May 6, 2019
The following system enhancements, updates and compliance changes are included with this release.
Compliance Changes
These compliance updates address changes in U-M policies related to biosafety questions and expanded requirements for Institutional Biosafety Committee (IBC) approval, and anticipated federal regulations related to Controlled Unclassified Information (CUI). The changes are summarized below; please refer to Research Activity Changes for more details.
Biosafety Changes
- Changes to biosafety questions in PAF Section 5 - Research Activity:
- Revised 4 questions and added 4 new questions.
- Added new high-level question to determine if biosafety applies to this project -
Does this project involve research in a U-M laboratory with biological materials? If “yes”, additional sub-question answers are required.
- These questions are required at the time you route the PAF for Unit Review and/or any time you submit PAF changes.
- When the PAF is in a non-editable state prior to award creation, PI & Project Team personnel can use Update Research Activity on the PAF Workspace to answer the new required compliance questions and/or add associated HUMs, PROs, IBCAs.
- For Award and Award Modifications, an IBCA will be required if the existing rDNA question is answered "Yes" for all Biosafety Levels:
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- Use of recombinant DNA (rDNA) or synthetic nucleic acid (SNA) molecules?
- The Compliance Status meter will display red until IBC Approval is given.
- Added an option for ORSP to indicate that IBC work will start at a Future Date.
- Use of recombinant DNA (rDNA) or synthetic nucleic acid (SNA) molecules?
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- In Unfunded Agreements (UFAs), changes are reflected in the Material Transfer Agreements (MTAs) and Other, and in the UFA Summary.
Other Compliance Changes
Controlled Substances
- Added new question on UFAs and PAF 5.10: Use of a controlled substance (as defined by the federal Controlled Substances Act) or Propofol in a U-M research laboratory?
Controlled Unclassified Information
- Split existing Export Controls, Classified Research and Enhanced IT Security question into two questions:
- Existing PAF question 5.9: Does the research project involve classified research or possible export controls?
- Updated question 5.6: Does the research project involve possible export controls or delivery of a physical item, such as a product or material, including models and prototypes?
- Added new security question 5.7: Are there any enhanced security requirements for this project (e.g., CUI, FISMA, or classified research)?
- If answered "Yes" or "Unsure", a request will be sent to the U-M Security Officer for review when the PAF moves to the "Negotiation in Progress" or "Processing Award" states.
Award and Award Modification Enhancements
- Enhanced the Unit Info tab
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- Renamed from “Unit Docs” to “Unit Info”
- This tab now displays Unit Documents, Institutional Terms & Conditions, Additional Special Terms & Conditions, Unit Comments, and Unit-Defined Terms & Conditions. PI & Project Team members can use the Manage Unit Documents and Manage Unit-Defined Terms and Conditions activities to update information on this tab.
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- Added the Primary Post Award Contact information to the PAF Workspace in all states.
- Modified PI attestation and COI language on Sign PAF, Sign Award, Sign UFA, Change Conflict of Interest activities and on Award Change Requests (ACRs).
- Updated the sort order on Budget Periods for Awards and Modifications:
- Start Date, End Date (oldest on top)
- Added Select email recipients to more Award email notifications:
- Manage Hold (on/off), Initiate Award Modification, Deliverable Reminders (for 14 and 21 days Past Due)
- Temporarily disabled the 35-day Past Due Deliverables Reminder email notification.
- Improved the system load time on the All Awards, Mods in Progress tab.
- Added the Project Grants(P/G) Title to the $$$ tab on the Award Workspace.
Central Offices
- Created a new Request Security Review activity to route a PAF, Award, or UFA to the U-M Security Officer for review, when there are enhanced security requirements (e.g., CUI, FISMA, or classified research).
Research Ethics & Compliance
- Created a new Security Reviewer role, workspace, and activities to track, update, and complete Security Reviews for PAFs, Awards, and UFAs.
ORSP
- Added a new Budget Period Totals page that appears after the Budget Information page in all Financial Award Modifications. It provides a real-time summary total of the budget periods.
- Spelled out NCE, No Cost Extension, on Award Budget Information pages.
- Enhanced Award Additional Special Terms and Conditions:
- Added the ability to add more than one.
- Added the ability to copy and paste formatted rich text.
- Added an Award/Modification workspace Cover Sheet activity (under Manage Data) to print an OCA Cover Page to put on top of a contract package.
- Added a required explanation textbox in the Request Ancillary Review activity. The entered text is sent in the activity email notification.
- Enabled the Set Award Relationship activity on Awards in “Project Closeout” and “Closed” states in addition to the “Active” state.
- Added an email notification to the COI office when a PAF moves to the “Negotiation in Progress” state.
- Added new options to bypass Compliance Hold evaluations:
- If an Award Modification is an Early Termination, the system no longer requires a compliance check; however, the Compliance Status meter will still show red for applicable approvals.
- Added new questions on Award/Award Modification - Compliance Factors pages to indicate that compliance work (human subjects, animal research, and/or biosafety) is done or not applicable.
- Example of HUM bypass question:
Do you want to bypass the system evaluation of all HUM IDs and agree that one of the following is true of this award record:- designated as a Parent AWD in eRPM and linked to Subproject AWDs, or
- not expected to hold an approved HUM ID due to the nature of the project activity code (e.g., Training Grant), or
- includes a written attestation from the Principal Investigator that states the human subjects work is complete?
Note: The PI written attestation could be a posted comment or an uploaded email.
- Example of HUM bypass question:
- Moved listers for Awards on Hold and Modifications on Hold from the Awards Inbox tab to the Awards In Progress tab on the ORSP-PR Home Workspace.
- Modified the method to add SUBKS to Awards/Modifications as a correction to the issue where one PAF creates two Awards and the same SUBKs are added to both awards.
- Fixed an issue where an HHMI Investigator workspace message was not displaying on the UFA Workspace.