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Institutional Review Board (IRB): Guidelines

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, MSOE IRB is comprised of seven people: IRB Director, IRB Administrator, and five board members including one non-scientist and one community representative. MSOE University's Vice President of Academics serves as the Institutional Official for MSOE IRB.

IRB at MSOE Contact Information

General IRB Email: IRB@msoe.edu

IRB Administrator – Kristin Shebesta
Email: shebesta@msoe.edu
Phone: (414) 277-7256

 

MSOE IRB Jurisdiction

MSOE Institutional Review Board (MSOE IRB) has jurisdiction over

  • Human subject research activities conducted at MSOE
  • Human subject research activities conducted by MSOE employees or agents at any location
  • Human subject research activities that use MSOE resources
 

2018 IRB Changes

Changes in the Federal Policy for the Protection of Human Subjects (the Common Rule) are scheduled to take effect on January 21, 2019 with intent to better protect study participants, reduce administrative burden, and facilitate valuable research.

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 MSOE IRB will accept protocols via IRBNet for new research projects and continuing review submittals using the current Common Rule guidelines and MSOE IRB forms until January 4, 2019.

 

MSOE Grant Policies and Procedures

Please review the MSOE Grant Policies and Procedures webpage for additional information on seeking outside funding and sponsored research.

IRB Approval

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
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
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.