Use of Human Subjects in Research  

Case Study  

Blood Samples 

You need more information before you can decide how to proceed. The research that your colleague is asking you to do -- research analyses on previously collected human samples -- is considered research with human subjects.

Therefore you must decide, based on the information you get from your colleague, whether or not your research analysis of these blood samples requires regular Stanford IRB review and approval before you begin.

Even though you have no contact with the people who provided these blood samples, you still have a responsibility to respect the rights and safeguard the welfare of the human subjects and to make sure that your research activities are in keeping with the Stanford FWA.

Before you begin, submit your research protocol to the IRB for prospective review and approval. Depending on how you and your colleague proceed, the protocol may qualify for an Exempt Review. In particular, the IRB will want to know whether the samples contain any IDENTIFIERS (codes, initials, etc.) that could link them to an individual. If they do, then your project requires a regular IRB review.

Remember that the Investigator does not decide whether a project requires a regular or exempt review - only the IRB makes that determination.