1. 1 KRA Research Compliance Kuali Days VI Presenters: Lori Schultz, University of Arizona E. Ray Stinson, Ph.D., Cornell University May 14, 2008

2. 2 KRA and Coeus Collaboration Coeus – Academic consortium of more than 46 institutions, some of which are using the compliance module to support their IRB –continues its development of additional compliance modules and functionality (Individual Financial COI, IACUC) KRA –Academic “consortium” with a community-source development mission to create (1) a single, web-based interface that achieves functional equivalence to Coeus, (2) meets stakeholder interface design requirements and (3) provides improved user help and implementation documentation Both organizations recognize the benefits that can accrue through the collaboration of KRA and Coeus schools in the development of new compliance modules.

3. 3 KRA/Coeus Joint Collaboration Coeus initially developed new functionality for supporting the IRB in 2002 and released the module in 2004 Coeus Enhancements since 2004 –Web-base interface (Coeus Lite) –Submission of protocols to the IRB Beginning in 2007 KRA used those modules as a base for a web-interface that achieves functional equivalence to Coeus

4. 4 KRA Compliance Modules Release 2.0 (August 2009) –IRB, Individual Financial Conflict of Interest Release 3.0 (September 2010) –Animal Care & Use* Release 4.0 (October 2011) –Bio-Safety*, Export Controls*, Chemical Safety/Chemical Tracking* *Joint development with the Coeus Consortium

5. 5 IACUC Compliance Module In 2007 Coeus Steering Committee identified the IACUC as high priority for the next compliance module As part of their collaboration with KRA they wanted to develop new modules as a web-based application with improved user help and implementation documentation

6. 6 IRB Module Support As part of the IRB module, Coeus was required to develop capabilities for –Appoint and manage committee membership –Schedule meetings –Submit protocols (new, continuations, amendments) to a committee –Assign protocols/continuations/amendments to a committee –Establish agendas for a committee –Record deliberations (Minutes) Information that is communicated to the Investigator (e.g. Conditions) or Private to the Committee Review Process (e.g. Waiver of documentation of consent) –Generate correspondence (Batch and Individual notifications) –Document Training Requirements –Documenting Special Review –Conducting queries

7. 7 IRB Module Support Development of institutional Yes/No questions (Coeus version 4.2) Development of questionnaire that is expandable depending upon response (Coeus version 4.3 and KRA)

8. 8 Compliance Committee Support In hindsight, those committee and protocol support activities are required for any compliance and/or review module Therefore as part of the jointly developed IACUC Compliance Module the committee and protocol support activities will be decoupled from the IRB Compliance Module for use by other compliance modules –Individual Financial Conflict of Interest –IACUC –Institutional Bio-safety Committee –Embryonic Stem Cell Oversight Committee –Chemical Safety Committee/Chemical Inventory –Radiation Safety –Other Institutional Review Committees

9. 9 IACUC Module Key Objectives Customer Focus: Develop all functionality in collaboration with investigators and all stakeholders Compliance: Define and develop IACUC protocol review functionality that meets regulatory requirements Collaboration: Develop the IACUC module applying the strengths of KRA and Coeus to the development effort Foundation: Build the IACUC module utilizing Coeus 4.3 IRB module as a foundation Process: Ensure timely and quality development of documentation through all project phases -- Scope Definition, Design and Testing User Documentation: Complete user documentation to support end user training and implementation

10. 10 Institutional Stakeholders IACUC - Oversight of the Animal Care Programs and the review and approval of individual protocols Primary Investigator - Submission of new, continuation, amendments to the IACUC for review and approval CO-Investigators and Key Personnel - Review of status and the details of new, continuation, amendments submitted by the PI to the IACUC for review and approval Animal Resources - Review of protocols submitted and/or approved by the IACUC Facilities Management - Review of protocols submitted and/or approved by the IACUC Research Compliance - Provided administrative support to the IACUC and evaluated compliance with approved protocols Training - Documentation of on-line courses, face-to-face training sessions and individualized instructions

11. 11 Institutional Stakeholders (continued) Bio-Safety Committee – Review of IACUC protocols for use of biological agents Occupational Medicine - Review of IACUC protocols for occupational risk to individuals coming into contract with the animals Environment Health and Safety - Review of IACUC protocol for radiation, biosafety, and other other environmental health issues Institutional Officials - Review of IACUC protocols and the general animal care and use program Sponsored Programs Offices - Determines the status of the review and approval of animal use protocols that correspond to grant applications and contract proposals Sponsors - Reports provided by the institution on the status of individual protocols, grant applications and contract proposals.

12. 12 Regulatory Agencies Stakeholders U. S. Department of Agriculture - Reports on the use of animals in agriculture and biomedical facilities NIH, Office of Laboratory Animal Welfare - Reports on the use of animals in biomedical research. Department of Homeland Security - Reports on the use of animals Federal Drug Administration - Reports on the use of animals in biomedical facilities. Center for Disease Control - Reports on exposures etc. Environmental Protection Agency - Reports on the use of animals Various State Agencies - Reports on the use of animals

13. 13 Accreditation Agencies Stakeholders Association for the Assessment and Accreditation of Laboratory Animal Care

14. 14 Benefits Improved access to information: Provide a single source to view and manage grant applications and IACUC compliance protocols through a common interface. Save time and hassle for investigators: Provides review and approval by the IACUC and ultimately other related compliance committees (e.g. Institutional Bio-safety Committee, Occupational Medicine, ESCRO) and the institution. Improve ongoing management: Allows for the notification of the need for an updated continuation report and for the ease of submission and approval of continuations and amendments. Improved data and timely reporting: Allows for the ease of reporting at the IACUC and institutional level for all activities that is proposed and/or approved for the use of animals (Inspections, USDA Reports, Incident Reports, OLAW Reports, state reporting requirements).

15. 15 Additional Benefits Linkages to Learning Management System –Responsible Conduct in Research Submission of research activities for compliance review, not IRB, IACUC, IBC, ESCRO, Occupational Medicine, Chemical Safety, Radiation Safety review

16. 16 IACUC First Release Protocol Submission to include all aspects of protocol submission and review –Protocol Development –Submission to the IACUC –Designated and/or Full Committee review by the IACUC –Generate all correspondence with the principal investigator and committee Committee management –Membership –Area of research expertise –Species Experience –Voting vs. Non-voting member and Committee Meeting schedules –Much like that already set up for the IRB.

17. 17 IACUC Future release(s) Inspections – Would include an addition process for supporting the semi- annual and annual report Census – Number of animals on hand each month. Procurement – Requisition,- collects the order data, or what the principal investigator proposes to purchase from a vendor, acquire from another institution or breed in-house. Receiving and cage card management. allows the animal facility to record what was actually received and generate data for cage cards or labels and to start health records for the incoming animals. Regulatory/Non-regulatory Reporting – OLAW (Annual Report); USDA (Annual report); AAALAC-I (Annual Report) Training and Educational Requirements – tracking personnel qualifications to work with vertebrate animals and continuing education of IACUC members. Post-approval monitoring – Assure activities proposed in protocols is equivalent to applications.

18. 18 Additional Compliance Modules – Conflict of Interest Faculty, staff, and students disclosure Tracking of disclosures, reviews and decisions Separate financial disclosure information –Confidential –Non-confidential Allow for uniqueness of state laws regarding COI different Training Requirements

19. 19 Additional Compliance Module – Bio- safety Submission of Memorandum of Understanding (MOU) on biological materials, including select agents Submission of MOU amendments and renewals Review of the MOU Production of IBC minutes Monitoring of approved MOU Reporting of non-compliance Facilities inspection

20. 20 Additional Compliance Module - Export Control Certification questionnaire with routing approval Office of Foreign Asset Control (OFAC) purchases Functionality to be determined

21. 21 Additional Compliance Module - Chemical Safety/Chemical Inventory Includes Controlled substance program Functionality to be determined

22. 22 Additional Compliance Module – Radiation Safety Functionality to be determined

23. 23 Additional Committee Module – Limited Submission and Intramural Programs Functionality to be determined

24. 24 Future Predictions Additional modules Bio-Safety, Export Controls, Chemical Safety/Chemical Inventory, Radiation Safety, Intramural, etc) may be developed by the consortium and/or institutions meeting their individual needs/timetable and then sharing the code back to the KRA community