Compliance - CPP
Regulatory Compliance at Cal Poly Pomona
Not everyone will be involved with these activities, but it’s good information to have available just in case.
| |Maya Monges-Hernandez , BS |
|Dr. Sadiq Shah, PhD |Compliance Associate, Office of Research Compliance |
|Associate Vice President for Research, |Bldg. 1, room 229 - 909.869.4215, mayah@cpp.edu |
|Innovation, and Economic Development |assisted by Esra Ibili BS and Desiree Vera BS |
|Institutional Official for IRB and IACUC | |
| |Research with humans |Research with vertebrate animals |
|oversight committee |IRB – Institutional Review Board |IACUC – Animal Care and Use Committee |
|chair(s) |Chair: Dr. Bonny Burns-Whitmore, professor, |Chair: Dr. Joanne Sohn, jsohn@cpp.edu |
| |bburnswhitmo@cpp.edu | |
| |Vice Chair: Dr. Heather wizikowski, hewizikowski@cpp.edu | |
|web URL | | |
|training |- must possess training in the discipline (e.g., research with minors, mouse IV injections) |
| |- staff are available to provide training as well |
| |- students must have faculty mentors for guidance in their conduct of research |
| |- (Collaborative Institutional Training |- the CITI lab animal training modules are |
| |Initiative), an on-line training course in the protection of |required as of 2011 |
| |human research subjects is required as of 2007 |- (ALL) from the American Association for|
| | |Laboratory Animal Science |
| |- CITI also provides courses on the Responsible Conduct of Research for non-animal and -human studies |
|safety |- risks (emotional, physical, reputation, etc.) to either |- chemical, ABSL (animal bio-safety), physical (bites and sharps), |
|concerns |subjects or investigative staff |radiation |
| |- “release” of private and personal information |- risk assessment (eRASQ) must be completed |
| |- adverse event reporting form available |- info from EH&S and the biosafety committee |
|applies to |- virtually any research project utilizing human volunteers |- vertebrate animals used in research and teaching, so Building 92 |
| |involving CPP, whether faculty or student |Animal Facility, Building 8 vivarium and frog room, Building 4 |
| |- contributions to “generalizable knowledge,” fitting the |BioTrek, Building 67 Equine Research Center, and AHS/AVS lab areas |
| |federal regulatory definition of research |- does not to traditional “agricultural” animals, unless used in |
| |- classroom teaching improvement projects often do not qualify,|bio-medical research or AHS/AVS teaching |
| |if not to be published |- does not to invertebrates |
|collaborations |- yes: with faculty from other institutions and persons |- yes: with other universities, with bio-tech firms |
| |utilizing CPP people | |
|regulatory bodies |- DHHS, Office for Human Research Protections (OHRP) |- NIH, Office of Laboratory Animal Welfare |
| | |- USDA |
|program |- none at this time |- The animal facilities were accredited (8X) by the Association for |
|recognition | |the Assessment and Accreditation of Laboratory Animal Care, Int’l |
| | |(AAALAC)- none at this time |
|the protocol |- submit your protocol via Cayuse; it is reviewed by the |- submit your protocol to the electronic protocol system for review by|
|application process |exempt, expedited, or full IRB method by members of the IRB |members of the IACUC |
|grants and contract |- with the grant office in ORSP (Research and Sponsored Programs), can assist in complying with regulations, rules, and policies at |
|development |federal, state, and CPP levels during the grant writing phase |
| |- will match the grant for funds against the research protocol application (sponsors and funders require compliance) |
Regulatory Compliance at Cal Poly Pomona.doc, version June ‘18
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