Indiana University

Student Projects

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As defined in the Common Rule Policy, "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 IRB does not normally include these projects under its operational definition of research. Rather, they are viewed as practicum resources of teaching.

 A. Examples of student projects that do not require review by the IUB IRB:

  • 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
  • Which do not involve physically or psychologically invasive, intrusive, or stressful procedures; and
  • Which do not have the potential for placing the subjects at more than minimal risk; and
  • Which do not involve a vulnerable population (e.g. children, adolescents, pregnant women, prisoners).

 B. Examples of student projects that do require review by the IUB IRB:

    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 IUB IRB review.


 

Procedures that are to be followed for all student research projects:

  • 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 review by the IUB IRB.

  • 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 for its review and approval prior to initiating the research.

  • If there is any doubt as to whether the project should be reviewed by the IRB, the IUB Human Subjects office should be contacted for assistance. If the Human Subjects office staff or the IRB believes that a particular project is subject to review by the IRB, the proposed project must be submitted for IRB review.  

  • In the event IRB review is not needed for a particular classroom project, the student 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 of informed consent when appropriate.

  • If there is reasonable expectation on the part of the instructor and the student that the project will be funded (regardless of source) and/or published, IRB approval must be obtained.

  • 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 IRB guidelines, IRB approval is required, the instructor shall complete one application 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 add the student as a co-investigator on his/her project for the stated purpose.

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. Also see the section titled What are my responsibilities? 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 IRB approval. While the Human Subjects office is able to offer assistance in how to complete the application, it cannot take the place of the sponsor.


Things to Remember: Prior to submission, you must have completed the following three required tasks:
     1. Complete the Research-Related Conflict of Interest Disclosure Form
     2. Provide agreements to participate in research
     3. Complete the required Human Subjects Protection Certification Test
                              
      *See the Pre Submission page for more details.
 

*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."