(New) Externally Funded Research

• Principal Investigator (PI) Requirements:  
  • A PI seeking to access Externally Funded Research from the STS RAC must be a surgeon participant in the STSND in good standing.  
    • A research scientist affiliated with an STSND surgeon participant in good standing also may be eligible (i.e., an STSND participant must be a listed co-investigator).  

1. STSND Participant ID: The 5-digit number corresponding to the investigator's participating institution in the ACSD, GTSD, CHSD, or the 4-letter code for Intermacs/Pedimacs participants;
2. Principal Investigator contact information and biosketch (NIH format preferred – 5 pages max);
3. File identifying any co-investigators (if applicable) and their contact information (e.g., email address) ;
4. File providing a full description of the research plan (shell tables are required); and

Research Plan

1. Study Background 
2. Overview -

     2.1 Research Question, Aims, & Hypotheses

             2.2 Rationale for Research Question

3. Study Plan/Approach 
        3.1   Study Patients

• Provide a clear logic for patient inclusion and exclusion criteria.  
• Make sure to include study years and corresponding database versions.  
• Specific database fields/variables (including sequence number and variable short names) and corresponding inclusion or exclusion “value” should be clearly indicated for each database version in your desired study time frame.  
• Consult with your team (and/or the project biostatistician if applying for de-identified data) and use “AND” and “OR” statements to construct your logic.
  
             3.1.1  Study Inclusion Criteria  
             3.1.2  Study Exclusion Criteria  
             3.1.3 Endpoints and Outcomes  
   
• Indicate whether only 30-day outcomes will be examined (and if so, specify which ones).
• Indicate if longer follow-up/outcomes are proposed (e.g., CMS linkage — currently available for adult cardiac and general thoracic proposals — or NDI linkage) and provide sufficient detail denoting how the proposal submission will be enhanced with linkage.  

Statistical Methods and Analysis Plan  

• Be as specific as possible.  
• Shell tables are required for presentation of anticipated results. Applications without shell tables may be deemed incomplete.  
  • Examples of shell tables can be found 
    here.

3.3  Dissemination Plans

• STS strongly suggests that investigators target the STS Annual Meeting and The Annals of Thoracic Surgery as the meeting and publication forums, respectively, for dissemination of research using the STSND.  
• 3.3.1 Peer-reviewed Journal to which submission is anticipated (if any)
• 3.3.2 National meetings at which abstract presentation is anticipated (if any)

Literature Cited 

Externally Funded Research Proposal Submission and Assessment  

• Prior to preparation of Externally Funded Research projects and proposal applications, prospective investigators are strongly encouraged to review the Current Projects web page, as well as the Published Research web page.  
  • This step is meant to avoid wasted effort on a proposal that would overlap with a previously approved STS project.  
• Investigators will complete a web-based application, specifically denoting whether external funds have been obtained or are being sought (e.g., for an upcoming NIH R01 application deadline) as part of the proposed research.
  • IMPORTANT: Proposals targeting a specific external funding deadline (e.g., NIH funding cycle deadlines) must be submitted for STS Research Task Force to review at least 90 days prior to formal NIH submission deadlines.
• STS RAC staff, working with investigators, will confirm completeness of the application and forward it to the appropriate STS Research Task Force for review.  
• Externally Funded Research proposals are reviewed and processed on a continuous and rolling basis.  
• The proposal review will focus on various key criteria, including 1) the scientific merit of the proposed research, 2) the feasibility of the research, and 3) overlap with ongoing approved STS research.  
• Investigators for approved Externally Funded Research projects will work with the STS RAC on next steps for the project, including but not limited to execution of data-sharing license agreements, application materials for grant submission deadlines (if application).
• Post-funding, investigators will work with the STS RAC to facilitate the required timely review of all science outputs from the research (abstracts, manuscripts). 

• Project fees for Externally Funded Research vary based on the extensiveness of the needed data access and research aims, the analysis plans including the expected analytic role from the STS RAC, longitudinal linkages needed for the research.  
• Contact Kristin Mathis for additional information regarding costs associated with Externally Funded Research projects.  

Investigators with approved Externally Funded Research projects may be required to execute a corresponding data-sharing license agreement depending on the intended analytic plan. Execution of additional agreements/disclosures may be required depending on the nature of the proposed research.

Refer to the Externally Funded Processes and Procedures document for detailed information regarding the Externally Funded proposal review process and submit your application today.

For more information, contact Kristin Mathis.