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IRB Forms & Templates

The Institutional Review Board (IRB) is charged with protecting the rights and welfare of participants in clinical trials and other human subjects research studies conducted at University of Michigan Health-West.

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 UM Health-West- 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

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

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.

The IRBManager User Guide will also familiarize you with navigating the electronic system as well as these FAQ’s.

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.

Research Activity
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
Informed Consent
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