Use of Human Subjects in Research  

Federalwide Assurance  
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The most frequently-conducted research activity by Stanford investigators that is EXEMPT is:

The study or collection of existing records or samples (e.g., pathological specimens, data) if these sources are publicly available or if the information is recorded by the investigator so that subjects cannot be identified directly or through identifiers linked to subjects.



An example is research analysis of stored human blood samples from which all identifiers have been completely removed.

In this hypothetical example of exempt research, the samples are "existing," (e.g., they are stored in a freezer), and there are no identifiers, therefore, subjects cannot be identified.

If you believe your research falls into one of the exempt categories, complete an Exempt Application [ online application is linked to Resources at the end of this tutorial, or available from the Research Compliance Office ] and send it to the IRB.

Do not begin research which you believe to be exempt until you receive written authorization from the IRB.



On the last several screens, you reviewed the steps you need to take if you think one of your research activities involving human subjects is EXEMPT from the requirement for regular IRB review and approval.

The next slides complete Question 3 of the decision tree by looking at what you need to do if you think the activity is NOT EXEMPT, i.e., your project requires a regular IRB review and approval.

 

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