tH DA D Default Paragraph FontRi@R  Table Normal4 l4a (k (No List jj NA Table Grid7:V06U`6 t Hyperlink >*B*phHH . 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Illingworth Oh+'0 $ D P \hpx ACUC Protocol Amendment PolicyBruce W KennedyNormalLaura C. Illingworth2Microsoft Office Word@F#@4M^@4M^&E  ՜.+,D՜.+,P  hp  Homed ACUC Protocol Amendment Policy Title 8@ _PID_HLINKSAL%https://academic.cpp.edu/animalcare/  !"#$&'()*+,./0123456789:;<=>@ABCDEFHIJKLMNQRoot Entry F`?[^SData %1Table-q"WordDocumentAHSummaryInformation(?DocumentSummaryInformation8GCompObjr  F Microsoft Word 97-2003 Document MSWordDocWord.Document.89q