Does My Project Need IRB Review? [Undergraduate researchers and faculty advisors click here for important information] All “research” involving human participants must be reviewed and approved by the Institutional Review Board (IRB) prior to beginning the research. The charge of the IRB is to weigh risks and benefits of participation in research and to protect the rights and welfare of the research participants. The IRB purview is for only those activities defined as research with human participants. In order to determine whether your project qualifies as “research with human participants,” 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 member 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. |
Examples: Activities Likely to Be Defined as “Research" for IRB Purposes. (click link for examples) Activities Likely NOT to Be Defined as “Research” for IRB Purposes. (click link for examples)
Research Protections Office: Location: |