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Pre-Submission Information

Pre-Submission Information

The Spectrum Health IRB requires documented completion of the human subject research protection training prior to submission. If this is your first involvement with a research study being conducted at Spectrum Health and you have not completed the training, visit the research education page for further instruction. If you are unsure about the status of your training, contact the Spectrum Health IRB office at 616.486.2031.

Regardless of affiliation with Spectrum Health, when conducting any research activities at Spectrum Health involving human subjects and their data the Spectrum Health IRB must review and approve the research or verify exempt status before it can be initiated. This also applies when Spectrum Health has written agreement to serve as the IRB of record.

The first step in the submission process is assessing the project for category of review. There are three categories of IRB review.

  • Exempt status review (very little risk)
  • Expedited review (minimal risk)
  • Full board review (greater than minimal risk) 
If there are any questions about how your project fits into the category of review there is consultation available. Contact the Spectrum Health IRB office for additional guidance at 616.486.2031.

For further guidance on the categories of review and subsequent submission requirements, reference the Investigator Manual. All IRB submission forms are located at our IRB Forms page. If you have any questions about the materials to be submitted, contact the Spectrum Health IRB office at 616.486.2031 or email irbassist@spectrumhealth.org for assistance.

Once the study has been reviewed and voted on at the convened IRB meeting, a letter indicating the outcome will be provided.