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 Human Subjects Committee (HSC) does not normally include these projects under its operational definition of research. Rather, they are viewed as practicum resources of teaching.

 A. Student projects which meet the following criteria, will not  require review by the HSC.

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*
4. Which do not involve a vulnerable population (e.g. children, pregnant women, prisoners)
   

 B. Student research, including classroom and independent study projects, theses and dissertations, 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.

 C. Special populations including pregnant women, fetuses, prisoners, mentally disabled, economically or educationally disadvantaged or children 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 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 HSC review.
2. 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 HSC for its review and approval prior to initiating the research. Hard copies of the application packet are available from the HSC at 509 E. 3rd Street.  Contact the HSC office by e-mail or at 855-3067. The forms may also be downloaded from the WWW at http://www.research.indiana.edu/rschcomp/instruct.html.
3. If there is any doubt as to whether the project should be reviewed by the HSC, the Human Subjects Committee office is to be contacted for assistance. If the HSC office staff or the HSC believes that a particular project is subject to regular HSC review, the proposed project must receive HSC review.  
4. 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.
5. 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.
6. 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 as long as the research falls within the parameters described in the "umbrella" form. Any research not within the described parameters would require separate approval.

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 HSC 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 HSC 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.research.indiana.edu/rschcomp/instruct.html.  Like our other forms, it is available in three formats.  You have to choose the format first, then the form you want.

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 IUB 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, 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, and (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 Human Subjects Committee office at 855-3067 if you have any questions about these procedures.

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*Minimal Risk, defined by HHS policy for the Protection of Human Research Subjects at 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."