Coeus Tiger Team Final Report August 5, 2010 Executive Summary As originally charged by UCSD leadership, the Coeus Tiger Team successfully concluded a campus upgrade from MIT Coeus version 3.8 to MIT Coeus 4.3.2. As part of this upgrade, the Tiger Team brought together all central offices involved in sponsored project administration, established consistent policies and processes for creating and updating Coeus records, developed and executed a rigorous quality assurance testing plan, and produced a comprehensive Coeus documentation & training website. These efforts have laid the foundation for a phased campus‐wide implementation of long anticipated online proposal development functionality. Once implemented, online proposal development will retire the antiquated paper based “RES” form, and replace it with a modern, real‐time electronic proposal preparation and submission system that includes a web‐based portal for department faculty and staff, integrates UCSD’s financial and research compliance systems, and incorporates system to system transmission to federal proposal and award systems. To realize cost savings and streamlining from electronic ‘cradle to grave’ sponsored project administration, the Tiger Team recommends the campus establish a standing advisory committee to continue the work begun by the Coeus Tiger Team. This successor committee will have responsibility for improving UCSD’s sponsored projects business processes; identifying electronic research administration needs; evaluating current and proposed modules and functionality of Kuali Coeus and other systems; developing project implementation plans in conjunction with various research administration stakeholders; and monitoring and managing the execution of these plans. The Tiger Team envisions that the first task of this successor committee will be to implement the proposal development and compliance modules as described in this report. I. Coeus Tiger Team In 2008, the Chancellor challenged the campus to identify strategic opportunities for administrative streamlining that could yield significant cost‐savings for the university. In response to this request, Vice Chancellor Relyea hosted a series of focus groups with campus leaders and managers to identify and prioritize potential streamlining projects. 1
Improving and upgrading UCSD’s contract and grant system (Coeus) was identified as the #1 priority during these meetings1. Subsequently, a nine member team was charged with developing and executing a plan for the successful upgrade and long‐term sustainability of UCSD’s Coeus system. Coeus Tiger Team members included: • Joni Ciarletta – Electrical and Computer Engineering • Jason DeFay – Research Affairs • Robert Dias – Administrative Computing and Telecommunications • Lynelle Gehrke – Office of Contract and Grant Administration • Pamela Alexander – Office of Contract and Grant Administration • Marianne Generales – Team Leader, Research Affairs • Elizabeth Meier – Scripps Institution of Oceanography • Isabella Bryant‐Parkinson – OPAFS • Alma Palazzolo – OPAFS • Nancy Roberts – Neurosciences • Andrea Rollins – Health Sciences Sponsored Projects Office One key expectation was that by migrating to the latest version of Coeus and taking advantage of increased functionality available in newer system versions, UCSD would be in a position to achieve higher levels of customer service at a lower overall cost. a. Background: Coeus at UCSD Coeus, the Greek Titan of Intelligence, is the name MIT gave to the research administration system they developed in the 1990s. UCSD licensed the right to use this software from MIT, and in 2002 began using it to track proposals and material transfer agreements, and manage awards. Since then, programmers in ACT have continually customized the application to better meet UCSD’s needs. Unfortunately, as a result of these programmatic enhancements, UCSD’s version of Coeus became expensive to maintain, and the campus was increasingly unable to accept periodic and routine program enhancements directly from the Coeus Consortium. Consequently, UCSD has not been able to use new system features such as the compliance modules, the proposal development platform, software bug fixes, and other system enhancements that were available to peer institutions using Coeus “out of the box” (e.g. Johns Hopkins, Cornell, MIT, Berkeley, etc). 1
During a four hour brainstorming session, members of the Rapid Process Redesign II (RPR II) team identified 112 ideas for process improvement then prioritized them. Of the top projects, Coeus was ranked as the highest priority (7 ‘red dots’) and received the second highest number of overall votes (376).
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The Rapid Process Redesign II (RPRII) Tiger Team initiative in 2008 provided the campus with a strategic opportunity to change direction and to accelerate the pace of upgrading to a newer, robust version of Coeus by focusing resources and attention on UCSD’s electronic research administration processes and requirements. b. Upgrade: Coeus 3.8 to 4.3.2 The Tiger Team’s mandate was to upgrade the Coeus version (3.8) in use to the enhanced 4.3 version permitting UCSD to begin accepting application upgrades from the Coeus Consortium and to more fully utilize two new tools: Coeus Proposal Development (KCPD) and Research Compliance functionality (e.g. Institutional Review Board (IRB), Embryonic Stem Cell Research Oversight (ESCR), and Conflict of Interest (COI) modules). The Tiger Team created five subcommittees and charged each with a specific set of tasks to accomplish. The subcommittee mechanism allowed the Tiger Team to engage critical departments and users in the process. The Tiger Team met on a monthly basis or more frequently as required to ensure progress. Additionally, a monthly Coeus “All Hands” meeting was arranged that was open to anyone at UCSD with an interest in the Coeus application and the Tiger Team process. The primary purpose of the “All Hands” was to provide all interested stakeholders with a chance to learn about Coeus, regardless of their level of day to day involvement with the application. Subcommittee Name / Responsibilities Status Data Structure Subcommittee: • Design and test a new flexible award structure to simplify data entry, streamline administrative reporting, and permit the successful migration of legacy Coeus 3.X data to the new version • Create required reports and data views for administrative offices and departments • Team Members (name / department, role) Lynelle Gehrke / OCGA – co‐chair
Elizabeth Meier / SIO – co‐chair
Pamela Alexander / OCGA – structures
Mary Brown / OCGA – testing
Patti Williams / OCGA – testing Fernan Balsalubre / SIO – structures / testing Anthony Slay / OCGA – testing/QA Andrea Rollins / HSSPO – proposal structure
Alma Palazzolo / OPAFS – dependencies / dept needs
Terri Varnell / SIO – testing/QA
Joni Ciarletta / ECE – consulting re: dept needs
Sandra Duckett / ACT – data warehouse resource
Cindy Lee / SDSC – programmer / DB2 user
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Completed Compliance & Audit Subcommittee: • Evaluate current and planned Coeus and Kuali Coeus research compliance modules • Document current research compliance business processes and procedures in (see Appendix 1) • Compare modules to current compliance tools and business processes at UCSD and develop medium and long‐term recommendations for improving research compliance (see Appendix 2) Fund Setup Subcommittee: • Create application requirements for a new Fund Setup application that would allow OPAFS to set up fund accounting information in IFIS, ISIS and PPS • Team Members (name / department, role) Alma Palazzolo / OPAFS – chair
Mojgan / ACT – vice chair Teresa Ornelas / OPAFS Peggy Taburiaux / OPAFS Isabella Parkinson / OPAFS Maria Cruz / OPAFS Pamela Alexander / OCGA – consulting
Ge (Ger) Zhang (ACT) – technical
Ashley Clipson / OPAFS – consulting
Mary Brown / OCGA – consulting
Fernan Balasalubre / SIO – consulting
Csilla Csori / SDSC – consulting
Nancy Roberts / Neuroscience – consulting re: dept notification / needs Joni Ciarletta / ECE – consulting re: dept notification / needs
Qinqping (Ping) Li / OPAFS – technical consulting
Customization Subcommittee: • Migrate legacy proposal and award data to new structure and clean up any award records to ensure data integrity • Identify appropriate user roles and field level security. Work with ACT to implement roles / security in Coeus via Single Sign On technology • Identify and clearly define all active data labels used in Coeus so all users shared a common understanding of Coeus data • Team Members (name / department, role) Andrea Rollins / HSSPPO ‐ co‐chair
Robert Dias / ACT ‐ co‐chair
Alma Palazzolo / OPAFS ‐ data cleanup
Anthony Slay / OCGA ‐ technical
Csilla Csori / SDSC ‐ consulting re: department needs
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Completed Completed Completed Elizabeth Meier / SIO ‐ consulting Fernan Balasalubre / SIO ‐ consulting
Gail Zydlewski / OCTA ‐ consulting
Ge Zhang / ACT ‐ consulting
Jean Linder / OCGA ‐ consulting
Kerry Nare / HSSPPO ‐ consulting
Mary Brown / OCGA ‐ data cleanup
Mojgan Amini / ACT ‐ technical
Nancy Wilson / SIO ‐ consulting
Pamela Alexander / OCGA ‐ consulting
Peter Ryan / HSSPPO ‐ technical
Purnima Govada / ACT ‐ technical
Sandra Duckett / ACT ‐ technical Terri Varnell / SIO ‐ consulting Documentation & Training Subcommittee: • Create a Coeus Data Dictionary and make it available to all UCSD users to improve understanding of Coeus data • Create comprehensive documentation and training materials to help staff better understand the role Coeus plays and how it is used by various offices (see Appendix 3 for plan detail) • Team Members (name / department, role) Jason DeFay / ORA ‐ co‐chair
Lynelle Gehrke / OCGA ‐ co‐chair
Amber O'Banion / COI ‐ documentation & training
Andrea Rollins / HSSPO ‐ consulting
Anthony Slay / OCGA ‐ Reports & Views
Donna Mulcahy / HR ‐ documentation & training
Elizabeh Meier / SIO ‐ Reports & Views
Fernan Balasaubre / SIO ‐ Reports & Views
Gail Zydlewski / OCTA ‐ consulting
Isabella Bryant‐Parkinson / OPAFS ‐ documentation & training
Joni Ciarletta / ECE ‐ consulting
Lynelle Gehrke / OCGA ‐ documentation & training
Marilyn Kaiser Brown / AA Space ‐ Reports & Views
Mary Brown / OCGA ‐ Reports & Views
Nancy Wilson / SIO ‐ Reports & Views
Pamela Alexander / OCGA ‐ Reports & Views
Patti Williams / OCGA ‐ Reports & Views
Purnima Govada / ACT ‐ data dictionary
Zana Parman / ORA ‐ documentation & training
Completed Each of these subcommittees worked with each other and the Tiger Team leadership to successfully migrate UCSD Coeus to version 4.3.2 on May 22nd 2010. 5
c. Benefits Achieved by Upgrade A number of benefits have been realized in upgrading to Coeus 4.3.2 including: • Single Sign On (SSO) account provisioning and access control • Reduction in Fund Setup time • Unified system usage and data entry procedures across contract and grant offices • Development of time saving customized summary reports and views • Retiring old technologies (from PowerBuilder to Java, from screen scraper to Web Services) • Creation of comprehensive documentation and training materials (data dictionary, interactive website, users manual, award structure and standardized data entry procedures) • Contribution of personalization engine to Coeus Consortium: The Personalization Engine is a subsystem that allows Universities to customize their version of Coeus through configuration files and not through direct system code changes, which was the only option. The Coeus Consortium stated that the UCSD Personalization Engine was “the most valuable contribution to the core system from any University”. d. Post­Upgrade Tasks The Coeus Tiger Team was also charged with several post‐upgrade tasks. The remainder of this report is dedicated to these objectives. Proposal Development • Develop a plan for the phased deployment of the Coeus Proposal Development Module to departments that included testing, user training, and appropriate internal controls to ensure reliability and quality of data • Develop appropriate user agreements, policies and procedures, and training plans for department Coeus users Research Compliance
• Develop a plan and timeline for the deployment of Coeus (or Kuali Coeus) compliance modules including COI, IRB, ESCRO and IACUC Electronic Research Administration Strategy
• Develop a long‐term strategy and sustainable funding model for managing Coeus at UCSD to ensure our system remains dynamic, up‐to‐date, responsive to user needs, and a best in class system 6
II. Post­Upgrade Tasks: Tiger Team Recommendations Soon after the Coeus Tiger Team was formed, the Coeus Consortium announced their intent to merge Coeus with the Kuali Foundation to modernize the technology stack underlying Coeus software and make other major enhancements to the underlying application architecture. As a result, Coeus will be phased out over the next two years and will be replaced with a new and functionally equivalent application called Kuali Coeus (KC). Kuali Coeus will include significant improvements over Coeus and will greatly expand functionality that directly affects the proposal development and compliance modules. Knowledge of the impending changes prompted the Tiger Team to reevaluate the post‐
upgrade tasks assigned as part of the RPR II. Given the planned Coeus phase‐out, the Team strongly recommends that UCSD wait until Kuali Coeus has been implemented to deploy the compliance and proposal development modules. Significant changes in application architecture, workflow and the user interface, will drive additional modifications to workflow processes. The rollout of new business tools to the campus, especially those involving faculty, requires a significant investment to develop appropriate training materials and ensure adequate training prior to implementation. There is no benefit in going through such an exercise twice in a short time‐frame. The costs in staff time and energy, not to mention the possible confusion among the user community, significantly outweigh any short term benefit in implementing the proposal development and compliance modules in the newly upgraded version of Coeus 4. To maintain forward progress and position the campus to implement Kuali Coues as a replacement to Coeus will require we make continued progress in a few key areas. In order to accomplish this very large undertaking, the Tiger Team recommends the campus create a standing working group with representatives from Research Affairs, ACT, OCGA, SIO C&G Office, HSSPO, and the academic divisions and departments. a. Kuali Coeus Proposal Development (KCPD) The Tiger Team recommends UCSD work to implement Kuali Coeus Proposal Development to provide faculty and departments with the tools to prepare and submit research proposals fully online. Key benefits of investing in electronic proposal development include: • Elimination of the paper Request for Extramural Support form (RES) and workload associated with this requirement • Increased accuracy of sponsored project data through elimination of manual and duplicate data entry by central office staff • Real‐time and automatic routing of proposal budgets to appropriate reviewers and approvers 7
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•
•
•
Shortened review and approval turnaround times by sponsored projects offices leading to increased customer satisfaction Increased accountability to federal agencies for compliance approvals and trainings required for award acceptance Greater transparency and accountability at all levels (PIs, department staff, MSOs, department chairs, Deans, Vice Chancellors, etc. ) as projects move through their lifecycle System‐to‐System electronic submission of proposals to Grants.Gov. Elimination of paper documents and need to mail to sponsors who accept submissions via Grants.gov UC Irvine and UC Berkeley are both in the process of implementing Kuali Coeus Proposal Development so they will be key collaborators for us. Like Berkeley however, our campus is one of only two UC’s to have implemented MIT’s original version of Coeus (Irvine is upgrading to KC from a home grown system). Because Berkeley and San Diego are both MIT Coeus users, other MIT Coeus schools are looking to us to learn how to upgrade from MIT Coeus to Kuali Coeus. Our two campuses will make data migration scripts available to other institutions migrating from MIT Coeus to Kuali Coeus. Based on UC Berkeley and Irvine’s experience implementing KCPD, we anticipate that once charged and resourced it will take approximately 24 months to successfully plan, test, pilot, and fully execute Proposal Development at UCSD assuming sufficient resources can be identified to facilitate its delivery. b. Kuali Coeus Compliance Modules Regulators are increasingly focused on compliance issues such as conflict of interest, human subjects, animal welfare, human embryonic stem cells, scientific misconduct, and bio‐safety concerns such as, select agents and gene therapy regulation. To implement effective controls for accountability that is streamlined and coordinated, will require a coherent set of tools to collect, review, report, store, and manage these requirements. The Tiger Team created a Compliance and Audit Subcommittee with members from research compliance offices and Audit and Management Advisory Services (AMAS). The subcommittee was charged with developing recommendations for the phased implementation of Kuali Coeus compliance modules at UCSD. In addition, the subcommittee was asked to document current compliance processes used by each office [Human Research Protections Program (HRPP), Institutional Animal Care and Use Committee (IACUC), COI, ESCRO and Environmental Health & Safety (EH&S)], evaluate current and planned functionality of Kuali Coeus (KC) and Coeus compliance modules, and identify appropriate timelines and possible resource needs for the implementation of new compliance modules. 8
The subcommittee made the following recommendations to the Tiger Team: • COI: Immediately implement the KC COI module • ESCRO: Immediately implement the KC IRB module • HRPP: Pilot the Kuali Coeus IRB module with the Behavioral and Social Sciences review committee. If the pilot is successful, HRPP will begin testing, planning and migration efforts for the biomedical IRBs. • IACUC: Participate in ongoing IACUC development efforts to monitor and influence the evolution of the module with the goal of moving development efforts to converge with UCSD’s homegrown system. At the point of functional convergence, the IACUC will consider implementing the Kuali Coeus IACUC module. • EH&S: Participate in future Bio‐safety, Radiation Safety and Chemical Tracking modules so the functionality of these compliance modules will also converge with UCSD’s existing systems. At the point of functional convergence, the IACUC will consider implementing the Kuali Coeus IACUC module. In order to successfully implement these compliance modules, the Coeus Compliance Committee recommended the Coeus Tiger Team identify, as part of the resource needs for implementing KCPD, appropriate resources to configure train, and integrate the KC compliance modules into UCSD’s sponsored research administration process. c. Recommendations for Implementation and Long Term Sustainability The Tiger Team was asked to develop a long‐term strategy for managing sponsored research activities at UCSD that included regular communication with stakeholders to ensure that UCSD’s electronic research administration tools continually evolve to meet the needs of our users. The Tiger Team believes that additional streamlining and cost saving benefits will flow to departments once these tools are implemented and recommends that sufficient budgetary and/or staff resources be made available to implement and maintain this system over its expected lifecycle. Resources requirements include2: • Technical support sufficient to install, configure, test, integrate and maintain Kuali Coeus 2.X into ACT’s existing technology stack 2
UC Berkeley has implemented Kuali Coeus 2.0 (Proposal Development) alongside Coeus 4.3 (back‐
office “Coeus Premium”) so the committee believes it is feasible to integrate KC 2.0 with Coeus 4.3 9
•
•
Development of online training resources and in person training sessions sufficient to reach all faculty, chairs, DBOs/MSO’s and support staff involved in the proposal preparation, review and approval, submission process These resources requirements are over and above current resource allocations dedicated to maintaining Coeus in production. To achieve this vision, the Tiger Team recommends that a standing Sponsored Project Administration Advisory Committee (SPAAC) be jointly appointed by the Vice Chancellors for External and Business Affairs, Research Affairs, Academic Affairs, Marine Sciences and Health Sciences. We recommend the committee include representatives from academic departments, central administrative offices, and a faculty representative. The committee will be responsible for identifying UCSD’s electronic research administration needs, evaluating current and proposed modules and functionality in KC and other systems, developing project implementation plans in conjunction with various research administration stakeholders and monitoring/managing the execution of project plans. The SPAAC will create subcommittees as necessary to implement various tasks that have been prioritized by the group. In order to ensure ongoing campus involvement in this process, we recommend continuing periodic “All Hands” meetings. These meetings are open to everyone at UCSD and provide a place for staff that new to Coeus to come and learn about the system, ask questions, and get involved. 10
Appendix 1: Research Compliance / Special Review Policies & Procedures Coeus 4.3.2 Special Review Procedures Version: August 5, 2010 UCSD Research Affairs 11
Appendix 1: Research Compliance / Special Review Policies & Procedures Contents 1 2 Overview ....................................................................................................................................................... 13 1.1 Special Review Types ............................................................................................................................ 14 1.2 Compliance Monitoring ......................................................................................................................... 15 Coeus Business Processes by Special Review Type..................................................................................... 16 2.1 Human Subjects...................................................................................................................................... 16 2.3.1 Office of Clinical Trial Administration (OCTA) Office................................................................. 17 2.1.1 Human Research Protections Program (HRPP) Office .................................................................. 17 2.1.2 Administrative Computing & Telecommunications (ACT) .......................................................... 18 2.2 Animal Subjects ..................................................................................................................................... 19 2.2.1 Institutional Animal Care and Use Committee (IACUC) ............................................................... 20 2.3 Grad Student Exception ......................................................................................................................... 20 2.4 Ship Use ................................................................................................................................................. 21 2.5 Diving ..................................................................................................................................................... 21 2.6 SIO Space ............................................................................................................................................... 22 2.7 Health Sciences Sponsored Projects Proposal Office (HSSPPO) .......................................................... 23 2.8 Space ...................................................................................................................................................... 23 2.9 PI Exception ........................................................................................................................................... 24 2.10 Conflict of Interest (COI) ................................................................................................................... 25 2.10.1 COI Office Processing .................................................................................................................... 26 2.11 Embryonic Stem Cell Research Oversight Committee (ESCRO) ...................................................... 27 2.11.1 ESCRO Office Processing .............................................................................................................. 28 Appendix 1: Human Subjects Processing ............................................................................................................. 29 Appendix 2: Conflict of Interest Processing ......................................................................................................... 30 12
Appendix 1: Research Compliance / Special Review Policies & Procedures 1 Overview Research projects involving certain types of activities require a special review and approval process. At UCSD we use the special review tab in the Coeus award and proposal modules to manage the special review status of sponsored projects. In addition to, the special review tab is also used to administer UCSD policies and procedures (e.g. PI Exception, Space, etc.). Figure 1: Coeus Special Review Tab At this time, Coeus does not manage individual compliance review processes. Instead, the sponsored projects offices use the Coeus special review tab to keep track of special reviews applicable to an individual proposal or award. As special reviews are completed, status updates are posted to Coeus so that the sponsored projects offices will know when all required reviews have been completed. Please note the sponsored projects office will not release an award until all required Special Reviews have been approved. No research activities may be conducted until all required approvals are in place. When a principal investigator (PI) submits a proposal, he/she is required to complete and sign a Request for Extramural Support form (RES form). To ensure that the academic department is aware, and approves, of faculty research activities, the department chair and business officer are required to review and sign the RES form. The proposal and RES are then submitted to the applicable Sponsored Projects Office (SPO) for review, 13
Appendix 1: Research Compliance / Special Review Policies & Procedures approval and submission to the sponsoring agency. Please note the RES form is only an internal UCSD document and is not forwarded to the sponsoring agency. The RES form contains a series of questions that help indicate which, if any, special reviews are applicable. When the proposal & RES form arrive in a Sponsored Projects Office for processing, the proposal information is entered into the Coeus institute proposal module & any applicable special reviews are noted in Coeus under the special review tab (see Figure 1) The following diagram outlines the process used to ensure all applicable reviews have been completed before research begins: Figure : Coeus Special Review Process Overview: Proposal Stage Proposal
•PI/Department fills out RES form & sends proposal to their sponsored projects office through their department business office for review/submission
• Proposal log entry is generated via Coeus or by PI/Department via Self Service Proposal Number system: https://www‐act.ucsd.edu/proposallog/proposallog •Sponsored Project Office reviews RES and enters proposal into Coeus Institute Proposal module
Coeus Data •If RES indicates special reviews are applicable, information is entered into the Special Review tab.
Entry
1.1 Special Review Types Coeus 4.3.2 is configured with the following special review types which are administered by the indicated offices. Review Type Responsible Office Human Subjects Animal Subjects Conflict of Interest OGSR (not in use) PI Exception HSSPPO Grad Student Exception Ship Use (SIO) IDC Waiver ESCRO Diving (SIO) Space (Campus) Human Research Protections Program
Animal Welfare Program
Conflict of Interest
Office of Graduate Studies
Depends on PI’s home department:
General Campus: Research Affairs Health Sciences: Health Sciences Deans Office SIO: SIO Directors Office Health Sciences Sponsored Projects Office
SIO Sponsored Projects Office
SIO Sponsored Projects Office
OCGA
Embryonic Stem Cell Research Oversight committee SIO: Sponsored Projects Office
General Campus: Academic Affairs
Space (OCTA) Space (SIO) Office of Clinical Trial Administration
SIO: Sponsored Projects Office
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Appendix 1: Research Compliance / Special Review Policies & Procedures Space (HS) Health Sciences Sponsored Projects Office
If confirmation of applicable approvals is not required by an agency at the proposal submission stage, a proposal may be submitted to the sponsoring agency for consideration without having received approval for all required special reviews. When all special reviews are complete and a new award is created in the Coeus award module, it is linked with the Coeus institute proposal record and the special review information is automatically copied into the award record. Figure 2: Coeus Special Review Process Overview: Award Stage
Award notice
Award Creation
• OCGA is notified of an award by agency or PI/department and all required special reviews are verified/updated in the proposal record
•Award is created in Coeus
•Special review details automatically imported into Coeus award record
•Compliance offices manage ongoing compliance
•Should a project or individual be in non‐compliance, the Sponsored Projects Office is notified
Compliance •Non‐compliance may result in project suspension
Monitoring
1.2 Compliance Monitoring After an award has been made, UCSD relies on the relevant compliance office, the lead department & ultimately the principal investigator to ensure that the sponsored project remains in compliance with applicable state, federal and local regulations. Research compliance begins with the principal investigator, but everyone involved in research has a responsibility to ensure the project remains in compliance. Should an individual investigator or research protocol loose approval for any reason after an award has been setup, the relevant compliance office must notify the sponsored projects office immediately so appropriate action can be taken 15
Appendix 1: Research Compliance / Special Review Policies & Procedures 2 Coeus Business Processes by Special Review Type Because the level of regulatory complexity varies significantly across different research areas, each special review type is handled differently. The following sections provide detailed descriptions of the special review process involved with each special review type at UCSD. 2.1
Human Subjects On the RES form (figure 3), Question “E” indicates whether or not human subjects will be used in the proposed research. If there is a Yes answer to this question, the SPO creates a new proposal in Coeus using the institute proposal module and adds a “Human Subjects” line to the special review tab. If there is no protocol number on the RES, and the pending box is checked, the status is set to “Pending”. If a protocol number was provided, that number is added to the Protocol Number field, the proposal status is marked “Routed for Review” and the materials are sent to HRPP for validation. For NIH proposals the materials are routed to HRPP when a “Just In Time” (JIT) requested is received. We will also verify the protocol is correct and will not change from pending to routed for review and add the protocol until it has been verified by HRPP. Since this may change it eliminates a step. Figure 3: RES Form Question E (Human Subjects) Exceptions for training grants: If a Human Subjects review is indicated on the RES and the proposal is an NIH training grant, the approval status is set to “Pending”. When the award is received, an email is sent to the PI informing him/her of his/her responsibilities on these types of grants and they are asked to confirm to OCGA they acknowledge and accept the required responsibilities. Once the Principal Investigator has provided the required acknowledgment, the status in Coeus for this special review is changed to “Not Required”. If the form does not have a protocol number and the pending box has not been checked, the Sponsored Projects Office contacts the department & asks for a correction. If an award notice is received OCGA checks the status of the Special Review tab in the Institute Proposal module to make sure all required approvals have been obtained. OCGA will not create an award until all required approvals are in place. In Coeus there are four valid statuses for Human Subjects approvals: Coeus: Valid Approval Statuses for Human Subjects Reviews Status Definition Pending Used when Human Subjects review is applicable but the Sponsored Projects Office has not been provided with an applicable protocol number from the department or PI. 16
Appendix 1: Research Compliance / Special Review Policies & Procedures Approved Not Approved Routed for Review Not Required Also used when a proposal is an NIH Training Grant & PI has not yet acknowledged receipt and acceptance of the compliance obligations email Used when Human Subjects are applicable and HRPP has verified that the indicated protocol number covers the scope of work proposed under the contract/grant HRPP has denied the protocol application
Used when a Sponsored Projects Office has routed the proposal to HRPP for validation that the scope of work is covered under the indicated protocol number Only used for NIH Training Grants and indicates that the PI has received and accepts responsibility for human subjects compliance under NIH guidelines 2.3.1 Office of Clinical Trial Administration (OCTA) Office OCTA creates proposal and award records for Clinical Trials & these types of entries require Human Subjects special reviews. Because clinical trials agreements are different from traditional contracts/grants, OCTA uses a different procedure for managing Human Subjects reviews. OCTA will not create an award record in Coeus until all required reviews have already been approved. When they do create a proposal record, they also add/update the HRPP system with the protocol and link the UCSD proposal number to it at the same time. Then they create an award record and link it to the previous proposal record. Coeus automatically pulls all the special review information from the proposal and adds it to the award document. However, because the HRPP/ACT Coeus update job only runs once per day, any updates to the protocol done by the HRPP system may not have been posted to the Coeus Proposal record. This would cause the Coeus award record to appear that the human subjects approval status is pending.& require OCTA to go back into the Coeus Award record and manually update the approval status after it is changed in Coeus. In order to make this extra step unnecessary, the HRPP/ACT Coeus update job updates the special review status for Human Subjects lines when the award type has been set to “clinical trial”. A more detailed workflow diagram of the OCTA business process for managing research projects that involve human subjects is contained in Appendix 1. 2.1.1 Human Research Protections Program (HRPP) Office After initial review & data entry into Coeus, the Sponsored Projects Office sends the proposal package to HRPP along with a request to verify that the proposed research is covered under the indicated protocol. The package contains the statement of work, and the RES form containing the protocol number, and the UCSD proposal number. 17
Appendix 1: Research Compliance / Special Review Policies & Procedures For NIH proposals there is a self contained section that has this information. Please note, as a result of the NIH Just in Time – JIT – process, this routing does not take place at proposal submission but rather, once NIH notifies the Sponsored Projects Office that it requires proof of compliance. •
If the protocol number provided to a Sponsored Projects Office and the statement of work DO NOT match the information maintained by HRPP, HRPP staff contact OCGA and work to identify/correct the problem. •
If the proposed research outlined in the statement of work is covered under the protocol number provided by the Sponsored Projects Office, and the protocol has been approved under the corresponding protocol application number, then the UCSD proposal number received from a Sponsored Projects Office is entered into HRPP’s compliance system. 2.1.2 Administrative Computing & Telecommunications (ACT) The HRPP compliance system creates a nightly batch file containing a list of UCSD proposal numbers entered into the HRPP system. The corresponding HRPP Protocol Numbers, the Review Committee Action Date, the Review Committee Action Type, and HRPP Protocol Expiration date. This file is encrypted & made available to download via the HRPP website. •
ACT downloads the file, unencrypts it and updates the appropriate Coeus proposal number with the results. •
For Clinical Trials, the job updates both Coeus award and proposal records. All other updates apply to proposal records only. •
Here is a list of the various approval statuses generated by the HRPP system that are included in the batch file, what they mean & the appropriate action that should be taken in Coeus: Human Research Protections Program: Approval Codes and Definition Definition Changes made to Coeus None Protocol application is scheduled to be reviewed by HRPP but it hasn’t happened yet Approved Protocol application has been reviewed Update the Approval status of the and approved by HRPP corresponding Human Subjects line to “Approved”. Enter Application & Expiration Dates into corresponding fields. Deferred HRPP has deferred action on the protocol None application Not Approved HRPP has not approved the protocol Not Approved application Status Pending 18
Appendix 1: Research Compliance / Special Review Policies & Procedures After all required approvals have been received, the Coeus institute proposal module is updated with the appropriate approval information & the OCGA award team creates the award. 2.2 Animal Subjects On the RES form (figure 4, Question “D” indicates whether or not animal subjects will be used in the proposed research. If the PI answers yes to this question, the SPO creates a new proposal in Coeus using the institute proposal module and adds an “Animal Subjects” line in the special review tab. If there is no protocol number on RES, and the pending box is checked, the status is set to “Pending” Figure 4: RES Form Question D (Animal Subjects) If a protocol number was provided, that number is added to the Protocol Number field, the proposal status is marked “Routed for Review” and the materials are sent to IACUC for validation. If an animal subjects review is indicated on the RES and the proposal is an NIH training grant, the approval status value is set to “Pending”. When the award is received, an email is sent to the PI informing him/her of his/her responsibilities on these types of grants and they are asked to confirm to OCGA they acknowledge and accept the required responsibilities. Once they have provided the required acknowledgment for these compliance obligations to OCGA , the status in Coeus for this special review is changed to “Not Required” If the form does not have a protocol number and the pending box has not been checked, the Sponsored Projects Office contacts the department & asks for a correction If an award notice is received OCGA checks the status of the Special Review tab in the Institute Proposal module to make sure all required approvals have been obtained. OCGA will not create an award until all required approvals are in place. In Coeus there are [four/five] valid statuses allowed for animal subjects approvals: Coeus: Valid Approval Statuses for Animal Subjects Reviews Status Definition Pending Approved Not Approved Used when Animal Subjects review is applicable but the Sponsored Projects Office has not been provided with an applicable protocol number from the department or PI. Also used when a proposal is an NIH Training Grant & PI has not yet acknowledged receipt and acceptance of the compliance obligations email Used when Animal Subjects are applicable and IACUC has verified that the indicated protocol number covers the scope of work proposed under the contract/grant IACUC has denied the protocol application
19
Appendix 1: Research Compliance / Special Review Policies & Procedures Routed for Review Not Required Used when a Sponsored Projects Office has routed the proposal to IACUC for validation that the scope of work is covered under the indicated protocol number Only used for NIH Training Grants and indicates that the PI has received and accepts responsibility for animal subjects compliance under NIH guidelines 2.2.1 Institutional Animal Care and Use Committee (IACUC) One of the Sponsored Projects Offices emails the IACUC office with a request for review. The email has the RES form and grant sections attached. Next, AWP staff does a side by side comparison of the grant with the animal protocol and emails back a response (approved or not approved) to the requesting office. The SPO then updates Coeus and processes the award. 2.3 Grad Student Exception Note: This review type is applicable to Scripps Institution of Oceanography (SIO) only. On the RES form (figure 5), Question “N” indicates whether or not graduate students are included in the proposal, and if so how many. If the PI answers no to this question and the annual direct costs are over $75,000 for a year, approval must be obtained. The PI provides a signed request for exception (addressed to the SIO Education Department Chair) along with the RES. Proposals solely for equipment, conference support or other non‐research activities which are not expected to contain Research Assistant support do not require a request for exception approval. Figure 5: RES Form Question N (Grad Student Exception)
•
•
•
•
•
During proposal review, the SIO Contracts & Grants Officer (C&G) will obtain Education Department approval or ascertain that approval is not required (such as when the annual direct costs are under $75,000 per year) After the C&G Officer has submitted the proposal, the Graduate Student information/status indicated on the RES is entered into Coeus. If the “Yes” box on the RES is checked, no entry is made on the Special Review tab. (The number of students supported is entered elsewhere in Coeus). If the “No” box is checked and the proposal is for non‐research activities (as indicated in the Type of Activity section), the sponsored projects office creates a “Grad Student Exception” line in the special review tab and the status is set to “Not Required” If the “No” box is checked and the proposal is for research activities, the sponsored projects office creates a “Grad Student Exception” line in the special review tab and the status is set to “Approved” or “Below Threshold” as applicable 20
Appendix 1: Research Compliance / Special Review Policies & Procedures In Coeus the three statuses used for Grad Student Exceptions are: Coeus: Status Descriptions for Grad Student Exception Review Status Definition Approved Not Required Below Threshold Used for proposals requiring Graduate Student Researcher support when an exception request has been approved by the SIO Education Department Chair Used for proposals solely for equipment, conference support or other non‐research activities that are not expected to provide for GSR support. Used when approval for an exception to Graduate Student Researcher (GSR) support is not required because the annual direct cost is under $75,000 a year. 2.4 Ship Use This special review type is applicable to SIO only. Due to limited “real estate” on the RES form, question M covers two topics. On the RES form (figure 6), Question M indicates whether a UNOLS ship or the R/P Flip will be used in the performance of the project and if so, the name of the ship. Figure 6: RES Form Question M (Diving/Ship Use) •
For sponsors other than NSF or ONR, if UNOLS ship use is indicated, the Sponsored Project office routes a copy of the proposal budget to SIO Ship Scheduling who confirms that the appropriate ship rates have been used before the proposal is submitted. •
For all proposals (regardless of sponsor) that indicate UNOLS ship or R/P Flip usage, the name of the vessel is recorded in the special review tab (in the Protocol number field). After the C&G Officer has submitted the proposal, a “Ship Use” line is created in the special review tab, the status of “Approved” and the name of the vessel as indicated on the RES are entered. Coeus: Status Description for Ship Use Review Status Definition Pending Approved Waiting for approval
Used for proposals requiring use of a UNOLS ship or R/P Flip 2.5 Diving This special review type is only applicable to SIO. Due to limited “real estate” on the RES form, question M covers two topics. On the RES form (figure 7), Question M indicates whether any surface or scuba diving will be done in the performance of the project. Figure 7: RES Form Question M (Diving/Ship Use) 21
Appendix 1: Research Compliance / Special Review Policies & Procedures •
If diving has been indicated, the C&G Officer routes the proposal for review by the SIO Diving Officer during the proposal review process. Any issues relating to the diving activities proposed are addressed before the proposal is submitted. Diving Office approval is indicated on the RES by their initials. •
After the C&G Officer has submitted the proposal, a “Diving” line is created in the special review tab, and the status of “Approved” is entered. Coeus: Status Description for Diving Review Status Definition Pending Approved Waiting for approval
Used for proposals that include diving as part of the project activities and that have been reviewed and approved by the Diving Program Office 2.6 SIO Space This review is only applicable to SIO. Question O indicates whether additional space will be required for the performance of the project. If “Yes”, a Space Addendum form is attached to the RES. Proposed projects that use existing, assigned space (indicated in Question “A”) do not require approval prior to the submission of the proposal. In those cases, a copy of the RES is sent to the SIO Capital Planning and Space Office when the proposal is submitted. Figure 8: RES Form Question O (Additional space)
First the SPO creates a new proposal in Coeus using the institute proposal module. A line is entered on the Special Review Tab for “Space”. If Question “O” is “No”, a copy of the RES is routed to the SIO Capital Planning and Space Office in order for the proposed usage to be verified and recorded in their records. The status “Routed for Review” is entered. The status will be changed to “Approved” at a later date, when the copy of the RES (with Space approval indicated) is returned to the Sponsored Project Office. Proposal submission is not dependent on approval of existing, assigned space. Receipt of space approval is verified prior to acceptance of an award, should the proposal be funded. If Question “O” is “Yes”, the status of “Pending” is entered. The C&G Officer obtains approval from the SIO Capital Planning and Space Office prior to submitting the proposal. After the C&G Officer has submitted the proposal, the approval and signature will be indicated on the RES and the status “Approved” entered into Coeus. Coeus: Status Description for SIO Space Review Status Definition Approved Used when the SIO Capital Planning and Space Office has indicated their approval by signature on the RES. 22
Appendix 1: Research Compliance / Special Review Policies & Procedures Pending Routed for Review Used during the SPO review process for proposals requesting additional space. Used for proposals using existing, assigned space which are awaiting SIO Capital Planning and Space Office approval. For these proposals, the review occurs after the proposal is submitted. 2.7 Health Sciences Sponsored Projects Proposal Office (HSSPPO) The special review type HSSPPO should only be used by the Health Sciences Sponsored Project Office. This special review type is used for both proposals that HSSPPO and OCGA have review responsibility for as designated by the proposal status (review‐OCGA /review‐HSSPPO). The special review type indicates that HS SPPO has reviewed the proposal and has approved it for submission. If HSSPPO has review responsibility, the HSSPPO Team will create the special review line for HSSPPO and will leave the status as pending. Upon completion of HSSPPO’s review the status will be changed to approved. The date of the approval will be entered in the “Appr. Date” field. If OCGA has review responsibility, OCGA will create the special review line for HSSPPO approval and will change the status to “Routed for Review”. Once the line has been created by OCGA only HSSPPO edits the status. When HSSPPO receives the proposal for review they add the date they received the proposal from OCGA in the “Appl Date” field. Upon completion of HSSPPO’s review the status will be changed to approved. The date of the approval will be entered in the “Appr. Date” field. 2.8 Space Figure 9: RES Form Question A (Space)
When Question A on the RES form is marked “Yes”, the SPO adds a special review line to the Coeus institute proposal module according to the following conditions: Review Type Used when Space (OCTA) Activity type is Clinical Trial Space (Campus) Lead Department belongs to Academic Affairs Space (HS) Lead Department belongs to Health Sciences Space (SIO) Lead Department belongs to SIO (see section 2.8) The appropriate central office uses this special review line to manage space assignments. If an award notice is received OCGA checks the status of the Special Review tab in the Institute Proposal module to make sure all required approvals have been obtained. 23
Appendix 1: Research Compliance / Special Review Policies & Procedures For proposals where HSSPPO has review responsibility they do not list space approval in Coeus. HSSPPO maintains space approval information in their internal system P‐tracker. HSSPPO will enter space approvals for proposals that have Health Sciences involvement that are submitted by either OCGA or SIO. 2.9 PI Exception Figure 10: RES Form Header (PI Exception)
The special review type “PI Exception” is used to determine whether or not the Principal Investigator (PI) and/or co‐principal investigators (Co‐PI) must obtain an exception to Policy and Procedure Manual rule 150‐
10. According to this UCSD policy, only certain employees are eligible to serve as PI and/or Co‐PI on sponsored projects. For a list of payroll title codes that are automatically eligible to submit proposals for extramural support, please see http://research.ucsd.edu/coresearch/TitleCodes.aspx When the PI Exception box is checked on the RES form, the sponsored projects office adds a “PI Exception” special review line. For all Health Sciences proposals where OCGA has review responsibility (as designated by the Proposal Status field “Review‐OCGA”), HSSPPO does not enter anything on the special review tab. HSSPPO will review the proposal and provide a copy of the approved exception to OCGA. For proposals that HSSPPO has review responsibility for (as designated by Proposal Status field “Review‐
HSSPPO”), where the PI or Co‐PI requires a PI Exception, HSSPPO will create a special review line for “PI Exception” and set the status as pending. If Health Sciences has delegated authority for the PI Exception, then once internal review/approval has been completed, HSSPPO will change the status from pending to approved, add the date of the approval in the “Appr. Date” field, and add a comment in the comments field noting the delegated authority. If Health Sciences does not have delegated authority for the PI Exception then HSSPPO will change the status from “Pending” to “Routed for Review” and add a comment in the comments field that states SOM has approved the PI exception and the date of the approval. OCGA is then responsible, once the PI exception has been approved by the Associate Vice Chancellor for Research to update the status to approved and add the approval date. 24
Appendix 1: Research Compliance / Special Review Policies & Procedures 2.10 Conflict of Interest (COI) Researchers who receive funding from certain federal sponsors, or certain nongovernmental entities are required to complete, sign and submit federal or state financial interest disclosure forms (Form 9510 for federal and Form 700‐U for nongovernmental). These forms are known as a “Conflict of Interest Disclosure” or Disclosure for short. Whether or not the PI, and all other individuals responsible for the design conduct or reporting of federally sponsored research, must submit a Disclosure is determined by federal regulations. In accordance with State regulations, only the PI is required to submit a Disclosure using the 700‐U form. Because the COI Disclosure is not a requirement for all funding agencies, staff should refer to the COI website to determine which, if any, form is required (9510 or 700‐U) See the federal agencies that require COI disclosure Form 9510 See the nongovernmental entities that do not require COI disclosure If a COI Disclosure is required, then the “Yes” box is checked in Question G of the RES form and the completed form(s) are sent to the SPO. Figure 11: Question G (Conflict of Interest)
When the sponsored projects office receives the RES they create a new record in the Coeus Institute Proposal module. If the Disclosure is incomplete – missing a signature and/or not all of the questions have been answered – then the SPO office returns the Disclosure to the Investigator for completion. Once complete, the SPO office forwards the original Disclosure to the COI office and submission of the proposal and/or execution of the contract can proceed. Unlike other special reviews, the sponsored projects office does not add a “Conflict of Interest” line in the Special Review Tab. Instead, the COI Office runs a nightly job that automatically adds a special review line based on the sponsor, federal and state requirements. The job also updates the status of each COI special review line (see section 2.13 for more detail) Valid Coeus Approval Statuses for COI Status Definition Under Review (COI) Approved Managed (COI) COI Office is currently reviewing this proposal
Proposal has been reviewed & approved by COI Office A postive disclosure was made and COI Office has 25
Appendix 1: Research Compliance / Special Review Policies & Procedures Not Required Not Approved Need Forms Below Threshold developed a management plan
COI Disclosure not required
No research can occurr due to potential conflict of interest Used when COI office has requested a revised form from PI DELETE FROM CODE TABLE
Please note that the Sponsored Projects Office will not create an award record in Coeus until after the Conflict of Interest special review line in the Institute Proposal module shows one of the following statuses: “Approved” or “Managed.” 2.10.1 COI Office Processing The COI office maintains a list of sponsors that require 9510 and 700‐U forms. Each night the COI Office runs a job that adds new Institute Proposal records to the COI database. Once the disclosure forms are received by the COI office, they are reviewed for disclosure of financial interests. If the Investigator did not disclose any financial interest it is considered a “Negative disclosure”. If the Investigator does disclose a financial interest, it is considered a “Positive disclosure.” Negative Disclosure Processing COI Staff update the COI database with a “Negative” status for the proposal and the following fields are updated: [Coeus Status] – Approved [Date Received] – Date Disclosure is received by COI Staff [Release Funding Date] – Date Disclosure is determined to be “Negative” The next time the COI Coeus update job is run, a new “Conflict of Interest” line in the Special Review tab will be added to Coeus with the following values: [Status] – Approved [Protocol Number] – First 8 characters of Investigator’s last name [Application Date] – Date Received [Approval Date] – Release Funding Date: This is the date that COI releases its hold on the funding. Or is the approval date for a particular review if there was a positive disclosure (see below) Positive Disclosure Processing COI Staff update the COI database with a “Positive” status for the proposal and the following fields are updated: [Coeus Status] – Under Review [Date Received] – Date Disclosure is received by COI Staff The next time the COI Coeus update job is run, a new “Conflict of Interest” line will be added to Coeus with the following values: 26
Appendix 1: Research Compliance / Special Review Policies & Procedures [Status] – Under Review [Protocol Number] – First 8 characters of Investigator’s last name [Application Date] – Date Received Next, the COI office adds the Investigator’s “Positive” Disclosure to the Independent Review Committee (IRC) meeting agenda. The IRC reviews the disclosure and recommends a management strategy. The COI office then sends a memo from the IRC to the Chancellor recommending implementation of the management strategy and the PI is copied. The COI Database is then updated with the following values: [Coeus Status] – Managed or Approved [Release Funding Date] – Date of IRC meeting The next time the COI Coeus update job is run, it will update the appropriate “Conflict of Interest” line in the Special Review Tab in Coeus with the following values: [Status] – Managed or Approved [Approval Date] – Release Funding Date: This is the date that COI releases its hold on the funding. Or is the approval date for a particular review if there was a positive disclosure (see above) See Appendix 2 for a detailed flow chart of the COI business process & description of the COI Coeus update job. 2.11 Embryonic Stem Cell Research Oversight Committee (ESCRO) Research involving the use or derifcation of pluripotent human stem cells must be reviewed and approved by UCSD’s Embryonic Stem Cell Research Oversight (ESCRO) Committee. When a principal investigator submits a proposal that requires review by the ESCRO Committee, then they answer YES in box F on the RES form: Figure 12: Human Embryonic Stem Cell Research (Question F)
If this box was checked a special review line is added with ESCRO as the review type. If the RES includes a protocol number it is entered into the protocol number field and if a date is provided it is entered into the “Appr. Date” field. The approval status field is then set to Pending. To date, sponsors do not require that the proposal be approved prior to submission for consideration. If an award is made, the SPO contacts ESCRO and asks them to verify that all listed protocols have been approved. After the ESCRO office has reviewed the proposal and matched it with the indicated protocols, the ESCRO office notifies the sponsored projects office whether or not the protocol is consistent with the proposed research. 27
Appendix 1: Research Compliance / Special Review Policies & Procedures If the proposed research is consistent with an approved ESCRO protocol, the SPO updates the special review line to Approved. If the protocol is not consistent, or was not approved by ESCRO, then either a correct protocol number is entered in the special review ESCRO line and the approval status is updated accordingly. Please note the SPO will only create an award record in Coeus when the ESCRO special review line in the Institute Proposal module shows that the ESCRO protocol is Approved. Status Descriptions for ESCRO Reviews Status Definition Pending Approved ESCRO office has not yet validated that proposal & scope of work match ESCRO has validated that proposal & scope of work match. 2.11.1 ESCRO Office Processing When the RES and proposal documents are received by the ESCRO office, staff review the proposal and related protocol (done only at award stage, or by request). If the protocol number provided on the RES form and the statement of work DO NOT match the protocol information maintained by ESCRO, ESCRO staff contact the sponsored projects office and work to identify/correct the problem. If the proposed research outlined in the statement of work is covered under the protocol number provided by the Sponsored Projects Office and the protocol has been approved under the corresponding protocol application number, ESCRO staff email this information to the SPO and they update the status in Coeus to Approved. Remaining sections to do if we decide to include them in this revision: OGSR (need to decide whether or not to delete this review type) IDC Waiver(need to decide whether or not to delete this review type) 28
Appendix 1: Research Compliance / Special Review Policies & Procedures Appendix 1.1: Human Subjects Processing 29
Appendix 1: Research Compliance / Special Review Policies & Procedures Appendix 1.2: Conflict of Interest Processing 30
Appendix 2: Coeus Compliance Committee Report Coeus Compliance Committee Report May 6th, 2009 31
Appendix 2: Coeus Compliance Committee Report Coeus Compliance Committee Recommendations: In January of 2009, the UCSD Coeus Tiger Team appointed a Compliance Subcommittee and tasked it with (1) exploring the costs/benefits of adopting Coeus compliance modules and (2) making specific recommendations about the possible adoption of those modules. Members of the committee included representatives from each of UCSD’s five research compliance offices, plus advisory members from Audit & Management Advisory Services and Research Affairs. Diane Ballard, Embryonic Stem Cell Research Oversight Committee Casey Cox, Human Research Protections Program Jason DeFay, Office of Research Affairs Amber O’Banion, Conflict of Interest Office Zana Parman, Office of Research Affairs Christa Perkins, Audit & Management Advisory Services Cecilia Tran, Institutional Animal Care and Use Committee Anitra Willis, Environment & Health Safety Beginning in January the committee met once a week to become familiar with Coeus, Kuali Coeus and each compliance office’s compliance management process. This report summarizes the results of those meetings and provides recommendations for the Coeus Tiger Team. Current Research Compliance Processes: UCSD’s decentralized computing and compliance structure has led to the development of various homegrown compliance systems over time & using a variety of different technologies. Compliance Office System type
Data platform
Technologies EH&S Web Application Oracle
Java IACUC Web Application
SQL Server
.NET / ASP IRB Web Application
FoxPro
FoxPro / CGI COI Database & paper
Paradox
ESCRO Spreadsheet & paper
Excel
In most cases these systems were built to solve the immediate administrative needs of each compliance department. However as the regulatory environment evolved and became more complex, UCSD’s compliance offices increasingly needed to share compliance information. Because UCSD’s research compliance offices do not share common standards, tools and technologies for managing and sharing compliance data, it has become increasingly challenging to ensure the institution remains in compliance across all areas. In some cases the sharing of compliance data is done manually, as with ESCRO (email and/or telephone), semi‐automatically by allowing appropriate staff from other compliance offices to use the local compliance system (ESCRO staff log into IRB system), and some minimal system to system data integration (IRB periodically emails protocols status file to ACT & it’s batch loaded into Coeus). Building software in a decentralized fashion can be expensive and inefficient. For example, UCSD built, uses and continues to maintain three different web based compliance applications for EH&S, 32 Appendix 2: Coeus Compliance Committee Report IACUC, and IRB. The applications have similar basic functions including protocol management and committee administration but were separately designed to accommodate the unique compliance requirements of each area. If, at the time each of system was built, the scope of each individual application had been expanded to include the requirements of the other compliance offices, it may have been possible to build a single compliance system that would have met the needs of all the research compliance offices. However, at the time these systems were developed most compliance offices reported to different Vice Chancellors, and research compliance activities were not coordinated across VC areas. As a consequence UCSD missed an opportunity to realize significant cost savings and improved compliance communication through coordinated tool development. Recommendations: In order to improve research compliance at UCSD, the Coeus Compliance Committee strongly recommends that the compliance offices increase their coordination and communication activities. One way this can be accomplished is by migrating to a shared electronic research compliance administration system. Unfortunately the current version of Coeus does not yet have a full suite of compliance tools available. Only IRB, COI and ESCRO functionality is available, and this functionality addresses the needs of UCSD’s compliance offices with varying levels of success. However this will change over the next one to five years as the Coeus Consortium merges with the Kuali Foundation and the new Kuali Coeus project continues to enhance existing compliance products and develop new compliance tools. The Coeus Compliance Committee offers the following recommendations for each of the five research compliance offices: Conflict of Interest Office (COI): COI has carefully reviewed the Coeus COI module and UCSD is actively involved in development efforts for the Kuali Coeus COI module that is scheduled for release late this year. The COI office recommends implementation of the Kuali Coeus COI module as soon as possible. Human Research Protections Program (HRPP): Currently, the Kuali Coeus IRB module does not meet the needs of the HRPP. However, HRPP recommends UCSD participate in KC IRB development efforts in order to monitor & facilitate the evolution of the KC IRB product to meet UCSD’s needs. In order to adopt the KC IRB module at UCSD, HRPP requires compatibility and integration into existing UCSD e‐IRB systems and processes. Specifically, the KC IRB product must meet three key functional requirements: 1) provide full electronic document upload, document linking, and website navigation for the investigator and IRB members and HRPP staff as well as IRB member and HRPP staff IRB project review; 2) provide comprehensive database management of documents and allow protected access by multiple users; and 33 Appendix 2: Coeus Compliance Committee Report 3) provide extensive reporting capability by HRPP staff including outgoing correspondence; internal and external audit reports and statistics. In order for the KC IRB module to meet these requirements, HRPP will initially dedicate one staff person to participate in weekly KC IRB SME Committee meetings. Active participation will help UCSD monitor new functional enhancements in the KC IRB module pipeline, and more importantly, serve as advocate for the evolution of the product so that it will eventually meet our requirements. When the KC IRB product fully meets our requirements, HRPP will begin testing the system & work on migrating the Social and Behavioral Sciences IRB over to KC IRB as a pilot. Should the pilot be successful, HRPP will begin testing, planning and migration efforts for our Biomedical IRBs. Embryonic Stem Cell Research Oversight Committee (ESCRO): The Compliance Committee recommends the Kuali Coeus IRB module be adopted for the immediate use of ESCRO. While Kuali Coeus does not yet have a stand‐alone ESCRO compliance module, the IRB module is anticipated to be flexible enough to be adapted for this purpose1. ESCRO will begin preliminary planning and testing as soon as possible with the goal of piloting Coeus Premium IRB for central office staff July 1, 2009. After a successful pilot implementation of Coeus IRB for the ESCRO office, ESCRO will begin testing & migration planning to implement the Kuali Coeus IRB which is planned for release during the second half of 2009 (see Appendix A). Institutional Animal Care and Use Committee (IACUC): The IACUC recommends UCSD continue participating in Coeus/Kuali IACUC development efforts in order to monitor the evolution of the KC IACUC product (scheduled for release in KC version 3.0; summer 2010). At this stage however, the KC IACUC system that is being proposed is modest and contains only a small fraction of the features found in UCSD’s more advanced IACUC system. As a result, the IACUC would only recommend migrating to the KC IACUC system if, and when, that KC product converges with the UCSD system. Due to resource constraints, the goal of UCSD’s involvement in the KC IACUC development process should be limited to influencing the evolution of the project in order to encourage convergence with UCSD’s homegrown system. As the KC IACUC product evolves over the next several years, UCSD’s IACUC will monitor product development. If the functionality in the KC IACUC module converges with, and ultimately exceeds UCSD’s system, then the UCSD IACUC will consider investing additional time/resources into the KC IACUC project and begin migration planning. Should the KC IACUC product evolve in a substantially different direction from UCSD, then UCSD should reduce its level of participation accordingly. 1
Yale University has successfully implemented the Coeus IRB module to serve both their IRB and ESCRO committees and has contributed their implementation process with other Coeus institutions. 34 Appendix 2: Coeus Compliance Committee Report Environmental Health and Safety (EH&S): The Compliance Committee recommends UCSD work with the Kuali Coeus Functional Council to help shape the evolution of their future Biosafety, Radiation Safety and Chemical Tracking modules so the functionality of those new compliance modules will converge with UCSD’s systems (KC modules not scheduled for release until KC 4.0; October 2011). When the KC Functional Council forms Subject Matter Expert (SME) groups to identify the scope for these three compliance modules, EH&S recommends UCSD consider dedicating staff resources to serve as, or work with, the SME leadership to contribute to these modules so they will meet UCSD’s needs. If/when those modules meet UCSD’s needs, EH&S recommends UCSD adopt those modules. Conclusion: In order to successfully implement each of the Kuali Coeus compliance modules described above, the Coeus Compliance Committee recommends the Coeus Tiger Team identify appropriate resources to assist the compliance offices in setting up, configuring and integrating the KC compliance modules into UCSD’s existing sponsored research administration process2. An essential requirement of a successful implementation of any ‘public facing’ Kuali Coeus compliance module will be the identification of dedicated training resources sufficient to meet the needs of UCSD’s large user population (e.g. similar to the recent UCSD eCert rollout). In the absence of appropriate training resources, the committee can not recommend implementing public facing compliance modules. An important recommendation of the committee is to create a standing committee that meets regularly, perhaps quarterly or biannually. This committee’s specific charge should be to improve communication and coordination across research compliance offices, particularly as it relates to compliance processes such as institutional review committee management and protocol submission, review and approval. The committee should also include technical representatives who can be encouraged to work together to address common problems and develop shared solutions. 2
UC Berkeley is planning to implement Kuali Coeus 2.0 (Proposal Development) alongside Coeus 4.3 (back‐office “Coeus Premium”), so the committee believes it is feasible to integrate KC 2.0 with Coeus 4.3 35 Appendix 2: Coeus Compliance Committee Report Appendix A: Kuali Coeus Development Timeline 36 Appendix 2: Coeus Compliance Committee Report Appendix B: Coeus Compliance Development Timeline Coeus Compliance Subcommittee Strategic Plan Draft Version: March 24, 2008 Introduction and Purpose The Coeus Compliance Subcommittee (Subcommittee) is charged with the design and development of Coeus system modules or functionality that are required by research institutions to meet their responsibilities and obligations in conducting federally supported research. This strategic plan serves as the core business plan upon which the Subcommittee’s operational decisions and actions must be founded. The Subcommittee’s mission, goals and strategies will be reviewed annually at a convened Subcommittee meeting to ensure they reflect the current status, objectives and strategies of the Coeus Consortium. Subcommittee Vision/Mission Statement The mission of the Coeus Compliance Subcommittee is to design, develop, and test system modules or functionality that are used by research institutions to ensure compliance in the management and conduct of federally funded research programs and activities. The research compliance modules or functionality integrate with the Coeus software and represent “Best Practice” solutions to promoting a comprehensive compliant research package. Values: The Compliance Subcommittee recognizes that best practice solutions can only be identified and developed by interacting with a broad constituency of entities that are knowledgeable in the areas of research compliance. Therefore, the Subcommittee consults with federal agencies and departments and others committed to ensuring research compliance when drafting and proposing software solutions. The Compliance Subcommittee further recognizes that research administration is a complex and evolving field. Therefore the Subcommittee strives to design solutions that remain flexible and that can evolve with the identification of new responsibilities and obligations. Finally, the Subcommittee realizes that the changing environment of research administration may distract Consortium support from the immediate needs of the Subcommittee. Therefore, the Subcommittee membership will seriously consider supporting the continuous development of Compliance functionality through the use of institutional infrastructure funds or other institutional resources to ensure continual development and market competitiveness. Strategies (Next 2‐3 years) 37 Appendix 2: Coeus Compliance Committee Report Identify significant gaps between compliance related functions or modules required by Consortium members but are either not present in Coeus or require modification to be useful to the Consortium membership. Complete specification documents and development of the suite of compliance modules needed to ensure that the Coeus product retains or gains competitiveness in the sponsored project market. Maximize the leveraging of Consortium funding, infrastructure funds, or other institutional resources in accomplishing goals. Goals 1) Complete development of modules where the Coeus product must meet or exceed the “best of breed” product to ensure user satisfaction and competitive market share. a. Thoroughly test and perform QA exercises on Coeus IRB Lite b. Develop user documentation c. Create IRB Viewer View d. Consider Adverse Event reporting functionality 2) Ensure Coeus users have the full capability of performing core compliance activities in the manner necessary to guarantee that federal obligations and responsibilities are satisfied or exceeded. a. Phase I of COI module modifications i. Complete specification documentation for Coeus COI ii. Complete development of Coeus COI to ensure institutional compliance with current regulations and guidance in this area iii. Test and perform QA exercises on Coeus COI to ensure quality product iv. Implement full version of Coeus COI into production version of Coeus v. Develop user documentation vi. Communicate results and market product to others b. Phase II of COI module modifications & enhancements i. Re‐design or implement next phase to ensure “best of breed”. ii. Test and perform QA exercises on Coeus COI to ensure quality product iii. Implement full version of Coeus COI into production version of Coeus iv. Communicate results and market product to others. 3) Identify and Design Coeus IACUC module a. Phase I of IACUC module i. Complete core functionality needed to ensure compliance ii. Test and perform QA exercises on Coeus COI to ensure quality product iii. Implement full version of Coeus COI into production version of Coeus iv. Develop user documentation v. Communicate results and market product to others b. Phase II of IACUC module i. Re‐design or implement next phase to ensure “best of breed” ii. Test and perform QA exercises on Coeus COI to ensure quality product 38 Appendix 2: Coeus Compliance Committee Report iii. Implement full version of Coeus COI into production version of Coeus iv. Communicate results and market product to others. Measuring Progress: Users involved in QA initiatives must complete testing scripts and compare them to specifications of enhancements and bug fixes identified for the release. At least annually, survey or other objective measure of user satisfaction must be developed and completed for each module of the Coeus product. Elements noting highest dissatisfaction will be presented and discussed with the Subcommittee, which is responsible for drafting a set of requirements necessary to bring the module up to a satisfactory standard. These findings and recommendations will be provided to the Consortium Steering Committee for their review. The Consortium Steering Committee will decide whether or not the product will continue to receive financial support for development. Action Items: (Within Calendar Year 2008) 1. The documentation of enhancements and bug fixes targeted for future releases must be reviewed during QA sessions. 2. Inconsistencies or shortcomings noted during QA sessions must be discussed at the conclusion of QA session 3. Time lines for fixes or enhancements identified in item 2. 4. Items that cannot be handled in this manner must be reported to the Subcommittee and Consortium Steering Committee for resolution. 5. Develop user documentation for Coeus IRB Premium and Lite. 6. Develop user documentation for Coeus COI. 7. Complete specification requirements for QA. 39 Appendix 2: Coeus Compliance Committee Report Appendix C: Kuali Coeus IACUC Module Features List IACUC Feature List Functionality 2008‐08‐15, Margo Barton (IUPUI) and Lisa Snider (Purdue University) IACUC Module Features 1) Official Electronic Record of All IACUC Protocol Applications and Approvals: The IACUC Module is the master record of all protocol applications received, processed and approved/denied by the institution’s animal care and use committee (IACUC). Once they are created, protocol records cannot be deleted but they can be modified until approved. 2) Compliance Committee Maintenance: A key part of the IACUC review process is the committee appointed by the institution to oversee a compliance program to meet federal, state, and local regulations. a)
Committee Setup: Create a committee, identify members, maintain meeting schedules, member contact information, area(s) of expertise. b) Assign and Manage Committee Members: Committee is made up of members who will join and leave the committee over time. Information entered for a member includes their term and role(s) (e.g., voting, non‐voting). c)
Setup Meeting Schedule: Create a list of future meeting times including the date, time and location of the meeting. A committee meeting date must exist before protocol applications can be assigned to the committee for review. Allow flexibility for designated member review. 3) Entry of protocol application data: A protocol application is made up of a number of data values entered by the investigator to provide adequate detail for institutional review and reporting requirements. a)
Core data elements: A common set of data describing the proposed research, teaching, or testing; project personnel; funding sources; and interested parties. b) Questionnaire: A more detailed set of questions or custom data defined by the institution allowing a detailed assessment of the project by the reviewers. The questionnaire must provide flexibility for the implementing institution, be robust to allow various question types (Yes/No, pull down menu, text, date, etc.) and some conditional branching capability. c)
Special Review: A list of other compliance reviews and statuses associated with this project. d) Permissions: Allow investigator or protocol application initiator to manage who has access to the protocol record and what their role(s) should be. e) Notes: Individual notes can be created and kept with each protocol electronic document f)
Attachments: Multiple formats and types of documents may be uploaded and stored with the protocol record. 4) Copy Protocol: Make a copy of an existing protocol record which can then be modified and submitted as a new study for review. 5) Printing: Ability to print a full protocol document or some summary views in a readable format. 6) Integration with other Modules: 40 Appendix 2: Coeus Compliance Committee Report IACUC Module Features a)
Linking IACUC protocols with proposals and awards: Through a parameter setting, the Institute Proposal module can be linked to IACUC module: Through parameter maintenance, the IACUC module can be linked to Proposal Development, Institute Proposal, and Award modules. The linkage actually lets you navigate between those records (i.e. the Institute proposal record) to the IACUC Protocol. When the link is turned on, you search for the IACUC Protocol, and the rest of the data field default in based on the IACUC Protocol record. b) Conflict of Interest: The investigator and key personnel must disclose any potential conflicts of interest that they may have related to the project being proposed for approval in this protocol application. 7) Protocol Application Submission for Review: Provide routing of protocol from the investigator to the IACUC administrative office collecting the necessary approvals based on the content and context of the protocol. 8) Assignment of Protocol for Review: a)
Level of review: Establish review type (e.g., designated or full committee) to be selected. b) Assignment to committee and meeting: select an appropriate committee and meeting date (make this an optional field to accommodate institutions that do not list protocols processed via designated member review in their minutes.) c)
Assign to reviewer: Reviewers can be selected from the members of the committee. d) Return to investigator: At any stage in the review process the document may be returned to the investigator with a request for additional information or clarification. 9) Review Results a)
Route protocol to reviewer: Notify reviewer that they have been assigned a protocol to review via their work queue and e‐mail. b) Provide access to protocols: Reviewers will need access to view protocols assigned to them for review and other protocols assigned to the committee of which they are a member (or if there is one committee they would need access to view all protocols). Note that a committee member may explicitly be restricted from accessing a protocol and reviewer comments (i.e when they are the PI or key person listed in the protocol application). c)
Allow entry of reviewer comments: The reviewer will be able to enter comments and a recommendation for the protocol application. Comments may be marked private or shared with the investigator. d) Provide routing back to the IACUC administrator: After entering the review comments the reviewer will return the document to the IACUC administrator for additional processing. 10) Record Committee Actions and Generation of Minutes
a)
Create Agenda: Create a formal agenda. b) Committee Attendance: record who was present at the meeting. This will impact the vote and quorum requirements.
c)
Collect comments and committee votes: For each protocol on the agenda enter comments and committee vote and decision. d) Enter additional committee actions: Enter additional actions taken by the committee that are not specific to an individual protocol. 11) Process amendments, renewal, terminations and other actions on an approved protocol: Allow researcher to submit requests for actions on approved protocols. Allow the IACUC administrator and reviewers to act on those actions. Maintain a history of all actions taken on a protocol 41 Appendix 2: Coeus Compliance Committee Report IACUC Module Features 12) Manage automated correspondence: Support the maintenance of template documents that can be used to communicate information with the investigator and other interested parties. Send proactive notices based on protocol status and date. Record history of all notifications sent. 13) Mark and maintain approved version of documents: Is this current Coeus functionality?
14) Workflow: Kuali Enterprise Workflow is used to throughout the life of the protocol document to transmit information and changes among the researcher, the IACUC administrator and the reviewers. 42 Appendix 3: Coeus Documentation and Training The focus of this subcommittee has been to develop a single, authoritative, and accurate source for Coeus documentation and training to streamline, standardize, and make Coeus business processes transparent to all users. To accomplish this, a website for storing and presenting Coeus related business processes has been developed http://coeus.ucsd.edu. In the coming months, the subcommittee will begin developing a new website using the campus content management system (CMS). This site will house materials targeted towards researchers and will be organized around the research administration process, including Coeus, at UCSD. 43
Appendix 3: Coeus Documentation and Training This new Online Research Guide will contain information about setting up labs, hiring personnel, applying for grants, and other frequently asked questions. A section of this website will be dedicated to sponsored research administration and Coeus (or Kuali Coeus) specific materials. The content currently on the http://coeus.ucsd.edu site will be moved to the new site, which we anticipate will be ready by September 2010. To ensure appropriate management of materials within the CMS, each central office will designate an individual who will be trained to use the CMS and will be responsible for updating the material. One member of the Documentation and Training Subcommittee will be designated as the final reviewer and approver for all updates to ensure the website is consistent in voice, style and content. 44