Office of the Dean
O’Dowd Hall, Room 428
586 Pioneer Drive
Rochester, MI 48309-4482
(map)
(248) 370-3634

Office Hours:
Monday – Friday: 8:00 a.m. – 5:00 p.m.

IRB Resources

Embark Program IRB Application Process

  1. Project Proposal is approved through the Embark Program.
  2. IRB application (or amendment) is prepared by the student and mentor collaboratively.
  3. All IRB applications require a pre-review by one of the Medical Education Directors:
  4. IRB application (or amendment) is submitted to appropriate IRB.

Who should be PI on the capstone project IRB? For IRB/regulatory purposes, the mentor should be listed as the PI on all IRB applications. This does not detract from the student’s leading role in the project as a co-investigator.

CITI Training

CITI Training – Required for all Key Personnel on an IRB application

CITI Training Instructions

Please be aware you may be required to complete additional modules based on your research study role, and the specifics of the study. You only need to complete the modules for the institution to which you intend to submit your IRB application.

Beaumont IRB

Please submit to the Beaumont IRB for all Beaumont based human subjects research projects. If you think your project does not involve human subjects, but is still occurring at Beaumont or with Beaumont resources, you may still need to submit an IRB application for official Beaumont IRB excusal. Please contact the Medical Education Directors for assistance with this process.

For IRB applications to Beaumont, please use the following information and steps.

  • 1. To access the Beaumont IRB online submission system (iMedris:) Beaumont IRB
    • Students – for iMedris registration, please see details on your Moodle page
      • Before you will be able to register for iMedris, your CITI training needs to be completed
    • For help with Beaumont ID, please contact: Monica Demres, demres@beaumont.edu
    • Beaumont IRB (HIC) iMedris Password Help – If you are already registered, and need help with your password, please click on the link and go to password self service.  If this doesn't work, please call the Beaumont IT help desk at 248-597-2727.

  • 2. Please view the following instruction documents prior to completing your IRB application. Students and Mentors should work together to complete the IRB documents. For IRB/regulatory purposes, the mentor should be listed as the PI on all IRB applications. This does not detract from the student’s leading role in the project as a co-investigator.
  • 3. Complete the Beaumont Computer-based Training (required to submit to Beaumont IRB) 2/23/17 - currently unavailable - please see Moodle page for more information
    • Use your iMedRIS login and password
      • Modules to be completed are:
        • Research institute compliance plan
        • Corporate compliance
        • Information privacy and security
      • If you're unable to find a module, try searching the catalog, i.e., go to "CBT Catalog," search for "research" - the compliance module should appear - then click "add."
      • Once you've completed the modules, create a pdf of your transcript, ensuring that both your name as well as the completed modules are visible.

  • 4. All key personnel need to complete the online Beaumont Conflict of Interest (COI) form.
    • New researchers in need of submitting a COI-Smart Annual Research Questionnaire should contact Erin Kozlowski at (248) 551-8252 or erin.kozlowski@beaumont.org prior to attempting to login and activate an account in COI-Smart.

  • 5. If your project will require funding through the Embark Program, please complete and submit a Budget Request Form prior to submitting your IRB. Funds will not be distributed until IRB approval is granted.

  • 6. Once the IRB documents (including CITI training, COI, Compliance Training, and all application documents) are completed, please contact the OUWB Medical Education Directors for pre-review and further submission instructions.

Oakland IRB

Please submit to the Oakland University IRB for all Oakland University, and/or Community based human subjects research projects. If you think your project does not involve human subjects, but is still occurring at Oakland University or with Oakland University resources, you may still need to submit a Non Human Subjects Research Determination Form (Form #12) through the Oakland University IRB for official IRB excusal. Please contact the Medical Education Directors for assistance with this process.

For IRB applications to Oakland University please use the following information and steps.

Statistical Consultation

  • Please submit an appointment request with Ms. Michelle Jankowski with this form: OUWB Statistical Consultation Request Form.
  • Please use these guidelines in preparing your data for analysis. Please review these guidelines and apply the advice when cleaning up your data before you meet with Ms. Jankowski. This will assist you in having a more productive meeting the first time and hopefully will prevent back and forth delays due to data not being ready for analysis.
  • Please be aware that statistical consultation are needed by students across all years (M1-M4) who are at various points in their research projects. There is currently a backlog of consultation requests and we are making every effort to accommodate all requests. She will respond to you as quickly as possible with an estimated wait time.
Statistical Analysis Software
Students are eligible to download the Oakland University site license of SPSS. 
  • Go to MySail on Oakland's website and log in.
  • At the right column is a link to the OU Appstore. 
  • Install the Apporto agent that allows download of the software. 
  • Access to two versions of SPSS is available.

Data Collection

Once your IRB application is approved, you may proceed with Data Collection specifically as described in your approved protocol(s).

  • Once IRB approval has been obtained, please contact Monica Demres (monica.demres@beaumont.org) for access.  There are additional training and attestation forms that will need to be completed through her office prior to gaining access.
  • M1 and M2 students will not have remote access to EPIC.  M1 and M2 students will only be able to obtain access to EPIC while on a Beaumont campus and Beaumont computer. 

Data Storage

Once your IRB application is approved, please use the approved mechanisms for Data Storage, as outlined in your approved IRB protocol(s).

  • Oakland University IRBs – Oakshare access – contact Julie Strong, Embark Program Coordinator, strong@oakland.edu, to create your research project folder in OakShare
    • Once your folder is created, access your folder through files.oakland.edu
    • You will be prompted for your netID username and password to enter your secure folder