MSOE Library Access during Safer at Home: The physical library space is closed until further notice. Online library resources will continue to be available and MSOE librarians will be providing remote support. For more information view the Virtual Library Guide.
Off-Campus Access Alert: You may encounter an error when accessing library databases with Google Chrome. If you encounter an error, please try clearing the browser's cache or try accessing the resource using another browser, such as Firefox or Internet Explorer. For more information view the Off-Campus Access Guide.
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.
MSOE Institutional Review Board (MSOE IRB) has jurisdiction over
Changes in the Federal Policy for the Protection of Human Subjects (the Common Rule) effective January 21, 2019 include the requirement of single IRB (sIRB) review for federally funded multi-site research slated to take effect January 20, 2020. The intent of sIRB review is to better protect study participants, reduce administrative burden, and facilitate valuable research. Provisions for certain exceptions to the requirements of sIRB review consider the number of sites and specific population needs.
These revisions are an effort to modernize, simplify, and enhance the current system of oversight. Full details are on the U.S. Department of Health & Human Services website.
Human subject researchers under MSOE jurisdiction should be aware that the MSOE IRB will continue to accept protocols via IRBNet for new research projects and continuing review submittals using the Revised Common Rule guidelines and MSOE IRB forms.
Please review the MSOE Grant Policies and Procedures webpage for additional information on seeking outside funding and sponsored research.
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.