Version 5.3

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:
        • 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.
  • 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
      • 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.
  • 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:
        1. designated as a Parent AWD in eRPM and linked to Subproject AWDs, or
        2. not expected to hold an approved HUM ID due to the nature of the project activity code (e.g., Training Grant), or
        3. 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.
  • 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.