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Theses Involving Human Subjects Research & Institutional Review Board Approval

Students who intend to pursue research using human subjects must submit a written description of their proposal and obtain IRB approval of the proposal prior to commencing research and data collection.  For the purposes of the IRB, research is defined as "any systematic investigation designed to contribute to a body of generalized public knowledge." The use of human subjects refers to "data collection through interaction with individuals or the collection of identifiable private information about individuals." Activities that meet this definition of human subjects research should be submitted to the IRB for review following the procedures described in full here. 

The student and the thesis mentor need to sign the application before the IRB will accept it for review.  Students who are conducting thesis research while on study abroad and who have received study approval from the sponsoring institution do not need to reapply for approval from the Wesleyan IRB provided that the student completes the data collection while on study abroad. However, they need to submit the original approval letter issued by the sponsoring institution to the Wesleyan IRB. The IRB website provides detailed instructions on how to submit your application.  Several resources are also available on this site which include an on-line tutorial about ethical conduct in research and a sample consent form. Applications for projects involving minimal risk typically are reviewed within one week.  Applications for projects involving more than minimal risk or vulnerable populations typically require at least three weeks to review.  

Approval is typically granted for one year.  If during that time the student makes substantive changes to the study protocol, a "change of protocol" application needs to be submitted to the IRB prior to implementing the protocol changes.  For projects that continue past the initial approval period, a "continuation application" needs to be submitted.  The IRB does not review applications between December 20 and January 15 or between July 15 and August 15. 

Please note that this additional step is federally mandated and the IRB operates according to the Code of Federal Regulations (Title 45, Part 46) of the U.S. Department of Health and Human Services.  The purpose of these regulations is to ensure that investigators do not unduly put at risk or harm people who are the subjects of research, and that subjects are aware of their rights as defined by federal regulations.   

Students who have additional questions that cannot be answered by the information posted on the IRB website, should contact Lisa Sacks, in Academic Affairs at (860)685-3428 or at lsacks@wesleyan.edu.