Crossing the line: When does the involvement of human subjects in testing of engineering capstone design projects require oversight by an IRB?

摘要

Engineering design projects in undergraduate 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, especially for medically related devices. Currently there is limited policy information specifically addressing testing with human subjects in capstone engineering design courses, even in biomedical engineering. Most policies are regarding the more specific category of Human Subjects Research (HSR) and are not clear about when device testing in capstone courses crosses the line into HSR that would require Institutional Review Board (IRB) approval and oversight.