The Institutional Review Board (IRB) is an administrative body established to protect the rights and well-being of human subjects recruited to participate in research activities. MSOE complies with requirements set forth in Title 45, Part 46 of the code of Federal Regulations (45 CFR 46), known as the “Common Rule,” as well as Wisconsin State laws and MSOE policies.
In accordance with regulatory standards, the MSOE IRB is comprised of ten people: IRB Director, IRB Administrator, and eight board members including three non-scientists and one community representative. MSOE's Vice President of Academics serves as the Institutional Official for the MSOE IRB.
The purpose of the IRB is to ensure the adequacy of the research plan, to minimize risks, and to maximize the benefits for human subjects who participate in research. If the investigator is a student, the research must be performed under the supervision of an MSOE faculty or staff member who, by his or her signature, assumes responsibility for the conduct of the research with respect to the proper safeguards of the rights of human subjects.
All students, staff, and faculty at MSOE planning to conduct research involving human subjects must submit an IRB protocol application form for review by the IRB. They must obtain approval from the MSOE IRB before human subjects are recruited and research begins.
Research is defined (45 CFR 46.102(d)) as “a systematic investigation, including methodology, development, testing and evaluation, designed to develop or contribute to generalizable knowledge.” This definition includes formal investigations from which the results will be publicly disseminated, pilot projects, exploratory research, and educational research.
IRB Approval is required to do research undertaken by students for classroom work, independent study, senior design, nursing professional practice projects, surveys, master’s degree theses, or any purpose not specifically listed. This includes research with human subjects conducted for non-academic purposes, as well.
Human subjects are defined (45 CFR 46.102(f)) as “a living individual about whom an investigator conducting research obtains data through intervention or interaction with the individual or the collection of identifiable private information.”
Intervention includes both physical procedures by which data is gathered (blood pressure readings, exercising, equipment design, etc.) and manipulations of the subject or the subject’s environment (heat, light, temperature, etc.).
Interaction includes communication or interpersonal contact between the investigator and subject (interviews, focus groups, surveys, etc.). Private information includes academic, financial, medical, and other documents about behavior that occurs in a context in which the subject can reasonably expect that no recording is taking place, or information the subject has provided for a specific purpose that can reasonably expect will not be made public.