IUSB Institutional Review Board
for the Protection of Human Subjects

As defined in CFR Title 45, Part 46 (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 IUSB IRB does not normally include these projects under its operational definition of research. Rather, they are viewed as practicum resources of teaching.

1. Student projects which meet the following criteria, subject to paragraphs B and C below, will not  require review by the IUSB IRB.
    
1. Research practica (usually in the form of course-related research projects and/or directed studies), the objective of which is to provide research experience for the student; and
2. Which do not involve physically or psychologically invasive, intrusive, or stressful procedures; and
3. Which, in the judgment of the instructor, do not have the potential for placing the subjects at more than minimal risk.
2. Student research, including classroom and independent study projects, theses and dissertations, that may place the subjects at more than minimal risk is subject to IUSB IRB 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 pregnant women, fetuses, prisoners, mentally disabled, economically or educationally disadvantaged or minors are considered vulnerable research subjects, and projects involving such subjects are subject to IUSB IRB review.

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

1. Instructors are responsible for screening individual research projects and making the initial determination as to whether the project may fall in the category of research as explained above, thus requiring IUSB IRB review.
2. The student and instructor must complete the Student Research Checklist and submit it to the IRB before the project begins.
3. If an instructor determines that a research project is assigned for the purpose of producing generalizable knowledge, may involve greater than minimal risk, or involves a vulnerable population, the project must be submitted on the appropriate forms provided by the IUSB IRB for its review and approval prior to initiating the research. Hard copies of the application packet are available from the IUSB IRB in the Office of Research, Administration Building 247. Contact the IUSB IRB office by email at sbirb@iusb.edu or by phone at 574-520-4181. The forms may also be downloaded at http://www.iusb.edu/~sbirb/. 
4. If there is any doubt as to whether the project should be reviewed, the IUSB IRB office is to be contacted for assistance. If the IUSB IRB office staff or the IUSB IRB believes that a particular project is subject to regular review, the proposed project must receive IUSB IRB review.  
5. In the event IUSB IRB 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.
6. If there is reasonable expectation on the part of the instructor and the student that the study will be funded (regardless of source), presented, and/or published IUSB IRB approval must be obtained.
7. In instances where a class of students will be conducting a group project as a part of the classroom instruction, and the instructor believes that, under our guidelines, IUSB IRB approval is required, the instructor shall present for approval one form setting forth the parameters of the research being conducted by the students. Each student must pass the IRB Certification test and be listed in the protocol as a co-investigator.
8. When a student is working on a project that already has human subjects approval and is active with a current 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, master's degree, or dissertation, the original principal investigator must submit an amendment to the IUSB IRB requesting the student be added as a co-investigator on his/her project for the stated purpose. Any student working in this capacity on a dissertation must also submit a separate application to the IUSB IRB describing the project and the data to be used. The "Dissertation Form" that includes directions for this type of submission is available for downloading at http://www.iusb.edu/~sbirb/. 
9. 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 IUSB 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 appointment is at another campus, applications are now to be reviewed according to where the research is to take place, as well as according to where the student or sponsor is located. If a project will take place solely on another IU campus, the project must be reviewed on that campus. Please see the new policy for more details. Sponsorship is more than simply a signature, and carries two responsibilities: (1) supervision of the student's research, and (2) assistance in preparing the student's application for IUSB IRB approval. While the IRB is able to offer assistance in how to complete the application, it cannot take the place of the sponsor.

We recommend that empirical efforts in advanced research coursework be reviewed following regular IUSB IRB procedures (to permit possible publication and/or presentation off campus and to prepare the student for additional research training).

Please contact the IUSB IRB office at sbirb@iusb.edu  or 574-520-4181 if you have any questions about these procedures.