IRB review is required for REGULATED non-exempt human subjects research.
Question 1 – Is this activity regulated?
Why you are seeking review?
If you are conducting regulated non-exempt human subject research, you have no choice; either IRB review or an exemption is required. Investigators of non-regulated studies often seek IRB review for other voluntary and involuntary reasons such as for journal publication, institutional policy and personal ethical principles.
Note: Investigators are sometimes asked to “get IRB review” when, in fact, it may be more appropriate to obtain an exemption or a determination that there is no human subject research. (If this happens to you and the person insists only approval will do, please call. Sometimes logic works and sometimes it is better to proceed with IRB review than fight.)
What are the sources of regulation?
When is review voluntary?
Please be aware the voluntary reviews are treated the same way as required reviews and investigators are expected to adhere to the same standards.
CONTINUE IF your project is regulated or if you wish voluntary review.
The Common Rule Graphic illustrates the agencies that have adopted it and gives the citation.
For purposes of the decision tree, we are using the regulations found at Title 45 of the Code of Federal Regulations, Part 46.102 http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html