Researchers

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

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.

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.

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.

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.

The online Self-Certification Tool for the Determination of Projects Not Considered Human Subject Research tool was developed to assist the Ascension community in determining when a project falls outside of the IRB's purview because it does not constitute human subject research.

This tool is for determining if a project qualifies as QI/Program Evaluation, a case report, or research that doesn’t involve human subjects.

 

This tool is not designed to determine all cases when a project falls outside of the IRB's purview. For more information about determining if a project constitutes human subject research or requires IRB approval, see the IRB website.

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.

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.

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.

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.

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.

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.