Changes to biosafety questions in PAF Section 5 - Research Activity:
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.
Use of recombinant DNA (rDNA) or synthetic nucleic acid (SNA) molecules?
If “yes”, an approved Institutional Biosafety Committee Application (IBCA) is required at the time of Award or Award Modification, regardless of biosafety level (BSL).
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 (Human Subjects Applications), PROs (Animal Protocols), and IBCAs. The Update Research Activity is available in states where the PAF is not editable for changes before ORSP creates an Award.
In Unfunded Agreements (UFAs), compliance changes are reflected in the Material Transfer Agreements (MTAs) and Other, and in the UFA Summary.
Other Compliance Changes
Added new question for use of controlled substances to PAF Section 5 - Research Activity and UFAs:
Use of controlled substances (as defined by the Federal Controlled Substances Act) or Propofol in a U‐M research laboratory?
Split existingExport Controls/Classified Research into two questions:
Does the research project involve possible export controls or delivery of a physical item, such as a product or material, including models and prototypes?
Are there any enhanced security requirements for this project (e.g., CUI, FISMA, or classified research)?
If “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.