Internal Review Board Resources
Embark Program IRB Application Process
- Project proposal is approved through the Embark Program.
- Institutional Review Board (IRB) application (or amendment) is prepared by the student and mentor collaboratively.
- All IRB applications can receive a pre-review by one of the Medical Education Directors via request in the Embark Program portal:
- Jean Szura, Ph.D. – Community-related projects; [email protected]
- Rose Wedemeyer, Ph.D. – Educational projects; [email protected]
- Tracy Wunderlich-Barillas, Ph.D. – Clinical projects; [email protected]
- IRB application (or amendment) is submitted to appropriate IRB.
Who should be the principal investigator (PI) on the Embark Program 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 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.
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.
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 (affiliate with William Beaumont Hospital) needs to be completed.
- You will need your Beaumont ID to log on to iMedRIS. This is the same login you use for HealthStream.
- For help with Beaumont ID, please contact: Dawn Burgess at [email protected]
- 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 (888) 481-2448. You will need to update your password once a year.
- Please view the instructions and example IRB applications on the OUWB Office of Research site. Please pay special attention to the required components for a Beaumont IRB submission (including HealthStream compliance modules, CVs, and a COI form). Students and mentors should work together to complete the IRB documents. For IRB/regulatory purposes, the mentor should be listed as the principal investigator (PI) on all IRB applications. This does not detract from the student’s leading role in the project as a co-investigator. Note, only Beaumont employees can serve as PI; fellows, residents, and OUWB faculty members cannot serve in this capacity.
- If your project will require funding through the Embark Program, please complete and submit a funding request in the Embark Portal-Oakland.caseware.com prior to submitting your IRB. Funds will not be distributed until IRB approval is granted.
- Once the IRB documents (including CITI training, COI, Compliance Training, and all application documents) are completed, you can request an OUWB IRB pre-review through the Embark Program portal.
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 is supported with Oakland University resources, you may still need to submit your study information through the Oakland University IRB for official "Non-human Subjects Research Determination"
For IRB applications to Oakland University, please access the OU Research Office resources here to obtain instructions and the necessary information to access online submission tool.
- Please know that only OU faculty can be listed as PI/Faculty advisor for OU IRB submissions. Beaumont faculty are ineligible at this time. If your mentor is a Beaumont employee, you will need to identify an OUWB/OU-based faculty to co-mentor.
- Once all IRB documents (including variables or data collection tools, recruitment materials including fliers and email/verbal scripts, and informed consent documents) are completed, you can request an OUWB IRB pre-review through the Embark Program.
- Statistical consults are available for study design and planning as well as data analysis assistance. Please see the OUWB Office of Research page for more information and a link to the consult request form.
- Please be aware that statistical consultation is needed by students across all years (M1-M4) who are at various points in their research projects. There may be a backlog of consultation requests depending on the time of year. Every effort is made to accommodate all requests.
- Go to MySail on Oakland's website and log in.
- In 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.
Once your IRB application is approved, you may proceed with data collection specifically as described in your approved protocol(s).
- For online surveys – please use Qualtrics
- Please see the OUWB Office of Research page for up to date information on Beaumont EPIC access.
- M1 and M2 students may request remote EPIC access which will be considered on a case-by-case basis.
Once your IRB application is approved, please use the approved mechanisms for data storage, as outlined in your approved IRB protocol(s).
- Beaumont IRBs - Sharepoint access: https://sp.beaumont.edu/madmin/medschool/SitePages/Home.aspx.
- Enter your username as “mswbh\username”
- Per the OU IT guidance, Google Drive is suitable for storage of identifiable information that is not sensitive or protected under FERPA (educational records) or HIPAA (medical records).
Any specific questions regarding data storage can be addressed during the optional IRB pre-review.