Conduct Research at Ascension Wisconsin

At AWRI, teams of research professionals assist researchers in the administration and conduct of research. 

Researcher Support Services

Teams of research professionals are available to assist Researchers through the required steps, reviews and approvals as part of starting a study, as well as ongoing support to ensure the safe, ethical and compliant conduct of research. 


Quick Links

Submit a CDA for an Industry Sponsored study.
Include Sponsor info and material.


Submit a proposal for an Investigator Initiated project. Complete and submit this form.

Request assistance in obtaining extramural or grant funding. Complete and submit this form.

QI Self-Certification Tool. Use this online tool if you think your project is Quality Improvement (QI) or Program Evaluation and not Human Subject Research.



IRB 
Training Requirements
About Research at AWRI
Staff and General Contacts
 

























Where to Start

How you start a research project depends on many factors, including the kind of research, project sponsor (Industry Sponsor, external, investigator initiated) and the funding or support (Industry, Grant, Department, etc.).

Review the steps below or refer to the AWRI Study Start-up Grid Reference Guide.

 

Planning Research

  •   Initial Idea

    A new research project may stem from an original investigator idea, or through an external or Industry Sponsor. 

    At this step:

    • Principal Investigator (PI) develops an understanding of the project, goals and required resources
    • PI gathers information about study start-up the approval process and initial study materials
  •   Institutional Approvals and Feasibilty Review
    AWRI staff facilitate required authorizations to ensure research meets standards and aligns with Ascensions values and priorities. This includes institutional administrative approval from the department/area leader. These reviews ensure that all research at Ascension Wisconsin has appropriate resources and support, and aligns with institutional goals and strategy.

    At this step:

    • Principal Investigator (PI) gets the information to the AWRI team members for assistance, depending on the type of study (see the AWRI Study Start-up Grid Quick Reference Guide) 
    •  AWRI staff access local feasibilty to conduct and support the study and  facilitate the required institutional approvals.
    • PI meets with the AWRI staff and other stakeholders to conduct a feasibilty meeting.

     

  •   Funding
    Sponsored Programs staff work with researchers to identify funding opportunities and manage all awards and grants for research. Funding opportunities may include internal foundation support as well as extramural funding and grants.
    The Clinical Research team may also provide support in identifying Industry funded trials.

    At this step:

    • Principal Investigator (PI) works with AWRI team members to identify, depending on the type of funding (see the AWRI Study Start-up Grid Quick Reference Guide)
    • PI writes the grant and works with Sponsored Programs to prepare the submission, as well as required reporting of funded grants.
  •   Protocol Development

    AWRI does not have dedicated staff to support protocol development and design. However, AWRI staff can help facilitate support through existing services such as experienced research mentors, collaborations with local universities, and Ascension departments like Data Analytics.

    At this step:

    • Principal Investigator (PI) identifies need (i.e. protocol writing, data collection, statistics).
    • Sponsored Programs staff assess the request and facilitates support.
    • Protocol and consent form templates available in the Template section here.
    • Other protocol management tools and templates are available here.



  •   Contracts and Agreements

    Contract specialists work with researchers, sponsors, collaborators and Ascension's legal team to negotiate and finalize all research agreements.

    At this step:

    • Sponsored Programs Contract Specialist works with Sponsor/Agency and Ascension Legal to negotiate the contract/agreement. 
    • Principal Investigator (PI) and Clinical Research staff work with Contract Specialist to review the final budget and contract.

Ethical and Regulatory Reviews

  •   Required Training and Disclosures 

    All researchers at Ascension Wisconsin are required to complete human subject training. There may be additional training requirements depending on regulations that govern the type of research or funding. In addition, any research staff working on funded research must complete a financial Conflict of Interest disclosure.

    At this step:

    • PI reviews the Research Education page for training requirements and instructions.
    • PI ensures that all research staff complete the requirements.
  •   IRB Review

    All research conducted at Ascension Wisconsin requires review by the AWRI IRB prior to begining. This includes research where the AWRI IRB is providing IRB oversight, as well as research where Ascension is not engaged or another IRB will serve as the IRB or record.  

    At this step:

    • PI and/or study team prepares IRB submission. AWRI Clinical Research staff may provide assistance with Industry funded research or clinical trials.
    • PI response to IRB and/or attends Board meeting.  
    • IRB completes review and determination/approval. 

     

     

  •   Safety and Ancillary Reviews

    Some studies may require additional review, such as Radiation Safety, Institutional Bio-safety or institutional scientific review. These reviews are typically facilitated through the IRB office and/or Clinical Research team. 

    At this step:

    • PI works with AWRI staff and other review bodies to ensure completion of required reviews.

     

     

Post Approval Conduct of Research

  •   Clinical Trials Support Staff

    The Clinical Research Department coordinators, research nurses and regulatory specialists are available to support Clinical Trials and funded projects. 

    At this step:

    • Clinical Research coordinators aid in the Site Initiation, recruitment, study conduct, and regulatory and administrative support.
    • PI provides ongoing oversight throughout the study.
  •   Finance and Billing Compliance

    Sponsored Programs team members assist in the ongoing financial management and reporting, subject payments, and billing compliance activities after a study begins.

    At this step:

    • PI and study team ensure appropriate documentation (i.e. W-9, billing forms). Clinical Research staff may assist for Industry funded and clinical trials.
    • Sponsored Programs staff  conduct all finance and billing compliance activities.
  •   Post Approval Monitoring and Research Education

    Research Education and Quality Management provides tools and protocol specific training, consultation and review.

    At this step:

    • PI and study team my utilize tools and request services.
    • REQM staff may contact the PI to complete a routine review.