Human Subject Regulations

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 protocol. The table below lists the 11 different decision charts with a link directly to each one. To access the full DHHS website, please click here. If you need further guidance regarding level of review determination, please contact the Office of Research Compliance and Integrity at or 616-331-9137. 

Question that is addressed


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?

If yes, what exemption category applies to your project?







Chart 2 - Exempt Review


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?

If your application is related to a continuing research, is that one eligible for an expedited review by the IRB?


Chart 8 - Expedited Review


Chart 9 - Expedited Continuing Review

Informed Consent

Can informed consent be waived or consent elements be altered?

Can documentation of informed consent be waived?


Chart 10 - Waiving/Altering of informed consent

Chart 11 - Waiving of documentation of informed consent