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Student Research Policy

As defined in Title 45, Part 46 - Protection of Human Subjects (Department of Health and Human Services policy for Protection of Human Research Subjects), "research" is a "systematic investigation designed to develop or contribute to generalizable knowledge," and a "human subject" is "a living individual about whom an investigator (whether professional or student) conducting research obtains (1) data through intervention or interaction with the individual, or (2) identifiable private information." Since class work assignments are usually not intended to or likely to lead to generalizable results, the Human Subjects Committee (HSC) only reviews such assignments under particular circumstances as outlined below.

1. Student projects which meet the following criteria, will not  require review by the HSC.
   1. Projects that involve research practica (usually in the form of course related research projects and/or directed studies); and
   2. Projects that do not involve physically or psychologically invasive, intrusive, or stressful procedures; and
   3. Projects that, in the judgment of the instructor, do not have the potential for placing the subjects at more than minimal risk* do not require review by the HSC.
   4. Projects that do not involve a vulnerable population (e.g. children, pregnant women, prisoners).

   Items B and C describe circumstances which will require HSC review.

2. Student research, including classroom and independent study projects, theses, that may place the subjects at more than minimal risk is subject to HSC review. In clinical courses, subjects will be considered to be at greater than minimal risk if the procedures used and/or the questions asked do not fall under what is construed as being ordinary practice. When the student researcher is also an AI/GA for the course from which the subjects will be recruited, the same concerns apply as are stated in the section titled Students as Subjects. Consideration should be given to the research setting when assessing risk.
3. Special populations including minors, pregnant women, fetuses, prisoners, mentally disabled, economically or educationally disadvantaged are considered vulnerable research subjects and, projects involving such subjects are subject to HSC review.

The following procedures are to be followed for all student research projects:

1. Instructors, along with their student, are to apply for Non-Research Student Project approval by submitting the application to the HSC office located at Tamarack Hall F04.
2. If the HSC office determines that a project is assigned for the purpose of producing generalizable knowledge, or that it may involve greater than minimal risk, or if vulnerable populations are participating, the project must be submitted on the appropriate forms provided by the HSC for its review and approval prior to initiating the research. A copy of the application packet can be downloaded from this site in Microsoft Word format.
3. In the event HSC review is not needed for a particular classroom research project, the student researcher and the instructor are not relieved of the obligation for ethical use of human subjects. Consequently, the researchers should adhere to ethical standards and use informed consent when appropriate.
4. If there is reasonable expectation on the part of the instructor and the student that the study will be funded (regardless of source) and/or published, HSC approval must be obtained.
5. In instances where a class of students will be conducting group or individual research projects as a part of the classroom instruction, and the instructor believes that, under our guidelines, HSC approval is required, the instructor shall present for Committee approval one form setting forth the parameters of the research being conducted by the students. The instructor should describe the types of research to be undertaken by the students, the nature of the subjects to be used, and the kinds of procedures to be used in the research projects. This means that individual forms are not to be filled out by each student researcher. Any research not within the described parameters would require separate approval.
6. For projects occurring in the public school setting, documentation must be obtained reflecting the public school principal and/or designee's awareness and approval of the project activity.  This can be obtained using the Administration Permission Form.

When a student is working on a project that already has human subjects approval, and that student will use some of that data to fulfill a course or degree requirement, such as honor's thesis, first year project, or master's degree, the original principal investigator must submit an amendment to the HSC requesting the student be added as a co-investigator on his/her project for the stated purpose. Any student working in the same capacity but who wishes to use the data for his/her dissertation must submit a separate application to the HSC describing the project and the data to be used. In all other situations student initiated research must be submitted as an independent project, NOT as an amendment to an already approved protocol. All student projects must be sponsored by one or more full-time IUN faculty, librarian, salaried clinical rank, or research rank appointee. See the section titled "Researcher Responsibility" for the list of allowable sponsor ranks. If the sponsor's appointments at another campus, the review must take place on that campus.

Sponsorship is more than simply a signature, and carries two responsibilities:

1. Supervision of the student's research
2. Assistance in preparing the student's application for Human Subjects Committee approval.

While the Committee is able to offer assistance in how to complete the HSC application, it cannot take the place of the sponsor.

Please contact the office of the at (219) 981-5646, if you have any questions about these procedures.

*Minimal Risk, defined by HHS policy for the Protection of Human Research Subjects at Title 45, Part 46 (i)- Protection of Human Subjects -- check this -- 45 CFR 46.102i, means that "the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests."