Guidance for undergraduate researchers and advisors

Undergraduate projects and theses pose unique issues and may or may not require IRB review. In particular, student-initiated and student-led projects and theses in the humanities and social sciences that are not intended for peer-reviewed journal publication may fall outside the federal defnition of "research" and thus not be subject to IRB review. It is the faculty advisor's responsibility to determine, in consultation with the student researcher, if this is the case for any given project. If further guidance is needed to make this determination, faculty advisors and student researchers are encouraged to contact RPO as early in the process as possible.

In order to determine whether a project qualifies as “research with human participants”, the faculty advisor and undergraduate researcher must consider the following:

Question #1       Is my project considered to be a research project? (Click the link for the definition of research)

If the answer to this question is NO, then it is not necessary to submit a human research protocol to the IRB. 

If the answer to this question is YES, then go on to question #2 below to determine whether your participants are considered to be human research participants for IRB purposes and whether you  need to submit a human research protocol to the IRB.

Question #2       Are the participants in my project considered to be human research participants? (Click the link for the definition of "human research participants")

If the answer to this question is NO, then it is not necessary to submit a human research protocol to the IRB. 

If the answer to this question is YES, then IRB review is necessary.

For the information you need to complete a human research protocol for submission to the IRB go to:             http://research.brown.edu/rschadmin/hrpo.php

It is only when a project meets the Federal definition of research that it crosses through the portal of the Brown University IRB’s purview.  Only then does the IRB start sorting those projects already within its purview into categories of “exempt” and “expedited” and “full review”. 

If a project does not meet the Federal definition, it is not submitted to RPO.  Neither the RPO staff nor the IRB decide whether a project meets the Federal definition of research. This determination is made by the faculty advisor who is the principal investigator of the project.  Once a faculty member has determined that a project does meet the Federal definition, it is submitted to RPO, which then decides to what review category a project is assigned.

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