The IRB monitors compliance with federal and state laws, hospital policies and ethical principles outlined in the Belmont Report.
The following forms and templates are designed to assist the IRB with its review. If you have questions or are having trouble with any of the documents listed, please contact the Clinical Research Department at 616.252.5020.
Pre-Submission Tools & Templates
Electronic Submission System
IRBManager is the electronic submission system used by Metro Health- University of Michigan Health for research involving human subjects.
Please contact the IRB Office if you need assistance, have questions, or to request a consultation regarding IRBManager by calling 616-252-5026 or by emailing firstname.lastname@example.org.
All prospective investigators should note that all IRB submissions must be made through IRBManager. Paper submissions will not be accepted.
IRBManager is a web-based tool and can be accessed from any internet browser. It is available at https://metrohealth.my.irbmanager.com.
You will need a username and password to access the system for the first time. Your password should be kept confidential and not shared with anyone. See the IRBManager User Guide for instructions on how to set up an account or contact the office of the IRB as noted above.
IRBManager is Title 21 CFR Part 11 compliant.
Miscellaneous Forms and Documents
Decision Making Tools
The U.S. Department of Health & Human Services (DHHS) provides “Human Subject Regulations Decision Charts” to help researchers determine the proper level of review needed for their proposal. The following table lists the 11 decision charts with a link directly to each one.
|Is your activity considered research?||Chart 1 Research|
|Exemptions to IRB Review|
|Is your human subjects research eligible for an exempt review by the IRB?||Chart 2, Exempt|
|If yes, what exemption category applies to your project?|
|Chart 3, Educational Setting Exemption|
|Chart 4, Tests, Surveys, Interviews, Public Behavior Observation Exemption|
|Chart 5, Existing Data, Documents, Records and Specimens Exemption|
|Chart 6, Public Benefit or Service Programs Exemption|
|Chart 7, Food Taste and Acceptance Studies Exemption|
|Expedited Review by the IRB|
|If no exemption applies, is your human subjects research eligible for an expedited review by the IRB?||Chart 8, Expedited Review|
|If your application is related to a continuing research, is that one eligible for an expedited review by the IRB?||Chart 9, Expedited Continuing Review|
|Can informed consent be waived or consent elements be altered?||Chart 10, Waiving/Altering of informed consent|
|Can documents of informed consent be waived?||Chart 11, Waiving of documentation of informed consent|