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MSOE Institutional Review Board (MSOE IRB)

IRB Approval

The purpose of IRB oversight is to ensure adequacy of the research plan, to minimize risks, and to maximize benefits for human subjects who participate in research activities. If the investigator is a student, the research must be performed under supervision of an MSOE faculty or staff member who, by their signature, assumes responsibility for the conduct of the research with respect to proper safeguards of the rights of human subjects (participants).

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.

MSOE IRB approval is required before human subject research is 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 (participants) conducted for non-academic purposes, as well. Data collection by students or faculty/staff for assessment purposes only does not need MSOE IRB approval. Proposals for research projects conducted as classroom activities need to be submitted to the MSOE IRB if the intention is to share results of the project in a public forum or through publication. Class projects in which results will only be presented to students enrolled in the course and instructor(s) assigned to the course do not need IRB approval. It is the instructor’s responsibility to ensure that there are minimal risks for both the student researchers and their participants. If the instructor assumes that the project could lead to further presentation of results, either through publication or public forum, those projects will need to be reviewed by the IRB prior to the activity. Results of classroom activities cannot be presented outside of the classroom without IRB approval; retroactive IRB approval is never granted.

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.