UICOMP Institutional Review Board: Not Research/Not Human Subject Research Determination

As of 11/1/2020:

As reported in the 2020 Fall Newsletter, the goal of the new Not Research/Not Human Subjects Research Determination process is to standardize the review of NR/NHSR and expedite the review of projects NOT indicative of research or human subjects research.  The new form will be available for use in the IRBNet Forms Library by Sunday, November 1, 2020.  

Do you need a Not Research or Not Human Subjects Research (NR/NHSR) Determination from the Peoria IRB? 

The Peoria IRB has a NEW form in the IRBNet Forms Library for this type of IRB review.  After November 1, 2020, any requests for a NR/NHSR Determination must be submitted into IRBNet using the “Determination of Human Subjects Research” form along with a project summary and any other pertinent documents.  If you have already submitted this type of request into IRBNet (prior to November 1^st), you are not required to modify your submission. 

• If you are seeking a NR/NHSR determination for a project involving OSF personnel, property (e.g., data), and/or premises, you are NOT required to obtain OSF permission PRIOR to submitting into IRBNet, however, Stephanie Madrigal must still be “SHARED (Read-Only)” in IRBNet for OSF tracking purposes.   
• Project Leaders employed by other sites, using other facilities or other facilities’ data DO NOT need to SHARE with their Hospital/Site Administrator.
   

The NEW form begins by identifying 4 categories that are not normally considered to be research under the Revised Common Rule.  If your project fits the definition of Quality Improvement (QI), you will be instructed to complete Section 6 of the form that helps support your claim of QI.   

If your project does not fit any of these, the form will help you decide if your project meets the definition of research.  If your project is representative of research, the form will help you to decide if your research involves human subjects.   

If the completed form indicates that your project is human subjects research, you must submit the project as a New Study in the usual fashion, including submitting for OSF permission for OSF human  research and sharing with your Hospital/Site Administrator at other sites. 

If the completed form indicates your project is NOT research or is NOT human subjects research, you may submit the form and related documents into IRBNet as described above.  Following IRB review, the results will be communicated in a letter posted in IRBNet.   

PLEASE NOTE:  Submitting for a NR/NHSR Determination is NOT a federal requirement, but a written determination may be required by your program of study, institution, or by a journal prior to publication.  Similarly, completion of the four (4) CITI courses (Biomedical/Social Behavioral, Conflict of Interest, Good Clinical Practice and Responsible Conduct of Research) is NOT required by the Peoria IRB before submitting NR/NHSR projects, but may be required for your program of study or by your institution.