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Upcoming PAF Question Changes: 
Action May Be Required

Changes will be made to the compliance questions in Proposal Approval Form (PAF) section 5, Research Activity, with the upcoming eResearch Proposal Management (eRPM) release on April 29, 2019 that may require project team action.

PAF Question Changes - what you will see

biohazard symbol1. A new high-level question for biological materials, with new sub-questions, replaces the four current questions relevant to work overseen by the U-M Institutional Biosafety Committee (IBC). This new IBC question set reduces the number of questions for those projects that will not involve biological materials, but captures more detailed information for those projects that will.  For example, you will now see options to:
  • Indicate if IBC approval for the research is pending, i.e., the IBC application (IBCA) is not yet submitted, at the time of proposal.

  • Associate an IBCA for all work subject to IBC oversight.
2.  A revised Export Controls question.

information security3.  A new security requirements question to indicate whether the proposed research involves data that may require specialized / enhanced information technology protections (e.g., Controlled Unclassified Information, federal information security management, or classified research).

4.  A new controlled substances question.

5.  A re-ordering of all the compliance questions.

These questions have been added or modified to better align proposals and awards with current U-M research compliance processes and policies. We recommend working with the Principal Investigator (PI) to answer the PAF compliance questions.

Project Team Action Items - what to expect

Changes to required PAF questions, like those in section 5, may necessitate project team action on or after April 29, 2019:
  • If your PAF is not yet routed or is returned for changes expect to answer the new questions.

  • If your PAF has been submitted to the sponsor, but not yet awarded, use the Update Research Activity option to change/update/complete the required compliance information.
Update Research Activity is an activity available on the PAF in the Submitted to Sponsor state to those with PAF edit rights.  This activity is used to associate a HUM (human subjects application) or PRO (animal protocol) with the PAF after submission to the sponsor.  As of April 29, 2019, this activity will also be available in the state of Processing Award and will be expanded to include the new IBC question set and allow the association of an IBCA to the PAF.

Impact on Awards

Pending awards as of April 29, 2019
As work with recombinant DNA (rDNA) or synthetic nucleic acid (SNA) requires IBC approval regardless of biosafety level (BSL), the need to identify the biosafety level in the PAF has been removed.  At the time of award processing, an approved IBCA for this work is required.  The award will be held until IBC approval is obtained for this work.

Note:  if the PAF is still accessible (i.e., award record not yet created), use the Update Research Activity option to associate the approved IBCA with the proposal, as applicable, and/or update the answers to the IBC questions.

Existing Awards
The IBC is working with the eResearch Proposal Management team to identify and apply the relevant IBCAs to existing awards where:
  • The answer to the rDNA/SNA question was “yes” and Biosafety Level 1 was selected.

  • The award references an old IBC registration instead of a current IBCA.
The IBC may contact the PI for additional information about awarded projects to clarify which IBC-related compliance factors are applicable to the work.

warning symbolIBC approval is required for all research with potentially hazardous biologics prior to the start of the research.  Your accurate answers to the IBC question set in the PAF are often the first step in ensuring that the PI and the laboratory will be in compliance with U-M policy and federal guidelines to appropriately work with these materials.
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