Please see below for information on using OneAegis for any human subject research protocols, request for amendments, continuing reviews, and/or development activities.
The purpose of the IRB 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 ethical 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 will submit an IRB protocol application packet for review by the IRB. Investigators must obtain approval from the MSOE IRB before human subject recruitment and research begins.
Research is defined (45 CFR 46.102(l)) as “a systematic investigation, including research 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 before 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.
Human subjects are defined (45 CFR 46.102(e)(1)) as “a living individual about whom an investigator (whether professional or student) conducting research: Obtains information or biospecimens through intervention or interaction with the individual, and uses, studies, or analyzes the information or biospecimens; or Obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens.” Human subjects give consent prior to and during their participation in the research project and may stop their involvement at any time without consequence.
Intervention, as defined (45 CFR 46.102(e)(2)), “includes both physical procedures by which information or biospecimens are gathered (e.g. venipuncture) and manipulations of the subject or the subject’s environment that are performed for research purposes.” Interaction, as defined (45 CFR 46.102(e)(3)), “includes communication or interpersonal contact between investigator and subject.” (e.g. interviews, focus groups, surveys, etc.).
Private information, as defined (45 CFR 46.102(e)(4)), includes academic, financial, medical, and other “information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place, and information that has been provided for specific purposes by an individual and that the individual can reasonably expect will not be made public (e.g. a medical record).”
Identifiable private information, as defined (45 CFR 46.102(e)(5)), “is private information for which the identity of the subject is or may readily be ascertained by the investigator or associated with the information.”
Identifiable biospecimen, as defined (45 CFR 46.102(e)(6)), “is a biospecimen for which the identity of the subject is or may readily be ascertained by the investigator or associated with the biospecimen.”