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Submission Process

The PH IRB requires documented completion of the CITI “Protection of Human Research Subjects” training prior to submission, effective May 1, 2011. If you are unsure about the status of your training, contact the PH IRB Office at (260) 266-8196.

When conducting any research activities at Parkview Health involving human subjects and/or their data, the IRB must review and approve your submission before research can begin. 

There are three categories of IRB review:

  • Exempt review (very little risk)
  • Expedited review (minimal risk)
  • Full board review (greater than minimal risk) 

The IRB coordinator, in consultation with the investigator, will determine the category for review of each study.  For further guidance on the categories of review and submission requirements, please see the Policies and Procedures section, or contact the PH IRB office at (260) 266-8196. PH IRB submission forms are available to assist with this process.

Study documents may be submitted electronically to the IRB Office for assistance and pre-review.  Contact us at (260) 266-8196 for questions and assistance with submission material.

See the IRB Calendar for meeting dates and submission deadlines regarding the timing of submission and potential subsequent approval.

For studies that must be reviewed at a full board meeting, the principal investigator (PI) is required to attend and present the study. Next, the study submission will be reviewed and voted on. Researchers will receive a letter indicating the outcome of this process.

See the IRB submission flow chart for a visual of this process. 

IRB forms are available for initial study submission and reporting other activities through the course of research studies.

 

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