Background: Engineering design projects in capstone courses are increasing in sophistication and real-world relevance every year. More complex projects with real customer needs require significantly more advanced testing for design verification and validation that often will involve human subjects. Projects that involve testing with human subjects often will require ethics evaluation, protocol approval, and continued oversight by an Institutional Review Board. When necessary, these legal procedures can require complex paperwork and lengthy reviews and thus can be seen as impediments to successful and timely completion of a capstone project. Therefore, students and faculty instructors need to be able to determine early and accurately when such IRB oversight is required for the design project. However, such determinations have not been easy to make. Consequently, both faculty and students might be hesitant to propose or initiate important and necessary testing protocols or even dissuaded from pursuing projects which might have such requirements.
Problem: Currently there is limited policy information specifically addressing human subjects testing in capstone engineering design courses. Most policies are regarding human subjects research (HSR) are not clear about when testing crosses the line into HSR that requires IRB approval.
Methods: This study involved a review of the literature concerning human subjects testing in engineering design projects and review of information from the diversity of university guidelines and literature regarding HSR in student courses and projects. The findings were used to clarify the ethical guidelines associated with research and testing with human subjects in capstone design courses. Additionally, they were used to propose a decision-making tool for determining if a design project will require IRB oversight based on early stage documents of the design proposal. The decision-making tool was then pilot tested with design documents and outcomes from several years of capstone design and refined.
Results: We present the results of evaluating this new decision-making tool using project design proposals (PDP) and final design history files (DHF) from several years of capstone design.
Next steps: Preliminary findings suggest that this decision tool could be used to determine at an early project stage whether IRB involvement is required and thus providing for a more efficient, effective, and ethical capstone design experience for students and faculty instructors. We discuss the limitations of the study as well as the need for future revisions of the tool to improve efficiency and effectiveness.
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