Prior Approval Requirements

What is prior approval? 

Prior Approval is the written approval by an authorized sponsor official (e.g., Grants Management Specialist, not a Program Officer) demonstrating prior consent before Duke may undertake certain activities or incur specific costs. Prior approval is a request (not a notification) and must be sought from the sponsor in advance. 

When do I need prior approval? 

Prior approval must always be sought in advance of undertaking the activity or incurring the cost that requires prior approval.  

What costs or activities or costs require prior approval? 

Each sponsor and each award may have different prior approval requirements, so it is important to read and understand the prior approval requirements described in the terms and conditions of the Notice of Award (NoA).  Some (but not all) of the most common prior approval requirements* include: 

  • Carryover. Some, but not all, award mechanisms require prior approval (the NoA will specify). Investigators and their administrators should review financial projections and understand the future financial needs/plans of the research. Request prior approval for carryover at least 30 days in advance of the need to spend the carryover - and before the budget period ends or the investigator is in overdraft. More information related to carryover requirements is in myRESEARCHpath

  • Reducing effort of Key Personnel by 25% or more. Effort should always reflect the actual time necessary to accomplish the project work. It is not appropriate to reduce effort just below the sponsor’s threshold for requiring prior approval (e.g., 24.9%) to avoid seeking prior approval. More information related to managing effort requirements is in myRESEARCHpath

  • Foreign Components. If any significant scientific element or segment of the project will be performed outside of the United States (whether grant funds are expended or not), prior approval for a foreign component is required. Examples of other grant-related activities that may be considered a foreign component include (but are not limited to): 

  1. Collaboration with investigators at a foreign site anticipated to result in co-authorship 
  2. Use of facilities or instrumentation at a foreign site 
  3. Receipt of financial support or resources from a foreign entity 
  • It can be challenging to discern whether a specific project activity is considered a foreign component, but the International Research Support Team can help! More information and a full list of Duke resources for international research is in myRESEARCHpath

  • Change in Project Scope. Any time there is a change to the methodology, approach, direction, aims, objectives, purpose, or other aspects of the project that were outlined in the approved scope of work, this is considered a change in scope and always requires prior approval.  

  • Certain subaward actions - Certain actions related to subawards require sponsor approval - for example: engaging a foreign entity or issuing a subaward based on fixed amounts. Investigators must communicate to their research administrators their intention to engage a collaborator outside of Duke early (and before engaging the collaborator) to determine whether prior approval may be needed. More information and a full list of Duke resources for international research is in myRESEARCHpath

*Please note that this is not an exhaustive list of prior approval requirements.  For a complete list of costs/activities that require prior sponsor approval, please review your NoA.  If in doubt about whether a particular cost/activity requires prior approval, please contact your grant administrator or ORA/ORS. 

 

What happens if I don’t get prior approval in advance? 

If Duke undertakes an activity or incurs a cost that requires prior approval without first seeking and obtaining prior approval, those activities or costs may be deemed unallowable by the sponsor and/or Duke could lose funding for the project. This means that Duke (the unit or the investigator) is responsible for any financial impact. 

 

Resources, tips, and tricks to ensure prior approval is obtained when needed: 

  • Read and understand the terms and conditions of the award. Sponsors convey this information in different ways, so make sure that you know what project activities require prior sponsor approval (for example, NIH has a dedicated section in the Grants Policy Statement describing prior approval requirements). 

  • Investigators and their research administrators should meet regularly to discuss the potential for project activities or costs that would require prior approval. Here is a Prior Approval Matrix to help with that conversation. 

  • Seek prior approval early! Prior approval must be sought at least 30 days in advance. Prior approval requests must be submitted to the sponsor by the Authorized Organizational Representative (ORA or ORS).  

 

How to request prior approval:  

Requests for prior approval must be initiated by a unit research administrator who makes the request of the Office of Research Administration (ORA) for Schools of Medicine or Nursing or the Office of Research Support (ORS) for Campus Schools. Only an authorized organizational representative (AOR) in ORA or ORS can make the request to an external sponsor. 

  • For Schools of Medicine or Nursing: Research Administrators should go to the Submit a Request feature (top right corner) in myRESEARCHhome, choose MNMC Admin Action, and complete that form (choose "Prior Approval"). 

  • For Campus Schools: Requests for campus-based projects should be coordinated by grant managers through designated ORS Assistant Directors.