Human Subjects Research and Course Projects

To: Deans, Directors, and Department Heads

From: Eva Pomerantz, Psychology Department, IRB Chair

Sue Keehn, IRB Director

Re: Human Subjects Research and Course Projects

This semester many faculty members will be assigning projects that involve human subjects research. The purpose of this memo is to clarify existing policies and to describe a new policy effecting students conducting human subjects research.

1. We have determined that human subjects research for purposes of a class assignment does not necessarily meet the federal definition of human subjects research and therefore does not need to go through the IRB approval process at the campus level. The key element in making this determination is that most student research does not contribute to “generalizable knowledge.” In other words, when an assignment is for a class only, and data and conclusions are not published or presented outside of the classroom the research does not lead to “generalizable knowledge”.

The policy is described below in detail and is also available on the IRB website at:

www.irb.uiuc.edu/regpol/Course_Assignments_and_IRB.pdf .

Please share this information with your faculty as appropriate. Contact the IRB Office with any questions.

2. Some faculty assign human subjects research projects that will not be covered under the policy described above. In cases where the assignment is essentially the same for each student, the faculty member may submit one IRB 1 form for review and approval that will serve as an umbrella approval for the entire class.

3. In the past we have noticed that some students submit their IRB 1 forms very late in the semester and they begin to run out of time to complete the research before the end of the semester. To help students plan appropriately, this semester we are announcing two special dates for student projects:

* Students who hope to begin their research in mid-October must submit by the September 16 deadline.

* Students who hope to begin their research in late November must submit by October 21. (All IRB meeting dates are listed on the IRB website at www.irb.uiuc.edu/bdcal.asp.)

We hope these policies will help the IRB review process run more smoothly for instructors and students this semester. We urge you to share this information with your faculty.

As always, please contact the IRB Office with any questions, concerns or clarifications.

Human Subjects Research and Course Projects

Learning how to conduct ethical research is an important part of a student’s educational experience. Ethical concerns are much greater when the research activities involve human subjects. At UIUC human subjects research protocols are reviewed and approved by the Institutional Review Board. However, some research projects assigned for coursework do not meet the definition of human subjects research and may not require IRB approval.

The purpose of this document is to clarify which course assignments do not require IRB review.

1. Course projects that DO NOT require IRB review and approval include:

A. Surveys, questionnaires, interviews, and public observations as long as:

* the survey/interview questions do NOT ask about any sensitive data (e.g., drug and alcohol use, sexual behavior or attitudes, emotional state of

mind, medical history, criminal background, academic standing, or other similar personal history that could be sensitive);

* the participants do not belong to any special population such as minors*, prisoners, cognitively impaired persons, pregnant women

or people who are unable to give fully informed consent;

* there is no way that the data collected could be linked back to the participant, or if it can, could reasonably place the subjects at risk of criminal

or civil liability or be damaging to the subjects'f inancialstanding, employability, or reputation.

B. Analysis of pre-existing anonymous data for which there is no identity key.

2. In addition, activities related to these projects may NOT involve:

* deception of any sort;

* audiotaping (unless the purpose of taping is only to transcribe field notes and the tape is destroyed immediately);

* videotaping;

* more than minimal risk to the subjects (meaning that the probability and magnitude of harm or discomfort are not greater than those ordinarily encountered in or during the performance of routine physical or psychological examinations or tests)

3. The data or data analysis from projects described above may NOT be presented outside of the classroom and may never be published in paper or electronic form. Such activities lead to generalizable knowledge and thus meet the federal definition of “human subjects research”.

It is important to keep in mind that any human subjects research activity that will ultimately contribute to part or all of a thesis, dissertation, or other type of publication or presentation must go through the IRB approval process. You may not present or publish data collected or conduct data analysis without IRB approval. There is no such thing as “retro-active” IRB approval.

In making a determination of whether or not a class research project requires IRB review, the instructor is encouraged to err on the side of caution and to contact the IRB office for assistance (irb@uiuc.edu <mailto:irb@uiuc.edu> or 333-2670).

The course instructor is responsible for communicating to the students the ethics of human subjects research, for ensuring the protection of human subjects and that a process is in place for obtaining voluntary informed consent from research subjects and for monitoring the students’ progress. Any questions should be directed to the IRB office.

UIUC policy and procedures, educational module, forms and related information can be found on the UIUC IRB website at: www.irb.uiuc.edu

* Minors (individuals under the age of 18) may be included in projects conducted in established or commonly accepted educational settings or involving normal educational practices such as research on instruction strategies, curricula or classroom management methods.

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