TEMPLE UNIVERSITY - FEDERAL DEMONSTRATION PARTNERSHIP (FDP)
EXEMPT WIZARD INSTRUCTIONS

Who/what is the Federal Demonstration Partnership?

The Federal Demonstration Partnership is a cooperative initiative among 10 federal agencies and 154 institutional recipients of federal funds. The FDP is a program convened by the Government-University-Industry Research Roundtable of the National Academies. Its purpose is to reduce the administrative burdens associated with research grants and contracts. More information about the FDP is found at: http://thefdp.org

What is the Exempt Wizard Demonstration?

The FDP has created a relatively short smart form to test pilot the effectiveness of investigator determinations of exemption. The purpose of this demonstration is to compare the determination of status (exempt versus not exempt) using the smart form versus the determination of status by an IRB staff member. If the demonstration is successful, the FDP will allow universities to implement the wizard using their own platforms. The desired outcome would be to allow investigators to make their own exempt determinations thereby freeing resources for IRB applications with a greater potential risk to subjects.

Why is Temple participating in the exempt wizard demonstration?

Human subjects regulations can be a tremendous and increasing burden on investigators. While all of those individuals involved in research using humans as subjects agree that the safety of the research participants is of paramount importance, spending extensive amounts of investigator and IRB staff time on research that qualifies for an exempt determination is not a good use of resources. In fact, the Office for Human Research Protection (OHRP) has indicated that they are interested in the outcome of using a system such as a smart form to allow investigators to make exempt determinations.

Who else is participating?

Some other institutions who are participating in the demonstration are: Harvard University, University of Washington, Boston University, University of Michigan, Michigan State University, and New York University.

Instructions for Completing the IRB Wizard

On the Application for Human Research and the Application for Classroom Projects Eforms you will see the following statement “IRB Wizard Response ID:___________”. Please use the link on the initial application form or use the link provided here in order to complete the IRB Wizard and obtain a Response ID.

IRB Wizard Link: https://asu.co1.qualtrics.com/jfe/form/SV_bNNPeeH9Dw8odi5

*If the link does not open in your browser, highlight the address and paste it into the address line of your browser and press “enter.”

Once on the Wizard application page, you will:

• Fill in the investigator’s contact name and email. 
• Select Temple University as the institution from the Institution drop box.
• Select the “Submit Study” box and click the red arrow (the “next” button) to move on to the next screen.
• Provide the IRB record number that you received when you initiated the Application for Human Research or the Application for Classroom Projects.
• Enter the Study Title and the Purpose of the study – this information should mirror the protocol that you intend to submit.
• Click the red arrow (the “next” button) to move on to the next screen.
• Continue answering the questions as they are applicable to the study protocol that you intend to submit.  
• Once you are finished answering the questions, the wizard will provide an unofficial determination and a response ID.  Copy and paste that response ID code on the IRB Wizard section of Application for Human Research or the Application for Classroom Projects eform.

Click here for detailed step by step instructions

If you have questions or wish to provide feedback/comments please submit these to the Federal Demonstration Project (FDP) at fdp@nas.edu.  Use the phrase “wizard demonstration” in the subject line please. Should you have questions about your Temple University protocol and the IRB Wizard submission process, please contact irb@temple.edu using the phrase “IRB Wizard” in the subject line.