Kuali Coeus Research Administration Project Business Process Design Document: IRB Future State KC-IRB 4: 45 CFR Designation

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1 Design Document: IRB Future State 1. Overview NOTE: The purpose of this document is to describe the future process at MSU. This is the defined procedure, AFTER the implementation of the Kuali Coeus (KC) Research Administration system. NOTE: The Principal Investigator is referred to throughout this document by the term, PI. This term is intended to include the PI and/or anyone designated by the PI. This process begins with the submission of a 118 application to the HRPP administrative office by the PI and ends with a Reviewer either granting or rejecting 118 status to the project. The process begins with the submission of the 118 application by the PI to the HRPP (Human Research Protection Program) administrative office; HRPP is notified (systemgenerated notification) of project submission. The 45 CFR or equivalent is used for projects where human subjects may be involved within the period of support but definite plans are not set forth (e.g., development of instruments). Upon receipt of the 118 application, a HRPP staff member s the application using the appropriate pre worksheet. The PI may be asked to supply additional information or documentation or respond to questions or comments relating to the 118 application project. The HRPP staff member assigns the application to a specific committee and schedule (or meeting) date. Within the Online Review tab, the HRPP staff member assigns a Reviewer; the selected Reviewer is notified of their assignment (system-generated notification). The assigned Reviewer accesses the KC IRB module to the 118 application and provide comments or select the appropriate 118 from the Standard Comments listing. (See/reference #18 Online Review.) Upon receipt of a 118 from the assigned Reviewer, the HRPP staff member completes and uploads the pre worksheet. 118 Designation Granted: The HRPP staff member generates and uploads a 118 letter within the application (Manage Review Attachments sub panel). The HRPP staff member notifies the PI that the research project qualifies (Send, Editor) and returns the application to the PI ( Return to PI action); control of application is returned to the PI (edit/modification capabilities). The PI is responsible for resubmitting the application to the HRPP administrative office once definitive plans have been developed (and prior to human subject research). (See/reference #24 Protocol Development/Submission process.) The HRPP staff member will note within the application the date the 118 was granted and the date that will expire. Note: No human subjects may be involved in the research study, regardless of the 118, until the study is ed and approved by the IRB. 118 Designation Not Granted: The HRPP staff member generates a 118 Designation Not Granted notice within the application. Page 1 of 5 Filename: Filename

2 Design Document: IRB Future State The HRPP staff member notifies the PI that the research project does not qualify or meets the criterion (Send, Editor) and returns the application to the PI ( Return to PI action); control of application is returned to the PI (edit/modification capabilities). The PI may either resubmit the (modified) application (once definitive plans have been developed) (see/reference #24 Protocol Development/Submission process) or elect to take steps to the application (not move forward with or cancel the research project). Page 2 of 5 Filename: Filename

3 Design Document: IRB Future State 2. Flow Diagram Page 3 of 5

4 Design Document: IRB Future State 3. Flow Steps Busin ess Proce ss Step Step Name Description of Step Input to Output of Responsible Party 1 Completes and submits 118 application (KC-IRB 24) PI completes 118 application and submits to the HRPP office. Create 118 application 118 application submission 2 receipt, application 3 HRPP initial staff process (KC-IRB 1) 4 Online Review process (KC-IRB 18) 5 Receives notification to project 6 Qualifies? 7 Manage attachments 8 Notify PI of () Return application to PI (Return to PI) 11 () HRPP office receipt (notification of project submission) of 118 application; HRPP staff s application. HRPP staff s project following the procedure in KC-IRB 1, HRPP Initial Review. HRPP staff initiates the Online Review process and assigns the 118 application to the appropriate committee/ers (see KC-IRB 18). Reviewer(s) receives system generated notification of assignment (online display). HRPP staff receives er of whether submitted application qualifies for 118. If submission qualifies, HRPP staff uploads 118 letter and other documents e.g., pre worksheet ( Manage Attachments ). If submission qualifies, HRPP staff notifies PI that research project qualifies. PI receives notification that submitted research project qualifies. HRPP staff returns research project to PI ( Return to PI action). Upon Return to PI action, system generated notification is sent to the PI. Project receipt (notification) Project ed Initiate online of assignment Whether project qualifies Qualifies Qualifies received Project Initiate online KC-IRB 18 Online Review KC-IRB 18, Online Review No: Notify PI Yes: Manage attachments Attachments uploaded sent to PI of 118 Documentation of 118 available 118 System generated notification sent received and PI may initiate Reviewer Page 4 of 5

5 Busin ess Proce ss Step Step Name 12 Project to HRPP once definitive plans have been developed (prior to human subject research) 13 Notify PI application does not qualify 14 () does not qualify 15 Return application to PI (Return to PI) 16 () 17 Resubmit application? Description of Step PI resubmits protocol as a research project to the HRPP office once definitive plans have been developed (prior to human subject research). If submission does not qualify for a 118, HRPP staff notifies PI. PI receives notification that submitted 118 application does not qualify. HRPP staff returns research project to PI ( Return to PI action). Upon Return to PI action, system generated notification is sent to the PI. PI determines whether to resubmit the application to the HRPP office. Kuali Coeus Research Administration Project Design Document: IRB Future State Input to Returned to PI Does not qualify received Does not qualify System generated notification sent Whether to resubmit or 18 Abandon protocol PI decides to protocol. Decision to 19 See Protocol Development/ Submission (KC-IRB 24) PI determines to resubmit the application to the HRPP administrative office (see Protocol Development/Submission KC-IRB 24). Returned to PI Output of Project through KC-IRB 24 sent to PI of 118 Documentation of that submission does not qualify available received and PI may initiate or No: Abandon Yes: Resubmit Abandon protocol Project through KC-IRB 24 Responsible Party Page 5 of 5